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FIERCE-21: Dose Escalation, Expansion Study of Vofatamab (B-701) in Treatment of Locally Advanced or Metastatic Urothelial Cell Carcinoma

Sponsor
Rainier Therapeutics (Industry)
Overall Status
Terminated
CT.gov ID
NCT02401542
Collaborator
(none)
71
Enrollment
65
Locations
3
Arms
53
Duration (Months)
1.1
Patients Per Site
0
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

This is a Phase 1/2(b), sequential, dose escalation, open-label, randomized expansion, multicenter, efficacy and safety study of vofatamab alone or in combination with docetaxel, or versus docetaxel in FGFR3 mutant/fusion subjects with Stage IV, locally advanced or metastatic UCC who have relapsed after, or are refractory to at least one prior line of chemotherapy. This study is divided into 3 phases: Phase 1b (Cohort 1), Phase 2 (Cohorts 2 and 3), and Phase 2b (Monotherapy Expansion Phase and Randomized Phase).

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

Detailed Description

This is a Phase 1/2(b), sequential, dose escalation, open-label, randomized expansion, multicenter, efficacy and safety study of vofatamab alone or in combination with docetaxel, or versus docetaxel in FGFR3 mutant/fusion subjects with Stage IV, locally advanced or metastatic UCC who have relapsed after, or are refractory to at least one prior line of chemotherapy. Vofatamab is a novel monoclonal antibody specific for fibroblast growth factor receptor 3 (FGFR3) that is being developed to target FGFR3-positive tumors.

This study is divided into 3 phases: Phase 1b (Cohort 1), Phase 2 (Cohorts 2 and 3), and Phase 2b (Monotherapy Expansion Phase and Randomized Phase).

Study Design

Study Type:
Interventional
Actual Enrollment :
71 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
A Dose Escalation, Expansion Study of Vofatamab (B-701) Alone, Plus Docetaxel, or Versus Docetaxel in Subjects With Locally Advanced or Metastatic Urothelial Cell Carcinoma Who Have Relapsed After, or Are Refractory to Standard Therapy
Study Start Date :
Jun 1, 2015
Actual Primary Completion Date :
Nov 1, 2019
Actual Study Completion Date :
Nov 1, 2019

Arms and Interventions

Arm Intervention/Treatment
Active Comparator: Vofatamab plus docetaxel

IV infusion of docetaxel, 75 mg/m2, followed by IV infusion of vofatamab, 25 mg/kg, on day one of each 21-day cycle. One additional IV infusion of vofatamab (25 mg/kg) given on Day 8 of Cycle 1. Dosing with vofatamab and docetaxel will continue in each patient until disease progression, unacceptable toxicity, death, or study exit, including withdrawal of patient consent or study termination. Docetaxel treatment beyond 12 cycles of therapy may be considered at the discretion of the treating investigator and Medical Monitor.

Drug: Vofatamab
Other Names:
  • B-701
  • MFGR1877S
  • R3Mab

    • Drug: Docetaxel
    Other Names:
  • Docefrez
  • Taxotere

    		•
    Placebo Comparator: Placebo plus docetaxel

    IV infusion of docetaxel, 75 mg/m2, followed by IV infusion of placebo on day one of each 21-day cycle. One additional IV infusion of placebo given on Day 8 of Cycle 1. Dosing of docetaxel and placebo will continue in each patient until disease progression, unacceptable toxicity, death, or study exit, including withdrawal of patient consent or study termination. Docetaxel treatment beyond 12 cycles of therapy may be considered at the discretion of the treating investigator and Medical Monitor

    Drug: Docetaxel
    Other Names:
  • Docefrez
  • Taxotere

    • Drug: Placebo
    Experimental: Vofatamab

    IV infusion vofatamab, 25 mg/kg on day one each 21-day cycle. One additional IV infusion of vofatamab (25 mg/kg) given on Day 8 of Cycle 1. Dosing of vofatamab will continue in each patient until disease progression, unacceptable toxicity, death, or study exit, including withdrawal of patient consent or study termination.

    Drug: Vofatamab
    Other Names:
  • B-701
  • MFGR1877S
  • R3Mab

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Primary Efficacy Outcome: Progression Free Survival (PFS) [3-4 years]

      Efficacy of vofatamab plus docetaxel, compared with docetaxel plus placebo, and vofatamab alone as measured by PFS; measured from randomization to first occurrence of disease progression (per RECIST v1.1) or death, whichever occurs first. A patient has had to receive at least one vofatamab dose. Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions.

    Eligibility Criteria

    Criteria

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

    1. Stage IV, locally advanced or metastatic (T4b, any N; or any T, N2-3) urothelial bladder cancer or TCC arising in another location of the urinary tract, including urethra, ureter, and renal pelvis

    2. Histological or cytological diagnosis of UCC.

    3. Relapsed after or are refractory to at least one prior line of chemotherapy which has not included a taxane (with the exception of Cohort 3 of Phase 2 and Phase 2b Monotherapy Expansion of Phase 2b which will allow the enrollment of patients with prior treatment with a taxane)

    4. Subjects must have received at least one prior chemotherapeutic regimen (at least one cycle each) for advanced or metastatic/recurrent disease, of which at least one regimen included a platinum agent (unless contraindicated).

    5. Prior neoadjuvant or adjuvant chemotherapy (without a taxane, except Cohort 3 of Phase 2 and Phase 2b Monotherapy Expansion, which will allow the enrollment of subjects with prior treatment with a taxane) is permitted and will not be counted as first-line chemotherapy, as long as the subject has not progressed within 12 months of the last dose.

    6. Measurable disease according to Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST v1.1)

    Phase 2 and Phase 2b Specific Inclusion Criteria:

    1. Patient must be confirmed to have a FGFR3 genomic alteration at the time of documentation of advanced disease.

    2. Relapsed after or are refractory to an immune checkpoint inhibitor. This inclusion criterion does not apply if the checkpoint inhibitor is contraindicated.

    Main Exclusion Criteria:

    • Prior anti-cancer therapy within 2 weeks prior to Cycle 1, Day 1

    • Prior treatment with an inhibitor that is targeted primarily to FGFRs

    • Clinically significant comorbid medical conditions or lab abnormalities

    • History of major bleeding (requiring a blood transfusion ≥ 2 units) not related to a tumor within the past 12 months

    • History of clinically significant coagulation or platelet disorder in the past 12 months

    • Currently receiving anticoagulation treatment

    • Incomplete healing from wounds from prior surgery

    • Known active bacterial, viral, fungal, mycobacterial, parasitic, or other infection at screening

