A Phase I/II Study of TRC105 in Metastatic Castrate Resistant Prostate Cancer (CRPC)

Sponsor
National Cancer Institute (NCI) (NIH)
Overall Status
Completed
CT.gov ID
NCT01090765
Collaborator
(none)
21
1
6
61.7
0.3

Study Details

Study Description

Brief Summary

Background:
  • Currently, there is no curative therapy for metastatic castrate-resistant prostate cancer (CRPC), a leading cause of death in men. However, researchers are exploring new treatments that involve drugs that prevent angiogenesis (the process by which new blood vessels are formed) and can slow or prevent tumor growth.

  • TRC105 is an experimental drug that blocks angiogenesis, and has been studied for possible use in treating different kinds of cancer. However, it has not been validated to treat prostate cancer in general or CRPC in particular.

Objectives:
  • To determine the effects of TRC105 as a treatment for CRPC

  • To determine the safety and effectiveness of TRC105 in treating CRPC

Eligibility:
  • Men at least 18 years of age who have been diagnosed with castrate-resistant prostate cancer for which existing treatments have not been effective.
Design:
  • Eligible individuals will have a series of blood and other tests to determine their suitability for participating in the study.

  • Participants will receive intravenous infusions of TRC105 in a 28-day treatment cycle. Participants will receive i.v. (intravenous) infusions of TRC105 every two weeks on days 1 and 15 of each 28-day cycle (cohorts 1, 2, 3, 5, and 6) and every week on days 1, 8, 15, and 22 of each 28 day cycle (cohort 4).

  • Participants will receive different doses of TRC105 depending on when they enter the study, up to a maximum tolerated dose or optimum treatment dose.

  • Frequent blood and urine tests will be performed during treatment, as well as other tests of cancer progression as directed by the study doctors. Participants will receive medicines to help prevent possible adverse side effects of TRC105, such as allergic reaction to the drug.

  • Participants will continue treatment with TRC105 until they or the study team decides that the medication is not beneficial. No additional testing will be required unless participants discontinue the treatment because of side effects (which the study doctors will follow until the side effects are resolved).

Condition or Disease Intervention/Treatment Phase
Phase 1/Phase 2

Detailed Description

Background:
  • Inhibition of angiogenesis has demonstrable antitumor efficacy against castrate-resistant prostate cancer (CRPC). TRC105 is a human/murine chimeric immunoglobulin heavy constant gamma 1 (IgG1) kappa monoclonal antibody that binds to human CD105 (endoglin), thus inhibiting angiogenesis and tumor growth. Data from an ongoing phase I clinical trial suggest that TRC105 is well tolerated with evidence of clinical efficacy in patients with metastatic CRPC.
Primary Objectives:
  • Define the maximum tolerable dose (MTD) of TRC105 given every one to two weeks.
Secondary Objectives:
  • Define the dose-limiting toxicities and toxicity profile of TRC105 given every one to two weeks

  • Evaluate time to disease progression, overall response rate and overall survival.

  • Describe the prostate specific antigen (PSA) response rate to therapy with TRC105

  • Characterize the pharmacokinetics of TRC105

  • Demonstrate a biologic effect of TRC105 in the patient and, when possible, on the tumor via laboratory evaluation of the molecular markers of angiogenesis before and after drug administration respectively

Eligibility:
  • Progressive, castrate-resistant, metastatic adenocarcinoma of the prostate

  • Eastern Cooperative Oncology Group (ECOG) less than or equal to 2

Design:
  • An initial single-arm, phase I dose escalation study open to all patients with progressive metastatic CRPC. The study will evaluate patients in five cohorts of escalating dose levels. A maximum of 30 patients will be needed to complete the phase I evaluation.

Study Design

Study Type:
Interventional
Actual Enrollment :
21 participants
Allocation:
Non-Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
A Phase I/II Study of TRC105 in Metastatic Castrate Resistant Prostate Cancer (CRPC)
Actual Study Start Date :
Feb 23, 2010
Actual Primary Completion Date :
Apr 1, 2014
Actual Study Completion Date :
Apr 17, 2015

Arms and Interventions

Arm Intervention/Treatment
Experimental: TRC105 1 mg/kg every 2 weeks

Intravenous infusion at 1 mg/kg every 2 weeks

Drug: TRC105

Experimental: TRC105 3 mg/kg every 2 weeks

Intravenous infusion at 3 mg/kg every 2 weeks

Drug: TRC105

Experimental: TRC105 10 mg/kg every 2 weeks

Intravenous infusion at 10 mg/kg every 2 weeks

Drug: TRC105

Experimental: TRC105 10 mg/kg weekly

Intravenous infusion at 10 mg/kg weekly

Drug: TRC105

Experimental: TRC105 15 mg/kg every 2 weeks

Intravenous infusion at 15 mg/kg every 2 weeks

Drug: TRC105

Experimental: TRC105 20 mg/kg every 2 weeks

Intravenous infusion at 20 mg/kg every 2 weeks

Drug: TRC105

Outcome Measures

Primary Outcome Measures

  1. Phase I: Maximum Tolerated Dose (MTD) of TRC105 Given Every Two Weeks. [6 months]

    The MTD, to be administered in the phase II portion, is defined as the highest dose studied for which the incidence of dose limiting toxicity (DLT) was less than 33%. TRC105 was administered at 20 mg/kg intravenous every two weeks until MTD was achieved.

Secondary Outcome Measures

  1. Number of Participants With Adverse Events [Date treatment consent signed to date off study, approximately 43 months, 5 days]

    Here is the number of participants with adverse events. For a detailed list of adverse events, see the adverse event module.

  2. Dose Limiting Toxicity (DLT) [First 28 days on study]

    Dose limiting toxicity is defined as any grade 3 or higher hematologic (excluding anemia) or non-hematologic toxicity considered to be possibly related to TRC105.

  3. Prostatic-Specific Antigen (PSA) Decline [1- week intervals up to 6 months]

    PSA decline (i.e., PSA greater than 4.0 ng/mL) is defined as two consecutively rising PSA values at a minimum of 1-week intervals (2.0 ng/mL is the minimum starting values for PSA). Normal PSA is 4.0 ng/mL or lower.

