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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT02426125




Registration number
NCT02426125
Ethics application status
Date submitted
21/04/2015
Date registered
24/04/2015

Titles & IDs
Public title
A Study of Ramucirumab (LY3009806) Plus Docetaxel in Participants With Urothelial Cancer
Scientific 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
Secondary ID [1] 0 0
I4T-MC-JVDC
Secondary ID [2] 0 0
15679
Universal Trial Number (UTN)
Trial acronym
RANGE
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Urothelial Carcinoma 0 0
Condition category
Condition code
Cancer 0 0 0 0
Non melanoma skin cancer
Cancer 0 0 0 0
Kidney
Cancer 0 0 0 0
Bladder - transitional cell cancer

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - Ramucirumab
Treatment: Drugs - Docetaxel
Treatment: Drugs - Placebo

Experimental: Ramucirumab + Docetaxel - Ramucirumab (10 milligram/kilogram \[mg/kg\]) intravenously (IV) plus docetaxel (75 milligram/square meter \[mg/m²\]) IV on day 1 of each 21-day cycle. Participants may continue to receive treatment until discontinuation criteria are met.

Placebo comparator: Placebo + Docetaxel - Placebo IV plus docetaxel (75 mg/m²) IV on day 1 of each 21-day cycle. Participants may continue to receive treatment until discontinuation criteria are met.


Treatment: Drugs: Ramucirumab
Administered IV

Treatment: Drugs: Docetaxel
Administered IV

Treatment: Drugs: Placebo
Administered IV
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Progression Free Survival (PFS)
Timepoint [1] 0 0
Randomization to Radiological Disease Progression or Death from Any Cause (Up to 18 Months)
Secondary outcome [1] 0 0
Overall Survival (OS)
Timepoint [1] 0 0
Randomization to Date of Death from Any Cause (Up to 31.1 Months)
Secondary outcome [2] 0 0
Percentage of Participants With an Objective Response Rate (ORR)
Timepoint [2] 0 0
Randomization to Disease Progression (Up to 29.7 Months)
Secondary outcome [3] 0 0
Percentage of Participants With Disease Control Rate (DCR)
Timepoint [3] 0 0
Randomization to Disease Progression (Up to 29.7 Months)
Secondary outcome [4] 0 0
Duration of Response (DoR)
Timepoint [4] 0 0
Date of Complete Response (CR) or Partial Response (PR) to Date of Objective Disease Progression or Death Due to Any Cause (Up to 28.4 Months)
Secondary outcome [5] 0 0
Time to Deterioration in Quality of Life (QoL) on the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Core 30 (EORTC QLQ-C30) - Global Health Status/ QoL Scale
Timepoint [5] 0 0
Randomization, 30 Days After Treatment Discontinuation (Up to 18 Months)
Secondary outcome [6] 0 0
Change From Baseline on the EuroQol 5-Dimension, 5-Level Questionnaire (EQ-5D-5L) Index Score
Timepoint [6] 0 0
Randomization, 30 Days After Treatment Discontinuation (Up to 18 Months)
Secondary outcome [7] 0 0
Change From Baseline on the EuroQol 5-Dimension, 5-Level Questionnaire (EQ-5D-5L) Visual Analogue Scale (VAS)
Timepoint [7] 0 0
Randomization, 30 Days After Treatment Discontinuation (Up to 18 Months)
Secondary outcome [8] 0 0
Pharmacokinetics (PK): Maximum Concentration (Cmax) of Ramucirumab
Timepoint [8] 0 0
Cycle 1 and Cycle 9, Day 1: Predose, Postdose
Secondary outcome [9] 0 0
PK: Minimum Concentration (Cmin) of Ramucirumab
Timepoint [9] 0 0
Day 1 of Cycle 2, 3, 5 and 9 (Predose and Postdose)
Secondary outcome [10] 0 0
Number of Participants With Anti-Ramucirumab Antibodies
Timepoint [10] 0 0
29.7 Months

Eligibility
Key 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.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key 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.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s


The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 3
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
13/07/2015
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
26/07/2022
Sample size
Target
Accrual to date
Final
530
Recruitment in Australia
Recruitment state(s)
Recruitment hospital [1] 0 0
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. - Adelaide
Recruitment hospital [2] 0 0
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. - Footscray
Recruitment hospital [3] 0 0
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. - Randwick
Recruitment hospital [4] 0 0
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. - Subiaco
Recruitment postcode(s) [1] 0 0
5000 - Adelaide
Recruitment postcode(s) [2] 0 0
3011 - Footscray
Recruitment postcode(s) [3] 0 0
2031 - Randwick
Recruitment postcode(s) [4] 0 0
6008 - Subiaco
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Arkansas
Country [2] 0 0
United States of America
State/province [2] 0 0
California
Country [3] 0 0
United States of America
State/province [3] 0 0
Colorado
Country [4] 0 0
United States of America
State/province [4] 0 0
Connecticut
Country [5] 0 0
United States of America
State/province [5] 0 0
Florida
Country [6] 0 0
United States of America
State/province [6] 0 0
Georgia
Country [7] 0 0
United States of America
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Hawaii
Country [8] 0 0
United States of America
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Indiana
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Louisiana
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Maryland
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Michigan
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Minnesota
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Nebraska
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New York
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Ohio
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Oklahoma
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Tennessee
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Texas
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Virginia
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Washington
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Belgium
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Brussels
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Belgium
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Leuven
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Wilrijk
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Canada
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Toronto
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Canada
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Vancouver
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Herlev
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Odense
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France
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Caen
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France
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Lille
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France
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Lyon
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France
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Montpellier
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France
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Paris
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France
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Rennes
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Dusseldorf
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Germany
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Jena
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Germany
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Tubingen
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Greece
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Athens
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Heraklion
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Patras
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Miskolc
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Haifa
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Kfar Saba
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Petach Tikva
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Tel Hashomer
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Rome
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Verona
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Seongnam
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Gdansk
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Baia Mare
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Cluj-Napoca
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Craiova
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Russian Federation
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Ivanovo
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Russian Federation
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Kazan
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Russian Federation
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Moscow
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Russian Federation
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Barcelona
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Spain
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Madrid
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Taiwan
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Kaohsiung
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Taichung
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Tainan
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Taipei
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Turkey
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Ankara
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Antalya
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Turkey
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Edirne
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Turkey
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Istanbul
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Turkey
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Malatya
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Ukraine
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Dnipropetrovsk
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Ukraine
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Kyiv
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Ukraine
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Lutsk
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United Kingdom
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Bebington
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United Kingdom
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Chelsea
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United Kingdom
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London
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United Kingdom
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Nottingham
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United Kingdom
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Southampton
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United Kingdom
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Sutton

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Eli Lilly and Company
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
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)
Address 0 0
Eli Lilly and Company
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
Anonymized individual patient level data will be provided in a secure access environment upon approval of a research proposal and a signed data sharing agreement.

Supporting document/s available: Study protocol, Statistical analysis plan (SAP), Clinical study report (CSR)
When will data be available (start and end dates)?
Data are available 6 months after the primary publication and approval of the indication studied in the US and EU, whichever is later. Data will be indefinitely available for requesting.
Available to whom?
A research proposal must be approved by an independent review panel and researchers must sign a data sharing agreement.
Available for what types of analyses?
How or where can data be obtained?
IPD available at link: https://vivli.org/


What supporting documents are/will be available?




Results publications and other study-related documents

No documents have been uploaded by study researchers.


Results are available at https://clinicaltrials.gov/study/NCT02426125