An Open-Label, Dose-Escalation Study of IMC-20D7S In Participants With Malignant Melanoma
NCT ID: NCT01137006
Last Updated: 2019-06-17
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE1
27 participants
INTERVENTIONAL
2010-06-30
2012-08-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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IMC-20D7S (1A-4A Cohorts)
Escalating doses up to 30 milligrams per kilogram (mg/kg) administered intravenously (i.v.) every 2 weeks; includes Cohorts 1A, 2A, 3A, and 4A.
IMC-20D7S (Cohort 1A)
5 mg/kg i.v. every 2 weeks.
Administered every other week on Days 1 and 15 of each treatment cycle.
If no dose-limiting toxicity (DLT) in first 3 participants or 1 DLT in 6 participants, then enrollment into Cohort 2A.
IMC-20D7S (Cohort 2A)
10 mg/kg i.v. every 2 weeks.
Administered every other week on Days 1 and 15 of each treatment cycle.
If no DLT in first 3 participants or 1 DLT in 6 participants in Cohort 2A, then enrollment into Cohort 3A.
IMC-20D7S (Cohort 3A)
20 mg/kg i.v. every 2 weeks.
Administered every other week on Days 1 and 15 of each treatment cycle.
If no DLT in first 3 participants or 1 DLT in 6 participants in Cohort 3A, then enrollment into Cohort 4A.
IMC-20D7S (Cohort 4A)
30 mg/kg i.v. every 2 weeks.
Administered every other week on Days 1 and 15 of each treatment cycle.
IMC-20D7S (1B-3B Cohorts)
Escalating doses up to 30 mg/kg administered i.v. every 3 weeks; includes Cohorts 1B, 2B, and 3B.
IMC-20D7S (Cohort 1B)
10 mg/kg i.v. every 3 weeks.
Administered every 3 weeks on Days 1 and 22 of each treatment cycle.
If no dose-limiting toxicity (DLT) in first 3 participants or 1 DLT in 6 participants in Cohort 1B, then enrollment into Cohort 2B.
IMC-20D7S (Cohort 2B)
20 mg/kg i.v. every 3 weeks.
Administered every 3 weeks on Days 1 and 22 of each treatment cycle.
If no DLT in first 3 participants or 1 DLT in 6 participants in Cohort 2B, then enrollment into Cohort 3B.
IMC-20D7S (Cohort 3B)
30 mg/kg i.v. every 3 weeks.
Administered every 3 weeks on Days 1 and 22 of each treatment cycle.
Interventions
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IMC-20D7S (Cohort 1A)
5 mg/kg i.v. every 2 weeks.
Administered every other week on Days 1 and 15 of each treatment cycle.
If no dose-limiting toxicity (DLT) in first 3 participants or 1 DLT in 6 participants, then enrollment into Cohort 2A.
IMC-20D7S (Cohort 2A)
10 mg/kg i.v. every 2 weeks.
Administered every other week on Days 1 and 15 of each treatment cycle.
If no DLT in first 3 participants or 1 DLT in 6 participants in Cohort 2A, then enrollment into Cohort 3A.
IMC-20D7S (Cohort 3A)
20 mg/kg i.v. every 2 weeks.
Administered every other week on Days 1 and 15 of each treatment cycle.
If no DLT in first 3 participants or 1 DLT in 6 participants in Cohort 3A, then enrollment into Cohort 4A.
IMC-20D7S (Cohort 4A)
30 mg/kg i.v. every 2 weeks.
Administered every other week on Days 1 and 15 of each treatment cycle.
IMC-20D7S (Cohort 1B)
10 mg/kg i.v. every 3 weeks.
Administered every 3 weeks on Days 1 and 22 of each treatment cycle.
If no dose-limiting toxicity (DLT) in first 3 participants or 1 DLT in 6 participants in Cohort 1B, then enrollment into Cohort 2B.
IMC-20D7S (Cohort 2B)
20 mg/kg i.v. every 3 weeks.
Administered every 3 weeks on Days 1 and 22 of each treatment cycle.
If no DLT in first 3 participants or 1 DLT in 6 participants in Cohort 2B, then enrollment into Cohort 3B.
IMC-20D7S (Cohort 3B)
30 mg/kg i.v. every 3 weeks.
Administered every 3 weeks on Days 1 and 22 of each treatment cycle.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Participant is ≥18 years of age
* Participant has either measurable disease as defined by Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST v1.1) or evaluable disease
* At least 21 days must have elapsed from major surgery, prior chemotherapy, prior treatment with an investigational agent or device, or prior radiation therapy. Relative to participant's treatment with non-approved biological products (eg, monoclonal antibodies), a minimum of 2 half-lives must have passed for eligibility to be considered
* Participant has resolution of all clinically significant toxic effects of prior cancer therapy to Grade ≤1 according to National Cancer Institute Common Terminology Criteria for Adverse Events version 4.02 (NCI-CTCAE v4.02)
* Participant has adequate hematological function, hepatic function, and renal function
Exclusion Criteria
* Participant has elective or planned surgery to be conducted during the trial
* Participant has documented and/or symptomatic brain or leptomeningeal metastases
* Participant is receiving systemic steroids or other immunosuppressive medications. (Intermittent use of steroid-containing medications e.g., for asthma exacerbation or for skin lesions is permitted)
* Participant has an uncontrolled undercurrent illness
* Participant has a concurrent active malignancy other than adequately treated nonmelanomatous skin cancer or other noninvasive carcinoma or in situ neoplasm
* Participant has a known allergy to any of the treatment components (monoclonal antibodies or other therapeutic proteins such as fresh frozen plasma, human serum albumin, cytokines, or interleukins). In the event that there is suspicion the participant may have allergies, the participant should be excluded
* Participant is pregnant or lactating
* Participant has known human immunodeficiency virus (HIV) or acquired immune deficiency syndrome (AIDS) infection
18 Years
ALL
No
Sponsors
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Eli Lilly and Company
INDUSTRY
Responsible Party
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Principal Investigators
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E-mail: ClinicalTrials@ ImClone.com
Role: STUDY_DIRECTOR
Eli Lilly and Company
Locations
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ImClone Investigational Site
Boston, Massachusetts, United States
ImClone Investigational Site
New York, New York, United States
Countries
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Other Identifiers
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CP22-0901
Identifier Type: OTHER
Identifier Source: secondary_id
I4Z-IE-JDEA
Identifier Type: OTHER
Identifier Source: secondary_id
13945
Identifier Type: -
Identifier Source: org_study_id
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