  4. Clinical Response [56 days (one cycle = 28 days, restaging post cycle 2)]

    Clinical response was assessed by the Response Evaluation Criteria in Solid Tumors (RECIST). Complete response (CR) is disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to <10 mm. Partial response (PR) is at least a 30% decrease in the sum of the diameters of target lesions, taking as reference the baseline sum diameters. Progressive disease (PD) is at least a 20% decrease in the sum of the diameters of target lesions, taking as reference the smallest sum on study (this includes the baseline sum if that is the smallest on study). Stable disease (SD) is neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum diameters while on study.

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
Male
Accepts Healthy Volunteers:
No
  • INCLUSION CRITERIA:
  1. Patients must have histopathological confirmation of prostate cancer by the Laboratory of Pathology of the National Cancer Institute (NCI), Pathology Department of the National Naval Medical Center or Pathology Department of Walter Reed Army Medical Center prior to entering this study. Patients whose pathology specimens are no longer available may be enrolled in the trial if the patient has a clinical course consistent with prostate cancer and available documentation from an outside pathology laboratory of the diagnosis. In cases where original tissue blocks or archival biopsy material is available, efforts will be made to contact referring physicians and outside pathology departments to have the material forwarded to the research team for use in correlative studies.

  2. Patients must have metastatic progressive castrate-resistant prostate cancer defined as progressive disease (see below) despite surgical castration or ongoing use of gonadotropin-releasing hormone agonists with confirmed castrate levels of testosterone.

Criteria of progression for trial eligibility are defined from the Prostate Cancer Clinical Trials Working Group-2. Clinically progressive prostate cancer must be evidenced and documented by any of the following parameters:

  1. Two consecutively rising prostate specific antigen (PSA) values at a minimum of 1-week intervals (2.0 ng/mL is the minimum starting value for PSA)

  2. Appearance of one or more new lesion on bone scans

  3. Progressive measurable disease by Response Evaluation Criteria in Solid Tumors (RECIST) 1.1

Patients on flutamide for at least 6 months must have disease progression at least 4 weeks after withdrawal. Patients on bicalutamide or nilutamide for at least 6 months must have progression at least 6 weeks after withdrawal.

All patients enrolled will be required to have measurable or non-measurable disease on imaging studies.

  1. Age greater than or equal to 18 years.

  2. Life expectancy of greater than 3 months.

  3. Eastern Cooperative Oncology Group (ECOG) performance status 0-2.

  4. Patients must have normal organ and marrow function as defined below:

  • Absolute neutrophil count greater than or equal to 1,500/mcL

  • Platelets greater than or equal to 100,000/mcL

  • Total bilirubin less than or equal to 1.5 times upper normal limits or less than 3 mg/dl in subjects with Gilbert's Syndrome

  • Aspartate aminotransferase (AST)/alanine aminotransferase (ALT) less than or equal to 2.5 times upper limit of normal

  • Creatinine less than or equal to 1.5 times upper normal limits OR creatinine clearance greater than or equal to 40 mL/min/1.73 m^2 for patients with creatinine levels above institutional normal, as calculated by the Cockcroft Gault formula.

  1. Patients must have recovered from any acute toxicity related to prior therapy, including surgery. Toxicity should be less than or equal to grade 1 or returned to baseline.

  2. All patients who have not undergone bilateral surgical castration must continue suppression of testosterone production by appropriate usage of gonadotropin releasing hormone (GnRH) agonists or antagonists.

  3. Patients must not have other invasive malignancies (within the past 2 years with the exception of non-melanoma skin cancers or non-invasive bladder cancer).

  4. Enrolled patients must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry, the duration of study participation and 3 months after the end of the treatment.

  5. Patient must be able to understand and willing to sign a written informed consent document.

  6. Patients on a stable dose of steroids of 10 mg/day or less can continue on steroids if they are on peptic ulcer disease prophylaxis with an H2-blocker or proton pump inhibitor.

EXCLUSION CRITERIA:
  1. Patients who have had chemotherapy, large field radiotherapy, or major surgery must wait 3 weeks prior to entering the study.

  2. Patients may not be receiving any agents not approved by the Food and Drug Administration (FDA) within the past 4 weeks.

  3. Patients with known brain metastases will be excluded from this clinical trial because of their poor prognosis and because they often develop progressive neurologic dysfunction that would confound the evaluation of neurologic and other adverse events.

  4. Proteinuria, as demonstrated by a 24 hour protein of (Bullet) 2000 mg. Urine protein will be screened by urine protein-creatinine ratio (UPC). For UPC ratio > 1.0, a 24-hour urine protein will need to be obtained and the level should be < 2000 mg for patient enrollment.

  5. Uncontrolled intercurrent illness including, but not limited to, hypertension (systolic blood pressure (BP) > 160, diastolic BP > 100), ongoing or active systemic infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia or psychiatric illness/social situations that would limit compliance with study requirements.

  6. Thrombolytic or treatment-dose anticoagulant use within 10 days prior to first dose with TRC105.

  7. Hemorrhage within 30 days of dosing.

  8. History of peptic ulcer disease or gastritis within 6 months of TRC105 administration, unless patient has received adequate treatment for peptic ulcer disease and has evidence of complete resolution documented by esophagogastroduodenoscopy (EGD).

  9. Corrected QT interval (QTc) > 500 msec.

  10. Known human immunodeficiency virus (HIV)-positive patients are excluded.

  11. History of hypersensitivity reaction to human or mouse antibody products.

  12. Patients with a history of familial bleeding disorders.

  13. Patients with a history of hereditary hemorrhagic telangiectasia (Osler-Weber-Rendu syndrome).

  14. Use of non-steroidal anti-inflammatory drugs (NSAIDs) beginning 14 days prior to the first TRC105 dose, with the exception of aspirin when clinically indicated.

