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

NCT ID: NCT00975767

Last Updated: 2015-01-08

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE1
• Total Enrollment: 126 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2009-08-31
• Study Completion Date: 2014-08-31

Brief Summary

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.

Conditions

Advanced Malignancies, Non-small Cell Lung Cancer

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

MGCD265+erlotinib

Group Type: EXPERIMENTAL

MGCD265+erlotinib

Intervention Type: DRUG

MGCD265 and erlotinib administered daily

MGCD265+docetaxel

Group Type: EXPERIMENTAL

MGCD265+docetaxel

Intervention Type: DRUG

MGCD265 administered daily; docetaxel administered once every 3 weeks

Interventions

MGCD265+erlotinib

MGCD265 and erlotinib administered daily

Intervention Type: DRUG

MGCD265+docetaxel

MGCD265 administered daily; docetaxel administered once every 3 weeks

Intervention Type: DRUG

Eligibility 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).

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Mirati Therapeutics Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Vanessa Tassell

Role: STUDY_DIRECTOR

MethylGene Inc.

Locations

Barbara Ann Karmanos Cancer Center

Detroit, Michigan, United States

Duke University Medical Center

Durham, North Carolina, United States

University of Pennsylvania Abramson Cancer Center

Philadelphia, Pennsylvania, United States

The University of Texas MD Anderson Cancer Center

Houston, Texas, United States

South Texas Accelerated Research Therapeutics, LLC

San Antonio, Texas, United States

Countries

United States

References

Patnaik A, Gadgeel S, Papadopoulos KP, Rasco DW, Haas NB, Der-Torossian H, Faltaos D, Potvin D, Tassell V, Tawashi M, Chao R, O'Dwyer PJ. Phase I Study of Glesatinib (MGCD265) in Combination with Erlotinib or Docetaxel in Patients with Advanced Solid Tumors. Target Oncol. 2022 Mar;17(2):125-138. doi: 10.1007/s11523-022-00875-0. Epub 2022 Mar 28.

Reference Type: DERIVED

PMID: 35347559 (View on PubMed)

Other Identifiers

265-103

Identifier Type: -

Identifier Source: org_study_id