Working…
Help guide our efforts to modernize ClinicalTrials.gov.
Send us your comments by March 14, 2020.
ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 1 of 1 for:    NCT02401542
Previous Study | Return to List | Next Study

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02401542
Recruitment Status : Terminated (program has been put on hold by the sponsor)
First Posted : March 30, 2015
Results First Posted : February 17, 2020
Last Update Posted : February 17, 2020
Sponsor:
Information provided by (Responsible Party):
Rainier Therapeutics

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Double (Participant, Investigator);   Primary Purpose: Treatment
Conditions Locally Advanced or Metastatic Urothelial Cell Carcinoma
Urinary Bladder Disease
Urological Diseases
Interventions Drug: Vofatamab
Drug: Docetaxel
Drug: Placebo
Enrollment 71
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Vofatamab Plus Docetaxel Vofatamab Placebo Plus Docetaxel
Hide 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
Arm/Group Title Vofatamab Plus Docetaxel Vofatamab Placebo Plus Docetaxel Total
Hide 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 Number of Baseline Participants 40 30 0 70
Hide Baseline Analysis Population Description
No patients were enrolled in the placebo plus docetaxel group.
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 40 participants 30 participants 0 participants 70 participants
<=18 years
0
   0.0%
0
   0.0%
0
0
   0.0%
Between 18 and 65 years
20
  50.0%
12
  40.0%
0
32
  45.7%
>=65 years
20
  50.0%
18
  60.0%
0
38
  54.3%
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 40 participants 30 participants 0 participants 70 participants
Female
7
  17.5%
6
  20.0%
0
13
  18.6%
Male
33
  82.5%
24
  80.0%
0
57
  81.4%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 40 participants 30 participants 0 participants 70 participants
American Indian or Alaska Native
0
   0.0%
0
   0.0%
0
0
   0.0%
Asian
3
   7.5%
12
  40.0%
0
15
  21.4%
Native Hawaiian or Other Pacific Islander
0
   0.0%
0
   0.0%
0
0
   0.0%
Black or African American
1
   2.5%
0
   0.0%
0
1
   1.4%
White
36
  90.0%
18
  60.0%
0
54
  77.1%
More than one race
0
   0.0%
0
   0.0%
0
0
   0.0%
Unknown or Not Reported
0
   0.0%
0
   0.0%
0
0
   0.0%
1.Primary Outcome
Title Primary Efficacy Outcome: Progression Free Survival (PFS)
Hide 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.
Time Frame 3-4 years
Hide Outcome Measure Data
Hide 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
Hide Arm/Group Description:
Vofatamab plus Docetaxel
Vofatamab plus Docetaxel
Vofatamab plus Docetaxel
Vofatamab Monotherpay
Vofatamab Monotherapy
Overall Number of Participants Analyzed 6 13 21 21 9
Mean (Standard Deviation)
Unit of Measure: Months
6.82  (5.35) 2.83  (2.73) 4.40  (4.15) 4.45  (3.27) 2.23  (1.45)
2.Secondary Outcome
Title Secondary Efficacy Outcome: Overall Survival (OS)
Hide Description Efficacy of vofatamab plus docetaxel, compared with docetaxel plus placebo, and vofatamab alone as measured by OS; measured from randomization to death. A patient has had to receive at least one vofatamab dose.
Time Frame up to 3-4 years
Outcome Measure Data Not Reported
3.Secondary Outcome
Title Efficacy Outcome - Objective Response Rate (ORR)
Hide Description Efficacy of vofatamab plus docetaxel, compared with docetaxel plus placebo, and vofatamab alone as measured by ORR; defined as the percentage of subjects who have baseline measurable disease and who achieve a best response of either complete response (CR) or partial response (PR) as assessed by the investigator using RECIST 1.1 criteria.