    • Presence of positive test results for Hepatitis B or Hepatitis C

    • Known history of human immunodeficiency virus (HIV) seropositive status

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Research Site Gilbert Arizona United States 85234
    2 Research Site Goodyear Arizona United States 85338
    3 Research Site Duarte California United States 91010
    4 Research Site Miami Florida United States 33140
    5 Reaserach Site Fort Wayne Indiana United States 46845
    6 Research Site Louisville Kentucky United States 40202
    7 Research Site Boston Massachusetts United States 02215
    8 Research Site Detroit Michigan United States 48201
    9 Research Site Rochester Minnesota United States 55905
    10 Research Site Syracuse New York United States 13210
    11 Research Site Dallas Texas United States 75390-9110
    12 Research Site Olomouc Czechia 77900
    13 Research Site Prague Czechia 12808
    14 Research Site Ancona Italy 60126
    15 Research Site Catania Italy 95123
    16 Research Site Milan Italy 20132
    17 Research Site Milan Italy 20133
    18 Research Site Milan Italy 20141
    19 Research Site Modena Italy 41124
    20 Research Site Napoli Italy 80131
    21 Research Site Negrar Italy 37024
    22 Research Site Siena Italy 53100
    23 Research Site Gwangju Korea, Republic of 61469
    24 Research Site Incheon Korea, Republic of 405-760
    25 Research Site Seongnam-si Korea, Republic of 13620
    26 Research Site Seoul Korea, Republic of 02841
    27 Research Site Seoul Korea, Republic of 03080
    28 Research Site Seoul Korea, Republic of 03722
    29 Research Site Seoul Korea, Republic of 05505
    30 Research Site Seoul Korea, Republic of 06351
    31 Research Site Badalona Spain 08916
    32 Research Site Barcelona Spain 08003
    33 Research Site Barcelona Spain 08026
    34 Research Site Barcelona Spain 08036
    35 Research Site Barcelona Spain 08908
    36 Research Site Granada Spain 18014
    37 Research Site Lugo Spain 27003
    38 Research Site Madrid Spain 28007
    39 Research Site Madrid Spain 28033
    40 Research Site Madrid Spain 28041
    41 Research Site Madrid Spain 28046
    42 Research Site Madrid Spain 28050
    43 Research Site Oviedo Spain 33011
    44 Research Site Pamplona Spain 31008
    45 Research Site Valencia Spain 46009
    46 Research Site Vigo Spain 36204
    47 Research Site Uppsala Sweden 751 85
    48 Research Site Kaohsiung Taiwan 81362
    49 Research Site Kaohsiung Taiwan 83301
    50 Research Site Taichung Taiwan 40447
    51 Research Site Taichung Taiwan 435
    52 Research Site Tainan Taiwan 704
    53 Research Site Taipei Taiwan 110
    54 Research Site Taipei Taiwan 11217
    55 Research Site Taoyuan Taiwan 333
    56 Research Site Adana Turkey 01330
    57 Research Site Ankara Turkey 06590
    58 Research Site Antalya Turkey 07059
    59 Research Site Bursa Turkey 16059
    60 Research Site Edirne Turkey 22030
    61 Research Site İstanbul Turkey 34732
    62 Research Site İzmir Turkey 35340
    63 Research Site Malatya Turkey 44280
    64 Research Site London United Kingdom SW36JJ
    65 Research Site Preston United Kingdom PR29HT

    Sponsors and Collaborators

    • Rainier Therapeutics

    Investigators

    • Study Chair: Rainier Therapeutics, Rainier Therapeutics

    Study Documents (Full-Text)

    More Information

    Publications

    None provided.
    Responsible Party:
    Rainier Therapeutics
    ClinicalTrials.gov Identifier:
    NCT02401542
    Other Study ID Numbers:
    • B-701-U21
    • 2017-001319-36
    First Posted:
    Mar 30, 2015
    Last Update Posted:
    Mar 9, 2020
    Last Verified:
    Feb 1, 2020
    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 Rainier Therapeutics
    Urothelial Cell Carcinoma
    UCC
    bladder cancer
    vofatamab
    FGFR3
    invasive bladder cancer
    targeted therapy
    Transitional Cell Carcinoma
    TCC
    Phase 2
    second line therapy
    monoclonal antibody
    docetaxel
    combination therapy
    Phase 1
    monotherapy
    B-701
    Additional relevant MeSH terms:
    Carcinoma
    Urinary Bladder Diseases
    Urologic Diseases
    Docetaxel

    Study Results

    Participant Flow

    Recruitment Details
    Pre-assignment Detail
    Arm/Group Title Vofatamab Plus Docetaxel Vofatamab Placebo Plus Docetaxel
    Arm/Group Description IV infusion of docetaxel, 75 mg/m2, followed by IV infusion of vofatamab, 25 mg/kg, on day one of each 21-day cycle. One additional IV infusion of vofatamab (25 mg/kg) given on Day 8 of Cycle 1. Dosing with vofatamab and docetaxel will continue in each patient until disease progression, unacceptable toxicity, death, or study exit, including withdrawal of patient consent or study termination. Docetaxel treatment beyond 12 cycles of therapy may be considered at the discretion of the treating investigator and Medical Monitor. Vofatamab Docetaxel IV infusion vofatamab, 25 mg/kg on day one each 21-day cycle. One additional IV infusion of vofatamab (25 mg/kg) given on Day 8 of Cycle 1. Dosing of vofatamab will continue in each patient until disease progression, unacceptable toxicity, death, or study exit, including withdrawal of patient consent or study termination. Vofatamab IV infusion of docetaxel, 75 mg/m2, followed by IV infusion of placebo on day one of each 21-day cycle. One additional IV infusion of placebo given on Day 8 of Cycle 1. Dosing of docetaxel and placebo will continue in each patient until disease progression, unacceptable toxicity, death, or study exit, including withdrawal of patient consent or study termination. Docetaxel treatment beyond 12 cycles of therapy may be considered at the discretion of the treating investigator and Medical Monitor Docetaxel Placebo
    Period Title: Overall Study
    STARTED 41 30 0
    COMPLETED 40 30 0
    NOT COMPLETED 1 0 0

    Baseline Characteristics

    Arm/Group Title Vofatamab Plus Docetaxel Vofatamab Placebo Plus Docetaxel Total
    Arm/Group Description IV infusion of docetaxel, 75 mg/m2, followed by IV infusion of vofatamab, 25 mg/kg, on day one of each 21-day cycle. One additional IV infusion of vofatamab (25 mg/kg) given on Day 8 of Cycle 1. Dosing with vofatamab and docetaxel will continue in each patient until disease progression, unacceptable toxicity, death, or study exit, including withdrawal of patient consent or study termination. Docetaxel treatment beyond 12 cycles of therapy may be considered at the discretion of the treating investigator and Medical Monitor. Vofatamab Docetaxel IV infusion vofatamab, 25 mg/kg on day one each 21-day cycle. One additional IV infusion of vofatamab (25 mg/kg) given on Day 8 of Cycle 1. Dosing of vofatamab will continue in each patient until disease progression, unacceptable toxicity, death, or study exit, including withdrawal of patient consent or study termination. Vofatamab IV infusion of docetaxel, 75 mg/m2, followed by IV infusion of placebo on day one of each 21-day cycle. One additional IV infusion of placebo given on Day 8 of Cycle 1. Dosing of docetaxel and placebo will continue in each patient until disease progression, unacceptable toxicity, death, or study exit, including withdrawal of patient consent or study termination. Docetaxel treatment beyond 12 cycles of therapy may be considered at the discretion of the treating investigator and Medical Monitor Docetaxel Placebo Total of all reporting groups
    Overall Participants 40 30 0 70
    Age (Count of Participants)
    <=18 years
    0
    0%
    0
    0%
    0
    NaN
    0
    0%
    Between 18 and 65 years
    20
    50%
    12
    40%
    0
    NaN
    32
    45.7%
    >=65 years
    20
    50%
    18
    60%
    0
    NaN
    38
    54.3%
    Sex: Female, Male (Count of Participants)
    Female
    7
    17.5%
    6
    20%
    0
    NaN
    13
    18.6%
    Male
    33
    82.5%
    24
    80%
    0
    NaN
    57
    81.4%
    Race (NIH/OMB) (Count of Participants)
    American Indian or Alaska Native
    0
    0%
    0
    0%
    0
    NaN
    0
    0%
    Asian
    3
    7.5%
    12
    40%
    0
    NaN
    15
    21.4%
    Native Hawaiian or Other Pacific Islander
    0
    0%
    0
    0%
    0
    NaN
    0
    0%
    Black or African American
    1
    2.5%
    0
    0%
    0
    NaN
    1
    1.4%
    White
    36
    90%
    18
    60%
    0
    NaN
    54
    77.1%
    More than one race
    0
    0%
    0
    0%
    0
    NaN
    0
    0%
    Unknown or Not Reported
    0
    0%
    0
    0%
    0
    NaN
    0
    0%

