Clinical trial NCT00533702: A Study of IMC-1121B (Ramucirumab) With or Without Dacarbazine in Metastatic Malignant Melanoma
Official title: Phase II Randomized, Open-Label Study of IMC-1121B With or Without Dacarbazine in Patients With Metastatic Malignant Melanoma
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Metastatic Malignant Melanoma
Keywords: Phase II
Melanoma
IMC-1121B
ImClone
Lead sponsor: Eli Lilly and Company
Sponsor class: INDUSTRY
First posted: 2007-09-21
Enrollment: 106
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The primary objective of this study is to determine the progression-free survival (PFS) of participants with previously untreated metastatic malignant melanoma when treated with IMC-1121B (ramucirumab) alone or in combination with dacarbazine.

Detailed description: The purpose of this study is to determine the antitumor activity and safety profile of IMC-1121B (ramucirumab) when used alone or in combination with dacarbazine in participants with metastatic melanoma who have not received prior chemotherapy for this disease.

Eligibility criteria: Inclusion Criteria:

* The participant has histologically or cytologically confirmed melanoma that is stage IV (metastatic)
* The participant has an Eastern Cooperative Oncology Performance Status (ECOG PS) of 0-1
* The participant has completed any prior radiotherapy, biologic/immunotherapy or vaccine therapy (for adjuvant or advanced disease) at least six weeks prior to the first dose of study therapy
* The participant has adequate hematological functions \[absolute neutrophil count (ANC) ≥ 1500 cells/microliter (μL), hemoglobin ≥ 9 grams/deciliter (g/dL) and platelets ≥ 100,000 cells/μL\].
* The participant has adequate hepatic function \[bilirubin within normal limits (WNL), aspartate transaminase (AST) and/or alanine transaminase (ALT) ≤ 2.5 times the upper limit of normal (ULN), or ≤ 5.0 times the ULN if the transaminase elevation is due to liver metastases\]
* The participant has serum creatinine ≤ 1.5 x ULN \[or a calculated creatinine clearance \> 60 milliliters/minute (mL/min)\]
* The participant's urinary protein ≤ 1+ on dipstick or routine urinalysis \[(UA); if urine dipstick or routine analysis is ≥ 2+, a 24-hour urine for protein must demonstrate \< 1000 milligrams (mg) of protein in 24 hours to allow participation in the study\]
* The participant must have adequate coagulation function as defined by International Normalized Ratio (INR) ≤ 1.5 and a partial thromboplastin time (PTT) ≤ 1.5 X ULN

Exclusion Criteria

* The participant has mucosal or intra-ocular melanoma
* The participant has known or suspected brain or leptomeningeal metastases
* The participant has had prior cytotoxic chemotherapy for metastatic malignant melanoma
* The participant has had more than one line of biologic, immunologic or vaccine-based therapy for metastatic malignant melanoma (including therapy for adjuvant or advanced disease)
* The participant has a nonhealing wound or ulcer
* The participant has a known alcohol or drug dependency
* The participant is pregnant or breastfeeding
* The participant has a coexisting medical or psychiatric problem of sufficient severity to limit compliance with the study and/or increase the risks associated with study participation or study drug administration or interfere with the interpretation of study results
* The participant has an ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, symptomatic or poorly controlled cardiac arrhythmia, psychiatric illness/social situations, or any other serious uncontrolled medical disorders in the opinion of the investigator

Primary outcomes:
measure: Progression Free Survival (PFS)
timeFrame: Baseline up to 36 months
Secondary outcomes:
measure: Number of Participants With Adverse Events (AE)
timeFrame: Baseline up to 40 months
measure: Percentage of Participants With Complete Response (CR) or Partial Response (PR) [Overall Response Rate (ORR)]
timeFrame: Cycle 1 Day 1 (of 21-day cycle) up to 17.1 months
measure: Duration of Response
timeFrame: Cycle 1 Day 1 (of 21-day cycle) up to 17.1 months
measure: Percentage of Participants With Stable Disease (SD) or Better (Disease Control Rate) at 6 Weeks
timeFrame: 6 weeks (2 cycles of treatment)
measure: Percentage of Participants With Stable Disease (SD) or Better (Disease Control Rate) at 12 Weeks
timeFrame: 12 weeks (4 cycles of treatment)
measure: Percentage of Participants With Complete Response (CR) or Partial Response (PR) (Response Rate) at 12 Weeks
timeFrame: 12 weeks (4 cycles of treatment)
measure: Maximum Concentration (Cmax) for Cycle 1 Day 1
timeFrame: Cycle 1 Day 1 (21-day cycle) 1-hour post infusion
measure: Maximum Concentration (Cmax) for Cycle 1 Day 7
timeFrame: Cycle 1 Day 7 (21-day cycle)
measure: Maximum Concentration (Cmax) for Cycle 1 Day 14
timeFrame: Cycle 1 Day 14 (21-day cycle)
Other outcomes:
Locations:
city: Decatur
country: United States
facility: ImClone Investigational Site
state: Alabama
city: Scottsdale
country: United States
facility: ImClone Investigational Site
state: Arizona
city: Scottsdale
country: United States
facility: ImClone Investigational Site
state: Arizona
city: Fresno
country: United States
facility: ImClone Investigational Site
state: California
city: San Francisco
country: United States
facility: ImClone Investigational Site
state: California
city: Aurora
country: United States
facility: ImClone Investigational Site
state: Colorado
city: Jacksonville
country: United States
facility: ImClone Investigational Site
state: Florida
city: Orlando
country: United States
facility: ImClone Investigational Site
state: Florida
city: Oxford
country: United States
facility: ImClone Investigational Site
state: Mississippi
city: Missoula
country: United States
facility: ImClone Investigational Site
state: Montana
city: Buffalo
country: United States
facility: ImClone Investigational Site
state: New York
city: New York City
country: United States
facility: ImClone Investigational Site
state: New York
city: New York
country: United States
facility: ImClone Investigational Site
state: New York
city: Willow Grove
country: United States
facility: ImClone Investigational Site
state: Pennsylvania
city: Dallas
country: United States
facility: ImClone Investigational Site
state: Texas
city: Houston
country: United States
facility: ImClone Investigational Site
state: Texas
city: Seattle
country: United States
facility: ImClone Investigational Site
state: Washington
Study officials:
affiliation: Eli Lilly and Company
name: 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)
role: STUDY_DIRECTOR
References:
citation: Carvajal RD, Wong MK, Thompson JA, Gordon MS, Lewis KD, Pavlick AC, Wolchok JD, Rojas PB, Schwartz JD, Bedikian AY. A phase 2 randomised study of ramucirumab (IMC-1121B) with or without dacarbazine in patients with metastatic melanoma. Eur J Cancer. 2014 Aug;50(12):2099-107. doi: 10.1016/j.ejca.2014.03.289. Epub 2014 Jun 12.