Time Frame up to 3-4 years
Outcome Measure Data Not Reported
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
Hide 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 (%) Affected / at Risk (%) Affected / at Risk (%)
Total   2/40 (5.00%)      1/30 (3.33%)      0/0    
Hide 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 (52.50%)      6/30 (20.00%)      0/0    
Blood and lymphatic system disorders       
Febrile Neutropenia   3/40 (7.50%)  3 0/30 (0.00%)  0 /0 
Neutropenia   2/40 (5.00%)  2 0/30 (0.00%)  0 /0 
Disseminated intravascular coagulation   1/40 (2.50%)  1 0/30 (0.00%)  0 /0 
Thrombocytopenia   1/40 (2.50%)  1 0/30 (0.00%)  0 /0 
Cardiac disorders       
Atrial fibrillation   1/40 (2.50%)  1 1/30 (3.33%)  1 /0 
Cyanosis   0/40 (0.00%)  0 1/30 (3.33%)  1 /0 
Myocardial infarction   1/40 (2.50%)  1 0/30 (0.00%)  0 /0 
Gastrointestinal disorders       
Vomiting   2/40 (5.00%)  2 0/30 (0.00%)  0 /0 
Abdominal pain   1/40 (2.50%)  1 0/30 (0.00%)  0 /0 
Anal incontinence   1/40 (2.50%)  1 0/30 (0.00%)  0 /0 
Constipation   1/40 (2.50%)  1 0/30 (0.00%)  0 /0 
Diarrhoea   1/40 (2.50%)  1 0/30 (0.00%)  0 /0 
Large intestinal obstruction   1/40 (2.50%)  1 0/30 (0.00%)  0 /0 
Nausea   1/40 (2.50%)  1 0/30 (0.00%)  0 /0 
Pancreatitis   1/40 (2.50%)  1 0/30 (0.00%)  0 /0 
Rectal haemorrhage   1/40 (2.50%)  1 0/30 (0.00%)  0 /0 
General disorders       
Pain   2/40 (5.00%)  2 0/30 (0.00%)  0 /0 
Chills   0/40 (0.00%)  0 1/30 (3.33%)  1 /0 
Fatigue   1/40 (2.50%)  1 0/30 (0.00%)  0 /0 
Mucosal inflammation   1/40 (2.50%)  1 0/30 (0.00%)  0 /0 
Non-cardiac chest pain   1/40 (2.50%)  1 0/30 (0.00%)  0 /0 
Pyrexia   1/40 (2.50%)  1 0/30 (0.00%)  0 /0 
Hepatobiliary disorders       
Cholecystitis   1/40 (2.50%)  1 0/30 (0.00%)  0 /0 
Liver injury   1/40 (2.50%)  1 0/30 (0.00%)  0 /0 
Immune system disorders       
Anaphylactic reaction   1/40 (2.50%)  1 0/30 (0.00%)  0 /0 
Infections and infestations       
Pneumonia   2/40 (5.00%)  2 0/30 (0.00%)  0 0/0  0
Sepsis   2/40 (5.00%)  2 0/30 (0.00%)  0 0/0  0
Urinary Tract Infection   0/40 (0.00%)  0 2/30 (6.67%)  2 0/0  0
Clostridium difficile infection   1/40 (2.50%)  1 0/30 (0.00%)  0 0/0  0
Neutropenic infection   1/40 (2.50%)  1 0/30 (0.00%)  0 0/0  0
Injury, poisoning and procedural complications       
Infusion related reaction   1/40 (2.50%)  1 1/30 (3.33%)  1 /0 
Overdose   1/40 (2.50%)  1 0/30 (0.00%)  0 /0 
Spinal compression fracture   1/40 (2.50%)  1 0/30 (0.00%)  0 /0 
Urinary tract stoma complication   1/40 (2.50%)  1 0/30 (0.00%)  0 /0 
Metabolism and nutrition disorders       
Hypercalcaemia   0/40 (0.00%)  0 2/30 (6.67%)  2 /0 
Musculoskeletal and connective tissue disorders       
Back pain   0/40 (0.00%)  0 1/30 (3.33%)  1 /0 
Pain in extremity   1/40 (2.50%)  1 0/30 (0.00%)  0 /0 
Nervous system disorders       
Haemorrhage intracranial   1/40 (2.50%)  1 0/30 (0.00%)  0 /0 
Psychiatric disorders       