    Outcome Measures

    1. Primary Outcome
    Title Primary Efficacy Outcome: Progression Free Survival (PFS)
    Description Efficacy of vofatamab plus docetaxel, compared with docetaxel plus placebo, and vofatamab alone as measured by PFS; measured from randomization to first occurrence of disease progression (per RECIST v1.1) or death, whichever occurs first. A patient has had to receive at least one vofatamab dose. Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions.
    Time Frame 3-4 years

    Outcome Measure Data

    Analysis Population Description
    [Not Specified]
    Arm/Group Title Mut/Fus Phase 1 Wild Type Phase 1 Mut/Fus Phase 2 Mut/Fus Phase 2 Monotherapy Mut/Fus Phase 2b Monotherapy
    Arm/Group Description Vofatamab plus Docetaxel Vofatamab plus Docetaxel Vofatamab plus Docetaxel Vofatamab Monotherpay Vofatamab Monotherapy
    Measure Participants 6 13 21 21 9
    Mean (Standard Deviation) [Months]
    6.82
    (5.35)
    2.83
    (2.73)
    4.40
    (4.15)
    4.45
    (3.27)
    2.23
    (1.45)

    Adverse Events

    Time Frame Adverse event data was collected from the time of informed consent through 30 days after the last dose of study drug.
    Adverse Event Reporting Description Safety was assessed through summaries of AEs, changes in key laboratory test results, ECGs and changes in vital signs.
    Arm/Group Title Vofatamab Plus Docetaxel Vofatamab Placebo Plus Docetaxel
    Arm/Group Description IV infusion of docetaxel, 75 mg/m2, followed by IV infusion of vofatamab, 25 mg/kg, on day one of each 21-day cycle. One additional IV infusion of vofatamab (25 mg/kg) given on Day 8 of Cycle 1. Dosing with vofatamab and docetaxel will continue in each patient until disease progression, unacceptable toxicity, death, or study exit, including withdrawal of patient consent or study termination. Docetaxel treatment beyond 12 cycles of therapy may be considered at the discretion of the treating investigator and Medical Monitor. Vofatamab Docetaxel IV infusion vofatamab, 25 mg/kg on day one each 21-day cycle. One additional IV infusion of vofatamab (25 mg/kg) given on Day 8 of Cycle 1. Dosing of vofatamab will continue in each patient until disease progression, unacceptable toxicity, death, or study exit, including withdrawal of patient consent or study termination. Vofatamab IV infusion of docetaxel, 75 mg/m2, followed by IV infusion of placebo on day one of each 21-day cycle. One additional IV infusion of placebo given on Day 8 of Cycle 1. Dosing of docetaxel and placebo will continue in each patient until disease progression, unacceptable toxicity, death, or study exit, including withdrawal of patient consent or study termination. Docetaxel treatment beyond 12 cycles of therapy may be considered at the discretion of the treating investigator and Medical Monitor Docetaxel Placebo
    All Cause Mortality
    Vofatamab Plus Docetaxel Vofatamab Placebo Plus Docetaxel
    Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
    Total 2/40 (5%) 1/30 (3.3%) 0/0 (NaN)
    Serious Adverse Events
    Vofatamab Plus Docetaxel Vofatamab Placebo Plus Docetaxel
    Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
    Total 21/40 (52.5%) 6/30 (20%) 0/0 (NaN)
    Blood and lymphatic system disorders
    Febrile Neutropenia 3/40 (7.5%) 3 0/30 (0%) 0 0/0 (NaN) 0
    Neutropenia 2/40 (5%) 2 0/30 (0%) 0 0/0 (NaN) 0
    Disseminated intravascular coagulation 1/40 (2.5%) 1 0/30 (0%) 0 0/0 (NaN) 0
    Thrombocytopenia 1/40 (2.5%) 1 0/30 (0%) 0 0/0 (NaN) 0
    Cardiac disorders
    Atrial fibrillation 1/40 (2.5%) 1 1/30 (3.3%) 1 1/0 (Infinity) 1
    Cyanosis 0/40 (0%) 0 1/30 (3.3%) 1 1/0 (Infinity) 1
    Myocardial infarction 1/40 (2.5%) 1 0/30 (0%) 0 0/0 (NaN) 0
    Gastrointestinal disorders
    Vomiting 2/40 (5%) 2 0/30 (0%) 0 0/0 (NaN) 0
    Abdominal pain 1/40 (2.5%) 1 0/30 (0%) 0 0/0 (NaN) 0
    Anal incontinence 1/40 (2.5%) 1 0/30 (0%) 0 0/0 (NaN) 0
    Constipation 1/40 (2.5%) 1 0/30 (0%) 0 0/0 (NaN) 0
    Diarrhoea 1/40 (2.5%) 1 0/30 (0%) 0 0/0 (NaN) 0
    Large intestinal obstruction 1/40 (2.5%) 1 0/30 (0%) 0 0/0 (NaN) 0
