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Metastatic Malignant MelanomaPhase 2NCT00533702

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

A Phase 2 study testing IMC-1121B (ramucirumab) and Dacarbazine in people with Metastatic Malignant Melanoma, run by Eli Lilly and Company at 17 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Metastatic Malignant Melanoma
What is being tested?
IMC-1121B (ramucirumab) and Dacarbazine
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
106 participants
Where
17 sitesUnited States
Study dates
Nov 2007to May 2011
Phase
Phase 2
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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
Show all 9Show fewer
  • 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

Trial locations and contacts

17 sites in 1 country.

17 sites in 1 country

United States17 sites

  • ImClone Investigational Site

    Aurora, Colorado, 80045

  • ImClone Investigational Site

    Buffalo, New York, 14263

  • ImClone Investigational Site

    Dallas, Texas, 75230

  • ImClone Investigational Site

    Decatur, Alabama, 35601

  • ImClone Investigational Site

    Fresno, California, 93720

  • ImClone Investigational Site

    Houston, Texas, 77030

  • ImClone Investigational Site

    Jacksonville, Florida, 32256

  • ImClone Investigational Site

    Missoula, Montana, 59806

  • ImClone Investigational Site

    New York, New York, 10016

  • ImClone Investigational Site

    New York, New York, 10021

  • ImClone Investigational Site

    Orlando, Florida, 32806

  • ImClone Investigational Site

    Oxford, Mississippi, 38655

  • ImClone Investigational Site

    San Francisco, California, 94109

  • ImClone Investigational Site

    Scottsdale, Arizona, 85258

  • ImClone Investigational Site

    Scottsdale, Arizona, 85260

  • ImClone Investigational Site

    Seattle, Washington, 98109

  • ImClone Investigational Site

    Willow Grove, Pennsylvania, 19090

Other trials in United States

About this study

Official title: Phase II Randomized, Open-Label Study of IMC-1121B With or Without Dacarbazine in Patients With Metastatic Malignant Melanoma

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.

Read the 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.

Being tested
IMC-1121B (ramucirumab), Dacarbazine
Keywords
Phase II, Melanoma, IMC-1121B, ImClone
Medical subject headings
Melanoma

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • IMC-1121B (ramucirumab)Biological

    Also called ramucirumab, LY3009806

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

  • DacarbazineDrug

    Also called DIC, Imidazole, Carboxamide

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

Study groups in NCT00533702
Study groupRoleWhat they receive
IMC-1121B (ramucirumab)ExperimentalIMC-1121B (ramucirumab)
Receives: Biological: IMC-1121B (ramucirumab)
IMC-1121B (ramucirumab) + dacarbazineActive comparatorIMC-1121B (ramucirumab) + dacarbazine
Receives: Biological: IMC-1121B (ramucirumab); Drug: Dacarbazine

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: Baseline up to 36 months

Secondary outcomes (9)

  1. Number of Participants With Adverse Events (AE)

    The number of participants who experienced any IMC-1121B (ramucirumab [RAM]) treatment-related and treatment emergent AE (TEAE), treatment-related TEAE of Grade ≥3, treatment-related TE serious AEs (SAEs), treatment-related TEAE resulting in death (Grade 5 AE) and any TEAEs resulting in death. A summary of SAEs and all other non-serious AEs, regardless of causality, is located in the Reported Adverse Events module.

    Measured: Baseline up to 40 months

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

    The ORR was defined as the percentage of all randomized participants with the best overall response of PR or CR using Response Evaluation Criteria in Solid Tumors (RECIST v1.0). CR was defined as the disappearance of all target and non-target lesions. PR was defined as at least a 30% decrease in sum of longest diameter of target lesions. CR and PR had to be confirmed by repeat assessments and performed no fewer than 4 weeks after the criteria for response were first met.