Contacts and Locations

Locations

Site City State Country Postal Code
1 National Institutes of Health Clinical Center, 9000 Rockville Pike Bethesda Maryland United States 20892

Sponsors and Collaborators

  • National Cancer Institute (NCI)

Investigators

  • Principal Investigator: William L Dahut, M.D., National Cancer Institute (NCI)

Study Documents (Full-Text)

More Information

Additional Information:

Publications

Responsible Party:
William Dahut Jr., M.D., Principal Investigator, National Institutes of Health Clinical Center (CC)
ClinicalTrials.gov Identifier:
NCT01090765
Other Study ID Numbers:
  • 100062
  • 10-C-0062
First Posted:
Mar 22, 2010
Last Update Posted:
May 22, 2018
Last Verified:
Apr 1, 2018
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
Yes
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by William Dahut Jr., M.D., Principal Investigator, National Institutes of Health Clinical Center (CC)
Additional relevant MeSH terms:

Study Results

Participant Flow

Recruitment Details
Pre-assignment Detail The study did not make it to the phase II (Arm 1-chemotherapy-naïve for metastatic disease (no prior antiangiogenic therapy) and Arm 2- post-docetaxel disease progression; evidence of disease progression despite prior docetaxel and bevacizumab) portion, thus no data is available for the phase II outcome measure "progression free survival".
Arm/Group Title TRC105 1 mg/kg Every 2 Weeks TRC105 3 mg/kg Every 2 Weeks TRC105 10 mg/kg Every 2 Weeks TRC105 10 mg/kg Weekly TRC105 15 mg/kg Every 2 Weeks TRC105 20 mg/kg Every 2 Weeks
Arm/Group Description Intravenous infusion at 1 mg/kg every 2 weeks Intravenous infusion at 3 mg/kg every 2 weeks Intravenous infusion at 10 mg/kg every 2 weeks Intravenous infusion at 10 mg/kg weekly Intravenous infusion at 15 mg/kg every 2 weeks Intravenous infusion at 20 mg/kg every 2 weeks
Period Title: Overall Study
STARTED 3 3 3 2 6 4
COMPLETED 3 3 3 1 4 3
NOT COMPLETED 0 0 0 1 2 1

Baseline Characteristics

Arm/Group Title TRC105 1 mg/kg Every 2 Weeks TRC105 3 mg/kg Every 2 Weeks TRC105 10 mg/kg Every 2 Weeks TRC105 10 mg/kg Weekly TRC105 15 mg/kg Every 2 Weeks TRC105 20 mg/kg Every 2 Weeks Total
Arm/Group Description Intravenous infusion at 1 mg/kg every 2 weeks Intravenous infusion at 3 mg/kg every 2 weeks Intravenous infusion at 10 mg/kg every 2 weeks Intravenous infusion at 10 mg/kg weekly Intravenous infusion at 15 mg/kg every 2 weeks Intravenous infusion at 20 mg/kg every 2 weeks Total of all reporting groups
Overall Participants 3 3 3 2 6 4 21
Age (Count of Participants)
<=18 years
0
0%
0
0%
0
0%
0
0%
0
0%
0
0%
0
0%
Between 18 and 65 years
2
66.7%
1
33.3%
1
33.3%
1
50%
4
66.7%
3
75%
12
57.1%
>=65 years
1
33.3%
2
66.7%
2
66.7%
1
50%
2
33.3%
1
25%
9
42.9%
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]
65.2
(19.05)
62.37
(9.01)
66.53
(16.14)
63.15
(4.45)
65.83
(12.56)
61.8
(7.56)
64.32
(11.09)
Sex: Female, Male (Count of Participants)
Female
0
0%
0
0%
0
0%
0
0%
0
0%
0
0%
0
0%
Male
3
100%
3
100%
3
100%
2
100%
6
100%
4
100%
21
100%
Ethnicity (NIH/OMB) (Count of Participants)
Hispanic or Latino
0
0%
0
0%
0
0%
0
0%
0
0%
0
0%
0
0%
Not Hispanic or Latino
3
100%
3
100%
3
100%
2
100%
6
100%
4
100%
21
100%
Unknown or Not Reported
0
0%
0
0%
0
0%
0
0%
0
0%
0
0%
0
0%
Race (NIH/OMB) (Count of Participants)
American Indian or Alaska Native
0
0%
0
0%
0
0%
0
0%
0
0%
0
0%
0
0%
Asian
0
0%
0
0%
0
0%
0
0%
0
0%
0
0%
0
0%
Native Hawaiian or Other Pacific Islander
0
0%
0
0%
0
0%
0
0%
0
0%
0
0%
0
0%
Black or African American
0
0%
2
66.7%
1
33.3%
1
50%
1
16.7%
2
50%
7
33.3%
White
3
100%
1
33.3%
2
66.7%
1
50%
5
83.3%
2
50%
14
66.7%
More than one race
0
0%
0
0%
0
0%
0
0%
0
0%
0
0%
0
0%
Unknown or Not Reported
0
0%
0
0%
0
0%
0
0%
0
0%
0
0%
0
0%
Region of Enrollment (participants) [Number]
United States
3
100%
3
100%
3
100%
2
100%
6
100%
4
100%
21
100%

Outcome Measures

1. Primary Outcome
Title Phase I: Maximum Tolerated Dose (MTD) of TRC105 Given Every Two Weeks.
Description The MTD, to be administered in the phase II portion, is defined as the highest dose studied for which the incidence of dose limiting toxicity (DLT) was less than 33%. TRC105 was administered at 20 mg/kg intravenous every two weeks until MTD was achieved.
Time Frame 6 months

Outcome Measure Data

Analysis Population Description
[Not Specified]
Arm/Group Title TRC105 20 mg/kg Every 2 Weeks
Arm/Group Description Intravenous infusion at 20 mg/kg every 2 weeks
Measure Participants 21
Number [mg/kg every 2 weeks]
20
2. Secondary Outcome
Title Number of Participants With Adverse Events
Description Here is the number of participants with adverse events. For a detailed list of adverse events, see the adverse event module.
Time Frame Date treatment consent signed to date off study, approximately 43 months, 5 days

Outcome Measure Data

Analysis Population Description
[Not Specified]
Arm/Group Title TRC105 1 mg/kg Every 2 Weeks TRC105 3 mg/kg Every 2 Weeks TRC105 10 mg/kg Every 2 Weeks TRC105 10 mg/kg Weekly TRC105 15 mg/kg Every 2 Weeks TRC105 20 mg/kg Every 2 Weeks
Arm/Group Description Intravenous infusion at 1 mg/kg every 2 weeks Intravenous infusion at 3 mg/kg every 2 weeks Intravenous infusion at 10 mg/kg every 2 weeks Intravenous infusion at 10 mg/kg weekly Intravenous infusion at 15 mg/kg every 2 weeks Intravenous infusion at 20 mg/kg every 2 weeks
Measure Participants 3 3 3 2 6 4
Count of Participants [Participants]
3
100%
3
100%
3
100%
2
100%
5
83.3%
4
100%
3. Secondary Outcome
Title Dose Limiting Toxicity (DLT)
Description Dose limiting toxicity is defined as any grade 3 or higher hematologic (excluding anemia) or non-hematologic toxicity considered to be possibly related to TRC105.
Time Frame First 28 days on study