    Nausea 1/40 (2.5%) 1 0/30 (0%) 0 0/0 (NaN) 0
    Pancreatitis 1/40 (2.5%) 1 0/30 (0%) 0 0/0 (NaN) 0
    Rectal haemorrhage 1/40 (2.5%) 1 0/30 (0%) 0 0/0 (NaN) 0
    General disorders
    Pain 2/40 (5%) 2 0/30 (0%) 0 0/0 (NaN) 0
    Chills 0/40 (0%) 0 1/30 (3.3%) 1 1/0 (Infinity) 1
    Fatigue 1/40 (2.5%) 1 0/30 (0%) 0 0/0 (NaN) 0
    Mucosal inflammation 1/40 (2.5%) 1 0/30 (0%) 0 0/0 (NaN) 0
    Non-cardiac chest pain 1/40 (2.5%) 1 0/30 (0%) 0 0/0 (NaN) 0
    Pyrexia 1/40 (2.5%) 1 0/30 (0%) 0 0/0 (NaN) 0
    Hepatobiliary disorders
    Cholecystitis 1/40 (2.5%) 1 0/30 (0%) 0 0/0 (NaN) 0
    Liver injury 1/40 (2.5%) 1 0/30 (0%) 0 0/0 (NaN) 0
    Immune system disorders
    Anaphylactic reaction 1/40 (2.5%) 1 0/30 (0%) 0 0/0 (NaN) 0
    Infections and infestations
    Pneumonia 2/40 (5%) 2 0/30 (0%) 0 0/0 (NaN) 0
    Sepsis 2/40 (5%) 2 0/30 (0%) 0 0/0 (NaN) 0
    Urinary Tract Infection 0/40 (0%) 0 2/30 (6.7%) 2 0/0 (NaN) 0
    Clostridium difficile infection 1/40 (2.5%) 1 0/30 (0%) 0 0/0 (NaN) 0
    Neutropenic infection 1/40 (2.5%) 1 0/30 (0%) 0 0/0 (NaN) 0
    Injury, poisoning and procedural complications
    Infusion related reaction 1/40 (2.5%) 1 1/30 (3.3%) 1 1/0 (Infinity) 1
    Overdose 1/40 (2.5%) 1 0/30 (0%) 0 0/0 (NaN) 0
    Spinal compression fracture 1/40 (2.5%) 1 0/30 (0%) 0 0/0 (NaN) 0
    Urinary tract stoma complication 1/40 (2.5%) 1 0/30 (0%) 0 0/0 (NaN) 0
    Metabolism and nutrition disorders
    Hypercalcaemia 0/40 (0%) 0 2/30 (6.7%) 2 2/0 (Infinity) 2
    Musculoskeletal and connective tissue disorders
    Back pain 0/40 (0%) 0 1/30 (3.3%) 1 1/0 (Infinity) 1
    Pain in extremity 1/40 (2.5%) 1 0/30 (0%) 0 0/0 (NaN) 0
    Nervous system disorders
    Haemorrhage intracranial 1/40 (2.5%) 1 0/30 (0%) 0 0/0 (NaN) 0
    Psychiatric disorders
    Confusional state 1/40 (2.5%) 1 0/30 (0%) 0 0/0 (NaN) 0
    Renal and urinary disorders
    Haematuria 1/40 (2.5%) 1 0/30 (0%) 0 0/0 (NaN) 0
    Renal failure 0/40 (0%) 0 1/30 (3.3%) 1 1/0 (Infinity) 1
    Urinary incontinence 1/40 (2.5%) 1 0/30 (0%) 0 0/0 (NaN) 0
    Reproductive system and breast disorders
    Scrotal oedema 1/40 (2.5%) 1 0/30 (0%) 0 0/0 (NaN) 0
    Respiratory, thoracic and mediastinal disorders
    Dyspnoea 0/40 (0%) 0 1/30 (3.3%) 1 1/0 (Infinity) 1
    Pulmonary embolism 1/40 (2.5%) 1 0/30 (0%) 0 0/0 (NaN) 0
    Pulmonary oedema 1/40 (2.5%) 1 0/30 (0%) 0 0/0 (NaN) 0
    Vascular disorders
    Deep vein thrombosis 1/40 (2.5%) 1 0/30 (0%) 0 0/0 (NaN) 0
    Hypertension 0/40 (0%) 0 1/30 (3.3%) 1 1/0 (Infinity) 1
    Hypotension 1/40 (2.5%) 1 0/30 (0%) 0 0/0 (NaN) 0
    Other (Not Including Serious) Adverse Events
    Vofatamab Plus Docetaxel Vofatamab Placebo Plus Docetaxel
    Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
    Total 40/40 (100%) 30/30 (100%) 0/0 (NaN)
    Blood and lymphatic system disorders
    Anemia 11/40 (27.5%) 11 2/30 (6.7%) 2 2/0 (Infinity) 2
    Anemia aggravated 2/40 (5%) 2 0/30 (0%) 0 0/0 (NaN) 0
    Leukocytosis 3/40 (7.5%) 3 0/30 (0%) 0 0/0 (NaN) 0
    Leukopenia 3/40 (7.5%) 3 0/30 (0%) 0 0/0 (NaN) 0
    Lymphocytopenia 2/40 (5%) 2 0/30 (0%) 0 0/0 (NaN) 0
    Neutropenia 7/40 (17.5%) 7 0/30 (0%) 0 0/0 (NaN) 0
    Thrombocytopenia 0/40 (0%) 0 1/30 (3.3%) 1 1/0 (Infinity) 1
    Cardiac disorders
    Atrial fibrillation 1/40 (2.5%) 1 0/30 (0%) 0 0/0 (NaN) 0
    Sinus tachycardia 1/40 (2.5%) 1 0/30 (0%) 0 0/0 (NaN) 0
    Tachycardia 1/40 (2.5%) 1 0/30 (0%) 0 0/0 (NaN) 0
    Congenital, familial and genetic disorders
    Hydrocele 1/40 (2.5%) 1 0/30 (0%) 0 0/0 (NaN) 0
    Ear and labyrinth disorders
    Ringing in ears 1/40 (2.5%) 1 0/30 (0%) 0 0/0 (NaN) 0
    Eye disorders
    Eye redness 1/40 (2.5%) 1 0/30 (0%) 0 0/0 (NaN) 0
    Eyes tearing 1/40 (2.5%) 1 0/30 (0%) 0 0/0 (NaN) 0
    Flashing lights 1/40 (2.5%) 1 0/30 (0%) 0 0/0 (NaN) 0
    Itching eyes 1/40 (2.5%) 1 0/30 (0%) 0 0/0 (NaN) 0
    Right cataract 1/40 (2.5%) 1 0/30 (0%) 0 0/0 (NaN) 0
    Tearing eyes 1/40 (2.5%) 1 0/30 (0%) 0 0/0 (NaN) 0
    Xerophthalmia 2/40 (5%) 2 0/30 (0%) 0 0/0 (NaN) 0
