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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

Phase 1/Phase 2
18 Years
Open (Enrolling)
Sarcoma, Soft Tissue

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Trial Information

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

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

Type of Study:


Study Design:

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Progression-free survival (PFS)

Outcome Description:

PFS is the primary outcome for the Phase 2 portion of the study. PFS is measured from the date of randomization until the first radiographic documentation of objective progression as defined by Response Evaluation Criteria in Solid Tumors (RECIST) (version 1.1) or death from any cause.

Outcome Time Frame:

23 months

Safety Issue:


Principal Investigator


Investigator Role:

Study Director

Investigator Affiliation:

ImClone LLC


United States: Food and Drug Administration

Study ID:




Start Date:

October 2010

Completion Date:

December 2014

Related Keywords:

  • Sarcoma, Soft Tissue
  • Sarcoma, Soft Tissue
  • Advanced Soft Tissue Sarcoma
  • Sarcoma



ImClone Investigational Site Denver, Colorado  80262
ImClone Investigational Site New York, New York  10021
ImClone Investigational Site St. Charles, Missouri  63301
ImClone Investigational Site Bakersfield, California  93309
ImClone Investigational Site Jacksonville, Florida  32207
ImClone Investigational Site Atlanta, Georgia  30318
ImClone Investigational Site Decatur, Illinois  62526
ImClone Investigational Site Minneapolis, Minnesota  55416
ImClone Investigational Site Cleveland, Ohio  44134
ImClone Investigational Site Greenville, South Carolina  29605
ImClone Investigational Site Memphis, Tennessee  38104
ImClone Investigational Site Dallas, Texas  75230
ImClone Investigational Site Green Bay, Wisconsin  54307
ImClone Investigational Site Winston-Salem, North Carolina  27103
ImClone Investigational Site Tucson, Arizona  85712
ImClone Investigational Site Seattle, Washington  98104