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Trial details imported from ClinicalTrials.gov

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




Registration number
NCT02426125
Ethics application status
Date submitted
21/04/2015
Date registered
24/04/2015
Date last updated
22/06/2021

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 in 21 day cycles. Participants may continue to receive treatment until discontinuation criteria are met.

Placebo Comparator: Placebo + Docetaxel - Placebo IV plus docetaxel (75 mg/m²) IV in 21 day cycles. 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) - PFS defined as time from first day of therapy to first evidence of disease progression defined by Response Evaluation Criteria in Solid Tumors (RECIST v1.1) or death from any cause. Progressive Disease (PD) is at least 20% increase in sum of diameters of target lesions, with reference being the smallest sum on study and plus absolute increase of at least 5 mm, or unequivocal progression of non-target lesions, or 1 or more new lesions. If participant does not have complete baseline disease assessment, then PFS time was censored at date of first dose, regardless of whether or not objectively determined disease progression or death has been observed for participant. If participant is not known to have died or have objective progression as of data inclusion cutoff date for analysis, PFS time was censored at last adequate tumor assessment date.
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) - OS is the time from the date of randomization to the date of death from any cause. For each participant who is not known to have died as of the data inclusion cutoff date for a particular analysis, OS was censored for that analysis at the last known alive date prior to the data inclusion cutoff date.
Timepoint [1] 0 0
Randomization to Date of Death from Any Cause (Up to 21 Months)
Secondary outcome [2] 0 0
Percentage of Participants With an Objective Response Rate (ORR) - Objective response rate is defined as the percentage of participants who achieve a best overall response of complete response (CR) + partial response (PR). ORR = CR + PR. CR is the disappearance of all non-target lesions and normalization of tumour marker level. All lymph nodes must be non-pathological in size (<10 mm short axis). PR is at least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters. CR: Disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to <10 mm. Tumor marker results must have normalized. Best overall response is classified based on the overall responses assessed by study investigators according to Response Evaluation Criteria In Solid Tumors (RECIST) Version 1.1.
Timepoint [2] 0 0
Randomization to Disease Progression (Up to 18 Months)
Secondary outcome [3] 0 0
Percentage of Participants With Disease Control Rate (DCR) - DCR is the percentage of participants with a best overall response of CR, PR, or Stable Disease (SD) as per Response using RECIST v1.1. Target lesions - CR: Disappearance of all lesions; any pathological lymph nodes must have reduction in short axis to <10 mm. PR: At least a 30% decrease in the sum of diameters of lesions vs the baseline sum. Progressive Disease (PD): At least a 20% increase in the sum of diameters of lesions vs the smallest sum on study (the sum must also demonstrate an absolute increase of at least 5 mm); or the appearance of new lesion(s). SD: Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD. Non target lesions - CR: Disappearance of all lesions and normalization of tumor marker levels; all lymph nodes must be non-pathological in size. Non-CR/Non-PD: Persistence of lesion(s) and/or maintenance of abnormal tumor marker levels. PD: Unequivocal progression of existing lesions or the appearance of new lesion(s).
Timepoint [3] 0 0
Randomization to Disease Progression (Up to 18 Months)
Secondary outcome [4] 0 0
Duration of Response (DoR) - Objective response was achieved if they had a best overall response of CR or PR. Target lesions- CR: Disappearance of all lesions; any pathological lymph nodes have reduction in short axis to <10 mm. PR: At least a 30% decrease in the sum of diameters of lesions vs the baseline sum. PD: At least a 20% increase in the sum of diameters of lesions vs the smallest sum on study(the sum must also demonstrate an absolute increase of at least 5 mm); or the appearance of new lesion(s). Non target lesions - CR: Disappearance of all lesions and normalization of tumour marker levels; all lymph nodes must be non-pathological in size. Non-CR/Non-PD: Persistence of lesion(s) and/or maintenance of abnormal tumor marker levels. PD: Unequivocal progression of existing lesions or the appearance of new lesion(s). If a participant was not known to have died or have radiographically documented PD as of the data inclusion cutoff date, DOR was censored at the date of the last adequate tumor assessment.
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 18 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 - Time to sustained deterioration was defined as time from randomization to first worsening in QoL with no subsequent non-worsened assessment. Worsening in global health status/QoL was defined as a decrease of =10 points on a 100-point scale. If a participant did not report worsening, time to sustained deterioration was censored at date of last non-worsened assessment. Scores for global health status/QoL range from 0 to 100 with; higher scores representing better QoL.
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 - The EQ-5D-5L is a standardized instrument for use as a measure of self-reported health status. Participants completed the 5-level (no problem, slight problem, moderate problem, severe problem, and inability or extreme problem), 5-dimension (mobility, self-care, usual activities, pain/discomfort, and anxiety/depression) questionnaire concerning their current health state. A unique EQ-5D health state is defined by combining 1 level from each of the 5 dimensions. Scores range from 0 (death) to 1 (perfect health), but scores <0 are possible based on the algorithm.
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) - The EQ-5D-5L is a standardized instrument for use as a measure of self-reported health status. A unique EQ-5D health state is defined by combining 1 level from each of the 5 dimensions. Participants indicated their current health status by marking on a visual analogue scale (VAS) ranging from 100 (best imaginable health state) to 0 (worst imaginable health state).
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 - Maximum concentration (Cmax) of Ramucirumab at the end of ramucirumab infusion
Timepoint [8] 0 0
Cycle 1 and Cycle 9, Day 1: Predose, Postdose
Secondary outcome [9] 0 0
PK: Minimum Concentration (Cmin) of Ramucirumab - Minimum concentration (Cmin) of Ramucirumab following administration every 3 weeks.
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 - Number of participants with positive treatment emergent anti-ramucirumab antibodies was summarized by treatment group.
Timepoint [10] 0 0
18 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
Gender
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
Active, not recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
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
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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
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.
Trial website
https://clinicaltrials.gov/show/NCT02426125
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

Summary results
Other publications