A Study of IMC-1121B (Ramucirumab) With or Without Dacarbazine in Metastatic Malignant Melanoma

NCT00533702 | Completed Phase 2 Results DMC

• 3 other identifiers: 13920CP12-0604I4T-IE-JVBO
• Study Type: interventional
• Target: 106
• Locations: 1 country
• Sites: 17

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.

Conditions

Metastatic Malignant Melanoma

Keywords

Phase II; Melanoma; IMC-1121B; ImClone

Outcome Measures

Primary Outcomes (1)

• Progression Free Survival (PFS)

  PFS was defined as the time from the first day of therapy to the first evidence of disease progression as defined by Response Evaluation Criteria in Solid Tumors (RECIST v1.0) or death from any cause. Progressive disease (PD) was defined as at least a 20% increase in the sum of the longest diameter (LD) of the target lesions, taking as reference the smallest sum LD recorded since the treatment started in comparison with the measurement of the nadir or the appearance of 1 or more new lesions. In addition, unequivocal progression of existing non-target lesions was considered PD. New or existing pleural effusion/ascites required cytological confirmation for PD according to the protocol. Participants who did not progress and who were alive or did not have documented progression or missed ≥2 visits, or had no post baseline assessment were censored at the day of their last tumor assessment.

  Baseline up to 36 months

Secondary Outcomes (9)

• Number of Participants With Adverse Events (AE)

  Baseline up to 40 months

• Percentage of Participants With Complete Response (CR) or Partial Response (PR) [Overall Response Rate (ORR)]

  Cycle 1 Day 1 (of 21-day cycle) up to 17.1 months

• Duration of Response

  Cycle 1 Day 1 (of 21-day cycle) up to 17.1 months

• Percentage of Participants With Stable Disease (SD) or Better (Disease Control Rate) at 6 Weeks

  6 weeks (2 cycles of treatment)

• Percentage of Participants With Stable Disease (SD) or Better (Disease Control Rate) at 12 Weeks

  12 weeks (4 cycles of treatment)

Study Arms (2)

IMC-1121B (ramucirumab)

EXPERIMENTAL

IMC-1121B (ramucirumab)

Biological: IMC-1121B (ramucirumab)

IMC-1121B (ramucirumab) + dacarbazine

ACTIVE COMPARATOR

IMC-1121B (ramucirumab) + dacarbazine

Biological: IMC-1121B (ramucirumab); Drug: Dacarbazine

Interventions

IMC-1121B (ramucirumab) BIOLOGICAL

10 milligrams/kilogram (mg/kg) intravenously every 3 weeks in the absence of disease progression, unacceptable toxicity, or other withdrawal criteria.

Also known as: ramucirumab, LY3009806

IMC-1121B (ramucirumab); IMC-1121B (ramucirumab) + dacarbazine

Dacarbazine DRUG

1000 milligrams/square meter (mg/m2) intravenously every 3 weeks in the absence of disease progression, unacceptable toxicity, or other withdrawal criteria.

Also known as: DIC, Imidazole, Carboxamide

IMC-1121B (ramucirumab) + dacarbazine

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Eli Lilly and Company: lead

Study Sites (17)

ImClone Investigational Site

Decatur, Alabama, 35601, United States

Location

ImClone Investigational Site

Scottsdale, Arizona, 85258, United States

Location

ImClone Investigational Site

Scottsdale, Arizona, 85260, United States

Location

ImClone Investigational Site

Fresno, California, 93720, United States

Location

ImClone Investigational Site

San Francisco, California, 94109, United States

Location

ImClone Investigational Site

Aurora, Colorado, 80045, United States

Location

ImClone Investigational Site

Jacksonville, Florida, 32256, United States

Location

ImClone Investigational Site

Orlando, Florida, 32806, United States

Location

ImClone Investigational Site

Oxford, Mississippi, 38655, United States

Location

ImClone Investigational Site

Missoula, Montana, 59806, United States

Location

ImClone Investigational Site

Buffalo, New York, 14263, United States

Location

ImClone Investigational Site

New York, New York, 10016, United States

Location

ImClone Investigational Site

New York, New York, 10021, United States

Location

ImClone Investigational Site

Willow Grove, Pennsylvania, 19090, United States

Location

ImClone Investigational Site

Dallas, Texas, 75230, United States

Location

ImClone Investigational Site

Houston, Texas, 77030, United States

Location

ImClone Investigational Site

Seattle, Washington, 98109, United States

Location

Related Publications (1)

• 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.

  PMID: 24930625 DERIVED

MeSH Terms

Conditions

Melanoma

Interventions

Ramucirumab; Dacarbazine; imidazole

Condition Hierarchy (Ancestors)

Neuroendocrine Tumors; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Nerve Tissue; Nevi and Melanomas; Skin Neoplasms; Neoplasms by Site; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins; Triazenes; Organic Chemicals; Imidazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Results Point of Contact

• Title: Chief Medical Officer
• Organization: Eli Lilly and company

800-545-5979

Study Officials

• 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

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 17, 2007
• First Posted: September 21, 2007
• Study Start: November 1, 2007
• Primary Completion: May 1, 2011
• Study Completion: May 1, 2011
• Last Updated: August 1, 2014
• Results First Posted: June 18, 2014

Record last verified: 2014-07

Locations

US (17)