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A Trial Of CVX-060, An Anti-Angiogenic COVX-Body, In Combination With Sunitinib In Patients With Advanced Renal Cell Carcinoma

Sponsor
Pfizer (Industry)
Overall Status
Terminated
CT.gov ID
NCT00982657
Collaborator
(none)
34
Enrollment
7
Locations
6
Arms
53.9
Duration (Months)
4.9
Patients Per Site
0.1
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The safety and tolerability of CVX-060 have been established in the first-in-human clinical trial, CVX-060-101. Thus, this phase Ib/II trial is to assess the safety and pharmacokinetics (PK) profiles of combining CVX-060 with sunitinib in patients with advanced solid tumors, and to subsequently assess the treatment efficacy of the combination treatment, as well as that of sunitinib alone in patients with advanced renal cell carcinoma (mRCC).

Condition or Disease Intervention/Treatment Phase
  • Drug: CVX-060 + sunitinib
  • Drug: CVX-060 + sunitinib
  • Drug: CVX-060 + sunitinib
  • Drug: CVX-060 + sunitinib
  • Drug: CVX-060 + sunitinib
  • Drug: Sunitinib
 Phase 2

Detailed Description

On 23-Nov-2010, B1131001 (CVX-060-102) was closed to enrollment due to emerging clinical data which led to a re-assessment of the strategic goals of the PF-04856884 program. The study enrolled the Phase 1b portion only. Subsequently, on 25-Oct-2012, due to data safety signals in a separate clinical trial with PF-04856884 (CVX-060), all PF-04856884 studies were discontinued and ongoing patients on B1131001 were permitted to remain on study at a reduced PF-04856884 dose if determined to have been deriving clinical benefit.

Study Design

Study Type:
Interventional
Actual Enrollment :
34 participants
Allocation:
Non-Randomized
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
A Phase Ib/ii, Multicenter, Trial Of Cvx-060, A Selective Angiopoietin-2 (Ang-2) Binding, Anti-angiogenic Covx-body, In Combination With Sunitinib In Patients With Advanced Renal Cell Carcinoma
Study Start Date :
Sep 1, 2009
Actual Primary Completion Date :
Mar 1, 2014
Actual Study Completion Date :
Mar 1, 2014

Arms and Interventions

Arm Intervention/Treatment
Experimental: Cohort 1

CVX-060 + sunitinib

Drug: CVX-060 + sunitinib
CVX-060 weekly infusions at 6.0 mg/kg + 50 mg sunitinib daily (4 out of 6 weeks)
Other Names:
  • CVX-060 / Sutent

    		•
    Experimental: Cohort 2

    CVX-060 + sunitinib

    Drug: CVX-060 + sunitinib
    CVX-060 weekly infusions at 12.0 mg/kg + 50 mg sunitinib daily (4 out of 6 weeks)
    Other Names:
  • CVX-060 / Sutent

    		•
    Experimental: Cohort 3

    CVX-060 + sunitinib

    Drug: CVX-060 + sunitinib
    CVX-060 weekly infusions at 15.0 mg/kg + 50 mg sunitinib daily (4 out of 6 weeks)
    Other Names:
  • CVX-060 / Sutent

    		•
    Experimental: Expanded cohort

    CVX-060 + sunitinib

    Drug: CVX-060 + sunitinib
    CVX-060 weekly infusions at TBD mg/kg + 50 mg sunitinib daily (4 out of 6 weeks)
    Other Names:
  • CVX-060 / Sutent

    		•
    Experimental: Phase II - Arm A

    CVX-060 + sunitinib

    Drug: CVX-060 + sunitinib
    CVX-060 weekly infusions at TBD mg/kg + 50 mg sunitinib daily (4 out of 6 weeks)
    Other Names:
  • CVX-060 / Sutent

    		•
    Active Comparator: Phase II - Arm B

    sunitinib alone

    Drug: Sunitinib
    50 mg sunitinib daily (4 out of 6 weeks)
    Other Names:
  • Sutent

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Maximum Tolerated Dose (MTD) [Baseline up to Cycle 1( Day 1 to Day 42)]

      The MTD was defined as the dose level at which less than or equal to (<=) 1/6 participants experienced Dose Limiting Toxicity (DLT) during the first cycle of treatment with the next higher dose having >= 2/6 participants with DLT.

    2. Progression-free Survival (PFS) [Baseline tumor progression/clinical deterioration or death (up to 28 days post last dose of study medication)]

      PFS was defined as the time from the first dose date to the first documentation of disease progression or death due to any cause, whichever occurred first.

    Secondary Outcome Measures

    1. Pharmacokinetic Parameters of CVX-060 [Pre-dose on Day 1 Cycle 1 ; post-dose on Day 1, 5, 8, 15, 22, 29 Cycle 1 , Day 1 Cycle 2, to Cycle 28 , end of study (7 days post last dose of study medication), follow-up visit (28 days post last dose of study medication)]

      Pharmacokinetic parameters Area under the Curve (AUC), Maximum Observed Serum Concentration (Cmax), Minimum Observed Serum Trough Concentration (Cmin), Clearance (CL), terminal elimination half life (t1/2) were planned to be analyzed.

    2. Number of Participants With Dose-limiting Toxicities (DLT) [Baseline up to 28 days post last dose of study medication]

      DLT included grade 4 neutropenia of >= 3 day duration or with grade 4 neutropenia associated with fever; grade 4 thrombocytopenia for >= 3 consecutive days; Proteinuria of >=2 grams (g) per 24 hours; inability to resume to CVX-060 or sunitinib within 14 days of scheduled administration due to treatment related toxicity; any Grade 3 nonhematologic toxicity except nausea, vomiting, and diarrhea; Grade 3 nausea, vomiting, or diarrhea which persists for >=48 hours; Any >= Grade 4 non-hematologic toxicity; Any additional hematological or non-hematological toxicity for which dose reduction was required or for which patient was discontinued from the trial.

    3. Serum Angiopoietin-2 (Ang-2) and Plasma Vascular Endothelial Growth Factor (VEGF) Levels [Ang-2 (Day 1, 2, 5, 8, 22, 29 Cycle 1, Day 1 Cycle 2 up to Cycle 28); VEGF (Day 1, 8, 15, 22 Cycle 1, Day 1 Cycle 2 up to Cycle 28)]

    4. Number of Participants With Treatment Emergent Serious Adverse Events (SAEs) and Non-Serious Adverse Events (Non-SAEs) [Baseline up to 28 days post last dose of study medication]

      An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. An SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Treatment-emergent are events between first dose of study drug and up to 28 days after last dose that were absent before treatment or that worsened relative to pre treatment state.

    5. Percentage of Participants With Objective Response [Baseline up to 7 days post last dose of study medication]

      Percentage of participants with objective response based assessment of confirmed complete response (CR) or confirmed partial response (PR) according to Response Evaluation Criteria in Solid Tumors (RECIST). Confirmed responses are those that persist on repeat imaging study at least 4 weeks after initial documentation of response. Per RECIST v1.0: CR defined as disappearance of all target lesions and non-target lesions. PR defined as >= 30% decrease in sum of the longest diameters (LD) of the target lesions taking as a reference the baseline sum LD according to RECIST associated to non-progressive disease response for non target lesions.

    6. Duration of Response [Baseline up to 7 days post last dose of study medication]

      Duration of response is defined as the time from the first documentation of objective tumor response to the first documentation of objective tumor progression or death due to any cause, whichever occurs first. Participants last known to be progression free are censored at the date of the last objective disease assessment that verified lack of disease progression.