    Gastrointestinal disorders
    Abdominal pain 9/40 (22.5%) 9 1/30 (3.3%) 1 1/0 (Infinity) 1
    Abdominal tenderness 1/40 (2.5%) 1 0/30 (0%) 0 0/0 (NaN) 0
    Aerophagia 1/40 (2.5%) 1 0/30 (0%) 0 0/0 (NaN) 0
    Ascites 1/40 (2.5%) 1 0/30 (0%) 0 0/0 (NaN) 0
    Burping 1/40 (2.5%) 1 0/30 (0%) 0 0/0 (NaN) 0
    Colitis 1/40 (2.5%) 1 0/30 (0%) 0 0/0 (NaN) 0
    Constipation 11/40 (27.5%) 11 0/30 (0%) 0 0/0 (NaN) 0
    Diarrhea 22/40 (55%) 22 2/30 (6.7%) 2 2/0 (Infinity) 2
    Dyspepsia 1/40 (2.5%) 1 0/30 (0%) 0 0/0 (NaN) 0
    Dysphagia 2/40 (5%) 2 0/30 (0%) 0 0/0 (NaN) 0
    Fecal incontinence 2/40 (5%) 2 0/30 (0%) 0 0/0 (NaN) 0
    Gas pain 1/40 (2.5%) 1 0/30 (0%) 0 0/0 (NaN) 0
    Gastralgia 1/40 (2.5%) 1 0/30 (0%) 0 0/0 (NaN) 0
    Gastritis 1/40 (2.5%) 1 0/30 (0%) 0 0/0 (NaN) 0
    Gastroesophageal reflux disease 1/40 (2.5%) 1 0/30 (0%) 0 0/0 (NaN) 0
    GERD 0/40 (0%) 0 1/30 (3.3%) 1 1/0 (Infinity) 1
    Heartburn 1/40 (2.5%) 1 0/30 (0%) 0 0/0 (NaN) 0
    Hematemesis 1/40 (2.5%) 1 0/30 (0%) 0 0/0 (NaN) 0
    Intestinal obstruction 0/40 (0%) 0 1/30 (3.3%) 1 1/0 (Infinity) 1
    Loose stools 3/40 (7.5%) 3 0/30 (0%) 0 0/0 (NaN) 0
    Mucositis oral 1/40 (2.5%) 1 0/30 (0%) 0 0/0 (NaN) 0
    Nausea 15/40 (37.5%) 15 2/30 (6.7%) 2 2/0 (Infinity) 2
    Nausea aggravated 1/40 (2.5%) 1 0/30 (0%) 0 0/0 (NaN) 0
    Oral ulceration 0/40 (0%) 0 1/30 (3.3%) 1 1/0 (Infinity) 1
    Pain abdominal 1/40 (2.5%) 1 0/30 (0%) 0 0/0 (NaN) 0
    Right lower quadrant pain 1/40 (2.5%) 1 0/30 (0%) 0 0/0 (NaN) 0
    Sores mouth 1/40 (2.5%) 1 0/30 (0%) 0 0/0 (NaN) 0
    Stomach cramps 1/40 (2.5%) 1 0/30 (0%) 0 0/0 (NaN) 0
    Stomachache 1/40 (2.5%) 1 0/30 (0%) 0 0/0 (NaN) 0
    Stomatitis 1/40 (2.5%) 1 0/30 (0%) 0 0/0 (NaN) 0
    Swelling abdomen 1/40 (2.5%) 1 0/30 (0%) 0 0/0 (NaN) 0
    Toothache 1/40 (2.5%) 1 0/30 (0%) 0 0/0 (NaN) 0
    Upper abdominal pain 1/40 (2.5%) 1 0/30 (0%) 0 0/0 (NaN) 0
    Vomiting 6/40 (15%) 6 3/30 (10%) 3 3/0 (Infinity) 3
    Xerostomia 1/40 (2.5%) 1 0/30 (0%) 0 0/0 (NaN) 0
    General disorders
    Ache 1/40 (2.5%) 1 0/30 (0%) 0 0/0 (NaN) 0
    Asthenia 7/40 (17.5%) 7 0/30 (0%) 0 0/0 (NaN) 0
    Chest pain 1/40 (2.5%) 1 0/30 (0%) 0 0/0 (NaN) 0
    Cold intolerance 1/40 (2.5%) 1 0/30 (0%) 0 0/0 (NaN) 0
    Drug fever 1/40 (2.5%) 1 0/30 (0%) 0 0/0 (NaN) 0
    Edema legs 2/40 (5%) 2 0/30 (0%) 0 0/0 (NaN) 0
    Edema of lower extremities 4/40 (10%) 4 0/30 (0%) 0 0/0 (NaN) 0
    Edematous feet 1/40 (2.5%) 1 0/30 (0%) 0 0/0 (NaN) 0
    Fatigue 17/40 (42.5%) 17 0/30 (0%) 0 0/0 (NaN) 0
    Fatigue aggravated 3/40 (7.5%) 3 0/30 (0%) 0 0/0 (NaN) 0
    Febrile reaction 1/40 (2.5%) 1 0/30 (0%) 0 0/0 (NaN) 0
    Fever 19/40 (47.5%) 19 1/30 (3.3%) 1 1/0 (Infinity) 1
    Flu like symptoms 2/40 (5%) 2 0/30 (0%) 0 0/0 (NaN) 0
    General body pain 0/40 (0%) 0 1/30 (3.3%) 1 1/0 (Infinity) 1
    Hyperpyrexia 0/40 (0%) 0 1/30 (3.3%) 1 1/0 (Infinity) 1
    Infusion site erythema 1/40 (2.5%) 1 0/30 (0%) 0 0/0 (NaN) 0
    Infusion site redness 1/40 (2.5%) 1 0/30 (0%) 0 0/0 (NaN) 0
    Intermittent fever 1/40 (2.5%) 1 0/30 (0%) 0 0/0 (NaN) 0
    Malaise 1/40 (2.5%) 1 0/30 (0%) 0 0/0 (NaN) 0
    Malleolus edema 1/40 (2.5%) 1 0/30 (0%) 0 0/0 (NaN) 0
    Mucositis 6/40 (15%) 6 0/30 (0%) 0 0/0 (NaN) 0
    Non-cardiac chest pain 1/40 (2.5%) 1 0/30 (0%) 0 0/0 (NaN) 0
    Pain aggravated 1/40 (2.5%) 1 0/30 (0%) 0 0/0 (NaN) 0
    Rigors 1/40 (2.5%) 1 0/30 (0%) 0 0/0 (NaN) 0
    Shivers 1/40 (2.5%) 1 0/30 (0%) 0 0/0 (NaN) 0
    Swelling of legs 1/40 (2.5%) 1 0/30 (0%) 0 0/0 (NaN) 0
    Swollen thumb 1/40 (2.5%) 1 0/30 (0%) 0 0/0 (NaN) 0
    Upper limb edema 1/40 (2.5%) 1 0/30 (0%) 0 0/0 (NaN) 0
    Weakness 2/40 (5%) 2 0/30 (0%) 0 0/0 (NaN) 0
    Weakness generalized 2/40 (5%) 2 0/30 (0%) 0 0/0 (NaN) 0
    Immune system disorders
    Drug allergy 2/40 (5%) 2 0/30 (0%) 0 0/0 (NaN) 0
    Infections and infestations
    Candidiasis 1/40 (2.5%) 1 0/30 (0%) 0 0/0 (NaN) 0
    Cellulitis 2/40 (5%) 2 0/30 (0%) 0 0/0 (NaN) 0
    Clostridium difficile infection 1/40 (2.5%) 1 0/30 (0%) 0 0/0 (NaN) 0
    Cold 1/40 (2.5%) 1 0/30 (0%) 0 0/0 (NaN) 0