Confusional state   1/40 (2.50%)  1 0/30 (0.00%)  0 /0 
Renal and urinary disorders       
Haematuria   1/40 (2.50%)  1 0/30 (0.00%)  0 /0 
Renal failure   0/40 (0.00%)  0 1/30 (3.33%)  1 /0 
Urinary incontinence   1/40 (2.50%)  1 0/30 (0.00%)  0 /0 
Reproductive system and breast disorders       
Scrotal oedema   1/40 (2.50%)  1 0/30 (0.00%)  0 /0 
Respiratory, thoracic and mediastinal disorders       
Dyspnoea   0/40 (0.00%)  0 1/30 (3.33%)  1 /0 
Pulmonary embolism   1/40 (2.50%)  1 0/30 (0.00%)  0 /0 
Pulmonary oedema   1/40 (2.50%)  1 0/30 (0.00%)  0 /0 
Vascular disorders       
Deep vein thrombosis   1/40 (2.50%)  1 0/30 (0.00%)  0 /0 
Hypertension   0/40 (0.00%)  0 1/30 (3.33%)  1 /0 
Hypotension   1/40 (2.50%)  1 0/30 (0.00%)  0 /0 
Indicates events were collected by systematic assessment
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Vofatamab Plus Docetaxel Vofatamab Placebo Plus Docetaxel
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   40/40 (100.00%)      30/30 (100.00%)      0/0    
Blood and lymphatic system disorders       
Anemia   11/40 (27.50%)  11 2/30 (6.67%)  2 /0 
Anemia aggravated   2/40 (5.00%)  2 0/30 (0.00%)  0 /0 
Leukocytosis   3/40 (7.50%)  3 0/30 (0.00%)  0 /0 
Leukopenia   3/40 (7.50%)  3 0/30 (0.00%)  0 /0 
Lymphocytopenia   2/40 (5.00%)  2 0/30 (0.00%)  0 /0 
Neutropenia   7/40 (17.50%)  7 0/30 (0.00%)  0 /0 
Thrombocytopenia   0/40 (0.00%)  0 1/30 (3.33%)  1 /0 
Cardiac disorders       
Atrial fibrillation   1/40 (2.50%)  1 0/30 (0.00%)  0 /0 
Sinus tachycardia   1/40 (2.50%)  1 0/30 (0.00%)  0 /0 
Tachycardia   1/40 (2.50%)  1 0/30 (0.00%)  0 /0 
Congenital, familial and genetic disorders       
Hydrocele   1/40 (2.50%)  1 0/30 (0.00%)  0 /0 
Ear and labyrinth disorders       
Ringing in ears   1/40 (2.50%)  1 0/30 (0.00%)  0 /0 
Eye disorders       
Eye redness   1/40 (2.50%)  1 0/30 (0.00%)  0 /0 
Eyes tearing   1/40 (2.50%)  1 0/30 (0.00%)  0 /0 
Flashing lights   1/40 (2.50%)  1 0/30 (0.00%)  0 /0 
Itching eyes   1/40 (2.50%)  1 0/30 (0.00%)  0 /0 
Right cataract   1/40 (2.50%)  1 0/30 (0.00%)  0 /0 
Tearing eyes   1/40 (2.50%)  1 0/30 (0.00%)  0 /0 
Xerophthalmia   2/40 (5.00%)  2 0/30 (0.00%)  0 /0 
Gastrointestinal disorders       
Abdominal pain   9/40 (22.50%)  9 1/30 (3.33%)  1 /0 
Abdominal tenderness   1/40 (2.50%)  1 0/30 (0.00%)  0 /0 
Aerophagia   1/40 (2.50%)  1 0/30 (0.00%)  0 /0 
Ascites   1/40 (2.50%)  1 0/30 (0.00%)  0 /0 
Burping   1/40 (2.50%)  1 0/30 (0.00%)  0 /0 
Colitis   1/40 (2.50%)  1 0/30 (0.00%)  0 /0 
Constipation   11/40 (27.50%)  11 0/30 (0.00%)  0 /0 
Diarrhea   22/40 (55.00%)  22 2/30 (6.67%)  2 /0 
Dyspepsia   1/40 (2.50%)  1 0/30 (0.00%)  0 /0 
Dysphagia   2/40 (5.00%)  2 0/30 (0.00%)  0 /0 
Fecal incontinence   2/40 (5.00%)  2 0/30 (0.00%)  0 /0 
Gas pain   1/40 (2.50%)  1 0/30 (0.00%)  0 /0 
Gastralgia   1/40 (2.50%)  1 0/30 (0.00%)  0 /0 
Gastritis   1/40 (2.50%)  1 0/30 (0.00%)  0 /0 