    7. Number of Participants With Anti- CVX-060 Antibodies [Baseline up to 28 days after last CVX-060 dose]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:

    • Histologically or cytologically confirmed advanced/metastatic solid tumor

    • Having received at least 1 prior systemic therapy for the treatment of advanced/metastatic solid tumors

    • Histologically or cytologically confirmed renal cell carcinoma with clear cell histology and evidence of metastasis (No previous systemic therapy for the treatment of metastatic renal cell carcinoma)

    • Adequate laboratory tests

    • Eastern Cooperative Oncology Group (ECOG) 0-1, Life expectancy > or = 12 weeks and age

    or = 18 years

    Exclusion Criteria:

    • Patients intolerant of prior anti-angiogenic agents

    • Recent history of bleeding or bleeding disorders

    • History of tumors in the brain

    • History of heart problems

    • History of severe allergic reaction to antibody therapy

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Premiere Oncology of Arizona Scottsdale Arizona United States 85258
    2 Premiere Oncology, A Medical Corporation Santa Monica California United States 90404
    3 Boston Baskin Cancer Foundation Southaven Mississippi United States 38671
    4 Providence Portland Medical Center Portland Oregon United States 97213
    5 Boston Baskin Cancer Foundation Bartlett Tennessee United States 38133
    6 Boston Baskin Cancer Foundation Germantown Tennessee United States 38138
    7 Boston Baskin Cancer Foundation Memphis Tennessee United States 38120

    Sponsors and Collaborators

    • Pfizer

    Investigators

    • Study Director: Pfizer CT.gov Call Center, Pfizer

    Study Documents (Full-Text)

    None provided.

    More Information

    Additional Information:

    Publications

    None provided.
    Responsible Party:
    Pfizer
    ClinicalTrials.gov Identifier:
    NCT00982657
    Other Study ID Numbers:
    • B1131001
    • CVX-060-102
    • 2010-022657-42
    First Posted:
    Sep 23, 2009
    Last Update Posted:
    Nov 20, 2015
    Last Verified:
    Oct 1, 2015
    Keywords provided by Pfizer
    Phase Ib Phase II Advanced solid tumor Clear cell renal cancer Sunitinib plus / minus CVX-060
    Additional relevant MeSH terms:
    Carcinoma, Renal Cell
    Sunitinib

    Study Results

    Participant Flow

    Recruitment Details
    Pre-assignment Detail The study was planned to be conducted in 2 phases, Phase 1b and Phase 2. On 23 Nov 2010, this study was closed to enrollment due to emerging clinical data which led to a re-assessment of strategic goals of the CVX-060 program. The study enrolled the Phase 1b portion only.
    Arm/Group Title CVX-060 6 mg/kg + Sunitinib 50 mg CVX-060 6 mg/kg + Sunitinib 37.5 mg CVX-060 12 mg/kg + Sunitinib 50 mg CVX-060 15 mg/kg + Sunitinib 50 mg
    Arm/Group Description CVX-060 6 milligram per kilogram (mg/kg) of body weight intravenous infusion administered once-weekly with oral 50 mg sunitinib capsule once daily up to 4 weeks followed by 2 weeks of off treatment (6-week cycle) until disease progression, unacceptable toxicity, withdrawal of consent or investigator's discretion. CVX-060 6 mg/kg of body weight intravenous infusion administered once-weekly with oral 37.5 mg sunitinib capsule once daily up to 4 weeks followed by 2 weeks off (6-week cycle) treatment until disease progression, unacceptable toxicity, withdrawal of consent or investigator's discretion. CVX-060 12 mg/kg of body weight intravenous infusion administered once-weekly with oral 50 mg sunitinib capsule once daily up to 4 weeks followed by 2 weeks off treatment (6-week cycle) until disease progression, unacceptable toxicity, withdrawal of consent or investigator's discretion. CVX-060 15 mg/kg of body weight intravenous infusion administered once-weekly with oral 50 mg sunitinib capsule once daily up to 4 weeks followed by 2 weeks off treatment (6-week cycle) until disease progression, unacceptable toxicity, withdrawal of consent or investigator's discretion.
    Period Title: Overall Study
    STARTED 12 3 3 16
    COMPLETED 11 3 1 7
    NOT COMPLETED 1 0 2 9

    Baseline Characteristics

    Arm/Group Title CVX-060 6 mg/kg + Sunitinib 50 mg CVX-060 6 mg/kg + Sunitinib 37.5 mg CVX-060 12 mg/kg + Sunitinib 50 mg CVX-060 15 mg/kg + Sunitinib 50 mg Total
    Arm/Group Description CVX-060 6 milligram per kilogram (mg/kg) of body weight intravenous infusion administered once-weekly with oral 50 mg sunitinib capsule once daily up to 4 weeks followed by 2 weeks of off treatment (6-week cycle) until disease progression, unacceptable toxicity, withdrawal of consent or investigator's discretion. CVX-060 6 mg/kg of body weight intravenous infusion administered once-weekly with oral 37.5 mg sunitinib capsule once daily up to 4 weeks followed by 2 weeks off (6-week cycle) treatment until disease progression, unacceptable toxicity, withdrawal of consent or investigator's discretion. CVX-060 12 mg/kg of body weight intravenous infusion administered once-weekly with oral 50 mg sunitinib capsule once daily up to 4 weeks followed by 2 weeks off treatment (6-week cycle) until disease progression, unacceptable toxicity, withdrawal of consent or investigator's discretion. CVX-060 15 mg/kg of body weight intravenous infusion administered once-weekly with oral 50 mg sunitinib capsule once daily up to 4 weeks followed by 2 weeks off treatment (6-week cycle) until disease progression, unacceptable toxicity, withdrawal of consent or investigator's discretion. Total of all reporting groups
    Overall Participants 12 3 3 16 34
    Age, Customized (Number) [Number]
    Less than (<) 18 years
    0
    (9.6) 0%
    0
    (8.5) 0%
    0
    (8.5) 0%
    0
    (13.7) 0%
    0
    0%
    18 to 44 years
    0
    0%
    0
    0%
    0
    0%
    2
    12.5%
    2
    5.9%
    45 to 64 years
    6
    50%
    2
    66.7%
    3
    100%
    9
    56.3%
    20
    58.8%
    Greater than or equal to (>=) 65 years
    6
    50%
    1
    33.3%
    0
    0%
    5
    31.3%
    12
    35.3%
    Sex: Female, Male (Count of Participants)
    Female
    6
    50%
    2
    66.7%
    2
    66.7%
    4
    25%
    14
    41.2%
    Male
    6
    50%
    1
    33.3%
    1
    33.3%
    12
    75%
    20
    58.8%

    Outcome Measures

    1. Primary Outcome
    Title Maximum Tolerated Dose (MTD)
    Description The MTD was defined as the dose level at which less than or equal to (<=) 1/6 participants experienced Dose Limiting Toxicity (DLT) during the first cycle of treatment with the next higher dose having >= 2/6 participants with DLT.
    Time Frame Baseline up to Cycle 1( Day 1 to Day 42)

    Outcome Measure Data

    Analysis Population Description
    The study was terminated during the Phase 1b phase by the sponsor prematurely. Due to the decision of not conducting the Phase II portion of the study, no MTD was assessed.
    Arm/Group Title All Participants
    Arm/Group Description All participants who received 6 mg/kg, 12mg/kg or 15 mg/kg of CVX-060 intravenous infusion along with oral 50 mg or 37.5 mg sunitinib capsule once daily up to 4 weeks followed by 2 weeks off treatment until disease progression, unacceptable toxicity, withdrawal of consent or investigator's discretion.
    Measure Participants 0
    2. Primary Outcome
    Title Progression-free Survival (PFS)
    Description PFS was defined as the time from the first dose date to the first documentation of disease progression or death due to any cause, whichever occurred first.
    Time Frame Baseline tumor progression/clinical deterioration or death (up to 28 days post last dose of study medication)