Outcome Measure Data

Analysis Population Description
[Not Specified]
Arm/Group Title TRC105 1 mg/kg Every 2 Weeks TRC105 3 mg/kg Every 2 Weeks TRC105 10 mg/kg Every 2 Weeks TRC105 10 mg/kg Weekly TRC105 15 mg/kg Every 2 Weeks TRC105 20 mg/kg Every 2 Weeks
Arm/Group Description Intravenous infusion at 1 mg/kg every 2 weeks Intravenous infusion at 3 mg/kg every 2 weeks Intravenous infusion at 10 mg/kg every 2 weeks Intravenous infusion at 10 mg/kg weekly Intravenous infusion at 15 mg/kg every 2 weeks Intravenous infusion at 20 mg/kg every 2 weeks
Measure Participants 3 3 3 2 6 4
Count of Participants [Participants]
0
0%
0
0%
0
0%
0
0%
1
16.7%
0
0%
4. Secondary Outcome
Title Prostatic-Specific Antigen (PSA) Decline
Description PSA decline (i.e., PSA greater than 4.0 ng/mL) is defined as two consecutively rising PSA values at a minimum of 1-week intervals (2.0 ng/mL is the minimum starting values for PSA). Normal PSA is 4.0 ng/mL or lower.
Time Frame 1- week intervals up to 6 months

Outcome Measure Data

Analysis Population Description
[Not Specified]
Arm/Group Title TRC105 1 mg/kg Every 2 Weeks TRC105 3 mg/kg Every 2 Weeks TRC105 10 mg/kg Every 2 Weeks TRC105 10 mg/kg Weekly TRC105 15 mg/kg Every 2 Weeks TRC105 20 mg/kg Every 2 Weeks
Arm/Group Description Intravenous infusion at 1 mg/kg every 2 weeks Intravenous infusion at 3 mg/kg every 2 weeks Intravenous infusion at 10 mg/kg every 2 weeks Intravenous infusion at 10 mg/kg weekly Intravenous infusion at 15 mg/kg every 2 weeks Intravenous infusion at 20 mg/kg every 2 weeks
Measure Participants 3 3 3 2 5 4
PSA Decline >4.0 ng/mL
0
0%
1
33.3%
2
66.7%
2
100%
1
16.7%
2
50%
Normal PSA <4.0 ng/mL
3
100%
2
66.7%
1
33.3%
0
0%
4
66.7%
2
50%
5. Secondary Outcome
Title Clinical Response
Description Clinical response was assessed by the Response Evaluation Criteria in Solid Tumors (RECIST). Complete response (CR) is disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to <10 mm. Partial response (PR) is at least a 30% decrease in the sum of the diameters of target lesions, taking as reference the baseline sum diameters. Progressive disease (PD) is at least a 20% decrease in the sum of the diameters of target lesions, taking as reference the smallest sum on study (this includes the baseline sum if that is the smallest on study). Stable disease (SD) is neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum diameters while on study.
Time Frame 56 days (one cycle = 28 days, restaging post cycle 2)

Outcome Measure Data

Analysis Population Description
[Not Specified]
Arm/Group Title TRC105 1 mg/kg Every 2 Weeks TRC105 3 mg/kg Every 2 Weeks TRC105 10 mg/kg Every 2 Weeks TRC105 10 mg/kg Weekly TRC105 15 mg/kg Every 2 Weeks TRC105 20 mg/kg Every 2 Weeks
Arm/Group Description Intravenous infusion at 1 mg/kg every 2 weeks Intravenous infusion at 3 mg/kg every 2 weeks Intravenous infusion at 10 mg/kg every 2 weeks Intravenous infusion at 10 mg/kg weekly Intravenous infusion at 15 mg/kg every 2 weeks Intravenous infusion at 20 mg/kg every 2 weeks
Measure Participants 3 3 3 2 6 4
Complete Response
0
0%
0
0%
0
0%
0
0%
0
0%
0
0%
Stable Disease
3
100%
2
66.7%
3
100%
2
100%
5
83.3%
4
100%
Progressive Disease
0
0%
1
33.3%
0
0%
0
0%
0
0%
0
0%
Inevaluable
0
0%
0
0%
0
0%
0
0%
1
16.7%
0
0%