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

  3. Duration of Response

    The duration of overall response was defined as the time from first assessment of complete response (CR) or partial response (PR) to the first date of progressive disease (PD) using Response Evaluation Criteria in Solid Tumors (RECIST v1.0), initiation of other or additional antitumor therapy, or death from any cause. CR was defined as the disappearance of all target lesions. PR was defined as having at least a 30% decrease in sum of longest diameter of target lesions. CR and PR had to be confirmed by repeat assessments and performed no fewer than 4 weeks after the criteria for response were first met. PD was defined as at least 20% increase in sum of longest diameter of target lesions. Participants who did not relapse were censored at the day of their last objective tumor assessment.

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

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

    Disease Control Rate (DCR) was defined as complete response (CR) plus partial response (PR) plus SD using Response Evaluation Criteria in Solid Tumors (RECIST v1.0). CR was defined as the disappearance of all target and non-target lesions and the normalization of non-target lesion tumor marker levels. PR was defined as at least a 30% decrease from baseline in sum of longest diameter of target lesions. CR and PR had to be confirmed by repeat assessments and performed no fewer than 4 weeks after the criteria for response were first met. SD was defined as: neither sufficient increase to qualify for progressive disease (PD) nor sufficient shrinkage to qualify for PR, taking as reference the smallest sum of the longest diameters recorded since treatment began. PD was defined as at least 20% increase in sum of longest diameter of target lesions.

    Measured: 6 weeks (2 cycles of treatment)

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

    Disease Control Rate (DCR) was defined as complete response (CR) plus partial response (PR) plus SD using Response Evaluation Criteria in Solid Tumors (RECIST v1.0). CR was defined as the disappearance of all target and non-target lesions and the normalization of non-target lesion tumor marker levels. PR was defined as at least a 30% decrease from baseline in sum of longest diameter of target lesions. CR and PR had to be confirmed by repeat assessments and performed no fewer than 4 weeks after the criteria for response were first met. Stable Disease (SD) was defined as: neither sufficient increase to qualify for progressive disease (PD) nor sufficient shrinkage to qualify for PR, taking as reference the smallest sum of the longest diameters recorded since treatment began. PD was defined as at least 20% increase in sum of longest diameter of target lesions.

    Measured: 12 weeks (4 cycles of treatment)

  6. Percentage of Participants With Complete Response (CR) or Partial Response (PR) (Response Rate) at 12 Weeks

    Response rate was defined as a CR or a PR using Response Evaluation Criteria in Solid Tumors (RECIST v1.0). CR was defined as the disappearance of all target and non-target lesions and the normalization of non-target lesion tumor marker levels. PR was defined as at least a 30% decrease from baseline in sum of longest diameter of target lesions. CR and PR had to be confirmed by repeat assessments and performed no fewer than 4 weeks after the criteria for response were first met.

    Measured: 12 weeks (4 cycles of treatment)

  7. Maximum Concentration (Cmax) for Cycle 1 Day 1

    Cmax was not calculated due to sparse sampling.

    Measured: Cycle 1 Day 1 (21-day cycle) 1-hour post infusion

  8. Maximum Concentration (Cmax) for Cycle 1 Day 7

    Cmax was not calculated due to sparse sampling.

    Measured: Cycle 1 Day 7 (21-day cycle)

  9. Maximum Concentration (Cmax) for Cycle 1 Day 14

    Cmax was not calculated due to sparse sampling.

    Measured: Cycle 1 Day 14 (21-day cycle)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted21 Sep 2007 (estimated)
  2. Study startNov 2007
  3. Primary completionMay 2011
  4. Study completionMay 2011

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
106 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00533702
Sponsor's protocol ID
13920
Other IDs
CP12-0604, I4T-IE-JVBO
Status last verified
Jul 2014
First submitted
17 Sep 2007
Last updated
1 Aug 2014
Data monitoring committee
Yes

Publications

  • 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.

    PubMed 24930625

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing IMC-1121B (ramucirumab) and Dacarbazine in people with Metastatic Malignant Melanoma, run by Eli Lilly and Company at 17 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 8 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 1 Aug 2014. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 17 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 18 Jun 2014). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Progression Free Survival (PFS) (time frame: Baseline up to 36 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00533702, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Aug 2014.

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