Gastroesophageal reflux disease   1/40 (2.50%)  1 0/30 (0.00%)  0 /0 
GERD   0/40 (0.00%)  0 1/30 (3.33%)  1 /0 
Heartburn   1/40 (2.50%)  1 0/30 (0.00%)  0 /0 
Hematemesis   1/40 (2.50%)  1 0/30 (0.00%)  0 /0 
Intestinal obstruction   0/40 (0.00%)  0 1/30 (3.33%)  1 /0 
Loose stools   3/40 (7.50%)  3 0/30 (0.00%)  0 /0 
Mucositis oral   1/40 (2.50%)  1 0/30 (0.00%)  0 /0 
Nausea   15/40 (37.50%)  15 2/30 (6.67%)  2 /0 
Nausea aggravated   1/40 (2.50%)  1 0/30 (0.00%)  0 /0 
Oral ulceration   0/40 (0.00%)  0 1/30 (3.33%)  1 /0 
Pain abdominal   1/40 (2.50%)  1 0/30 (0.00%)  0 /0 
Right lower quadrant pain   1/40 (2.50%)  1 0/30 (0.00%)  0 /0 
Sores mouth   1/40 (2.50%)  1 0/30 (0.00%)  0 /0 
Stomach cramps   1/40 (2.50%)  1 0/30 (0.00%)  0 /0 
Stomachache   1/40 (2.50%)  1 0/30 (0.00%)  0 /0 
Stomatitis   1/40 (2.50%)  1 0/30 (0.00%)  0 /0 
Swelling abdomen   1/40 (2.50%)  1 0/30 (0.00%)  0 /0 
Toothache   1/40 (2.50%)  1 0/30 (0.00%)  0 /0 
Upper abdominal pain   1/40 (2.50%)  1 0/30 (0.00%)  0 /0 
Vomiting   6/40 (15.00%)  6 3/30 (10.00%)  3 /0 
Xerostomia   1/40 (2.50%)  1 0/30 (0.00%)  0 /0 
General disorders       
Ache   1/40 (2.50%)  1 0/30 (0.00%)  0 /0 
Asthenia   7/40 (17.50%)  7 0/30 (0.00%)  0 /0 
Chest pain   1/40 (2.50%)  1 0/30 (0.00%)  0 /0 
Cold intolerance   1/40 (2.50%)  1 0/30 (0.00%)  0 /0 
Drug fever   1/40 (2.50%)  1 0/30 (0.00%)  0 /0 
Edema legs   2/40 (5.00%)  2 0/30 (0.00%)  0 /0 
Edema of lower extremities   4/40 (10.00%)  4 0/30 (0.00%)  0 /0 
Edematous feet   1/40 (2.50%)  1 0/30 (0.00%)  0 /0 
Fatigue   17/40 (42.50%)  17 0/30 (0.00%)  0 /0 
Fatigue aggravated   3/40 (7.50%)  3 0/30 (0.00%)  0 /0 
Febrile reaction   1/40 (2.50%)  1 0/30 (0.00%)  0 /0 
Fever   19/40 (47.50%)  19 1/30 (3.33%)  1 /0 
Flu like symptoms   2/40 (5.00%)  2 0/30 (0.00%)  0 /0 
General body pain   0/40 (0.00%)  0 1/30 (3.33%)  1 /0 
Hyperpyrexia   0/40 (0.00%)  0 1/30 (3.33%)  1 /0 
Infusion site erythema   1/40 (2.50%)  1 0/30 (0.00%)  0 /0 
Infusion site redness   1/40 (2.50%)  1 0/30 (0.00%)  0 /0 
Intermittent fever   1/40 (2.50%)  1 0/30 (0.00%)  0 /0 
Malaise   1/40 (2.50%)  1 0/30 (0.00%)  0 /0 
Malleolus edema   1/40 (2.50%)  1 0/30 (0.00%)  0 /0 
Mucositis   6/40 (15.00%)  6 0/30 (0.00%)  0 /0 
Non-cardiac chest pain   1/40 (2.50%)  1 0/30 (0.00%)  0 /0 
Pain aggravated   1/40 (2.50%)  1 0/30 (0.00%)  0 /0 
Rigors   1/40 (2.50%)  1 0/30 (0.00%)  0 /0 
Shivers   1/40 (2.50%)  1 0/30 (0.00%)  0 /0 
Swelling of legs   1/40 (2.50%)  1 0/30 (0.00%)  0 /0 
Swollen thumb   1/40 (2.50%)  1 0/30 (0.00%)  0 /0 
Upper limb edema   1/40 (2.50%)  1 0/30 (0.00%)  0 /0 
Weakness   2/40 (5.00%)  2 0/30 (0.00%)  0 /0 
Weakness generalized   2/40 (5.00%)  2 0/30 (0.00%)  0 /0 
Immune system disorders       
Drug allergy   2/40 (5.00%)  2 0/30 (0.00%)  0 /0 
Infections and infestations       
Candidiasis   1/40 (2.50%)  1 0/30 (0.00%)  0 /0 
Cellulitis   2/40 (5.00%)  2 0/30 (0.00%)  0 /0 