    Common cold 1/40 (2.5%) 1 0/30 (0%) 0 0/0 (NaN) 0
    Conjunctivitis 1/40 (2.5%) 1 0/30 (0%) 0 0/0 (NaN) 0
    Orchitis 1/40 (2.5%) 1 0/30 (0%) 0 0/0 (NaN) 0
    Otitis externa 0/40 (0%) 0 1/30 (3.3%) 1 1/0 (Infinity) 1
    Paronychia 1/40 (2.5%) 1 0/30 (0%) 0 0/0 (NaN) 0
    Pneumonia 1/40 (2.5%) 1 0/30 (0%) 0 0/0 (NaN) 0
    Sinusitis 1/40 (2.5%) 1 0/30 (0%) 0 0/0 (NaN) 0
    Stye 1/40 (2.5%) 1 0/30 (0%) 0 0/0 (NaN) 0
    Upper respiratory infection 5/40 (12.5%) 5 0/30 (0%) 0 0/0 (NaN) 0
    Upper respiratory tract infection 1/40 (2.5%) 1 0/30 (0%) 0 0/0 (NaN) 0
    Urinary infection 0/40 (0%) 0 1/30 (3.3%) 1 1/0 (Infinity) 1
    Urinary tract infection 6/40 (15%) 6 0/30 (0%) 0 0/0 (NaN) 0
    Urosepsis 1/40 (2.5%) 1 0/30 (0%) 0 0/0 (NaN) 0
    UTI 1/40 (2.5%) 1 0/30 (0%) 0 0/0 (NaN) 0
    Vaginal yeast infection 1/40 (2.5%) 1 0/30 (0%) 0 0/0 (NaN) 0
    Viral upper respiratory tract infection 1/40 (2.5%) 1 0/30 (0%) 0 0/0 (NaN) 0
    Zona 1/40 (2.5%) 1 0/30 (0%) 0 0/0 (NaN) 0
    Injury, poisoning and procedural complications
    Achilles tendon injury 1/40 (2.5%) 1 0/30 (0%) 0 0/0 (NaN) 0
    Ankle sprain 1/40 (2.5%) 1 0/30 (0%) 0 0/0 (NaN) 0
    Bruising of foot 1/40 (2.5%) 1 0/30 (0%) 0 0/0 (NaN) 0
    Compression fracture 1/40 (2.5%) 1 0/30 (0%) 0 0/0 (NaN) 0
    Contusion 1/40 (2.5%) 1 0/30 (0%) 0 0/0 (NaN) 0
    Contusion of foot 1/40 (2.5%) 1 0/30 (0%) 0 0/0 (NaN) 0
    Fall 1/40 (2.5%) 1 0/30 (0%) 0 0/0 (NaN) 0
    Fractured ribs 1/40 (2.5%) 1 0/30 (0%) 0 0/0 (NaN) 0
    Infusion related reaction 4/40 (10%) 4 0/30 (0%) 0 0/0 (NaN) 0
    Postoperative pain 1/40 (2.5%) 1 0/30 (0%) 0 0/0 (NaN) 0
    Puncture wound 1/40 (2.5%) 1 0/30 (0%) 0 0/0 (NaN) 0
    Skin laceration 1/40 (2.5%) 1 0/30 (0%) 0 0/0 (NaN) 0
    Investigations
    Abnormal ECG 0/40 (0%) 0 1/30 (3.3%) 1 1/0 (Infinity) 1
    Absolute neutrophil count decreased 1/40 (2.5%) 1 0/30 (0%) 0 0/0 (NaN) 0
    Activated partial thromboplastin time prolonged 1/40 (2.5%) 1 0/30 (0%) 0 0/0 (NaN) 0
    Alkaline phosphatase increased 2/40 (5%) 2 0/30 (0%) 0 0/0 (NaN) 0
    ALP increased 1/40 (2.5%) 1 0/30 (0%) 0 0/0 (NaN) 0
    ALT increased 4/40 (10%) 4 0/30 (0%) 0 0/0 (NaN) 0
    AST increased 4/40 (10%) 4 0/30 (0%) 0 0/0 (NaN) 0
    Bilirubin total increased 1/40 (2.5%) 1 0/30 (0%) 0 0/0 (NaN) 0
    Blood bilirubin increased 1/40 (2.5%) 1 0/30 (0%) 0 0/0 (NaN) 0
    Creatinine increased 7/40 (17.5%) 7 1/30 (3.3%) 1 1/0 (Infinity) 1
    GGT increased 1/40 (2.5%) 1 0/30 (0%) 0 0/0 (NaN) 0
    Lipase increased 1/40 (2.5%) 1 0/30 (0%) 0 0/0 (NaN) 0
    Lymphocyte count decreased 1/40 (2.5%) 1 0/30 (0%) 0 0/0 (NaN) 0
    Neutrophil count decreased 5/40 (12.5%) 5 0/30 (0%) 0 0/0 (NaN) 0
    Neutrophil count increased 1/40 (2.5%) 1 0/30 (0%) 0 0/0 (NaN) 0
    Platelet count decreased 2/40 (5%) 2 0/30 (0%) 0 0/0 (NaN) 0
    Protein total increased 1/40 (2.5%) 1 0/30 (0%) 0 0/0 (NaN) 0
    QT prolonged 1/40 (2.5%) 1 0/30 (0%) 0 0/0 (NaN) 0
    SGOT increased 1/40 (2.5%) 1 0/30 (0%) 0 0/0 (NaN) 0
    ST segment elevation 1/40 (2.5%) 1 0/30 (0%) 0 0/0 (NaN) 0
    WBC decreased 1/40 (2.5%) 1 0/30 (0%) 0 0/0 (NaN) 0
    Weight loss 1/40 (2.5%) 1 0/30 (0%) 0 0/0 (NaN) 0
    White blood cell decreased 1/40 (2.5%) 1 0/30 (0%) 0 0/0 (NaN) 0
    Metabolism and nutrition disorders
    Anorexia 10/40 (25%) 10 2/30 (6.7%) 2 2/0 (Infinity) 2
    Appetite lost 2/40 (5%) 2 0/30 (0%) 0 0/0 (NaN) 0
    Decreased appetite 1/40 (2.5%) 1 0/30 (0%) 0 0/0 (NaN) 0
    Fluid retention 1/40 (2.5%) 1 0/30 (0%) 0 0/0 (NaN) 0
    Glucose intolerance 0/40 (0%) 0 1/30 (3.3%) 1 1/0 (Infinity) 1
    Gout 1/40 (2.5%) 1 0/30 (0%) 0 0/0 (NaN) 0
    Hypercalcemia 5/40 (12.5%) 5 1/30 (3.3%) 1 1/0 (Infinity) 1
    Hyperglycaemia 5/40 (12.5%) 5 1/30 (3.3%) 1 1/0 (Infinity) 1
    Hyperkalemia 4/40 (10%) 4 1/30 (3.3%) 1 1/0 (Infinity) 1
    Hyperuricemia 1/40 (2.5%) 1 1/30 (3.3%) 1 1/0 (Infinity) 1
    Hypoalbuminemia 3/40 (7.5%) 3 0/30 (0%) 0 0/0 (NaN) 0
    Hypocalcemia 1/40 (2.5%) 1 1/30 (3.3%) 1 1/0 (Infinity) 1
    Hypokalemia 3/40 (7.5%) 3 1/30 (3.3%) 1 1/0 (Infinity) 1
    Hypomagnesemia 5/40 (12.5%) 5 0/30 (0%) 0 0/0 (NaN) 0
