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Study of the Safety and Pharmacokinetics of IMC-3G3 in Japanese Patients With Solid Tumors

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
ImClone LLC
ClinicalTrials.gov Identifier:
NCT01199822
First received: September 8, 2010
Last updated: February 8, 2012
Last verified: November 2011
  Purpose

Participants in this single-center, open-label, dose-escalation, Phase 1 study will initially receive intravenous (I.V.) IMC-3G3 once every 2 weeks or on Days 1 and 8 every 3 weeks for 6 weeks (one cycle). After the first cycle, patients experiencing an overall response of complete response (CR), partial response (PR), or stable disease (SD) will continue to receive IMC-3G3 at their cohort dose and schedule until there is evidence of progressive disease (PD), or until other withdrawal criteria are met.


Condition Intervention Phase
Malignancy
Metastasis
Biological: IMC-3G3
Phase 1

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: 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

Resource links provided by NLM:


Further study details as provided by ImClone LLC:

Primary Outcome Measures:
  • Number of participants with Adverse Events (AEs) [ Time Frame: Approximately 16 weeks ] [ Designated as safety issue: Yes ]
  • Number of participants with Serious Adverse Events (SAEs) [ Time Frame: Approximately 16 weeks ] [ Designated as safety issue: Yes ]
  • Number of Patients with a Dose- Limiting Toxicity (DLT) in Cycle 1 [ Time Frame: Approximately 6 weeks ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Maximum concentration (Cmax) [ Time Frame: Approximately 16 weeks ] [ Designated as safety issue: No ]
    Cmax for both dosing schedules (Cohort 2, IMC-3G3 administered every 2 weeks) (Cohorts 1 and 3, IMC-3G3 administered every 3 weeks ) will be evaluated during Cycles 1, 2 and 3

  • Area under concentration (AUC) [ Time Frame: Approximately 16 weeks ] [ Designated as safety issue: No ]
    AUC for both dosing schedules (Cohort 2, IMC-3G3 administered every 2 weeks) (Cohorts 1 and 3, IMC-3G3 administered every 3 weeks ) will be evaluated during Cycles 1, 2 and 3

  • Terminal Half-life (t 1/2) [ Time Frame: Approximately 16 weeks ] [ Designated as safety issue: No ]
    t 1/2 for both dosing schedules (Cohort 2, IMC-3G3 administered every 2 weeks) (Cohorts 1 and 3, IMC-3G3 administered every 3 weeks ) will be evaluated during Cycles 1, 2 and 3

  • Clearance (Cl) [ Time Frame: Approximately 16 weeks ] [ Designated as safety issue: No ]
    Cl for both dosing schedules (Cohort 2, IMC-3G3 administered every 2 weeks) (Cohorts 1 and 3, IMC-3G3 administered every 3 weeks ) will be evaluated during Cycles 1, 2 and 3

  • Volume of distribution at steady state (Vss) [ Time Frame: Approximately 16 weeks ] [ Designated as safety issue: No ]
    Vss for both dosing schedules (Cohort 2, IMC-3G3 administered every 2 weeks) (Cohorts 1 and 3, IMC-3G3 administered every 3 weeks ) will be evaluated during Cycles 1, 2 and 3

  • Serum Anti-IMC-3G3 Antibody Assessment (immunogenicity) [ Time Frame: Approximately 16 weeks ] [ Designated as safety issue: No ]

Enrollment: 16
Study Start Date: September 2010
Study Completion Date: January 2012
Primary Completion Date: January 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: IMC-3G3 Biological: IMC-3G3

Cohort 1

10 mg/kg i.v., administered on Days 1 and 8, every 3 weeks

Biological: IMC-3G3

Cohort 2

20 mg/kg i.v., administered every 2 weeks

Biological: IMC-3G3

Cohort 3

15 mg/kg i.v., administered on days 1 and 8, every 3 weeks


  Eligibility

Ages Eligible for Study:   20 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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 elapsed
  • 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 investigator
  • 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 non-approved
  • 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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01199822

Locations
Japan
ImClone Investigational Site
Kashiwa, Chiba, Japan
Sponsors and Collaborators
ImClone LLC
Investigators
Study Director: E-mail: ClinicalTrials@ ImClone.com ImClone LLC
  More Information

No publications provided

Responsible Party: ImClone LLC
ClinicalTrials.gov Identifier: NCT01199822     History of Changes
Other Study ID Numbers: 13940, CP15-0907, 15B-IE-JGDF, 21-3720
Study First Received: September 8, 2010
Last Updated: February 8, 2012
Health Authority: Japan: Institutional Review Board

ClinicalTrials.gov processed this record on November 20, 2014