Clostridium difficile infection   1/40 (2.50%)  1 0/30 (0.00%)  0 /0 
Cold   1/40 (2.50%)  1 0/30 (0.00%)  0 /0 
Common cold   1/40 (2.50%)  1 0/30 (0.00%)  0 /0 
Conjunctivitis   1/40 (2.50%)  1 0/30 (0.00%)  0 /0 
Orchitis   1/40 (2.50%)  1 0/30 (0.00%)  0 /0 
Otitis externa   0/40 (0.00%)  0 1/30 (3.33%)  1 /0 
Paronychia   1/40 (2.50%)  1 0/30 (0.00%)  0 /0 
Pneumonia   1/40 (2.50%)  1 0/30 (0.00%)  0 /0 
Sinusitis   1/40 (2.50%)  1 0/30 (0.00%)  0 /0 
Stye   1/40 (2.50%)  1 0/30 (0.00%)  0 /0 
Upper respiratory infection   5/40 (12.50%)  5 0/30 (0.00%)  0 /0 
Upper respiratory tract infection   1/40 (2.50%)  1 0/30 (0.00%)  0 /0 
Urinary infection   0/40 (0.00%)  0 1/30 (3.33%)  1 /0 
Urinary tract infection   6/40 (15.00%)  6 0/30 (0.00%)  0 /0 
Urosepsis   1/40 (2.50%)  1 0/30 (0.00%)  0 /0 
UTI   1/40 (2.50%)  1 0/30 (0.00%)  0 /0 
Vaginal yeast infection   1/40 (2.50%)  1 0/30 (0.00%)  0 /0 
Viral upper respiratory tract infection   1/40 (2.50%)  1 0/30 (0.00%)  0 /0 
Zona   1/40 (2.50%)  1 0/30 (0.00%)  0 /0 
Injury, poisoning and procedural complications       
Achilles tendon injury   1/40 (2.50%)  1 0/30 (0.00%)  0 /0 
Ankle sprain   1/40 (2.50%)  1 0/30 (0.00%)  0 /0 
Bruising of foot   1/40 (2.50%)  1 0/30 (0.00%)  0 /0 
Compression fracture   1/40 (2.50%)  1 0/30 (0.00%)  0 /0 
Contusion   1/40 (2.50%)  1 0/30 (0.00%)  0 /0 
Contusion of foot   1/40 (2.50%)  1 0/30 (0.00%)  0 /0 
Fall   1/40 (2.50%)  1 0/30 (0.00%)  0 /0 
Fractured ribs   1/40 (2.50%)  1 0/30 (0.00%)  0 /0 
Infusion related reaction   4/40 (10.00%)  4 0/30 (0.00%)  0 /0 
Postoperative pain   1/40 (2.50%)  1 0/30 (0.00%)  0 /0 
Puncture wound   1/40 (2.50%)  1 0/30 (0.00%)  0 /0 
Skin laceration   1/40 (2.50%)  1 0/30 (0.00%)  0 /0 
Investigations       
Abnormal ECG   0/40 (0.00%)  0 1/30 (3.33%)  1 /0 
Absolute neutrophil count decreased   1/40 (2.50%)  1 0/30 (0.00%)  0 /0 
Activated partial thromboplastin time prolonged   1/40 (2.50%)  1 0/30 (0.00%)  0 /0 
Alkaline phosphatase increased   2/40 (5.00%)  2 0/30 (0.00%)  0 /0 
ALP increased   1/40 (2.50%)  1 0/30 (0.00%)  0 /0 
ALT increased   4/40 (10.00%)  4 0/30 (0.00%)  0 /0 
AST increased   4/40 (10.00%)  4 0/30 (0.00%)  0 /0 
Bilirubin total increased   1/40 (2.50%)  1 0/30 (0.00%)  0 /0 
Blood bilirubin increased   1/40 (2.50%)  1 0/30 (0.00%)  0 /0 
Creatinine increased   7/40 (17.50%)  7 1/30 (3.33%)  1 /0 
GGT increased   1/40 (2.50%)  1 0/30 (0.00%)  0 /0 
Lipase increased   1/40 (2.50%)  1 0/30 (0.00%)  0 /0 
Lymphocyte count decreased   1/40 (2.50%)  1 0/30 (0.00%)  0 /0 
Neutrophil count decreased   5/40 (12.50%)  5 0/30 (0.00%)  0 /0 
Neutrophil count increased   1/40 (2.50%)  1 0/30 (0.00%)  0 /0 
Platelet count decreased   2/40 (5.00%)  2 0/30 (0.00%)  0 /0 
Protein total increased   1/40 (2.50%)  1 0/30 (0.00%)  0 /0 
QT prolonged   1/40 (2.50%)  1 0/30 (0.00%)  0 /0 
SGOT increased   1/40 (2.50%)  1 0/30 (0.00%)  0 /0 
ST segment elevation   1/40 (2.50%)  1 0/30 (0.00%)  0 /0 