    Outcome Measure Data

    Analysis Population Description
    The study was terminated during the Phase 1b phase by the sponsor prematurely. Due to the decision of not conducting the Phase II portion of the study.The PFS endpoint was a pre-specified endpoint for the Phase II portion of the study, and was therefore not assessed.
    Arm/Group Title CVX-060 6 mg/kg + Sunitinib 50 mg CVX-060 6 mg/kg + Sunitinib 37.5 mg CVX-060 12 mg/kg + Sunitinib 50 mg CVX-060 15 mg/kg + Sunitinib 50 mg
    Arm/Group Description CVX-060 6 milligram per kilogram (mg/kg) of body weight intravenous infusion administered once-weekly with oral 50 mg sunitinib capsule once daily up to 4 weeks followed by 2 weeks of off treatment (6-week cycle) until disease progression, unacceptable toxicity, withdrawal of consent or investigator's discretion. CVX-060 6 mg/kg of body weight intravenous infusion administered once-weekly with oral 37.5 mg sunitinib capsule once daily up to 4 weeks followed by 2 weeks off (6-week cycle) treatment until disease progression, unacceptable toxicity, withdrawal of consent or investigator's discretion. CVX-060 12 mg/kg of body weight intravenous infusion administered once-weekly with oral 50 mg sunitinib capsule once daily up to 4 weeks followed by 2 weeks off treatment (6-week cycle) until disease progression, unacceptable toxicity, withdrawal of consent or investigator's discretion. CVX-060 15 mg/kg of body weight intravenous infusion administered once-weekly with oral 50 mg sunitinib capsule once daily up to 4 weeks followed by 2 weeks off treatment (6-week cycle) until disease progression, unacceptable toxicity, withdrawal of consent or investigator's discretion.
    Measure Participants 0 0 0 0
    3. Secondary Outcome
    Title Pharmacokinetic Parameters of CVX-060
    Description Pharmacokinetic parameters Area under the Curve (AUC), Maximum Observed Serum Concentration (Cmax), Minimum Observed Serum Trough Concentration (Cmin), Clearance (CL), terminal elimination half life (t1/2) were planned to be analyzed.
    Time Frame Pre-dose on Day 1 Cycle 1 ; post-dose on Day 1, 5, 8, 15, 22, 29 Cycle 1 , Day 1 Cycle 2, to Cycle 28 , end of study (7 days post last dose of study medication), follow-up visit (28 days post last dose of study medication)

    Outcome Measure Data

    Analysis Population Description
    The study was terminated during the Phase 1b phase by the sponsor prematurely. Due to the decision of not conducting the phase II portion of the study,pharmacokinetics assessment was not conducted.
    Arm/Group Title CVX-060 6 mg/kg + Sunitinib 50 mg CVX-060 6 mg/kg + Sunitinib 37.5 mg CVX-060 12 mg/kg + Sunitinib 50 mg CVX-060 15 mg/kg + Sunitinib 50 mg
    Arm/Group Description CVX-060 6 milligram per kilogram (mg/kg) of body weight intravenous infusion administered once-weekly with oral 50 mg sunitinib capsule once daily up to 4 weeks followed by 2 weeks of off treatment (6-week cycle) until disease progression, unacceptable toxicity, withdrawal of consent or investigator's discretion. CVX-060 6 mg/kg of body weight intravenous infusion administered once-weekly with oral 37.5 mg sunitinib capsule once daily up to 4 weeks followed by 2 weeks off (6-week cycle) treatment until disease progression, unacceptable toxicity, withdrawal of consent or investigator's discretion. CVX-060 12 mg/kg of body weight intravenous infusion administered once-weekly with oral 50 mg sunitinib capsule once daily up to 4 weeks followed by 2 weeks off treatment (6-week cycle) until disease progression, unacceptable toxicity, withdrawal of consent or investigator's discretion. CVX-060 15 mg/kg of body weight intravenous infusion administered once-weekly with oral 50 mg sunitinib capsule once daily up to 4 weeks followed by 2 weeks off treatment (6-week cycle) until disease progression, unacceptable toxicity, withdrawal of consent or investigator's discretion.
    Measure Participants 0 0 0 0
    4. Secondary Outcome
    Title Number of Participants With Dose-limiting Toxicities (DLT)
    Description DLT included grade 4 neutropenia of >= 3 day duration or with grade 4 neutropenia associated with fever; grade 4 thrombocytopenia for >= 3 consecutive days; Proteinuria of >=2 grams (g) per 24 hours; inability to resume to CVX-060 or sunitinib within 14 days of scheduled administration due to treatment related toxicity; any Grade 3 nonhematologic toxicity except nausea, vomiting, and diarrhea; Grade 3 nausea, vomiting, or diarrhea which persists for >=48 hours; Any >= Grade 4 non-hematologic toxicity; Any additional hematological or non-hematological toxicity for which dose reduction was required or for which patient was discontinued from the trial.
    Time Frame Baseline up to 28 days post last dose of study medication

    Outcome Measure Data

    Analysis Population Description
    Safety Analysis set consisted of all participants who received at least 1 dose of study medication.
    Arm/Group Title CVX-060 6 mg/kg + Sunitinib 50 mg CVX-060 6 mg/kg + Sunitinib 37.5 mg CVX-060 12 mg/kg + Sunitinib 50 mg CVX-060 15 mg/kg + Sunitinib 50 mg
    Arm/Group Description CVX-060 6 milligram per kilogram (mg/kg) of body weight intravenous infusion administered once-weekly with oral 50 mg sunitinib capsule once daily up to 4 weeks followed by 2 weeks of off treatment (6-week cycle) until disease progression, unacceptable toxicity, withdrawal of consent or investigator's discretion. CVX-060 6 mg/kg of body weight intravenous infusion administered once-weekly with oral 37.5 mg sunitinib capsule once daily up to 4 weeks followed by 2 weeks off (6-week cycle) treatment until disease progression, unacceptable toxicity, withdrawal of consent or investigator's discretion. CVX-060 12 mg/kg of body weight intravenous infusion administered once-weekly with oral 50 mg sunitinib capsule once daily up to 4 weeks followed by 2 weeks off treatment (6-week cycle) until disease progression, unacceptable toxicity, withdrawal of consent or investigator's discretion. CVX-060 15 mg/kg of body weight intravenous infusion administered once-weekly with oral 50 mg sunitinib capsule once daily up to 4 weeks followed by 2 weeks off treatment (6-week cycle) until disease progression, unacceptable toxicity, withdrawal of consent or investigator's discretion.
    Measure Participants 12 3 3 16
    Number [participants]
    2
    16.7%
    1
    33.3%
    0
    0%
    2
    12.5%
    5. Secondary Outcome
    Title Serum Angiopoietin-2 (Ang-2) and Plasma Vascular Endothelial Growth Factor (VEGF) Levels
    Description
    Time Frame Ang-2 (Day 1, 2, 5, 8, 22, 29 Cycle 1, Day 1 Cycle 2 up to Cycle 28); VEGF (Day 1, 8, 15, 22 Cycle 1, Day 1 Cycle 2 up to Cycle 28)

    Outcome Measure Data

    Analysis Population Description
    The study was terminated during the Phase 1b phase by the sponsor prematurely. Due to the decision of not conducting the phase II portion of the study, pharmacodynamics assessment was not conducted.
    Arm/Group Title CVX-060 6 mg/kg + Sunitinib 50 mg CVX-060 6 mg/kg + Sunitinib 37.5 mg CVX-060 12 mg/kg + Sunitinib 50 mg CVX-060 15 mg/kg + Sunitinib 50 mg
    Arm/Group Description CVX-060 6 milligram per kilogram (mg/kg) of body weight intravenous infusion administered once-weekly with oral 50 mg sunitinib capsule once daily up to 4 weeks followed by 2 weeks off treatment (6-week cycle) until disease progression, unacceptable toxicity, withdrawal of consent or investigator's discretion. CVX-060 6 mg/kg of body weight intravenous infusion administered once-weekly with oral 37.5 mg sunitinib capsule once daily up to 4 weeks followed by 2 weeks off treatment (6-week cycle) until disease progression, unacceptable toxicity ,withdrawal of consent or investigator's discretion. CVX-060 12 mg/kg of body weight intravenous infusion administered once-weekly with oral 50 mg sunitinib capsule once daily up to 4 weeks followed by 2 weeks off treatment (6-week cycle) until disease progression, unacceptable toxicity ,withdrawal of consent or investigator's discretion. CVX-060 15 mg/kg of body weight intravenous infusion administered once-weekly with oral 50 mg sunitinib capsule once daily up to 4 weeks followed by 2 weeks off treatment (6-week cycle) until disease progression, unacceptable toxicity ,withdrawal of consent or investigator's discretion.
    Measure Participants 0 0 0 0
    6. Secondary Outcome
    Title Number of Participants With Treatment Emergent Serious Adverse Events (SAEs) and Non-Serious Adverse Events (Non-SAEs)
    Description An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. An SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Treatment-emergent are events between first dose of study drug and up to 28 days after last dose that were absent before treatment or that worsened relative to pre treatment state.
    Time Frame Baseline up to 28 days post last dose of study medication

