Overview

This trial is active, not recruiting.

Condition sarcoma, soft tissue
Treatments imc-3g3, doxorubicin, dexrazoxane
Phase phase 1/phase 2
Target PDGF
Sponsor Eli Lilly and Company
Start date October 2010
End date August 2014
Trial size 146 participants
Trial identifier NCT01185964, 14055, CP15-0806, I5B-IE-JGDG

Summary

The main purpose of this study is to gather information about the use of an investigational drug called IMC-3G3 with a drug for soft tissue sarcoma called doxorubicin.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification safety/efficacy study
Intervention model parallel assignment
Masking open label
Primary purpose treatment
Arm
(Experimental)
All cycles are 21 days. Cycles 1-4: IMC-3G3 15 mg/kg on days 1+8, and doxorubicin 75 mg/m2 on day 1 Cycles 5-8: IMC-3G3 15 mg/kg on days 1+8, and doxorubicin 75 mg/m2 and dexrazoxane 750 mg/m2 on day 1 All subsequent cycles: IMC-3G3 15 mg/kg on days 1+8
imc-3g3 LY3012207
IMC-3G3 15 mg/kg by intravenous transfusion (I.V.) on days 1+8 of a 21-day cycle
doxorubicin
Doxorubicin 75 mg/m2 by intravenous injection on day 1 of the 21-day cycle.
dexrazoxane
Dexrazoxane given at 750 mg/m2 by intravenous injection on day 1 of the 21-day cycle prior to administration of each doxorubicin infusion during cycles 5-8 for prevention of cardiotoxicity.
(Experimental)
All cycles are 21 days. Cycles 1-4: IMC-3G3 15 mg/kg on days 1+8, and doxorubicin 75 mg/m2 on day 1 Cycles 5-8: IMC-3G3 15 mg/kg on days 1+8, and doxorubicin 75 mg/m2 and dexrazoxane 750 mg/m2 on day 1 All subsequent cycles: IMC-3G3 15 mg/kg on days 1+8
imc-3g3 LY3012207
IMC-3G3 15 mg/kg by intravenous transfusion (I.V.) on days 1+8 of a 21-day cycle
doxorubicin
Doxorubicin 75 mg/m2 by intravenous injection on day 1 of the 21-day cycle.
dexrazoxane
Dexrazoxane given at 750 mg/m2 by intravenous injection on day 1 of the 21-day cycle prior to administration of each doxorubicin infusion during cycles 5-8 for prevention of cardiotoxicity.
(Active Comparator)
All cycles are 21 days. Cycles 1-4: doxorubicin 75 mg/m2 on day 1 Cycles 5-8: dexrazoxane 750 mg/m2 and doxorubicin 75 mg/m2 on day 1 All subsequent cycles or earlier if disease progresses: IMC-3G3 15 mg/kg on days 1+8
doxorubicin
Doxorubicin 75 mg/m2 by intravenous injection on day 1 of the 21-day cycle.
dexrazoxane
Dexrazoxane given at 750 mg/m2 by intravenous injection on day 1 of the 21-day cycle prior to administration of each doxorubicin infusion during cycles 5-8 for prevention of cardiotoxicity.

Primary Outcomes

Measure
Progression-free survival (PFS)
time frame: 23 months
Summary of Safety for the Phase 1b Portion of the Study
time frame: up to 24 weeks

Secondary Outcomes

Measure
Overall Survival (OS)
time frame: 23 months
Percentage of Participants with Objective Response (Objective Response Rate)
time frame: 23 months
Pharmacokinetic (PK) Profile of IMC-3G3
time frame: up to week 24
Proportion of Participants Who are Progression-free (PFS) at 3 Months
time frame: 3 months

Eligibility Criteria

Male or female participants at least 18 years old.

Inclusion Criteria: - The patient has histologically- or cytologically-confirmed malignant soft tissue sarcoma (STS), including uterine leiomyosarcoma - The patient has advanced STS, not amenable to treatment with surgery or radiotherapy - The patient's Eastern Cooperative Oncology Group (ECOG) performance status is 0-2 - The patient has available tumor tissue from either the primary or metastatic tumor for determination of PDGFRα expression - The patient has adequate hematologic function as defined by an absolute neutrophil count (ANC) ≥ 1500 μL, hemoglobin ≥ 9.0 g/dL, and a platelet count of 100,000/μL obtained within 2 weeks prior to study entry - The patient has adequate hepatic function as defined by a total bilirubin ≤ 1.5 mg/dL, and aspartate transaminase (AST) and alanine transaminase (ALT) ≤ 3.0 times the upper limit of normal (ULN) - The patient has adequate renal function as defined by serum creatinine ≤ 1.5 × the institutional ULN. If creatinine is above the ULN, the patient's creatinine clearance is ≥ 45 mL/min - The patient has urinary protein ≤ 1+ on dipstick or routine urinalysis; if urine dipstick or routine analysis is ≥ 2+, a 24-hour urine for protein must demonstrate < 1 g of protein in 24 hours to allow participation - Because the teratogenicity of IMC-3G3 is not known, women of childbearing potential (WOCBP) and sexually active males must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry and for the duration of study participation Exclusion Criteria: - The patient has histologically- or cytologically-confirmed Kaposi's sarcoma - The patient has untreated central nervous system metastases - The patient received prior treatment with doxorubicin, daunorubicin, idarubicin, and/or other anthracyclines and anthracenediones (ie, mitoxantrone) - The patient received prior radiation therapy to the mediastinal/pericardial area - The patient has a history of another primary cancer, with the exception of a) curatively resected nonmelanomatous skin cancer; b) curatively treated cervical carcinoma in situ; or c) other primary solid tumor treated with curative intent, no known active disease present, and no treatment administered during the last 3 years prior to study entry - The patient is receiving concurrent treatment with other anticancer therapy, including other chemotherapy, immunotherapy, hormonal therapy, radiotherapy, chemo-embolization, targeted therapy, or an investigational agent - The patient has an elective or a planned major surgery to be performed during the course of the study - The patient has an uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, requiring parenteral antibiotics, symptomatic congestive heart failure, severe myocardial insufficiency, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements - The patient has unstable angina pectoris, angioplasty, cardiac stenting, or myocardial infarction 6 months prior to study entry - The patient has known immunodeficiency virus (HIV) infection - The patient, if female, is pregnant or lactating - The patient has a known allergy to any of the treatment components

Additional Information

Official title A Phase 1b/2 Randomized Phase 2 Study Evaluating the Efficacy of Doxorubicin With or Without a Human Anti-PDGFRα Monoclonal Antibody (IMC-3G3) in the Treatment of Advanced Soft Tissue Sarcoma
Trial information was received from ClinicalTrials.gov and was last updated in August 2014.
Information provided to ClinicalTrials.gov by Eli Lilly and Company.