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A Study of Ramucirumab (LY3009806) Plus Docetaxel in Participants With Urothelial Cancer (RANGE)

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ClinicalTrials.gov Identifier: NCT02426125
Recruitment Status : Active, not recruiting
First Posted : April 24, 2015
Last Update Posted : November 20, 2018
Sponsor:
Information provided by (Responsible Party):
Eli Lilly and Company

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.

Condition or disease Intervention/treatment Phase
Urothelial Carcinoma Drug: Ramucirumab Drug: Docetaxel Drug: Placebo Phase 3

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 466 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
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
Actual Study Start Date : July 13, 2015
Actual Primary Completion Date : April 21, 2017
Estimated Study Completion Date : June 20, 2019


Arm Intervention/treatment
Experimental: Ramucirumab + Docetaxel
Ramucirumab intravenously (IV) plus docetaxel IV in 21 day cycles. Participants may continue to receive treatment until discontinuation criteria are met.
Drug: Ramucirumab
Administered IV
Other Name: LY3009806

Drug: Docetaxel
Administered IV

Placebo Comparator: Placebo + Docetaxel
Placebo IV plus docetaxel IV in 21 day cycles. Participants may continue to receive treatment until discontinuation criteria are met.
Drug: Docetaxel
Administered IV

Drug: Placebo
Administered IV




Primary Outcome Measures :
  1. Progression Free Survival [ Time Frame: Randomization to Radiological Disease Progression or Death from Any Cause (Approximately 19 Months) ]
    Progression Free Survival


Secondary Outcome Measures :
  1. Overall Survival [ Time Frame: Randomization to Date of Death from Any Cause (Approximately 33 Months) ]
    Overall Survival

  2. Objective Response Rate (ORR) [ Time Frame: Randomization to Disease Progression (Approximately 33 Months) ]
    Objective Response Rate (ORR)

  3. Disease Control Rate [ Time Frame: Randomization to Disease Progression (Approximately 33 Months) ]
    Disease Control Rate

  4. Duration of Response (DoR) [ Time Frame: Date of Complete Response (CR) or Partial Response (PR) to Date of Objective Disease Progression or Death Due to Any Cause (Approximately 33 Months) ]
    Duration of Response (DoR)

  5. Change from Baseline on the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-C30 (EORTC QLQ-C30) [ Time Frame: Randomization, 30 Days After Treatment Discontinuation (Approximately 33 Months) ]
    Change from Baseline on the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-C30 (EORTC QLQ-C30)

  6. Change from Baseline on the EuroQol 5-Dimension, 5-Level Questionnaire (EQ-5D-5L) [ Time Frame: Randomization, 30 Days After Treatment Discontinuation (Approximately 33 Months) ]
    Change from Baseline on the EuroQol 5-Dimension, 5-Level Questionnaire (EQ-5D-5L)

  7. Pharmacokinetics (PK): Minimum Concentration (Cmin) of Ramucirumab [ Time Frame: Predose Cycle 1 through 30 Days After Treatment Discontinuation (Approximately 33 Months) ]
    Pharmacokinetics (PK): Minimum Concentration (Cmin) of Ramucirumab

  8. Number of Participants with Anti-Ramucirumab Antibodies [ Time Frame: Predose Cycle 1 through 30 Days After Treatment Discontinuation (Approximately 33 Months) ]
    Number of Participants with Anti-Ramucirumab Antibodies



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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 PD-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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02426125


  Show 141 Study Locations
Sponsors and Collaborators
Eli Lilly and Company
Investigators
Study Director: 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) Eli Lilly and Company

Additional Information:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Eli Lilly and Company
ClinicalTrials.gov Identifier: NCT02426125     History of Changes
Other Study ID Numbers: 15679
I4T-MC-JVDC ( Other Identifier: Eli Lilly and Company )
2014-003655-66 ( EudraCT Number )
First Posted: April 24, 2015    Key Record Dates
Last Update Posted: November 20, 2018
Last Verified: November 16, 2018

Keywords provided by Eli Lilly and Company:
carcinoma of the bladder
carcinoma of the urethra
carcinoma the of ureter
carcinoma of the renal pelvis
transitional cell carcinoma
transitional cell tumor
RANGE
bladder cancer

Additional relevant MeSH terms:
Carcinoma
Carcinoma, Transitional Cell
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Docetaxel
Ramucirumab
Antineoplastic Agents
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action