    Outcome Measure Data

    Analysis Population Description
    Safety Analysis set consisted of all participants who received at least 1 dose of study medication.
    Arm/Group Title CVX-060 6 mg/kg + Sunitinib 50 mg CVX-060 6 mg/kg + Sunitinib 37.5 mg CVX-060 12 mg/kg + Sunitinib 50 mg CVX-060 15 mg/kg + Sunitinib 50 mg
    Arm/Group Description CVX-060 6 milligram per kilogram (mg/kg) of body weight intravenous infusion administered once-weekly with oral 50 mg sunitinib capsule once daily up to 4 weeks followed by 2 weeks off treatment (6-week cycle) until disease progression, unacceptable toxicity, withdrawal of consent or investigator's discretion. CVX-060 6 mg/kg of body weight intravenous infusion administered once-weekly with oral 37.5 mg sunitinib capsule once daily up to 4 weeks followed by 2 weeks off treatment (6-week cycle) until disease progression, unacceptable toxicity, withdrawal of consent occurred or investigator's discretion. CVX-060 12 mg/kg of body weight intravenous infusion administered once-weekly with oral 50 mg sunitinib capsule once daily up to 4 weeks followed by 2 weeks off treatment (6-week cycle) until disease progression, unacceptable toxicity, withdrawal of consent or investigator's discretion. CVX-060 15 mg/kg of body weight intravenous infusion administered once-weekly with oral 50 mg sunitinib capsule once daily up to 4 weeks followed by 2 weeks off treatment (6-week cycle) until disease progression, unacceptable toxicity, withdrawal of consent or investigator's discretion.
    Measure Participants 12 3 3 16
    SAEs
    4
    33.3%
    0
    0%
    1
    33.3%
    8
    50%
    non-SAEs
    12
    100%
    3
    100%
    3
    100%
    16
    100%
    7. Secondary Outcome
    Title Percentage of Participants With Objective Response
    Description Percentage of participants with objective response based assessment of confirmed complete response (CR) or confirmed partial response (PR) according to Response Evaluation Criteria in Solid Tumors (RECIST). Confirmed responses are those that persist on repeat imaging study at least 4 weeks after initial documentation of response. Per RECIST v1.0: CR defined as disappearance of all target lesions and non-target lesions. PR defined as >= 30% decrease in sum of the longest diameters (LD) of the target lesions taking as a reference the baseline sum LD according to RECIST associated to non-progressive disease response for non target lesions.
    Time Frame Baseline up to 7 days post last dose of study medication

    Outcome Measure Data

    Analysis Population Description
    Safety Analysis set consisted of all participants who received at least 1 dose of study medication. Here 'N' (number of participants analyzed) signifies those participants who were evaluable for this outcome measure.
    Arm/Group Title CVX-060 6 mg/kg + Sunitinib 50 mg CVX-060 6 mg/kg + Sunitinib 37.5 mg CVX-060 12 mg/kg + Sunitinib 50 mg CVX-060 15 mg/kg + Sunitinib 50 mg
    Arm/Group Description CVX-060 6 milligram per kilogram (mg/kg) of body weight intravenous infusion administered once-weekly with oral 50 mg sunitinib capsule once daily up to 4 weeks followed by 2 weeks off treatment (6 week cycle) until disease progression, unacceptable toxicity, withdrawal of consent or investigator's discretion. CVX-060 6 mg/kg of body weight intravenous infusion administered once-weekly with oral 37.5 mg sunitinib capsule once daily up to 4 weeks followed by 2 weeks off treatment (6 week cycle) until disease progression, unacceptable toxicity, withdrawal of consent or investigator's discretion. CVX-060 12 mg/kg of body weight intravenous infusion administered once-weekly with oral 50 mg sunitinib capsule once daily up to 4 weeks followed by 2 weeks off treatment (6 week cycle) until disease progression, unacceptable toxicity, withdrawal of consent or investigator's discretion. CVX-060 15 mg/kg of body weight intravenous infusion administered once-weekly with oral 50 mg sunitinib capsule once daily up to 4 weeks followed by 2 weeks off treatment (6 week cycle) until disease progression, unacceptable toxicity, withdrawal of consent or investigator's discretion.
    Measure Participants 12 3 3 12
    Number (95% Confidence Interval) [Percentage of participants]
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    8. Secondary Outcome
    Title Duration of Response
    Description Duration of response is defined as the time from the first documentation of objective tumor response to the first documentation of objective tumor progression or death due to any cause, whichever occurs first. Participants last known to be progression free are censored at the date of the last objective disease assessment that verified lack of disease progression.
    Time Frame Baseline up to 7 days post last dose of study medication

    Outcome Measure Data

    Analysis Population Description
    Duration of response was not calculated as there were no participants with objective response.
    Arm/Group Title CVX-060 6 mg/kg + Sunitinib 50 mg CVX-060 6 mg/kg + Sunitinib 37.5 mg CVX-060 12 mg/kg + Sunitinib 50 mg CVX-060 15 mg/kg + Sunitinib 50 mg
    Arm/Group Description CVX-060 6 milligram per kilogram (mg/kg) of body weight intravenous infusion administered once-weekly with oral 50 mg sunitinib capsule once daily up to 4 weeks followed by 2 weeks off treatment (6 week cycle) until disease progression, unacceptable toxicity, withdrawal of consent or investigator's discretion. CVX-060 6 mg/kg of body weight intravenous infusion administered once-weekly with oral 37.5 mg sunitinib capsule once daily up to 4 weeks followed by 2 weeks off treatment (6 week cycle) until disease progression, unacceptable toxicity, withdrawal of consent or investigator's discretion. CVX-060 12 mg/kg of body weight intravenous infusion administered once-weekly with oral 50 mg sunitinib capsule once daily up to 4 weeks followed by 2 weeks off treatment (6 week cycle) until disease progression, unacceptable toxicity, withdrawal of consent or investigator's discretion. CVX-060 15 mg/kg of body weight intravenous infusion administered once-weekly with oral 50 mg sunitinib capsule once daily up to 4 weeks followed by 2 weeks off treatment (6 week cycle) until disease progression, unacceptable toxicity, withdrawal of consent or investigator's discretion.
    Measure Participants 0 0 0 0
    9. Secondary Outcome
    Title Number of Participants With Anti- CVX-060 Antibodies
    Description
    Time Frame Baseline up to 28 days after last CVX-060 dose

    Outcome Measure Data

    Analysis Population Description
    The study was terminated during the Phase 1b phase by the sponsor prematurely. Due to the decision of not conducting the phase II portion of the study, no Anti-CVX-060 antibody assessment was conducted.
    Arm/Group Title CVX-060 6 mg/kg + Sunitinib 50 mg CVX-060 6 mg/kg + Sunitinib 37.5 mg CVX-060 12 mg/kg + Sunitinib 50 mg CVX-060 15 mg/kg + Sunitinib 50 mg
    Arm/Group Description CVX-060 6 milligram per kilogram (mg/kg) of body weight intravenous infusion administered once-weekly with oral 50 mg sunitinib capsule once daily up to 4 weeks followed by 2 weeks off treatment (6 week cycle) until disease progression, unacceptable toxicity, withdrawal of consent or investigator's discretion. CVX-060 6 mg/kg of body weight intravenous infusion administered once-weekly with oral 37.5 mg sunitinib capsule once daily up to 4 weeks followed by 2 weeks off treatment (6 week cycle) until disease progression, unacceptable toxicity, withdrawal of consent or investigator's discretion. CVX-060 12 mg/kg of body weight intravenous infusion administered once-weekly with oral 50 mg sunitinib capsule once daily up to 4 weeks followed by 2 weeks off treatment (6 week cycle) until disease progression, unacceptable toxicity, withdrawal of consent or investigator's discretion. CVX-060 15 mg/kg of body weight intravenous infusion administered once-weekly with oral 50 mg sunitinib capsule once daily up to 4 weeks followed by 2 weeks off treatment (6 week cycle) until disease progression, unacceptable toxicity, withdrawal of consent or investigator's discretion.
    Measure Participants 0 0 0 0