    Hyponatremia 5/40 (12.5%) 5 0/30 (0%) 0 0/0 (NaN) 0
    Hypophosphatemia 5/40 (12.5%) 5 0/30 (0%) 0 0/0 (NaN) 0
    Hyporexia 1/40 (2.5%) 1 0/30 (0%) 0 0/0 (NaN) 0
    Inappetence 1/40 (2.5%) 1 0/30 (0%) 0 0/0 (NaN) 0
    Iron deficiency 1/40 (2.5%) 1 0/30 (0%) 0 0/0 (NaN) 0
    Musculoskeletal and connective tissue disorders
    Arthralgia 2/40 (5%) 2 0/30 (0%) 0 0/0 (NaN) 0
    Arthromyalgia 1/40 (2.5%) 1 0/30 (0%) 0 0/0 (NaN) 0
    Back pain 7/40 (17.5%) 7 1/30 (3.3%) 1 1/0 (Infinity) 1
    Costal pain 1/40 (2.5%) 1 0/30 (0%) 0 0/0 (NaN) 0
    Cramp in hand 1/40 (2.5%) 1 0/30 (0%) 0 0/0 (NaN) 0
    Cramp legs 1/40 (2.5%) 1 0/30 (0%) 0 0/0 (NaN) 0
    Dorsal pain 1/40 (2.5%) 1 0/30 (0%) 0 0/0 (NaN) 0
    Flank pain 2/40 (5%) 2 0/30 (0%) 0 0/0 (NaN) 0
    Foot pain 1/40 (2.5%) 1 0/30 (0%) 0 0/0 (NaN) 0
    Groin pain 1/40 (2.5%) 1 0/30 (0%) 0 0/0 (NaN) 0
    Joint ache 1/40 (2.5%) 1 0/30 (0%) 0 0/0 (NaN) 0
    Leg cramps 1/40 (2.5%) 1 0/30 (0%) 0 0/0 (NaN) 0
    Leg pain 4/40 (10%) 4 0/30 (0%) 0 0/0 (NaN) 0
    Low back pain 3/40 (7.5%) 3 0/30 (0%) 0 0/0 (NaN) 0
    Lower extremities weakness of 1/40 (2.5%) 1 0/30 (0%) 0 0/0 (NaN) 0
    Muscle weakness 1/40 (2.5%) 1 0/30 (0%) 0 0/0 (NaN) 0
    Muscular pain 1/40 (2.5%) 1 0/30 (0%) 0 0/0 (NaN) 0
    Myalgia 2/40 (5%) 2 0/30 (0%) 0 0/0 (NaN) 0
    Pain flank 1/40 (2.5%) 1 0/30 (0%) 0 0/0 (NaN) 0
    Pain in thigh 1/40 (2.5%) 1 0/30 (0%) 0 0/0 (NaN) 0
    Shoulder pain 1/40 (2.5%) 1 0/30 (0%) 0 0/0 (NaN) 0
    Spinal stenosis NOS 1/40 (2.5%) 1 0/30 (0%) 0 0/0 (NaN) 0
    Swollen joint 1/40 (2.5%) 1 0/30 (0%) 0 0/0 (NaN) 0
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    Cancer pain 0/40 (0%) 0 1/30 (3.3%) 1 1/0 (Infinity) 1
    Nervous system disorders
    Dizziness 1/40 (2.5%) 1 0/30 (0%) 0 0/0 (NaN) 0
    Dysgeusia 5/40 (12.5%) 5 0/30 (0%) 0 0/0 (NaN) 0
    Headache 4/40 (10%) 4 0/30 (0%) 0 0/0 (NaN) 0
    Loss of consciousness 1/40 (2.5%) 1 0/30 (0%) 0 0/0 (NaN) 0
    Migraine 1/40 (2.5%) 1 0/30 (0%) 0 0/0 (NaN) 0
    Neurogenic claudication 1/40 (2.5%) 1 0/30 (0%) 0 0/0 (NaN) 0
    Neuropathic pain 1/40 (2.5%) 1 0/30 (0%) 0 0/0 (NaN) 0
    Neuropathy 4/40 (10%) 4 0/30 (0%) 0 0/0 (NaN) 0
    Neuropathy peripheral 2/40 (5%) 2 0/30 (0%) 0 0/0 (NaN) 0
    Numbness in feet 1/40 (2.5%) 1 0/30 (0%) 0 0/0 (NaN) 0
    Orthostatic dizziness 1/40 (2.5%) 1 0/30 (0%) 0 0/0 (NaN) 0
    Right arm paresis 1/40 (2.5%) 1 0/30 (0%) 0 0/0 (NaN) 0
    Sensory neuropathy 1/40 (2.5%) 1 0/30 (0%) 0 0/0 (NaN) 0
    Syncope 1/40 (2.5%) 1 0/30 (0%) 0 0/0 (NaN) 0
    Tingling 1/40 (2.5%) 1 0/30 (0%) 0 0/0 (NaN) 0
    Product Issues
    Catheter leakage 1/40 (2.5%) 1 0/30 (0%) 0 0/0 (NaN) 0
    Catheter occlusion 1/40 (2.5%) 1 0/30 (0%) 0 0/0 (NaN) 0
    Psychiatric disorders
    Adjustment disorder 1/40 (2.5%) 1 0/30 (0%) 0 0/0 (NaN) 0
    Anxiety 2/40 (5%) 2 1/30 (3.3%) 1 1/0 (Infinity) 1
    Anxiety aggravated 1/40 (2.5%) 1 0/30 (0%) 0 0/0 (NaN) 0
    Confusional state 1/40 (2.5%) 1 0/30 (0%) 0 0/0 (NaN) 0
    Delirium 1/40 (2.5%) 1 0/30 (0%) 0 0/0 (NaN) 0
    Depression 2/40 (5%) 2 0/30 (0%) 0 0/0 (NaN) 0
    Insomnia 6/40 (15%) 6 1/30 (3.3%) 1 1/0 (Infinity) 1
    Nightmares 1/40 (2.5%) 1 0/30 (0%) 0 0/0 (NaN) 0
    Sleeplessness 1/40 (2.5%) 1 0/30 (0%) 0 0/0 (NaN) 0
    Renal and urinary disorders
    Acute kidney injury 1/40 (2.5%) 1 0/30 (0%) 0 0/0 (NaN) 0
    Dysuria 1/40 (2.5%) 1 0/30 (0%) 0 0/0 (NaN) 0
    Dysuria aggravated 1/40 (2.5%) 1 0/30 (0%) 0 0/0 (NaN) 0
    Hematuria 3/40 (7.5%) 3 1/30 (3.3%) 1 1/0 (Infinity) 1
    Nocturia 1/40 (2.5%) 1 0/30 (0%) 0 0/0 (NaN) 0
    Proteinuria 2/40 (5%) 2 0/30 (0%) 0 0/0 (NaN) 0
    Renal failure 1/40 (2.5%) 1 0/30 (0%) 0 0/0 (NaN) 0
    Urethral discharge 0/40 (0%) 0 1/30 (3.3%) 1 1/0 (Infinity) 1
    Urinary frequency 1/40 (2.5%) 1 0/30 (0%) 0 0/0 (NaN) 0
    Urinary retention 3/40 (7.5%) 3 0/30 (0%) 0 0/0 (NaN) 0
    Reproductive system and breast disorders
    Pelvic pain 1/40 (2.5%) 1 0/30 (0%) 0 0/0 (NaN) 0
    Penile bleeding 1/40 (2.5%) 1 0/30 (0%) 0 0/0 (NaN) 0