WBC decreased   1/40 (2.50%)  1 0/30 (0.00%)  0 /0 
Weight loss   1/40 (2.50%)  1 0/30 (0.00%)  0 /0 
White blood cell decreased   1/40 (2.50%)  1 0/30 (0.00%)  0 /0 
Metabolism and nutrition disorders       
Anorexia   10/40 (25.00%)  10 2/30 (6.67%)  2 /0 
Appetite lost   2/40 (5.00%)  2 0/30 (0.00%)  0 /0 
Decreased appetite   1/40 (2.50%)  1 0/30 (0.00%)  0 /0 
Fluid retention   1/40 (2.50%)  1 0/30 (0.00%)  0 /0 
Glucose intolerance   0/40 (0.00%)  0 1/30 (3.33%)  1 /0 
Gout   1/40 (2.50%)  1 0/30 (0.00%)  0 /0 
Hypercalcemia   5/40 (12.50%)  5 1/30 (3.33%)  1 /0 
Hyperglycaemia   5/40 (12.50%)  5 1/30 (3.33%)  1 /0 
Hyperkalemia   4/40 (10.00%)  4 1/30 (3.33%)  1 /0 
Hyperuricemia   1/40 (2.50%)  1 1/30 (3.33%)  1 /0 
Hypoalbuminemia   3/40 (7.50%)  3 0/30 (0.00%)  0 /0 
Hypocalcemia   1/40 (2.50%)  1 1/30 (3.33%)  1 /0 
Hypokalemia   3/40 (7.50%)  3 1/30 (3.33%)  1 /0 
Hypomagnesemia   5/40 (12.50%)  5 0/30 (0.00%)  0 /0 
Hyponatremia   5/40 (12.50%)  5 0/30 (0.00%)  0 /0 
Hypophosphatemia   5/40 (12.50%)  5 0/30 (0.00%)  0 /0 
Hyporexia   1/40 (2.50%)  1 0/30 (0.00%)  0 /0 
Inappetence   1/40 (2.50%)  1 0/30 (0.00%)  0 /0 
Iron deficiency   1/40 (2.50%)  1 0/30 (0.00%)  0 /0 
Musculoskeletal and connective tissue disorders       
Arthralgia   2/40 (5.00%)  2 0/30 (0.00%)  0 /0 
Arthromyalgia   1/40 (2.50%)  1 0/30 (0.00%)  0 /0 
Back pain   7/40 (17.50%)  7 1/30 (3.33%)  1 /0 
Costal pain   1/40 (2.50%)  1 0/30 (0.00%)  0 /0 
Cramp in hand   1/40 (2.50%)  1 0/30 (0.00%)  0 /0 
Cramp legs   1/40 (2.50%)  1 0/30 (0.00%)  0 /0 
Dorsal pain   1/40 (2.50%)  1 0/30 (0.00%)  0 /0 
Flank pain   2/40 (5.00%)  2 0/30 (0.00%)  0 /0 
Foot pain   1/40 (2.50%)  1 0/30 (0.00%)  0 /0 
Groin pain   1/40 (2.50%)  1 0/30 (0.00%)  0 /0 
Joint ache   1/40 (2.50%)  1 0/30 (0.00%)  0 /0 
Leg cramps   1/40 (2.50%)  1 0/30 (0.00%)  0 /0 
Leg pain   4/40 (10.00%)  4 0/30 (0.00%)  0 /0 
Low back pain   3/40 (7.50%)  3 0/30 (0.00%)  0 /0 
Lower extremities weakness of   1/40 (2.50%)  1 0/30 (0.00%)  0 /0 
Muscle weakness   1/40 (2.50%)  1 0/30 (0.00%)  0 /0 
Muscular pain   1/40 (2.50%)  1 0/30 (0.00%)  0 /0 
Myalgia   2/40 (5.00%)  2 0/30 (0.00%)  0 /0 
Pain flank   1/40 (2.50%)  1 0/30 (0.00%)  0 /0 
Pain in thigh   1/40 (2.50%)  1 0/30 (0.00%)  0 /0 
Shoulder pain   1/40 (2.50%)  1 0/30 (0.00%)  0 /0 
Spinal stenosis NOS   1/40 (2.50%)  1 0/30 (0.00%)  0 /0 
Swollen joint   1/40 (2.50%)  1 0/30 (0.00%)  0 /0 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)       
Cancer pain   0/40 (0.00%)  0 1/30 (3.33%)  1 /0 
Nervous system disorders       
Dizziness   1/40 (2.50%)  1 0/30 (0.00%)  0 /0 
Dysgeusia   5/40 (12.50%)  5 0/30 (0.00%)  0 /0 
Headache   4/40 (10.00%)  4 0/30 (0.00%)  0 /0 
Loss of consciousness   1/40 (2.50%)  1 0/30 (0.00%)  0 /0 
Migraine   1/40 (2.50%)  1 0/30 (0.00%)  0 /0 
Neurogenic claudication   1/40 (2.50%)  1 0/30 (0.00%)  0 /0 