    Adverse Events

    Time Frame
    Adverse Event Reporting Description The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
    Arm/Group Title CVX-060 6 mg/kg + Sunitinib 50 mg CVX-060 6 mg/kg + Sunitinib 37.5 mg CVX-060 12 mg/kg + Sunitinib 50 mg CVX-060 15 mg/kg + Sunitinib 50 mg
    Arm/Group Description CVX-060 6 milligram per kilogram (mg/kg) of body weight intravenous infusion administered once-weekly with oral 50 mg sunitinib capsule once daily up to 4 weeks followed by 2 weeks of off treatment (6-week cycle) until disease progression, unacceptable toxicity, withdrawal of consent or investigator's discretion. CVX-060 6 mg/kg of body weight intravenous infusion administered once-weekly with oral 37.5 mg sunitinib capsule once daily up to 4 weeks followed by 2 weeks off (6-week cycle) treatment until disease progression, unacceptable toxicity, withdrawal of consent or investigator's discretion. CVX-060 12 mg/kg of body weight intravenous infusion administered once-weekly with oral 50 mg sunitinib capsule once daily up to 4 weeks followed by 2 weeks off treatment (6-week cycle) until disease progression, unacceptable toxicity, withdrawal of consent or investigator's discretion. CVX-060 15 mg/kg of body weight intravenous infusion administered once-weekly with oral 50 mg sunitinib capsule once daily up to 4 weeks followed by 2 weeks off treatment (6-week cycle) until disease progression, unacceptable toxicity, withdrawal of consent or investigator's discretion.
    All Cause Mortality
    CVX-060 6 mg/kg + Sunitinib 50 mg CVX-060 6 mg/kg + Sunitinib 37.5 mg CVX-060 12 mg/kg + Sunitinib 50 mg CVX-060 15 mg/kg + Sunitinib 50 mg
    Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
    Total / (NaN) / (NaN) / (NaN) / (NaN)
    Serious Adverse Events
    CVX-060 6 mg/kg + Sunitinib 50 mg CVX-060 6 mg/kg + Sunitinib 37.5 mg CVX-060 12 mg/kg + Sunitinib 50 mg CVX-060 15 mg/kg + Sunitinib 50 mg
    Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
    Total 4/12 (33.3%) 0/3 (0%) 1/3 (33.3%) 8/16 (50%)
    Blood and lymphatic system disorders
    Thrombotic thrombocytopenic purpura 1/12 (8.3%) 0/3 (0%) 0/3 (0%) 0/16 (0%)
    Cardiac disorders
    Cardio-respiratory arrest 0/12 (0%) 0/3 (0%) 1/3 (33.3%) 0/16 (0%)
    Gastrointestinal disorders
    Abdominal pain 0/12 (0%) 0/3 (0%) 0/3 (0%) 3/16 (18.8%)
    Abdominal pain lower 1/12 (8.3%) 0/3 (0%) 0/3 (0%) 0/16 (0%)
    Colitis ischaemic 0/12 (0%) 0/3 (0%) 0/3 (0%) 1/16 (6.3%)
    Diarrhoea 0/12 (0%) 0/3 (0%) 0/3 (0%) 1/16 (6.3%)
    Gastrointestinal haemorrhage 0/12 (0%) 0/3 (0%) 0/3 (0%) 1/16 (6.3%)
    Ileal perforation 0/12 (0%) 0/3 (0%) 0/3 (0%) 1/16 (6.3%)
    General disorders
    Disease progression 0/12 (0%) 0/3 (0%) 1/3 (33.3%) 0/16 (0%)
    Generalised oedema 0/12 (0%) 0/3 (0%) 1/3 (33.3%) 0/16 (0%)
    Pyrexia 0/12 (0%) 0/3 (0%) 0/3 (0%) 1/16 (6.3%)
    Infections and infestations
    Bacteraemia 0/12 (0%) 0/3 (0%) 1/3 (33.3%) 0/16 (0%)
    Herpes oesophagitis 0/12 (0%) 0/3 (0%) 0/3 (0%) 1/16 (6.3%)
    Metabolism and nutrition disorders
    Failure to thrive 0/12 (0%) 0/3 (0%) 0/3 (0%) 1/16 (6.3%)
    Nervous system disorders
    Dizziness 0/12 (0%) 0/3 (0%) 0/3 (0%) 1/16 (6.3%)
    Grand mal convulsion 0/12 (0%) 0/3 (0%) 0/3 (0%) 1/16 (6.3%)
    Ischaemic stroke 0/12 (0%) 0/3 (0%) 0/3 (0%) 1/16 (6.3%)
    Respiratory, thoracic and mediastinal disorders
    Dyspnoea 0/12 (0%) 0/3 (0%) 0/3 (0%) 1/16 (6.3%)
    Productive cough 0/12 (0%) 0/3 (0%) 0/3 (0%) 1/16 (6.3%)
    Respiratory failure 1/12 (8.3%) 0/3 (0%) 0/3 (0%) 0/16 (0%)
    Vascular disorders
    Haemorrhage 1/12 (8.3%) 0/3 (0%) 0/3 (0%) 0/16 (0%)
    Other (Not Including Serious) Adverse Events
    CVX-060 6 mg/kg + Sunitinib 50 mg CVX-060 6 mg/kg + Sunitinib 37.5 mg CVX-060 12 mg/kg + Sunitinib 50 mg CVX-060 15 mg/kg + Sunitinib 50 mg
    Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
    Total 12/12 (100%) 3/3 (100%) 3/3 (100%) 16/16 (100%)
    Blood and lymphatic system disorders
    Anaemia 0/12 (0%) 0/3 (0%) 0/3 (0%) 1/16 (6.3%)
    Leukopenia 0/12 (0%) 0/3 (0%) 0/3 (0%) 1/16 (6.3%)
    Lymphopenia 1/12 (8.3%) 0/3 (0%) 0/3 (0%) 1/16 (6.3%)
    Neutropenia 2/12 (16.7%) 0/3 (0%) 0/3 (0%) 4/16 (25%)
    Thrombocytopenia 4/12 (33.3%) 1/3 (33.3%) 0/3 (0%) 4/16 (25%)
    Cardiac disorders
    Palpitations 0/12 (0%) 0/3 (0%) 0/3 (0%) 1/16 (6.3%)
    Ear and labyrinth disorders
    Ear discomfort 0/12 (0%) 0/3 (0%) 0/3 (0%) 1/16 (6.3%)
    Ear pain 1/12 (8.3%) 0/3 (0%) 0/3 (0%) 1/16 (6.3%)
    Tinnitus 0/12 (0%) 1/3 (33.3%) 1/3 (33.3%) 0/16 (0%)
    Endocrine disorders
    Hyperthyroidism 0/12 (0%) 0/3 (0%) 0/3 (0%) 1/16 (6.3%)
    Hypogonadism 0/12 (0%) 0/3 (0%) 0/3 (0%) 1/16 (6.3%)
    Hypothyroidism 2/12 (16.7%) 1/3 (33.3%) 2/3 (66.7%) 4/16 (25%)
