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Advanced Malignancies, Non-small Cell Lung CancerPhase 1NCT00975767

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

A Phase 1 study testing MGCD265+erlotinib and MGCD265+docetaxel in people with Advanced Malignancies, Non-small Cell Lung Cancer, run by Mirati Therapeutics Inc. at 5 sites in United States.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
MGCD265+erlotinib and MGCD265+docetaxel
Could I receive a placebo?
No, everyone receives an active treatment
How many people
126 participants
Where
5 sitesUnited States
Study dates
Aug 2009to Aug 2014
Phase
Phase 1
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.
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  • 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.

Who cannot join

  • 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.
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  • 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).

Trial locations and contacts

5 sites in 1 country.

5 sites in 1 country

United States5 sites

  • Barbara Ann Karmanos Cancer Center

    Detroit, Michigan, 48201

  • Duke University Medical Center

    Durham, North Carolina, 27710

  • The University of Texas MD Anderson Cancer Center

    Houston, Texas, 77030

  • University of Pennsylvania Abramson Cancer Center

    Philadelphia, Pennsylvania, 19104

  • South Texas Accelerated Research Therapeutics, LLC

    San Antonio, Texas, 78229

Other trials in United States

About this study

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)

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.

Being tested
MGCD265+erlotinib, MGCD265+docetaxel
Medical subject headings
Carcinoma, Non-Small-Cell Lung

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • MGCD265+erlotinibDrug

    MGCD265 and erlotinib administered daily

  • MGCD265+docetaxelDrug

    MGCD265 administered daily; docetaxel administered once every 3 weeks

Study groups in NCT00975767
Study groupRoleWhat they receive
MGCD265+erlotinibExperimentalNot described
Receives: Drug: MGCD265+erlotinib
MGCD265+docetaxelExperimentalNot described
Receives: Drug: MGCD265+docetaxel

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Phase I: Safety profile (including maximum tolerated dose and dose limiting toxicities)

    Measured: 1 year

  2. Phase II: Antitumor activity of MGCD265+erlotinib and MGCD265+docetaxel

    Measured: 1 year

Secondary outcomes (4)

  1. Phase I: Pharmacokinetic profiles of MGCD265+erlotinib and MGCD265+docetaxel

    Measured: 2 months

  2. Phase I and Phase II: Pharmacodynamic profiles of MGCD265+erlotinib and MGCD265+docetaxel

    Measured: 1 year

  3. Phase I: Antitumor activity of MGCD265+erlotinib and MGCD265+docetaxel.

    Measured: 1 year

  4. Phase II: Safety profile of MGCD265+erlotinib and MGCD265+docetaxel;

    Measured: 1 year

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted11 Sep 2009 (estimated)
  2. Study startAug 2009
  3. Primary completionJul 2013
  4. Study completionAug 2014

Why it stopped: The study was terminated due to a need for a reformulation of the study drug. Phase 1 completed, no patients enrolled in Phase 2.

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1
Primary purpose
Treatment
Allocation
Non-randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
126 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00975767
Sponsor's protocol ID
265-103
Status last verified
Jan 2015
First submitted
10 Sep 2009
Last updated
8 Jan 2015
Results posted
No
Data monitoring committee
No

Publications

  • 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.

    PubMed 35347559

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing MGCD265+erlotinib and MGCD265+docetaxel in people with Advanced Malignancies, Non-small Cell Lung Cancer, run by Mirati Therapeutics Inc. at 5 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 29 inclusion and 20 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 8 Jan 2015. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 5 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study was stopped early (reason given: The study was terminated due to a need for a reformulation of the study drug. Phase 1 completed, no patients enrolled in Phase 2.). Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Phase I: Safety profile (including maximum tolerated dose and dose limiting toxicities) (time frame: 1 year). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00975767, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Jan 2015.

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