Adverse Events

Time Frame Date treatment consent signed to date off study, approximately 43 months, 5 days
Adverse Event Reporting Description
Arm/Group Title TRC105 1 mg/kg Every 2 Weeks TRC105 3 mg/kg Every 2 Weeks TRC105 10 mg/kg Every 2 Weeks TRC105 10 mg/kg Weekly TRC105 15 mg/kg Every 2 Weeks TRC105 20 mg/kg Every 2 Weeks
Arm/Group Description Intravenous infusion at 1 mg/kg every 2 weeks Intravenous infusion at 3 mg/kg every 2 weeks Intravenous infusion at 10 mg/kg every 2 weeks Intravenous infusion at 10 mg/kg weekly Intravenous infusion at 15 mg/kg every 2 weeks Intravenous infusion at 20 mg/kg every 2 weeks
All Cause Mortality
TRC105 1 mg/kg Every 2 Weeks TRC105 3 mg/kg Every 2 Weeks TRC105 10 mg/kg Every 2 Weeks TRC105 10 mg/kg Weekly TRC105 15 mg/kg Every 2 Weeks TRC105 20 mg/kg Every 2 Weeks
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total 0/3 (0%) 0/3 (0%) 0/3 (0%) 0/2 (0%) 0/6 (0%) 0/4 (0%)
Serious Adverse Events
TRC105 1 mg/kg Every 2 Weeks TRC105 3 mg/kg Every 2 Weeks TRC105 10 mg/kg Every 2 Weeks TRC105 10 mg/kg Weekly TRC105 15 mg/kg Every 2 Weeks TRC105 20 mg/kg Every 2 Weeks
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total 2/3 (66.7%) 3/3 (100%) 3/3 (100%) 2/2 (100%) 2/6 (33.3%) 1/4 (25%)
Blood and lymphatic system disorders
Anemia 0/3 (0%) 1/3 (33.3%) 1 1/3 (33.3%) 1 0/2 (0%) 1 0/6 (0%) 1 0/4 (0%) 1
Cardiac disorders
Chest pain - cardiac 0/3 (0%) 1/3 (33.3%) 1 0/3 (0%) 1 0/2 (0%) 1 0/6 (0%) 1 0/4 (0%) 1
Gastrointestinal disorders
Constipation 0/3 (0%) 1/3 (33.3%) 1 0/3 (0%) 1 0/2 (0%) 1 0/6 (0%) 1 0/4 (0%) 1
Nausea 0/3 (0%) 0/3 (0%) 1/3 (33.3%) 1 0/2 (0%) 1 0/6 (0%) 1 0/4 (0%) 1
Abdominal pain 0/3 (0%) 0/3 (0%) 0/3 (0%) 1/2 (50%) 1 1/6 (16.7%) 1 0/4 (0%) 1
Small intestinal obstruction 0/3 (0%) 0/3 (0%) 0/3 (0%) 1/2 (50%) 1 0/6 (0%) 1 0/4 (0%) 1
Vomiting 0/3 (0%) 0/3 (0%) 0/3 (0%) 1/2 (50%) 2 0/6 (0%) 2 0/4 (0%) 2
General disorders
Infusion related reaction 1/3 (33.3%) 1 0/3 (0%) 1 0/3 (0%) 1 0/2 (0%) 1 0/6 (0%) 1 0/4 (0%) 1
Chills 0/3 (0%) 0/3 (0%) 0/3 (0%) 1/2 (50%) 1 0/6 (0%) 1 0/4 (0%) 1
Fever 0/3 (0%) 0/3 (0%) 0/3 (0%) 1/2 (50%) 1 0/6 (0%) 1 0/4 (0%) 1
Hepatobiliary disorders
Gallbladder obstruction 1/3 (33.3%) 1 0/3 (0%) 1 0/3 (0%) 1 0/2 (0%) 1 0/6 (0%) 1 0/4 (0%) 1
Infections and infestations
Lung infection 0/3 (0%) 1/3 (33.3%) 1 0/3 (0%) 1 0/2 (0%) 1 0/6 (0%) 1 0/4 (0%) 1
Skin infection 0/3 (0%) 0/3 (0%) 1/3 (33.3%) 1 0/2 (0%) 1 0/6 (0%) 1 0/4 (0%) 1
Urinary tract infection 0/3 (0%) 0/3 (0%) 0/3 (0%) 1/2 (50%) 1 0/6 (0%) 1 0/4 (0%) 1
Investigations
CPK increased 0/3 (0%) 0/3 (0%) 1/3 (33.3%) 1 0/2 (0%) 1 0/6 (0%) 1 0/4 (0%) 1
Creatinine increased 0/3 (0%) 0/3 (0%) 2/3 (66.7%) 2 0/2 (0%) 2 0/6 (0%) 2 0/4 (0%) 2
Metabolism and nutrition disorders
Dehydration 0/3 (0%) 0/3 (0%) 1/3 (33.3%) 1 0/2 (0%) 1 0/6 (0%) 1 0/4 (0%) 1
Musculoskeletal and connective tissue disorders
Bone pain 0/3 (0%) 0/3 (0%) 1/3 (33.3%) 1 0/2 (0%) 1 0/6 (0%) 1 0/4 (0%) 1
Generalized muscle weakness 0/3 (0%) 0/3 (0%) 1/3 (33.3%) 1 0/2 (0%) 1 0/6 (0%) 1 0/4 (0%) 1
Muscle weakness lower limb 0/3 (0%) 0/3 (0%) 0/3 (0%) 1/2 (50%) 1 0/6 (0%) 1 0/4 (0%) 1
Back pain 0/3 (0%) 0/3 (0%) 0/3 (0%) 0/2 (0%) 1/6 (16.7%) 1 0/4 (0%) 1
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Neoplasms benign, malignant and unspecified (incl cysts and polyps) - Other, specify 0/3 (0%) 1/3 (33.3%) 1 0/3 (0%) 1 1/2 (50%) 1 1/6 (16.7%) 1 1/4 (25%) 1
Nervous system disorders
Transient ischemic attacks 0/3 (0%) 0/3 (0%) 1/3 (33.3%) 1 0/2 (0%) 1 0/6 (0%) 1 0/4 (0%) 1