    Eye disorders
    Cataract 0/12 (0%) 0/3 (0%) 0/3 (0%) 1/16 (6.3%)
    Conjunctivitis 1/12 (8.3%) 0/3 (0%) 0/3 (0%) 0/16 (0%)
    Diplopia 0/12 (0%) 0/3 (0%) 0/3 (0%) 1/16 (6.3%)
    Glaucoma 0/12 (0%) 0/3 (0%) 0/3 (0%) 1/16 (6.3%)
    Lacrimation increased 1/12 (8.3%) 0/3 (0%) 1/3 (33.3%) 1/16 (6.3%)
    Periorbital oedema 1/12 (8.3%) 0/3 (0%) 1/3 (33.3%) 4/16 (25%)
    Photophobia 1/12 (8.3%) 0/3 (0%) 0/3 (0%) 0/16 (0%)
    Photopsia 0/12 (0%) 0/3 (0%) 0/3 (0%) 1/16 (6.3%)
    Retinal oedema 0/12 (0%) 0/3 (0%) 0/3 (0%) 1/16 (6.3%)
    Retinal tear 0/12 (0%) 0/3 (0%) 0/3 (0%) 1/16 (6.3%)
    Scleral discolouration 1/12 (8.3%) 0/3 (0%) 0/3 (0%) 0/16 (0%)
    Vision blurred 0/12 (0%) 1/3 (33.3%) 0/3 (0%) 1/16 (6.3%)
    Vitreous floaters 0/12 (0%) 0/3 (0%) 0/3 (0%) 1/16 (6.3%)
    Gastrointestinal disorders
    Abdominal distension 4/12 (33.3%) 1/3 (33.3%) 0/3 (0%) 2/16 (12.5%)
    Abdominal pain 2/12 (16.7%) 0/3 (0%) 1/3 (33.3%) 1/16 (6.3%)
    Abdominal pain lower 0/12 (0%) 0/3 (0%) 0/3 (0%) 1/16 (6.3%)
    Abdominal pain upper 2/12 (16.7%) 0/3 (0%) 0/3 (0%) 0/16 (0%)
    Abdominal tenderness 1/12 (8.3%) 0/3 (0%) 0/3 (0%) 0/16 (0%)
    Ascites 1/12 (8.3%) 1/3 (33.3%) 1/3 (33.3%) 1/16 (6.3%)
    Cheilitis 0/12 (0%) 0/3 (0%) 0/3 (0%) 1/16 (6.3%)
    Constipation 2/12 (16.7%) 0/3 (0%) 1/3 (33.3%) 4/16 (25%)
    Dental caries 0/12 (0%) 0/3 (0%) 0/3 (0%) 1/16 (6.3%)
    Diarrhoea 8/12 (66.7%) 3/3 (100%) 2/3 (66.7%) 11/16 (68.8%)
    Dry mouth 2/12 (16.7%) 0/3 (0%) 0/3 (0%) 4/16 (25%)
    Dyspepsia 6/12 (50%) 0/3 (0%) 1/3 (33.3%) 5/16 (31.3%)
    Dysphagia 2/12 (16.7%) 0/3 (0%) 0/3 (0%) 3/16 (18.8%)
    Flatulence 1/12 (8.3%) 1/3 (33.3%) 1/3 (33.3%) 2/16 (12.5%)
    Gastrooesophageal reflux disease 0/12 (0%) 0/3 (0%) 1/3 (33.3%) 3/16 (18.8%)
    Gingival pain 0/12 (0%) 0/3 (0%) 0/3 (0%) 1/16 (6.3%)
    Haematochezia 0/12 (0%) 0/3 (0%) 0/3 (0%) 1/16 (6.3%)
    Haemorrhoids 1/12 (8.3%) 0/3 (0%) 0/3 (0%) 0/16 (0%)
    Melaena 0/12 (0%) 0/3 (0%) 0/3 (0%) 1/16 (6.3%)
    Nausea 8/12 (66.7%) 2/3 (66.7%) 1/3 (33.3%) 7/16 (43.8%)
    Oesophageal discomfort 0/12 (0%) 0/3 (0%) 0/3 (0%) 1/16 (6.3%)
    Oesophageal stenosis 1/12 (8.3%) 0/3 (0%) 0/3 (0%) 0/16 (0%)
    Oral pain 1/12 (8.3%) 0/3 (0%) 0/3 (0%) 3/16 (18.8%)
    Proctalgia 0/12 (0%) 0/3 (0%) 0/3 (0%) 1/16 (6.3%)
    Rectal haemorrhage 1/12 (8.3%) 0/3 (0%) 0/3 (0%) 0/16 (0%)
    Retching 1/12 (8.3%) 0/3 (0%) 0/3 (0%) 0/16 (0%)
    Salivary hypersecretion 0/12 (0%) 0/3 (0%) 0/3 (0%) 1/16 (6.3%)
    Sensitivity of teeth 0/12 (0%) 0/3 (0%) 0/3 (0%) 1/16 (6.3%)
    Stomatitis 0/12 (0%) 1/3 (33.3%) 0/3 (0%) 1/16 (6.3%)
    Tongue geographic 0/12 (0%) 0/3 (0%) 0/3 (0%) 1/16 (6.3%)
    Tongue ulceration 1/12 (8.3%) 0/3 (0%) 0/3 (0%) 0/16 (0%)
    Vomiting 4/12 (33.3%) 0/3 (0%) 2/3 (66.7%) 8/16 (50%)
    General disorders
    Chest discomfort 1/12 (8.3%) 0/3 (0%) 0/3 (0%) 0/16 (0%)
    Chest pain 0/12 (0%) 0/3 (0%) 0/3 (0%) 2/16 (12.5%)
    Chills 2/12 (16.7%) 1/3 (33.3%) 0/3 (0%) 4/16 (25%)
    Cyst 1/12 (8.3%) 0/3 (0%) 0/3 (0%) 0/16 (0%)
    Early satiety 1/12 (8.3%) 0/3 (0%) 0/3 (0%) 1/16 (6.3%)
    Face oedema 0/12 (0%) 0/3 (0%) 0/3 (0%) 1/16 (6.3%)
    Fatigue 7/12 (58.3%) 3/3 (100%) 2/3 (66.7%) 12/16 (75%)
    Generalised oedema 1/12 (8.3%) 0/3 (0%) 1/3 (33.3%) 1/16 (6.3%)
    Influenza like illness 0/12 (0%) 0/3 (0%) 1/3 (33.3%) 1/16 (6.3%)
    Irritability 0/12 (0%) 0/3 (0%) 0/3 (0%) 1/16 (6.3%)
    Malaise 1/12 (8.3%) 0/3 (0%) 0/3 (0%) 0/16 (0%)
    Mucosal inflammation 2/12 (16.7%) 0/3 (0%) 0/3 (0%) 3/16 (18.8%)
    Oedema 2/12 (16.7%) 1/3 (33.3%) 0/3 (0%) 0/16 (0%)
    Oedema peripheral 5/12 (41.7%) 2/3 (66.7%) 1/3 (33.3%) 3/16 (18.8%)
    Pain 0/12 (0%) 0/3 (0%) 0/3 (0%) 2/16 (12.5%)
    Pyrexia 1/12 (8.3%) 0/3 (0%) 0/3 (0%) 1/16 (6.3%)
    Temperature intolerance 0/12 (0%) 0/3 (0%) 1/3 (33.3%) 0/16 (0%)
    Hepatobiliary disorders
    Hyperbilirubinaemia 0/12 (0%) 1/3 (33.3%) 0/3 (0%) 1/16 (6.3%)
    Immune system disorders
    Hypersensitivity 1/12 (8.3%) 0/3 (0%) 0/3 (0%) 0/16 (0%)
    Seasonal allergy 1/12 (8.3%) 0/3 (0%) 0/3 (0%) 1/16 (6.3%)
    Infections and infestations
    Bacteraemia 0/12 (0%) 0/3 (0%) 1/3 (33.3%) 0/16 (0%)
    Bronchitis 1/12 (8.3%) 0/3 (0%) 0/3 (0%) 0/16 (0%)
    Candida infection 0/12 (0%) 0/3 (0%) 0/3 (0%) 1/16 (6.3%)
    Chronic sinusitis 1/12 (8.3%) 0/3 (0%) 0/3 (0%) 1/16 (6.3%)
    Conjunctivitis viral 0/12 (0%) 0/3 (0%) 0/3 (0%) 1/16 (6.3%)
    Eye infection 0/12 (0%) 0/3 (0%) 0/3 (0%) 1/16 (6.3%)
    Fungal skin infection 0/12 (0%) 0/3 (0%) 0/3 (0%) 1/16 (6.3%)
    Gastroenteritis 1/12 (8.3%) 0/3 (0%) 0/3 (0%) 0/16 (0%)
    Herpes oesophagitis 0/12 (0%) 0/3 (0%) 0/3 (0%) 1/16 (6.3%)
    Influenza 0/12 (0%) 0/3 (0%) 0/3 (0%) 1/16 (6.3%)
    Pneumonia 1/12 (8.3%) 0/3 (0%) 0/3 (0%) 1/16 (6.3%)
