A Study of MGCD265 Given With Erlotinib or Docetaxel in Subjects With Advanced Malignancies or Non-Small Cell Lung Cancer

This study is currently recruiting participants. (see Contacts and Locations)
Verified January 2014 by MethylGene Inc.
Sponsor:
Information provided by (Responsible Party):
MethylGene Inc.
ClinicalTrials.gov Identifier:
NCT00975767
First received: September 10, 2009
Last updated: January 9, 2014
Last verified: January 2014
  Purpose

The main purpose of this study is to assess the safety profile of MGCD265 when administered in combination with the marketed anticancer drugs erlotinib and docetaxel.


Condition Intervention Phase
Advanced Malignancies, Non-small Cell Lung Cancer
Drug: MGCD265+erlotinib
Drug: MGCD265+docetaxel
Phase 1
Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Phase I/II Study of MGCD265 in Combination With Erlotinib or Docetaxel in Subjects With Advanced Malignancies and in Subjects With Advanced Non-Small Cell Lung Cancer (NSCLC)

Resource links provided by NLM:


Further study details as provided by MethylGene Inc.:

Primary Outcome Measures:
  • Phase I: Safety profile (including maximum tolerated dose and dose limiting toxicities) [ Time Frame: 1 year ] [ Designated as safety issue: No ]
  • Phase II: Antitumor activity of MGCD265+erlotinib and MGCD265+docetaxel [ Time Frame: 1 year ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Phase I: Pharmacokinetic profiles of MGCD265+erlotinib and MGCD265+docetaxel [ Time Frame: 2 months ] [ Designated as safety issue: No ]
  • Phase I and Phase II: Pharmacodynamic profiles of MGCD265+erlotinib and MGCD265+docetaxel [ Time Frame: 1 year ] [ Designated as safety issue: No ]
  • Phase I: Antitumor activity of MGCD265+erlotinib and MGCD265+docetaxel. [ Time Frame: 1 year ] [ Designated as safety issue: No ]
  • Phase II: Safety profile of MGCD265+erlotinib and MGCD265+docetaxel; [ Time Frame: 1 year ] [ Designated as safety issue: No ]

Estimated Enrollment: 150
Study Start Date: August 2009
Estimated Study Completion Date: August 2015
Estimated Primary Completion Date: May 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: MGCD265+erlotinib Drug: MGCD265+erlotinib
MGCD265 and erlotinib administered daily
Experimental: MGCD265+docetaxel Drug: MGCD265+docetaxel
MGCD265 administered daily; docetaxel administered once every 3 weeks

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Part 1:

    • Patients with advanced metastatic or unresectable solid malignancy that is refractory to standard therapy and/or existing therapies.
    • Evaluable disease.
    • Documented progressive disease during or following most recent treatment regimen.
    • Adequate hepatic parameters.
    • Age ≥18 years.
    • Life expectancy greater than 3 months.
    • Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
    • Adequate renal function.
    • Adequate bone marrow function.
    • Capable of understanding and complying with the protocol and written informed consent.
    • Negative pregnancy test for women of childbearing potential.
    • Use of adequate contraception as needed.
    • Subjects consenting to optional fresh biopsies, must not require concurrent anticoagulation medication.
  • Part 2:

    • Histologically or cytologically confirmed advanced Stage 3b or 4 NSCLC.
    • Measurable disease per RECIST.
    • At least one prior chemotherapy regimen for advanced disease.
    • No prior erlotinib or docetaxel therapy.
    • Documented progressive disease during or following most recent treatment regimen.
    • Adequate hepatic parameters.
    • Age ≥18 years.
    • Life expectancy greater than 3 months.
    • Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
    • Adequate renal function.
    • Adequate bone marrow function.
    • Capable of understanding and complying with the protocol and written informed consent.
    • Negative pregnancy test for women of childbearing potential.
    • Use of adequate contraception as needed.

Exclusion Criteria:

  • Recent anticancer treatment.
  • Prior treatment with an investigational cmet inhibitor or HCF inhibitor or antibody.
  • Uncontrolled concurrent illness.
  • History of bleeding diathesis or coagulopathy.
  • History of stroke or transient ischemic attack.
  • History of a cardiovascular illness.
  • QT interval corrected for heart rate (QTc) >470 msec.
  • Left ventricular ejection fraction (LVEF) <50%.
  • Immunocompromised subjects.
  • Lack of recovery to grade ≤1 from significant adverse events due to antineoplastic agents, investigational drugs, or other medications administered prior to study enrollment.
  • Symptomatic or uncontrolled brain metastases requiring current treatment.
  • Active gastrointestinal conditions or a history of abdominal fistula, gastrointestinal perforation or intra-abdominal abscess.
  • History of other malignancy treated with curative intent within the 5 previous years.
  • Lung tumor lesions with increased likelihood of bleeding.
  • History of major surgery within 28 days of first receipt of study drug.
  • History of autologous bone marrow transplant (BMT) within the previous five years, or subjects with organ transplants or allogeneic BMT.
  • Nursing or pregnant women; female subjects of childbearing potential must have a negative pregnancy test at screening.
  • Unable to swallow oral medications or with pre-existing gastrointestinal disorders that might interfere with proper absorption of oral drugs.
  • Any other condition or finding that in the opinion of the Investigator or Medical Monitor may render the subject at excessive risk for treatment complications or may render difficult the evaluation of treatment response.
  • Allergy or hypersensitivity to components of either the MGCD265, erlotinib or docetaxel formulations (depending on the group that the subject is assigned to).
  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: NCT00975767

Contacts
Contact: Vanessa Tassell 858-332-3410 tassellv@mirati.com
Contact: Mary Collier 858-332-3410 collierm@mirati.com

Locations
United States, Michigan
Barbara Ann Karmanos Cancer Center Recruiting
Detroit, Michigan, United States, 48201
Principal Investigator: Shirish Gadgeel, MD         
United States, North Carolina
Duke University Medical Center Not yet recruiting
Durham, North Carolina, United States, 27710
Principal Investigator: John Strickler, MD         
United States, Pennsylvania
University of Pennsylvania Abramson Cancer Center Recruiting
Philadelphia, Pennsylvania, United States, 19104
Principal Investigator: Peter O'Dwyer, MD         
United States, Texas
The University of Texas MD Anderson Cancer Center Not yet recruiting
Houston, Texas, United States, 77030
Principal Investigator: Jennifer Wheler, MD         
South Texas Accelerated Research Therapeutics, LLC Recruiting
San Antonio, Texas, United States, 78229
Principal Investigator: Amita Patnaik, MD         
Sponsors and Collaborators
MethylGene Inc.
Investigators
Study Director: Vanessa Tassell MethylGene Inc.
  More Information

No publications provided

Responsible Party: MethylGene Inc.
ClinicalTrials.gov Identifier: NCT00975767     History of Changes
Other Study ID Numbers: 265-103
Study First Received: September 10, 2009
Last Updated: January 9, 2014
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Neoplasms
Carcinoma, Non-Small-Cell Lung
Lung Neoplasms
Carcinoma, Bronchogenic
Bronchial Neoplasms
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Lung Diseases
Respiratory Tract Diseases
Docetaxel
Erlotinib
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action
Protein Kinase Inhibitors
Enzyme Inhibitors

ClinicalTrials.gov processed this record on August 28, 2014