Vasovagal reaction 0/3 (0%) 0/3 (0%) 0/3 (0%) 0/2 (0%) 1/6 (16.7%) 1 0/4 (0%) 1
Psychiatric disorders
Confusion 0/3 (0%) 0/3 (0%) 1/3 (33.3%) 1 0/2 (0%) 1 0/6 (0%) 1 0/4 (0%) 1
Renal and urinary disorders
Acute kidney injury 0/3 (0%) 0/3 (0%) 2/3 (66.7%) 2 0/2 (0%) 2 0/6 (0%) 2 0/4 (0%) 2
Urinary retention 0/3 (0%) 0/3 (0%) 1/3 (33.3%) 1 0/2 (0%) 1 0/6 (0%) 1 0/4 (0%) 1
Bladder spasm 0/3 (0%) 0/3 (0%) 0/3 (0%) 1/2 (50%) 1 0/6 (0%) 1 0/4 (0%) 1
Other (Not Including Serious) Adverse Events
TRC105 1 mg/kg Every 2 Weeks TRC105 3 mg/kg Every 2 Weeks TRC105 10 mg/kg Every 2 Weeks TRC105 10 mg/kg Weekly TRC105 15 mg/kg Every 2 Weeks TRC105 20 mg/kg Every 2 Weeks
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total 3/3 (100%) 3/3 (100%) 3/3 (100%) 2/2 (100%) 5/6 (83.3%) 4/4 (100%)
Blood and lymphatic system disorders
Anemia 2/3 (66.7%) 3 2/3 (66.7%) 2 3/3 (100%) 14 2/2 (100%) 3 2/6 (33.3%) 5 3/4 (75%) 7
Cardiac disorders
Sinus tachycardia 1/3 (33.3%) 2 0/3 (0%) 2 1/3 (33.3%) 1 1/2 (50%) 1 0/6 (0%) 1 0/4 (0%) 1
Chest pain - cardiac 0/3 (0%) 2/3 (66.7%) 2 0/3 (0%) 2 0/2 (0%) 2 0/6 (0%) 2 0/4 (0%) 2
Sinus bradycardia 0/3 (0%) 1/3 (33.3%) 1 0/3 (0%) 1 0/2 (0%) 1 0/6 (0%) 1 0/4 (0%) 1
Atrial fibrillation 0/3 (0%) 0/3 (0%) 1/3 (33.3%) 2 0/2 (0%) 2 0/6 (0%) 2 0/4 (0%) 2
Gastrointestinal disorders
Constipation 1/3 (33.3%) 1 2/3 (66.7%) 2 2/3 (66.7%) 2 0/2 (0%) 2 1/6 (16.7%) 1 0/4 (0%) 1
Dry mouth 1/3 (33.3%) 1 0/3 (0%) 1 1/3 (33.3%) 1 0/2 (0%) 1 0/6 (0%) 1 0/4 (0%) 1
Nausea 1/3 (33.3%) 2 2/3 (66.7%) 3 2/3 (66.7%) 5 2/2 (100%) 4 0/6 (0%) 4 0/4 (0%) 4
Abdominal pain 0/3 (0%) 2/3 (66.7%) 2 1/3 (33.3%) 1 1/2 (50%) 1 0/6 (0%) 1 0/4 (0%) 1
Gastritis 0/3 (0%) 1/3 (33.3%) 1 0/3 (0%) 1 0/2 (0%) 1 0/6 (0%) 1 0/4 (0%) 1
Gastroesophageal reflux disease 0/3 (0%) 1/3 (33.3%) 1 0/3 (0%) 1 0/2 (0%) 1 0/6 (0%) 1 0/4 (0%) 1
Vomiting 0/3 (0%) 3/3 (100%) 3 1/3 (33.3%) 1 2/2 (100%) 3 0/6 (0%) 3 0/4 (0%) 3
Duodenal ulcer 0/3 (0%) 0/3 (0%) 1/3 (33.3%) 1 0/2 (0%) 1 0/6 (0%) 1 0/4 (0%) 1
Dysphagia 0/3 (0%) 0/3 (0%) 1/3 (33.3%) 1 0/2 (0%) 1 0/6 (0%) 1 0/4 (0%) 1
Gastrointestinal disorders - Other, specify (black tarry stools) 0/3 (0%) 0/3 (0%) 1/3 (33.3%) 1 0/2 (0%) 1 0/6 (0%) 1 0/4 (0%) 1
Hemorrhoids 0/3 (0%) 0/3 (0%) 2/3 (66.7%) 2 0/2 (0%) 2 0/6 (0%) 2 0/4 (0%) 2
Periodontal disease 0/3 (0%) 0/3 (0%) 1/3 (33.3%) 1 1/2 (50%) 1 0/6 (0%) 1 0/4 (0%) 1
Diarrhea 0/3 (0%) 0/3 (0%) 0/3 (0%) 1/2 (50%) 2 0/6 (0%) 2 0/4 (0%) 2
Mucositis oral 0/3 (0%) 0/3 (0%) 0/3 (0%) 1/2 (50%) 1 0/6 (0%) 1 0/4 (0%) 1
Oral hemorrhage 0/3 (0%) 0/3 (0%) 0/3 (0%) 1/2 (50%) 1 3/6 (50%) 3 1/4 (25%) 1
Upper gastrointestinal hemorrhage 0/3 (0%) 0/3 (0%) 0/3 (0%) 1/2 (50%) 1 0/6 (0%) 1 0/4 (0%) 1
Gastrointestinal disorders - Other, specify (gastroenteritis) 0/3 (0%) 0/3 (0%) 0/3 (0%) 0/2 (0%) 0/6 (0%) 1/4 (25%) 1
General disorders
Chills 2/3 (66.7%) 2 3/3 (100%) 3 1/3 (33.3%) 2 0/2 (0%) 2 2/6 (33.3%) 2 1/4 (25%) 1
Edema limbs 1/3 (33.3%) 1 0/3 (0%) 1 3/3 (100%) 3 1/2 (50%) 1 1/6 (16.7%) 1 1/4 (25%) 1
Fatigue 1/3 (33.3%) 1 1/3 (33.3%) 2 0/3 (0%) 2 1/2 (50%) 1 1/6 (16.7%) 1 2/4 (50%) 3
Fever 1/3 (33.3%) 2 2/3 (66.7%) 6 3/3 (100%) 13 0/2 (0%) 13 1/6 (16.7%) 1 2/4 (50%) 4
Infusion related reaction 2/3 (66.7%) 5 1/3 (33.3%) 1 2/3 (66.7%) 2 0/2 (0%) 2 0/6 (0%) 2 1/4 (25%) 2
Pain 1/3 (33.3%) 4 1/3 (33.3%) 2 2/3 (66.7%) 2 1/2 (50%) 1 1/6 (16.7%) 2 2/4 (50%) 4
Malaise 0/3 (0%) 0/3 (0%) 1/3 (33.3%) 1 0/2 (0%) 1 0/6 (0%) 1 0/4 (0%) 1
Infusion site extravasation 0/3 (0%) 0/3 (0%) 0/3 (0%) 0/2 (0%) 1/6 (16.7%) 1 0/4 (0%) 1
Infections and infestations