    Rhinitis 0/12 (0%) 0/3 (0%) 0/3 (0%) 1/16 (6.3%)
    Sinusitis 0/12 (0%) 0/3 (0%) 0/3 (0%) 1/16 (6.3%)
    Staphylococcal infection 1/12 (8.3%) 0/3 (0%) 0/3 (0%) 0/16 (0%)
    Tinea pedis 1/12 (8.3%) 0/3 (0%) 0/3 (0%) 0/16 (0%)
    Tooth infection 1/12 (8.3%) 0/3 (0%) 0/3 (0%) 0/16 (0%)
    Upper respiratory tract infection 1/12 (8.3%) 0/3 (0%) 0/3 (0%) 1/16 (6.3%)
    Urinary tract infection 1/12 (8.3%) 0/3 (0%) 1/3 (33.3%) 1/16 (6.3%)
    Vulvovaginal mycotic infection 1/12 (8.3%) 0/3 (0%) 0/3 (0%) 0/16 (0%)
    Injury, poisoning and procedural complications
    Anal injury 0/12 (0%) 1/3 (33.3%) 0/3 (0%) 0/16 (0%)
    Excoriation 0/12 (0%) 1/3 (33.3%) 0/3 (0%) 1/16 (6.3%)
    Fall 1/12 (8.3%) 0/3 (0%) 0/3 (0%) 1/16 (6.3%)
    Hand fracture 0/12 (0%) 0/3 (0%) 0/3 (0%) 1/16 (6.3%)
    Laceration 0/12 (0%) 0/3 (0%) 1/3 (33.3%) 0/16 (0%)
    Muscle strain 0/12 (0%) 1/3 (33.3%) 0/3 (0%) 0/16 (0%)
    Wound 1/12 (8.3%) 0/3 (0%) 0/3 (0%) 0/16 (0%)
    Investigations
    Activated partial thromboplastin time prolonged 0/12 (0%) 0/3 (0%) 0/3 (0%) 1/16 (6.3%)
    Alanine aminotransferase increased 0/12 (0%) 0/3 (0%) 0/3 (0%) 2/16 (12.5%)
    Aspartate aminotransferase increased 0/12 (0%) 0/3 (0%) 0/3 (0%) 4/16 (25%)
    Bilirubin conjugated increased 1/12 (8.3%) 0/3 (0%) 0/3 (0%) 0/16 (0%)
    Blood alkaline phosphatase increased 0/12 (0%) 0/3 (0%) 0/3 (0%) 1/16 (6.3%)
    Blood creatinine increased 0/12 (0%) 0/3 (0%) 0/3 (0%) 2/16 (12.5%)
    International normalised ratio increased 0/12 (0%) 0/3 (0%) 0/3 (0%) 1/16 (6.3%)
    Neutrophil count decreased 0/12 (0%) 0/3 (0%) 0/3 (0%) 1/16 (6.3%)
    Occult blood positive 0/12 (0%) 1/3 (33.3%) 0/3 (0%) 0/16 (0%)
    Oxygen saturation decreased 0/12 (0%) 1/3 (33.3%) 0/3 (0%) 0/16 (0%)
    Weight decreased 1/12 (8.3%) 0/3 (0%) 1/3 (33.3%) 4/16 (25%)
    White blood cell count decreased 0/12 (0%) 1/3 (33.3%) 0/3 (0%) 1/16 (6.3%)
    Metabolism and nutrition disorders
    Decreased appetite 6/12 (50%) 1/3 (33.3%) 0/3 (0%) 6/16 (37.5%)
    Dehydration 2/12 (16.7%) 0/3 (0%) 0/3 (0%) 3/16 (18.8%)
    Hyperglycaemia 0/12 (0%) 0/3 (0%) 0/3 (0%) 1/16 (6.3%)
    Hyperkalaemia 0/12 (0%) 0/3 (0%) 0/3 (0%) 1/16 (6.3%)
    Hyperlipidaemia 0/12 (0%) 0/3 (0%) 0/3 (0%) 1/16 (6.3%)
    Hypoalbuminaemia 0/12 (0%) 0/3 (0%) 1/3 (33.3%) 0/16 (0%)
    Hypocalcaemia 0/12 (0%) 0/3 (0%) 0/3 (0%) 1/16 (6.3%)
    Hypoglycaemia 1/12 (8.3%) 0/3 (0%) 0/3 (0%) 0/16 (0%)
    Hypokalaemia 5/12 (41.7%) 0/3 (0%) 1/3 (33.3%) 1/16 (6.3%)
    Hypomagnesaemia 2/12 (16.7%) 0/3 (0%) 0/3 (0%) 0/16 (0%)
    Hyponatraemia 2/12 (16.7%) 0/3 (0%) 1/3 (33.3%) 1/16 (6.3%)
    Hypophagia 1/12 (8.3%) 0/3 (0%) 0/3 (0%) 0/16 (0%)
    Iron deficiency 0/12 (0%) 0/3 (0%) 0/3 (0%) 1/16 (6.3%)
    Vitamin B12 deficiency 0/12 (0%) 0/3 (0%) 0/3 (0%) 1/16 (6.3%)
    Musculoskeletal and connective tissue disorders
    Arthralgia 2/12 (16.7%) 0/3 (0%) 0/3 (0%) 3/16 (18.8%)
    Back pain 0/12 (0%) 2/3 (66.7%) 0/3 (0%) 3/16 (18.8%)
    Bursitis 1/12 (8.3%) 0/3 (0%) 0/3 (0%) 0/16 (0%)
    Joint effusion 1/12 (8.3%) 0/3 (0%) 0/3 (0%) 0/16 (0%)
    Joint swelling 0/12 (0%) 0/3 (0%) 0/3 (0%) 1/16 (6.3%)
    Muscle spasms 1/12 (8.3%) 0/3 (0%) 0/3 (0%) 1/16 (6.3%)
    Muscular weakness 1/12 (8.3%) 1/3 (33.3%) 0/3 (0%) 2/16 (12.5%)
    Musculoskeletal pain 0/12 (0%) 0/3 (0%) 0/3 (0%) 2/16 (12.5%)
    Myalgia 0/12 (0%) 0/3 (0%) 0/3 (0%) 3/16 (18.8%)
    Neck pain 0/12 (0%) 0/3 (0%) 0/3 (0%) 1/16 (6.3%)
    Pain in extremity 1/12 (8.3%) 1/3 (33.3%) 0/3 (0%) 4/16 (25%)
    Pain in jaw 1/12 (8.3%) 0/3 (0%) 0/3 (0%) 0/16 (0%)
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    Prostate cancer 0/12 (0%) 0/3 (0%) 0/3 (0%) 1/16 (6.3%)
    Nervous system disorders
    Ataxia 0/12 (0%) 0/3 (0%) 0/3 (0%) 2/16 (12.5%)
    Carotid artery stenosis 0/12 (0%) 0/3 (0%) 0/3 (0%) 1/16 (6.3%)
    Cognitive disorder 0/12 (0%) 0/3 (0%) 0/3 (0%) 2/16 (12.5%)
    Dizziness 1/12 (8.3%) 0/3 (0%) 1/3 (33.3%) 3/16 (18.8%)
    Dysgeusia 5/12 (41.7%) 0/3 (0%) 2/3 (66.7%) 6/16 (37.5%)
    Headache 0/12 (0%) 0/3 (0%) 0/3 (0%) 3/16 (18.8%)
    Hemisensory neglect 0/12 (0%) 0/3 (0%) 0/3 (0%) 1/16 (6.3%)
    Hypoaesthesia 1/12 (8.3%) 0/3 (0%) 0/3 (0%) 0/16 (0%)
    Migraine with aura 0/12 (0%) 0/3 (0%) 0/3 (0%) 1/16 (6.3%)
    Neuropathy peripheral 0/12 (0%) 0/3 (0%) 1/3 (33.3%) 1/16 (6.3%)
    Sciatica 1/12 (8.3%) 0/3 (0%) 0/3 (0%) 0/16 (0%)
    Sinus headache 0/12 (0%) 0/3 (0%) 0/3 (0%) 1/16 (6.3%)
    Syncope 0/12 (0%) 0/3 (0%) 0/3 (0%) 2/16 (12.5%)
    Vocal cord paralysis 1/12 (8.3%) 0/3 (0%) 0/3 (0%) 0/16 (0%)
    Psychiatric disorders
    Anxiety 2/12 (16.7%) 0/3 (0%) 0/3 (0%) 1/16 (6.3%)
    Depression 0/12 (0%) 0/3 (0%) 1/3 (33.3%) 1/16 (6.3%)
    Insomnia 2/12 (16.7%) 1/3 (33.3%) 0/3 (0%) 3/16 (18.8%)
    Renal and urinary disorders
