Brief Title
A Study of Ramucirumab (LY3009806) Plus Docetaxel in Participants With Urothelial Cancer
Official Title
A Phase 3, Randomized, Double-Blind, Placebo-Controlled Study of Ramucirumab Plus Docetaxel Versus Placebo Plus Docetaxel in Patients With Locally Advanced or Unresectable or Metastatic Urothelial Carcinoma Who Progressed on or After Platinum-Based Therapy
Brief Summary
The main purpose of this study is to evaluate the safety and efficacy of the study drug
ramucirumab in combination with docetaxel in participants with urothelial cancer who failed
prior platinum-based therapy.
Study Phase
Phase 3
Study Type
Interventional
Primary Outcome
Progression Free Survival (PFS)
Secondary Outcome
Overall Survival (OS)
Condition
Urothelial Carcinoma
Intervention
Ramucirumab
Study Arms / Comparison Groups
Ramucirumab + Docetaxel
Description: Ramucirumab (10 milligram/kilogram [mg/kg]) intravenously (IV) plus docetaxel (75 milligram/square meter [mg/m²]) IV in 21 day cycles. Participants may continue to receive treatment until discontinuation criteria are met.
Publications
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
Recruitment Information
Recruitment Status
Drug
Estimated Enrollment
530
Start Date
July 13, 2015
Completion Date
July 26, 2022
Primary Completion Date
April 21, 2017
Eligibility Criteria
Inclusion Criteria:
- Have histologically or cytologically confirmed, locally advanced or unresectable or
metastatic urothelial (transitional cell) carcinoma of the bladder, urethra, ureter,
or renal pelvis.
- Had disease progression while on a platinum containing regimen in the first-line
setting or within 14 months after completing the first-line platinum regimen.
Participants who received treatment with one immune checkpoint inhibitor regimen are
eligible (for example Programmed death 1 (PD-1), Programmed death-ligand 1 (PDL1), or
CTLA4) and may have a longer interval since prior platinum-containing therapy (≤24
months).
- Have a life expectancy of ≥3 months.
- Have received no more than one prior systemic chemotherapy regimen in the relapsed or
metastatic setting. Prior treatment with no more than one prior immune checkpoint
inhibitor is permitted and will not be considered as a line of systemic chemotherapy.
- Have measurable disease or nonmeasurable but evaluable disease as defined by Response
Evaluation Criteria in Solid Tumors, Version 1.1 (RECIST 1.1).
- Have an Eastern Cooperative Oncology Group (ECOG) of 0 or 1.
- Have adequate hematologic function.
- Have adequate coagulation function.
- Have adequate hepatic function.
- The participant does not have:
- cirrhosis at a level of Child-Pugh B (or worse)
- cirrhosis (any degree) and a history of hepatic encephalopathy or clinically
meaningful ascites resulting from cirrhosis
- Have adequate renal function as defined by creatinine clearance >30
milliliters/minute.
- Have urinary protein ≤1+ on dipstick or routine urinalysis.
- The participant is willing to provide blood, urine, and tissue samples for research
purposes.
Exclusion Criteria:
- Have received more than one prior systemic chemotherapy regimen for metastatic
disease.
- Have received prior systemic taxane therapy for transitional cell carcinoma (TCC) of
the bladder, urethra, ureter, or renal pelvis in any setting (neoadjuvant, adjuvant,
metastatic).
- Have received more than one prior antiangiogenic agent (that is, bevacizumab,
sorafenib, sunitinib) for TCC of the urothelium.
- Have received radiation therapy within 4 weeks (≤4 weeks) prior to randomization or
has not recovered from toxic effects of the treatment that was given >4 weeks prior to
randomization.
- Have a history of uncontrolled hereditary or acquired bleeding or thrombotic
disorders.
- Have experienced a Grade ≥3 bleeding event within 3 months (≤3 months) prior to
randomization.
- Have uncontrolled intercurrent illness, including, but not limited to symptomatic
anemia, uncontrolled hypertension, symptomatic congestive heart failure, unstable
angina pectoris, symptomatic or poorly controlled cardiac arrhythmia, psychiatric
illness, or any other serious uncontrolled medical disorders.
- Have experienced any arterial or venothrombotic or thromboembolic events, including,
but not limited to myocardial infarction, transient ischemic attack, or
cerebrovascular accident, within 6 months (≤6 months) prior to randomization.
- Have known untreated brain metastases, uncontrolled spinal cord compression, or
leptomeningeal disease.
- Have human immunodeficiency virus (HIV) infection or acquired immunodeficiency
syndrome-related illness.
- Have undergone major surgery within 28 days (≤28 days) prior to randomization or
subcutaneous venous access device placement within 7 days (≤7 days) prior to
randomization.
- The participant is pregnant prior to randomization or lactating.
- Have a concurrent malignancy or had another malignancy within 5 years (≤5 years) of
study enrollment.
Gender
All
Ages
18 Years - N/A
Accepts Healthy Volunteers
No
Contacts
Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST), ,
Location Countries
Australia
Location Countries
Australia
Administrative Informations
NCT ID
NCT02426125
Organization ID
15679
Secondary IDs
I4T-MC-JVDC
Responsible Party
Sponsor
Study Sponsor
Eli Lilly and Company
Study Sponsor
Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST), Study Director, Eli Lilly and Company
Verification Date
July 2022