Urinary tract infection 1/3 (33.3%) 1 1/3 (33.3%) 1 1/3 (33.3%) 1 0/2 (0%) 1 0/6 (0%) 1 0/4 (0%) 1
Mucosal infection 0/3 (0%) 0/3 (0%) 0/3 (0%) 1/2 (50%) 1 0/6 (0%) 1 0/4 (0%) 1
Lung infection 0/3 (0%) 0/3 (0%) 0/3 (0%) 0/2 (0%) 0/6 (0%) 1/4 (25%) 1
Injury, poisoning and procedural complications
Bruising 0/3 (0%) 0/3 (0%) 1/3 (33.3%) 1 0/2 (0%) 1 0/6 (0%) 1 0/4 (0%) 1
Fall 0/3 (0%) 0/3 (0%) 1/3 (33.3%) 2 0/2 (0%) 2 0/6 (0%) 2 0/4 (0%) 2
Fracture 0/3 (0%) 0/3 (0%) 1/3 (33.3%) 1 0/2 (0%) 1 0/6 (0%) 1 0/4 (0%) 1
Vascular access complication 0/3 (0%) 0/3 (0%) 0/3 (0%) 0/2 (0%) 1/6 (16.7%) 1 0/4 (0%) 1
Investigations
Activated partial thromboplastin time prolonged 1/3 (33.3%) 3 0/3 (0%) 3 1/3 (33.3%) 1 0/2 (0%) 1 0/6 (0%) 1 0/4 (0%) 1
Creatinine increased 1/3 (33.3%) 1 0/3 (0%) 1 1/3 (33.3%) 1 0/2 (0%) 1 1/6 (16.7%) 1 1/4 (25%) 1
Fibrinogen decreased 1/3 (33.3%) 2 0/3 (0%) 2 0/3 (0%) 2 0/2 (0%) 2 0/6 (0%) 2 0/4 (0%) 2
Platelet count decreased 2/3 (66.7%) 2 1/3 (33.3%) 1 1/3 (33.3%) 1 0/2 (0%) 1 0/6 (0%) 1 0/4 (0%) 1
Weight gain 1/3 (33.3%) 1 0/3 (0%) 1 0/3 (0%) 1 0/2 (0%) 1 0/6 (0%) 1 0/4 (0%) 1
Alkaline phosphatase increased 0/3 (0%) 1/3 (33.3%) 2 0/3 (0%) 2 1/2 (50%) 1 1/6 (16.7%) 1 0/4 (0%) 1
Aspartate aminotransferase increased 0/3 (0%) 1/3 (33.3%) 1 0/3 (0%) 1 0/2 (0%) 1 0/6 (0%) 1 1/4 (25%) 1
White blood cell decreased 0/3 (0%) 1/3 (33.3%) 1 0/3 (0%) 1 0/2 (0%) 1 0/6 (0%) 1 0/4 (0%) 1
CPK increased 0/3 (0%) 0/3 (0%) 1/3 (33.3%) 2 0/2 (0%) 2 0/6 (0%) 2 0/4 (0%) 2
Weight loss 0/3 (0%) 0/3 (0%) 2/3 (66.7%) 4 0/2 (0%) 4 0/6 (0%) 4 0/4 (0%) 4
Alanine aminotransferase increased 0/3 (0%) 0/3 (0%) 0/3 (0%) 0/2 (0%) 0/6 (0%) 1/4 (25%) 1
Metabolism and nutrition disorders
Hyperglycemia 1/3 (33.3%) 4 2/3 (66.7%) 5 0/3 (0%) 5 0/2 (0%) 5 0/6 (0%) 5 0/4 (0%) 5
Hyperkalemia 1/3 (33.3%) 1 0/3 (0%) 1 0/3 (0%) 1 0/2 (0%) 1 1/6 (16.7%) 2 0/4 (0%) 2
Hypophosphatemia 1/3 (33.3%) 1 1/3 (33.3%) 1 1/3 (33.3%) 1 1/2 (50%) 1 0/6 (0%) 1 1/4 (25%) 1
Anorexia 0/3 (0%) 1/3 (33.3%) 1 2/3 (66.7%) 2 0/2 (0%) 2 0/6 (0%) 2 1/4 (25%) 1
Dehydration 0/3 (0%) 0/3 (0%) 1/3 (33.3%) 1 0/2 (0%) 1 0/6 (0%) 1 1/4 (25%) 1
Hypermagnesemia 0/3 (0%) 0/3 (0%) 1/3 (33.3%) 1 0/2 (0%) 1 0/6 (0%) 1 0/4 (0%) 1
Hyperuricemia 0/3 (0%) 0/3 (0%) 2/3 (66.7%) 3 0/2 (0%) 3 0/6 (0%) 3 0/4 (0%) 3
Hypoalbuminemia 0/3 (0%) 0/3 (0%) 1/3 (33.3%) 1 0/2 (0%) 1 1/6 (16.7%) 1 1/4 (25%) 1
Hypocalcemia 0/3 (0%) 0/3 (0%) 2/3 (66.7%) 2 0/2 (0%) 2 1/6 (16.7%) 1 1/4 (25%) 1
Hypokalemia 0/3 (0%) 0/3 (0%) 2/3 (66.7%) 3 1/2 (50%) 1 0/6 (0%) 1 0/4 (0%) 1
Hypomagnesemia 0/3 (0%) 0/3 (0%) 1/3 (33.3%) 2 0/2 (0%) 2 0/6 (0%) 2 0/4 (0%) 2
Musculoskeletal and connective tissue disorders
Back pain 1/3 (33.3%) 1 0/3 (0%) 1 1/3 (33.3%) 1 1/2 (50%) 1 0/6 (0%) 1 0/4 (0%) 1
Bone pain 2/3 (66.7%) 2 3/3 (100%) 4 2/3 (66.7%) 6 0/2 (0%) 6 0/6 (0%) 6 1/4 (25%) 1
Muscle weakness upper limb 1/3 (33.3%) 1 0/3 (0%) 1 0/3 (0%) 1 0/2 (0%) 1 0/6 (0%) 1 0/4 (0%) 1
Myalgia 1/3 (33.3%) 2 1/3 (33.3%) 1 0/3 (0%) 1 0/2 (0%) 1 1/6 (16.7%) 1 1/4 (25%) 1
Chest wall pain 0/3 (0%) 0/3 (0%) 1/3 (33.3%) 1 0/2 (0%) 1 0/6 (0%) 1 0/4 (0%) 1
Generalized muscle weakness 0/3 (0%) 0/3 (0%) 0/3 (0%) 1/2 (50%) 1 0/6 (0%) 1 0/4 (0%) 1
Musculoskeletal and connective tissue disorder - Other, specify 0/3 (0%) 0/3 (0%) 0/3 (0%) 0/2 (0%) 1/6 (16.7%) 1 0/4 (0%) 1
Neck pain 0/3 (0%) 0/3 (0%) 0/3 (0%) 0/2 (0%) 1/6 (16.7%) 1 0/4 (0%) 1
Nervous system disorders
Dysgeusia 1/3 (33.3%) 1 0/3 (0%) 1 0/3 (0%) 1 0/2 (0%) 1 0/6 (0%) 1 0/4 (0%) 1