    Azotaemia 0/12 (0%) 0/3 (0%) 1/3 (33.3%) 0/16 (0%)
    Chromaturia 0/12 (0%) 0/3 (0%) 0/3 (0%) 1/16 (6.3%)
    Dysuria 0/12 (0%) 0/3 (0%) 0/3 (0%) 2/16 (12.5%)
    Haematuria 0/12 (0%) 0/3 (0%) 0/3 (0%) 1/16 (6.3%)
    Micturition urgency 0/12 (0%) 0/3 (0%) 0/3 (0%) 1/16 (6.3%)
    Nocturia 0/12 (0%) 1/3 (33.3%) 0/3 (0%) 1/16 (6.3%)
    Proteinuria 3/12 (25%) 0/3 (0%) 1/3 (33.3%) 2/16 (12.5%)
    Urinary hesitation 0/12 (0%) 0/3 (0%) 0/3 (0%) 1/16 (6.3%)
    Urinary incontinence 0/12 (0%) 0/3 (0%) 0/3 (0%) 2/16 (12.5%)
    Urinary retention 0/12 (0%) 0/3 (0%) 0/3 (0%) 2/16 (12.5%)
    Urinary tract pain 0/12 (0%) 0/3 (0%) 0/3 (0%) 1/16 (6.3%)
    Reproductive system and breast disorders
    Breast discharge 0/12 (0%) 1/3 (33.3%) 0/3 (0%) 0/16 (0%)
    Erectile dysfunction 0/12 (0%) 0/3 (0%) 0/3 (0%) 1/16 (6.3%)
    Genital haemorrhage 0/12 (0%) 0/3 (0%) 0/3 (0%) 1/16 (6.3%)
    Genital pain 0/12 (0%) 0/3 (0%) 0/3 (0%) 1/16 (6.3%)
    Genital swelling 0/12 (0%) 0/3 (0%) 0/3 (0%) 1/16 (6.3%)
    Penile haemorrhage 0/12 (0%) 0/3 (0%) 0/3 (0%) 1/16 (6.3%)
    Perineal pain 0/12 (0%) 0/3 (0%) 0/3 (0%) 1/16 (6.3%)
    Respiratory, thoracic and mediastinal disorders
    Cough 3/12 (25%) 1/3 (33.3%) 0/3 (0%) 4/16 (25%)
    Dysphonia 2/12 (16.7%) 2/3 (66.7%) 0/3 (0%) 1/16 (6.3%)
    Dyspnoea 0/12 (0%) 0/3 (0%) 1/3 (33.3%) 4/16 (25%)
    Dyspnoea exertional 0/12 (0%) 0/3 (0%) 1/3 (33.3%) 0/16 (0%)
    Epistaxis 1/12 (8.3%) 1/3 (33.3%) 0/3 (0%) 3/16 (18.8%)
    Haemoptysis 0/12 (0%) 0/3 (0%) 0/3 (0%) 1/16 (6.3%)
    Lung consolidation 0/12 (0%) 0/3 (0%) 0/3 (0%) 1/16 (6.3%)
    Nasal congestion 1/12 (8.3%) 0/3 (0%) 0/3 (0%) 0/16 (0%)
    Nasal discomfort 1/12 (8.3%) 0/3 (0%) 0/3 (0%) 0/16 (0%)
    Nasal disorder 1/12 (8.3%) 0/3 (0%) 0/3 (0%) 0/16 (0%)
    Nasal dryness 1/12 (8.3%) 0/3 (0%) 0/3 (0%) 0/16 (0%)
    Oropharyngeal pain 1/12 (8.3%) 0/3 (0%) 0/3 (0%) 0/16 (0%)
    Pleural effusion 1/12 (8.3%) 0/3 (0%) 0/3 (0%) 1/16 (6.3%)
    Productive cough 1/12 (8.3%) 2/3 (66.7%) 0/3 (0%) 1/16 (6.3%)
    Sinus congestion 0/12 (0%) 0/3 (0%) 0/3 (0%) 1/16 (6.3%)
    Vocal cord atrophy 0/12 (0%) 1/3 (33.3%) 0/3 (0%) 0/16 (0%)
    Wheezing 1/12 (8.3%) 0/3 (0%) 0/3 (0%) 1/16 (6.3%)
    Skin and subcutaneous tissue disorders
    Alopecia 0/12 (0%) 0/3 (0%) 0/3 (0%) 1/16 (6.3%)
    Decubitus ulcer 0/12 (0%) 0/3 (0%) 1/3 (33.3%) 0/16 (0%)
    Dry skin 2/12 (16.7%) 1/3 (33.3%) 0/3 (0%) 2/16 (12.5%)
    Ecchymosis 1/12 (8.3%) 0/3 (0%) 0/3 (0%) 1/16 (6.3%)
    Erythema 0/12 (0%) 0/3 (0%) 0/3 (0%) 1/16 (6.3%)
    Hyperhidrosis 1/12 (8.3%) 1/3 (33.3%) 0/3 (0%) 0/16 (0%)
    Night sweats 0/12 (0%) 0/3 (0%) 1/3 (33.3%) 0/16 (0%)
    Palmar-plantar erythrodysaesthesia syndrome 4/12 (33.3%) 0/3 (0%) 0/3 (0%) 3/16 (18.8%)
    Petechiae 1/12 (8.3%) 0/3 (0%) 0/3 (0%) 0/16 (0%)
    Pruritus 2/12 (16.7%) 0/3 (0%) 1/3 (33.3%) 2/16 (12.5%)
    Rash 4/12 (33.3%) 1/3 (33.3%) 1/3 (33.3%) 1/16 (6.3%)
    Rash macular 0/12 (0%) 0/3 (0%) 0/3 (0%) 1/16 (6.3%)
    Skin discolouration 0/12 (0%) 0/3 (0%) 0/3 (0%) 2/16 (12.5%)
    Skin exfoliation 0/12 (0%) 0/3 (0%) 0/3 (0%) 1/16 (6.3%)
    Skin fissures 0/12 (0%) 0/3 (0%) 0/3 (0%) 1/16 (6.3%)
    Skin hypopigmentation 0/12 (0%) 0/3 (0%) 0/3 (0%) 1/16 (6.3%)
    Yellow skin 0/12 (0%) 0/3 (0%) 1/3 (33.3%) 1/16 (6.3%)
    Surgical and medical procedures
    Facial operation 0/12 (0%) 0/3 (0%) 0/3 (0%) 1/16 (6.3%)
    Vascular disorders
    Flushing 1/12 (8.3%) 1/3 (33.3%) 0/3 (0%) 0/16 (0%)
    Hypertension 6/12 (50%) 1/3 (33.3%) 1/3 (33.3%) 9/16 (56.3%)

    Limitations/Caveats

    On 25 Oct 2012, due to data safety signals in separate clinical trial with CVX-060, all CVX-060 studies were discontinued. Ongoing participants in B1131001 were permitted to remain on study at a reduced dose if determined to derive clinical benefit.

    More Information

    Certain Agreements

    Principal Investigators are NOT employed by the organization sponsoring the study.

    Pfizer has the right to review disclosures, requesting a delay of less than 60 days. Investigator will postpone single center publications until after disclosure of pooled data (all sites), less than 12 months from study completion/termination at all participating sites. Investigator may not disclose previously undisclosed confidential information other than study results.

    Results Point of Contact

    Name/Title Pfizer ClinicalTrials.gov Call Center
    Organization Pfizer, Inc.
    Phone 1-800-718-1021
    Email ClinicalTrials.gov_Inquiries@pfizer.com
    Responsible Party:
    Pfizer
    ClinicalTrials.gov Identifier:
    NCT00982657
    Other Study ID Numbers:
    • B1131001
    • CVX-060-102
    • 2010-022657-42
    First Posted:
    Sep 23, 2009
    Last Update Posted:
    Nov 20, 2015
    Last Verified:
    Oct 1, 2015