    Penile pain 1/40 (2.5%) 1 0/30 (0%) 0 0/0 (NaN) 0
    Respiratory, thoracic and mediastinal disorders
    Adult respiratory distress syndrome 1/40 (2.5%) 1 0/30 (0%) 0 0/0 (NaN) 0
    Airway compromise 1/40 (2.5%) 1 0/30 (0%) 0 0/0 (NaN) 0
    Breathlessness 1/40 (2.5%) 1 0/30 (0%) 0 0/0 (NaN) 0
    Cough 6/40 (15%) 6 0/30 (0%) 0 0/0 (NaN) 0
    Cough aggravated 2/40 (5%) 2 0/30 (0%) 0 0/0 (NaN) 0
    Crackles lung 1/40 (2.5%) 1 0/30 (0%) 0 0/0 (NaN) 0
    Dyspnea 5/40 (12.5%) 5 0/30 (0%) 0 0/0 (NaN) 0
    Dyspnea exacerbated 0/40 (0%) 0 1/30 (3.3%) 1 1/0 (Infinity) 1
    Dyspnea exertional 3/40 (7.5%) 3 0/30 (0%) 0 0/0 (NaN) 0
    Epistaxis 5/40 (12.5%) 5 0/30 (0%) 0 0/0 (NaN) 0
    Exertional dyspnea 1/40 (2.5%) 1 0/30 (0%) 0 0/0 (NaN) 0
    Hemoptysis 3/40 (7.5%) 3 0/30 (0%) 0 0/0 (NaN) 0
    Hypoxemia 1/40 (2.5%) 1 0/30 (0%) 0 0/0 (NaN) 0
    Hypoxia 2/40 (5%) 2 0/30 (0%) 0 0/0 (NaN) 0
    Increased shortness of breath 1/40 (2.5%) 1 0/30 (0%) 0 0/0 (NaN) 0
    Itchy throat 1/40 (2.5%) 1 0/30 (0%) 0 0/0 (NaN) 0
    Nasal sinus discharge 1/40 (2.5%) 1 0/30 (0%) 0 0/0 (NaN) 0
    Shortness of breath 2/40 (5%) 2 0/30 (0%) 0 0/0 (NaN) 0
    Sinus congestion 1/40 (2.5%) 1 0/30 (0%) 0 0/0 (NaN) 0
    Sore throat 2/40 (5%) 2 0/30 (0%) 0 0/0 (NaN) 0
    Sputum 1/40 (2.5%) 1 0/30 (0%) 0 0/0 (NaN) 0
    Sputum bloody 1/40 (2.5%) 1 0/30 (0%) 0 0/0 (NaN) 0
    Wheezing 1/40 (2.5%) 1 0/30 (0%) 0 0/0 (NaN) 0
    Wheezing aggravated 1/40 (2.5%) 1 0/30 (0%) 0 0/0 (NaN) 0
    Skin and subcutaneous tissue disorders
    Alopecia 11/40 (27.5%) 11 0/30 (0%) 0 0/0 (NaN) 0
    Desquamation 1/40 (2.5%) 1 0/30 (0%) 0 0/0 (NaN) 0
    Erythema 1/40 (2.5%) 1 0/30 (0%) 0 0/0 (NaN) 0
    Erythema facial 1/40 (2.5%) 1 0/30 (0%) 0 0/0 (NaN) 0
    Hair loss 2/40 (5%) 2 0/30 (0%) 0 0/0 (NaN) 0
    Hyperkeratosis 1/40 (2.5%) 1 0/30 (0%) 0 0/0 (NaN) 0
    Itch 1/40 (2.5%) 1 0/30 (0%) 0 0/0 (NaN) 0
    Localized itching 2/40 (5%) 2 0/30 (0%) 0 0/0 (NaN) 0
    Maculopapular rash 1/40 (2.5%) 1 0/30 (0%) 0 0/0 (NaN) 0
    Nail changes 2/40 (5%) 2 0/30 (0%) 0 0/0 (NaN) 0
    Nail loss 1/40 (2.5%) 1 0/30 (0%) 0 0/0 (NaN) 0
    Nail toxicity 1/40 (2.5%) 1 0/30 (0%) 0 0/0 (NaN) 0
    Onychodystrophy 1/40 (2.5%) 1 0/30 (0%) 0 0/0 (NaN) 0
    Onycholysis 2/40 (5%) 2 0/30 (0%) 0 0/0 (NaN) 0
    Pruritus 4/40 (10%) 4 0/30 (0%) 0 0/0 (NaN) 0
    Rash 6/40 (15%) 6 0/30 (0%) 0 0/0 (NaN) 0
    Rash both legs 1/40 (2.5%) 1 0/30 (0%) 0 0/0 (NaN) 0
    Rash face 1/40 (2.5%) 1 0/30 (0%) 0 0/0 (NaN) 0
    Rash maculo-papular 1/40 (2.5%) 1 0/30 (0%) 0 0/0 (NaN) 0
    Rash pruritic 1/40 (2.5%) 1 0/30 (0%) 0 0/0 (NaN) 0
    Redness 0/40 (0%) 0 1/30 (3.3%) 1 1/0 (Infinity) 1
    Redness of face 0/40 (0%) 0 1/30 (3.3%) 1 1/0 (Infinity) 1
    Skin disorder 1/40 (2.5%) 1 0/30 (0%) 0 0/0 (NaN) 0
    Skin peeling 1/40 (2.5%) 1 0/30 (0%) 0 0/0 (NaN) 0
    Skin rash 2/40 (5%) 2 0/30 (0%) 0 0/0 (NaN) 0
    Skin ulcer bleeding 0/40 (0%) 0 1/30 (3.3%) 1 1/0 (Infinity) 1
    Skin ulceration 1/40 (2.5%) 1 0/30 (0%) 0 0/0 (NaN) 0
    Vascular disorders
    Deep vein thrombosis leg 0/40 (0%) 0 1/30 (3.3%) 1 1/0 (Infinity) 1
    Flushed face 2/40 (5%) 2 0/30 (0%) 0 0/0 (NaN) 0
    Hypertension 3/40 (7.5%) 3 1/30 (3.3%) 1 1/0 (Infinity) 1
    Hypertension aggravated 1/40 (2.5%) 1 0/30 (0%) 0 0/0 (NaN) 0
    Hypertension worsened 1/40 (2.5%) 1 0/30 (0%) 0 0/0 (NaN) 0
    Hypotension 3/40 (7.5%) 3 0/30 (0%) 0 0/0 (NaN) 0
    Iliac vein thrombosis 0/40 (0%) 0 1/30 (3.3%) 1 1/0 (Infinity) 1
    Inferior venacaval thrombosis 0/40 (0%) 0 1/30 (3.3%) 1 1/0 (Infinity) 1
    Lymphedema 1/40 (2.5%) 1 0/30 (0%) 0 0/0 (NaN) 0
    Phlebitis 2/40 (5%) 2 0/30 (0%) 0 0/0 (NaN) 0

    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 Chief Medical Officer
    Organization Rainier Therapeutics
    Phone 510-878-2486
    Email Sabella@RainierRx.com
    Responsible Party:
    Rainier Therapeutics
    ClinicalTrials.gov Identifier:
    NCT02401542
    Other Study ID Numbers:
    • B-701-U21
    • 2017-001319-36
    First Posted:
    Mar 30, 2015
    Last Update Posted:
    Mar 9, 2020
    Last Verified:
    Feb 1, 2020