Headache 2/3 (66.7%) 2 3/3 (100%) 9 1/3 (33.3%) 1 2/2 (100%) 2 3/6 (50%) 4 3/4 (75%) 4
Memory impairment 1/3 (33.3%) 1 0/3 (0%) 1 0/3 (0%) 1 0/2 (0%) 1 0/6 (0%) 1 0/4 (0%) 1
Peripheral sensory neuropathy 1/3 (33.3%) 2 0/3 (0%) 2 0/3 (0%) 2 0/2 (0%) 2 0/6 (0%) 2 0/4 (0%) 2
Neuralgia 0/3 (0%) 1/3 (33.3%) 2 0/3 (0%) 2 0/2 (0%) 2 0/6 (0%) 2 0/4 (0%) 2
Cognitive disturbance 0/3 (0%) 0/3 (0%) 1/3 (33.3%) 1 0/2 (0%) 1 0/6 (0%) 1 0/4 (0%) 1
Transient ischemic attacks 0/3 (0%) 0/3 (0%) 1/3 (33.3%) 1 0/2 (0%) 1 0/6 (0%) 1 0/4 (0%) 1
Tremor 0/3 (0%) 0/3 (0%) 1/3 (33.3%) 1 0/2 (0%) 1 0/6 (0%) 1 0/4 (0%) 1
Trigeminal nerve disorder 0/3 (0%) 0/3 (0%) 1/3 (33.3%) 1 0/2 (0%) 1 0/6 (0%) 1 0/4 (0%) 1
Psychiatric disorders
Anxiety 0/3 (0%) 0/3 (0%) 0/3 (0%) 0/2 (0%) 0/6 (0%) 1/4 (25%) 1
Renal and urinary disorders
Hematuria 1/3 (33.3%) 1 0/3 (0%) 1 0/3 (0%) 1 1/2 (50%) 1 0/6 (0%) 1 0/4 (0%) 1
Renal and urinary disorders - Other, specify (initiating urination) 1/3 (33.3%) 1 0/3 (0%) 1 0/3 (0%) 1 0/2 (0%) 1 0/6 (0%) 1 0/4 (0%) 1
Urinary tract obstruction 1/3 (33.3%) 1 0/3 (0%) 1 1/3 (33.3%) 1 0/2 (0%) 1 0/6 (0%) 1 0/4 (0%) 1
Proteinuria 0/3 (0%) 1/3 (33.3%) 1 0/3 (0%) 1 0/2 (0%) 1 0/6 (0%) 1 0/4 (0%) 1
Urinary frequency 0/3 (0%) 0/3 (0%) 1/3 (33.3%) 1 0/2 (0%) 1 0/6 (0%) 1 0/4 (0%) 1
Urinary retention 0/3 (0%) 0/3 (0%) 1/3 (33.3%) 1 0/2 (0%) 1 0/6 (0%) 1 0/4 (0%) 1
Urinary tract pain 0/3 (0%) 0/3 (0%) 1/3 (33.3%) 1 0/2 (0%) 1 0/6 (0%) 1 0/4 (0%) 1
Bladder spasm 0/3 (0%) 0/3 (0%) 0/3 (0%) 1/2 (50%) 1 0/6 (0%) 1 0/4 (0%) 1
Respiratory, thoracic and mediastinal disorders
Cough 1/3 (33.3%) 1 1/3 (33.3%) 1 2/3 (66.7%) 2 0/2 (0%) 2 0/6 (0%) 2 0/4 (0%) 2
Dyspnea 1/3 (33.3%) 1 0/3 (0%) 1 1/3 (33.3%) 1 0/2 (0%) 1 0/6 (0%) 1 2/4 (50%) 2
Bronchopulmonary hemorrhage 0/3 (0%) 0/3 (0%) 1/3 (33.3%) 1 0/2 (0%) 1 0/6 (0%) 1 0/4 (0%) 1
Epistaxis 0/3 (0%) 0/3 (0%) 2/3 (66.7%) 2 2/2 (100%) 2 4/6 (66.7%) 7 2/4 (50%) 3
Hoarseness 0/3 (0%) 0/3 (0%) 1/3 (33.3%) 1 0/2 (0%) 1 0/6 (0%) 1 0/4 (0%) 1
Wheezing 0/3 (0%) 0/3 (0%) 1/3 (33.3%) 1 0/2 (0%) 1 0/6 (0%) 1 0/4 (0%) 1
Skin and subcutaneous tissue disorders
Hyperhidrosis 1/3 (33.3%) 1 0/3 (0%) 1 1/3 (33.3%) 2 0/2 (0%) 2 0/6 (0%) 2 0/4 (0%) 2
Skin and subcutaneous tissue disorders - Other, specify (petechiae) 0/3 (0%) 0/3 (0%) 1/3 (33.3%) 1 0/2 (0%) 1 0/6 (0%) 1 0/4 (0%) 1
Skin ulceration 0/3 (0%) 0/3 (0%) 1/3 (33.3%) 1 0/2 (0%) 1 0/6 (0%) 1 0/4 (0%) 1
Purpura 0/3 (0%) 0/3 (0%) 0/3 (0%) 1/2 (50%) 1 0/6 (0%) 1 0/4 (0%) 1
Rash maculo-papular 0/3 (0%) 0/3 (0%) 0/3 (0%) 1/2 (50%) 1 0/6 (0%) 1 1/4 (25%) 1
Pruritus 0/3 (0%) 0/3 (0%) 0/3 (0%) 0/2 (0%) 0/6 (0%) 1/4 (25%) 1
Vascular disorders
Flushing 1/3 (33.3%) 1 1/3 (33.3%) 1 2/3 (66.7%) 3 0/2 (0%) 3 2/6 (33.3%) 4 1/4 (25%) 1
Hypotension 1/3 (33.3%) 1 0/3 (0%) 1 1/3 (33.3%) 1 0/2 (0%) 1 0/6 (0%) 1 0/4 (0%) 1
Hot flashes 0/3 (0%) 0/3 (0%) 0/3 (0%) 1/2 (50%) 1 0/6 (0%) 1 0/4 (0%) 1
Thromboembolic event 0/3 (0%) 0/3 (0%) 0/3 (0%) 1/2 (50%) 1 0/6 (0%) 1 0/4 (0%) 1

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

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

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.

Results Point of Contact

Name/Title Dr. William Dahut
Organization National Cancer Institute
Phone 301-496-4251
Email dahutw@mail.nih.gov
Responsible Party:
William Dahut Jr., M.D., Principal Investigator, National Institutes of Health Clinical Center (CC)
ClinicalTrials.gov Identifier:
NCT01090765
Other Study ID Numbers:
  • 100062
  • 10-C-0062
First Posted:
Mar 22, 2010
Last Update Posted:
May 22, 2018
Last Verified:
Apr 1, 2018