Neuropathic pain   1/40 (2.50%)  1 0/30 (0.00%)  0 /0 
Neuropathy   4/40 (10.00%)  4 0/30 (0.00%)  0 /0 
Neuropathy peripheral   2/40 (5.00%)  2 0/30 (0.00%)  0 /0 
Numbness in feet   1/40 (2.50%)  1 0/30 (0.00%)  0 /0 
Orthostatic dizziness   1/40 (2.50%)  1 0/30 (0.00%)  0 /0 
Right arm paresis   1/40 (2.50%)  1 0/30 (0.00%)  0 /0 
Sensory neuropathy   1/40 (2.50%)  1 0/30 (0.00%)  0 /0 
Syncope   1/40 (2.50%)  1 0/30 (0.00%)  0 /0 
Tingling   1/40 (2.50%)  1 0/30 (0.00%)  0 /0 
Product Issues       
Catheter leakage   1/40 (2.50%)  1 0/30 (0.00%)  0 /0 
Catheter occlusion   1/40 (2.50%)  1 0/30 (0.00%)  0 /0 
Psychiatric disorders       
Adjustment disorder   1/40 (2.50%)  1 0/30 (0.00%)  0 /0 
Anxiety   2/40 (5.00%)  2 1/30 (3.33%)  1 /0 
Anxiety aggravated   1/40 (2.50%)  1 0/30 (0.00%)  0 /0 
Confusional state   1/40 (2.50%)  1 0/30 (0.00%)  0 /0 
Delirium   1/40 (2.50%)  1 0/30 (0.00%)  0 /0 
Depression   2/40 (5.00%)  2 0/30 (0.00%)  0 /0 
Insomnia   6/40 (15.00%)  6 1/30 (3.33%)  1 /0 
Nightmares   1/40 (2.50%)  1 0/30 (0.00%)  0 /0 
Sleeplessness   1/40 (2.50%)  1 0/30 (0.00%)  0 /0 
Renal and urinary disorders       
Acute kidney injury   1/40 (2.50%)  1 0/30 (0.00%)  0 /0 
Dysuria   1/40 (2.50%)  1 0/30 (0.00%)  0 /0 
Dysuria aggravated   1/40 (2.50%)  1 0/30 (0.00%)  0 /0 
Hematuria   3/40 (7.50%)  3 1/30 (3.33%)  1 /0 
Nocturia   1/40 (2.50%)  1 0/30 (0.00%)  0 /0 
Proteinuria   2/40 (5.00%)  2 0/30 (0.00%)  0 /0 
Renal failure   1/40 (2.50%)  1 0/30 (0.00%)  0 /0 
Urethral discharge   0/40 (0.00%)  0 1/30 (3.33%)  1 /0 
Urinary frequency   1/40 (2.50%)  1 0/30 (0.00%)  0 /0 
Urinary retention   3/40 (7.50%)  3 0/30 (0.00%)  0 /0 
Reproductive system and breast disorders       
Pelvic pain   1/40 (2.50%)  1 0/30 (0.00%)  0 /0 
Penile bleeding   1/40 (2.50%)  1 0/30 (0.00%)  0 /0 
Penile pain   1/40 (2.50%)  1 0/30 (0.00%)  0 /0 
Respiratory, thoracic and mediastinal disorders       
Adult respiratory distress syndrome   1/40 (2.50%)  1 0/30 (0.00%)  0 /0 
Airway compromise   1/40 (2.50%)  1 0/30 (0.00%)  0 /0 
Breathlessness   1/40 (2.50%)  1 0/30 (0.00%)  0 /0 
Cough   6/40 (15.00%)  6 0/30 (0.00%)  0 /0 
Cough aggravated   2/40 (5.00%)  2 0/30 (0.00%)  0 /0 
Crackles lung   1/40 (2.50%)  1 0/30 (0.00%)  0 /0 
Dyspnea   5/40 (12.50%)  5 0/30 (0.00%)  0 /0 
Dyspnea exacerbated   0/40 (0.00%)  0 1/30 (3.33%)  1 /0 
Dyspnea exertional   3/40 (7.50%)  3 0/30 (0.00%)  0 /0 
Epistaxis   5/40 (12.50%)  5 0/30 (0.00%)  0 /0 
Exertional dyspnea   1/40 (2.50%)  1 0/30 (0.00%)  0 /0 
Hemoptysis   3/40 (7.50%)  3 0/30 (0.00%)  0 /0 
Hypoxemia   1/40 (2.50%)  1 0/30 (0.00%)  0 /0 
Hypoxia   2/40 (5.00%)  2 0/30 (0.00%)  0 /0 
Increased shortness of breath   1/40 (2.50%)  1 0/30 (0.00%)  0 /0 
Itchy throat   1/40 (2.50%)  1 0/30 (0.00%)  0 /0 
Nasal sinus discharge   1/40 (2.50%)  1 0/30 (0.00%)  0 /0 
Shortness of breath   2/40 (5.00%)  2 0/30 (0.00%)  0 /0 
Sinus congestion   1/40 (2.50%)  1 0/30 (0.00%)  0 /0 
