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A Phase 1 Study Evaluating the Safety and Pharmacokinetic Profiles of IMC-3G3 Administered in a 2-week, or 3-week Schedule to Japanese Patients With Advanced Solid Tumors

Phase 1
20 Years
Not Enrolling
Malignancy, Metastasis

Thank you

Trial Information

A Phase 1 Study Evaluating the Safety and Pharmacokinetic Profiles of IMC-3G3 Administered in a 2-week, or 3-week Schedule to Japanese Patients With Advanced Solid Tumors

Inclusion Criteria:

- Solid tumor that has been histopathologically or cytologically documented

- Advanced primary or recurrent solid tumor patient who has not responded to standard
therapy or for whom no standard therapy is available

- Measurable or nonmeasurable lesions

- An Eastern Cooperative Oncology Group performance status score of 0-1

- Able to provide informed consent

- Has a life expectancy of > 3 months

- Adequate hematologic function

- Adequate hepatic function

- Has adequate renal function

- Agrees to use adequate contraception for the duration of study participation and for
at least 12 weeks after the last dose of study therapy

- Adequate recovery from recent surgery, chemotherapy, and radiation therapy (including
palliative radiation therapy). At least 28 days (6 weeks for nitrosoureas or
mitomycin C) must have elapsed from major surgery, prior chemotherapy, prior
treatment with an investigational agent or device, or prior radiation therapy. For
treatment with non-approved monoclonal antibodies, a minimum of 8 weeks must have

- Is willing to comply with study procedures until the End-of-Therapy visit

Exclusion Criteria:

- Received chemotherapy or therapeutic radiotherapy within 28 days (6 weeks for
nitrosoureas or mitomycin C) prior to entering the study, or has ongoing side effects
≥ Grade 2 due to agents administered more than 28 days earlier

- Has undergone major surgery (eg, laparotomy, thoracotomy, removal of organ[s]) within
28 days prior to study entry

- Elective or planned surgery to be conducted during the trial

- Documented and/or symptomatic brain or leptomeningeal metastases (patients who are
clinically stable [no symptoms during the 4 weeks prior to study entry] with an
assessment that no further treatment [radiation, surgical excision, or administration
of steroids] is required are permitted to enter the study)

- Uncontrolled intercurrent illness including, but not limited to:

- Active infection requiring systemic antibiotic treatment excluding oral
administration (≥ Grade 3 [NCI-CTCAE Version 4.02])

- Congestive heart failure (Class III or IV per the New York Heart Association
classification for heart disease)

- Angina pectoris, angioplasty, stenting, or myocardial infarction within 6 months

- Uncontrolled hypertension (systolic blood pressure > 150 mm Hg, diastolic blood
pressure > 95 mm Hg)

- Cardiac arrhythmia requiring treatment (National Cancer Institute - Common
Terminology , or asymptomatic sustained ventricular tachycardia

- Peripheral neuropathy of any etiology ≥ Grade 2 (NCI-CTCAE Version 4.02); or

- Any other serious uncontrolled medical disorder(s) in the opinion of the

- Participated in clinical studies of non-approved experimental agents or procedures
within 4 weeks prior to study for small molecules, or 8 weeks prior to study entry
for non-approved monoclonal antibodies

- Received any previous treatment with agents targeting the PDGF or PDGFR, approved or

- Known allergy to any of the treatment components (IMC-3G3, histidine, glycine, sodium
chloride, mannitol, or polysorbate)

- If female, is pregnant (confirmed by urine or serum pregnancy test) or lactating

- Known alcohol or drug dependency

- Hepatitis B virus (HBV) antigen-, hepatitis C virus (HCV) antibody-, or human
immunodeficiency (HIV) antibody-positive (asymptomatic healthy carriers with
detectable HBV-DNA, HCV-RNA may be enrolled into the trial)

- Assessed as inadequate for the study by the investigator

Type of Study:


Study Design:

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Number of participants with Adverse Events (AEs)

Outcome Time Frame:

Approximately 16 weeks

Safety Issue:


Principal Investigator

E-mail: ClinicalTrials@

Investigator Role:

Study Director

Investigator Affiliation:

ImClone LLC


Japan: Institutional Review Board

Study ID:




Start Date:

September 2010

Completion Date:

January 2012

Related Keywords:

  • Malignancy
  • Metastasis
  • Neoplasms
  • Neoplasm Metastasis