Advanced CancerPhase 1NCT00697632
Safety Study of Oral MGCD265 Administered Without Interruption to Subjects With Advanced Malignancies
A Phase 1 study testing MGCD265 in people with Advanced Cancer, run by Mirati Therapeutics Inc. at 19 sites in 3 countries.
Trial summary
In this study, MGCD265, a new anticancer drug under investigation, is given daily to patients with advanced malignancies to study its safety profile. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Advanced Cancer
- What is being tested?
- MGCD265
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 180 participants
- Where
- 19 sitesin 3 countries
- Study dates
- Jun 2008to Jan 2019
- 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
- Advanced metastatic or unresectable malignancy that is refractory to standard therapy and/or existing therapies are not likely to achieve clinical benefit, and/or the patient declines to receive standard treatment such as chemotherapy.
- Evaluable disease;
- Last dose of prior chemotherapy, radiation therapy, or investigational agents occurred at least 4 weeks before the start of therapy;
- Recovery from the adverse effects ≤ grade 1;
- Acceptable ECOG status 0, 1, or 2;
- Life expectancy greater than 3 months following study entry;
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- Adequate laboratory values;
- For patients enrolling in the four expansion cohorts:
- NSCLC patients must meet criteria for MET and/or Axl expression or,
- HNSCC patients must meet criteria for MET and/or Axl expression or,
- NSCLC patients must meet criteria for amplification of the MET gene locus, defined MET mutations, or rearrangements involving the AXL or MET gene locus or;
- Patients with tumor types such as HNSCC, papillary renal carcinoma, gastric adenocarcinoma, and other solid tumors must meet criteria for amplification of the MET gene locus, defined MET mutations, or rearrangements involving the AXL or MET gene locus
Who cannot join
- Uncontrolled concurrent illness;
- History of cardiovascular illness;
- QTc > 470 msec (including subjects on medication);
- Left ventricular ejection fraction (LVEF) < 50%;
- Immunocompromised subjects;
- History of bone marrow transplant;
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- Lung tumor lesions with increased likelihood of bleeding;
- Symptomatic or uncontrolled brain metastases;
- Unable to swallow oral medications or with pre-existing gastrointestinal disorders.
Trial locations and contacts
19 sites in 3 countries.
19 sites in 3 countries
United States12 sites
Dana-Farber Cancer Institute
Boston, Massachusetts, 02115
University of Chicago
Chicago, Illinois, 60637
City of Hope
Duarte, California, 91010
Duke University Medical Center
Durham, North Carolina, 27710
University of Texas, MD Anderson Cancer Center
Houston, Texas, 77030
Columbia University, Herbert Irving Comprehensive Cancer Center
New York, New York, 10032
UC Irvine Medical Center
Orange, California, 92868
Fox Chase Cancer Center
Philadelphia, Pennsylvania, 19111
Huntsman Cancer Institute
Salt Lake City, Utah, 84112
UC San Diego
San Diego, California, 92093
Seattle Cancer Care Alliance
Seattle, Washington, 98109
Washington University, Alvin J. Siteman Cancer Center
St Louis, Missouri, 63110
South Korea4 sites
National Cancer Center
Gyeonggi-do, 410-769
Seoul National University Hosptial
Seoul, 110-744
Samsung Medical Center
Seoul, 135-710
Yonsei University Health System, Severance Hospital
Seoul
Canada3 sites
Cross Cancer Institute
Edmonton, Alberta, T6G 1Z2
Jewish General Hospital
Montreal, Quebec, H3T IE2
British Columbia Cancer Agency, Vancouver Center
Vancouver, British Columbia, V5Z 4E6
About this study
Official title: Open-Label Dose-Escalation Trial to Evaluate the Safety, Pharmacokinetics, and Pharmacodynamics of Daily Oral MGCD265 Administered Without Interruption to Subjects With Advanced Malignancies
In this study, MGCD265, a new anticancer drug under investigation, is given daily to patients with advanced malignancies to study its safety profile.
Read the detailed description
MGCD265 belongs to a new class of drugs with anticancer potential, known as tyrosine kinase inhibitors. MGCD265 was shown to slow down the growth of human cancer cells in mice. Clinical studies are being pursued to evaluate the safety of MGCD265 in cancer patients.
In this study, MGCD265 is orally administered on a daily basis to patients with advanced malignancies.