Sore throat   2/40 (5.00%)  2 0/30 (0.00%)  0 /0 
Sputum   1/40 (2.50%)  1 0/30 (0.00%)  0 /0 
Sputum bloody   1/40 (2.50%)  1 0/30 (0.00%)  0 /0 
Wheezing   1/40 (2.50%)  1 0/30 (0.00%)  0 /0 
Wheezing aggravated   1/40 (2.50%)  1 0/30 (0.00%)  0 /0 
Skin and subcutaneous tissue disorders       
Alopecia   11/40 (27.50%)  11 0/30 (0.00%)  0 /0 
Desquamation   1/40 (2.50%)  1 0/30 (0.00%)  0 /0 
Erythema   1/40 (2.50%)  1 0/30 (0.00%)  0 /0 
Erythema facial   1/40 (2.50%)  1 0/30 (0.00%)  0 /0 
Hair loss   2/40 (5.00%)  2 0/30 (0.00%)  0 /0 
Hyperkeratosis   1/40 (2.50%)  1 0/30 (0.00%)  0 /0 
Itch   1/40 (2.50%)  1 0/30 (0.00%)  0 /0 
Localized itching   2/40 (5.00%)  2 0/30 (0.00%)  0 /0 
Maculopapular rash   1/40 (2.50%)  1 0/30 (0.00%)  0 /0 
Nail changes   2/40 (5.00%)  2 0/30 (0.00%)  0 /0 
Nail loss   1/40 (2.50%)  1 0/30 (0.00%)  0 /0 
Nail toxicity   1/40 (2.50%)  1 0/30 (0.00%)  0 /0 
Onychodystrophy   1/40 (2.50%)  1 0/30 (0.00%)  0 /0 
Onycholysis   2/40 (5.00%)  2 0/30 (0.00%)  0 /0 
Pruritus   4/40 (10.00%)  4 0/30 (0.00%)  0 /0 
Rash   6/40 (15.00%)  6 0/30 (0.00%)  0 /0 
Rash both legs   1/40 (2.50%)  1 0/30 (0.00%)  0 /0 
Rash face   1/40 (2.50%)  1 0/30 (0.00%)  0 /0 
Rash maculo-papular   1/40 (2.50%)  1 0/30 (0.00%)  0 /0 
Rash pruritic   1/40 (2.50%)  1 0/30 (0.00%)  0 /0 
Redness   0/40 (0.00%)  0 1/30 (3.33%)  1 /0 
Redness of face   0/40 (0.00%)  0 1/30 (3.33%)  1 /0 
Skin disorder   1/40 (2.50%)  1 0/30 (0.00%)  0 /0 
Skin peeling   1/40 (2.50%)  1 0/30 (0.00%)  0 /0 
Skin rash   2/40 (5.00%)  2 0/30 (0.00%)  0 /0 
Skin ulcer bleeding   0/40 (0.00%)  0 1/30 (3.33%)  1 /0 
Skin ulceration   1/40 (2.50%)  1 0/30 (0.00%)  0 /0 
Vascular disorders       
Deep vein thrombosis leg   0/40 (0.00%)  0 1/30 (3.33%)  1 /0 
Flushed face   2/40 (5.00%)  2 0/30 (0.00%)  0 /0 
Hypertension   3/40 (7.50%)  3 1/30 (3.33%)  1 /0 
Hypertension aggravated   1/40 (2.50%)  1 0/30 (0.00%)  0 /0 
Hypertension worsened   1/40 (2.50%)  1 0/30 (0.00%)  0 /0 
Hypotension   3/40 (7.50%)  3 0/30 (0.00%)  0 /0 
Iliac vein thrombosis   0/40 (0.00%)  0 1/30 (3.33%)  1 /0 
Inferior venacaval thrombosis   0/40 (0.00%)  0 1/30 (3.33%)  1 /0 
Lymphedema   1/40 (2.50%)  1 0/30 (0.00%)  0 /0 
Phlebitis   2/40 (5.00%)  2 0/30 (0.00%)  0 /0 
Indicates events were collected by systematic assessment
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
Layout table for Results Point of Contact information
Name/Title: Chief Medical Officer
Organization: Rainier Therapeutics
Phone: 510-878-2486
EMail: Sabella@RainierRx.com
Layout table for additonal information
Responsible Party: Rainier Therapeutics
ClinicalTrials.gov Identifier: NCT02401542    
Other Study ID Numbers: B-701-U21
2017-001319-36 ( EudraCT Number )
First Submitted: March 16, 2015
First Posted: March 30, 2015
Results First Submitted: February 3, 2020
Results First Posted: February 17, 2020
Last Update Posted: February 17, 2020