- Conditions
- Advanced Cancer
- Being tested
- MGCD265
- Keywords
- MET, AXL, VEGFR, NSCLC, HNSCC (Head and neck squamous cell carcinoma), Tumor, Safety, Phase 1, Solid tumor
- Medical subject headings
- Squamous Cell Carcinoma of Head and Neck, Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MGCD265Drug
Oral daily administration without interruption
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Not described Receives: Drug: MGCD265 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety and tolerability
Measured: 1 year [Anticipated]
Secondary outcomes (3)
Pharmacokinetics
Measured: 1 year [Anticipated]
Pharmacodynamics
Measured: 1 year [Anticipated]
Clinical response
Measured: 1 year [Anticipated]
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jun 2008 (estimated)
- Study startJun 2008
- Primary completionSep 2018
- Study completionJan 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Advanced CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 180 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mirati Therapeutics Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00697632
- Sponsor's protocol ID
- 265-101
- Status last verified
- Feb 2019
- First submitted
- 14 May 2008
- Last updated
- 12 Feb 2019
- Results posted
- No
- Data monitoring committee
- No
Publications
Kollmannsberger C, Hurwitz H, Bazhenova L, Cho BC, Hong D, Park K, Reckamp KL, Sharma S, Der-Torossian H, Christensen JG, Faltaos D, Potvin D, Tassell V, Chao R, Shapiro GI. Phase I Study Evaluating Glesatinib (MGCD265), An Inhibitor of MET and AXL, in Patients with Non-small Cell Lung Cancer and Other Advanced Solid Tumors. Target Oncol. 2023 Jan;18(1):105-118. doi: 10.1007/s11523-022-00931-9. Epub 2022 Dec 2.
PubMed 36459255
Study at a glance
From the registry record, last updated by the sponsor on 12 Feb 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Open-Label Dose-Escalation Trial to Evaluate the Safety, Pharmacokinetics, and Pharmacodynamics of Daily Oral MGCD265 Administered Without Interruption to Subjects With Advanced Malignancies
- ClinicalTrials.gov ID
- NCT00697632
- Acronym / sponsor ID
- 265-101
- Conditions
- Advanced Cancer
- Keywords
- MET, AXL, VEGFR, NSCLC, HNSCC (Head and neck squamous cell carcinoma), Tumor, Safety, Phase 1
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 180 participants (actual)
- Lead sponsor
- Mirati Therapeutics Inc.Industry (pharma, biotech, devices)
- Study start
- Jun 2008
- Primary completion
- Sep 2018 (actual)
- Study completion
- Jan 2019 (actual)
- First posted
- 16 Jun 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
In this study, MGCD265, a new anticancer drug under investigation, is given daily to patients with advanced malignancies to study its safety profile.
Detailed description
MGCD265 belongs to a new class of drugs with anticancer potential, known as tyrosine kinase inhibitors. MGCD265 was shown to slow down the growth of human cancer cells in mice. Clinical studies are being pursued to evaluate the safety of MGCD265 in cancer patients.
In this study, MGCD265 is orally administered on a daily basis to patients with advanced malignancies.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Drug: MGCD265 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- Advanced metastatic or unresectable malignancy that is refractory to standard therapy and/or existing therapies are not likely to achieve clinical benefit, and/or the patient declines to receive standard treatment such as chemotherapy.
- Evaluable disease;
- Last dose of prior chemotherapy, radiation therapy, or investigational agents occurred at least 4 weeks before the start of therapy;
- Recovery from the adverse effects ≤ grade 1;
- Acceptable ECOG status 0, 1, or 2;
Key exclusion criteria (9 listed)
- Uncontrolled concurrent illness;
- History of cardiovascular illness;
- QTc > 470 msec (including subjects on medication);
- Left ventricular ejection fraction (LVEF) < 50%;
- Immunocompromised subjects;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MGCD265Oral daily administration without interruption | Drug | 1 |
Primary outcome
Safety and tolerability
Time frame: 1 year [Anticipated]
3 secondary outcomes
Pharmacokinetics
Time frame: 1 year [Anticipated]
Pharmacodynamics
Time frame: 1 year [Anticipated]
Clinical response
Time frame: 1 year [Anticipated]
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Feb 2019.
- Derived from this study: PubMed 36459255Kollmannsberger C, Hurwitz H, Bazhenova L, Cho BC, Hong D, Park K, Reckamp KL, Sharma S, Der-Torossian H, Christensen JG, Faltaos D, Potvin D, Tassell V, Chao R, Shapiro GI. Phase I Study Evaluating Glesatinib (MGCD265), An Inhibitor of MET and AXL, in Patients with Non-small Cell Lung Cancer and Other Advanced Solid Tumors. Target Oncol. 2023 Jan;18(1):105-118. doi: 10.1007/s11523-022-00931-9. Epub 2022 Dec 2.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
19 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing MGCD265 in people with Advanced Cancer, run by Mirati Therapeutics Inc. at 19 sites in 3 countries.
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 12 inclusion and 9 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: finished, as of the sponsor's last update on 12 Feb 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 19 sites in United States, South Korea, Canada. 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Safety and tolerability (time frame: 1 year [Anticipated]). 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 NCT00697632, 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 12 Feb 2019.