Advanced MalignanciesPhase 1NCT00679133
Safety Study of Oral MGCD265 Administered With Interruption to Subjects With Advanced Malignancies
A Phase 1 study testing MGCD265 in people with Advanced Malignancies, run by Mirati Therapeutics Inc. at 2 sites in United States.
Trial summary
In this study, MGCD265, a new anticancer drug under investigation, is given daily on a 7 days on / 7 days off schedule 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 Malignancies
- 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
- 47 participants
- Where
- 2 sitesUnited States
- Study dates
- Apr 2008to Mar 2011
- 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
- Patients with advanced metastatic or unresectable malignancy that is refractory to standard therapy and/or existing therapies are not likely to achieve clinical benefit. The patient's disease must be histologically confirmed;
- Evaluable disease;
- Last dose of prior chemotherapy, radiation therapy, or investigational agents occurred at least 4 weeks before the start of therapy on Cycle 1 Day 1;
- Recovery from the adverse effects of prior therapy at the time of enrollment to ≤ grade 1 (excluding alopecia);
- Age ≥ 18 years;
- Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1, or 2;
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- Life expectancy greater than 3 months following study entry;
- Adequate renal function;
- Adequate hepatic parameters;
- Adequate bone marrow function;
- A negative serum pregnancy test at screening for women of childbearing potential (WOCBP);
- Agreement by WOCBP or men whose sexual partners are WOCBP to use two methods of adequate contraception hormonal and barrier method) prior to study entry and for the duration of the study. WOCBP and men whose sexual partners are WOCBP must continue to use two methods of contraception for 28 days and 90 days, respectively, after the last dose of study medication;
- Ability to understand and willingness to sign a written informed consent document;
- Willingness and ability to comply with study visits and activities to be performed only at the study center; and
- For the Expanded MTD Cohort, the subject must have tumors that are accessible to biopsy.
Who cannot join
- Subjects with uncontrolled concurrent illness;
- Subjects with a history of a cardiovascular illness;
- Subjects with QTc > 470 msec (including subjects on medication);
- Subjects with left ventricular ejection fraction (LVEF) < 50%;
- Subjects with leukemias or myelodysplastic syndrome;
- Immunocompromised subjects;
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- Subjects with a history of autologous bone marrow transplant (BMT) within the previous five years, or subjects with organ transplants or allogeneic BMT;
- Subjects with lung tumor lesions with increased likelihood of bleeding, including: history of hemoptysis; evidence of cavitation; and invasion of aorta or pulmonary arteries by the tumor;
- Subjects with a history of brain metastasis or leptomeningeal disease; subjects with tumors likely to metastasize to the brain should have a scan performed within 2 months of start of study to rule out brain metastasis (for example breast, lung, melanoma, sarcoma, etc.);
- Subjects unable to swallow oral medications or with pre-existing gastrointestinal disorders that might interfere with proper absorption of oral drugs;
- Subjects with a history of major surgery within 28 days of first receipt of study drug;
- Nursing or pregnant women;
- Subjects with any other diseases, metabolic dysfunction, physical examination finding, or clinical laboratory finding that, in the opinion of the Investigator, contraindicates the use of MGCD265 Drug Product or that may render the subject at excessively high risk for treatment complications; or
- Subjects with a known hypersensitivity to any of the components of the MGCD265 Drug Product.
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Karmanos Cancer Institute
Detroit, Michigan, 48201
University of Texas M.D. Anderson Cancer Center
Houston, Texas, 77030
About this study
Official title: Open-Label Dose-Escalation Trial to Evaluate the Safety, Pharmacokinetics, and Pharmacodynamics of Oral MGCD265 Administered With Interruption to Subjects With Advanced Malignancies
In this study, MGCD265, a new anticancer drug under investigation, is given daily on a 7 days on / 7 days off schedule 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, oral MGCD265 is administered daily on a 7 days on / 7 days off schedule to patients with advanced malignancies.
- Conditions
- Advanced Malignancies
- Being tested
- MGCD265
- Keywords
- c-Met, VEGFR, Ron, Cancer, Tumor, Safety, Phase 1
- Medical subject headings
- Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MGCD265Drug
Oral daily administration; 7 days on / 7 days off
| 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 May 2008 (estimated)
- Study startApr 2008
- Primary completionMar 2011
- Study completionMar 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Advanced MalignanciesStudies 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
- 47 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mirati Therapeutics Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Manuela Juretic, Study director, MethylGene Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00679133
- Sponsor's protocol ID
- 265-102
- Status last verified
- Jan 2015
- First submitted
- 14 May 2008
- Last updated
- 8 Jan 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Jan 2015. 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 Oral MGCD265 Administered With Interruption to Subjects With Advanced Malignancies
- ClinicalTrials.gov ID
- NCT00679133
- Acronym / sponsor ID
- 265-102
- Conditions
- Advanced Malignancies
- Keywords
- c-Met, VEGFR, Ron, Cancer, Tumor, Safety, Phase 1
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 47 participants (actual)
- Lead sponsor
- Mirati Therapeutics Inc.Industry (pharma, biotech, devices)
- Study start
- Apr 2008
- Primary completion
- Mar 2011 (actual)
- Study completion
- Mar 2011 (actual)
- First posted
- 16 May 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 on a 7 days on / 7 days off schedule 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, oral MGCD265 is administered daily on a 7 days on / 7 days off schedule 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 (15 listed)
- Patients with advanced metastatic or unresectable malignancy that is refractory to standard therapy and/or existing therapies are not likely to achieve clinical benefit. The patient's disease must be histologically confirmed;
- Evaluable disease;
- Last dose of prior chemotherapy, radiation therapy, or investigational agents occurred at least 4 weeks before the start of therapy on Cycle 1 Day 1;
- Recovery from the adverse effects of prior therapy at the time of enrollment to ≤ grade 1 (excluding alopecia);
- Age ≥ 18 years;
Key exclusion criteria (14 listed)
- Subjects with uncontrolled concurrent illness;
- Subjects with a history of a cardiovascular illness;
- Subjects with QTc > 470 msec (including subjects on medication);
- Subjects with left ventricular ejection fraction (LVEF) < 50%;
- Subjects with leukemias or myelodysplastic syndrome;
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; 7 days on / 7 days off | 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 8 Jan 2015.
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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.
Manuela Juretic study director
MethylGene Inc.
2 sites in 1 country: 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 Malignancies, run by Mirati Therapeutics Inc. at 2 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 15 inclusion and 14 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 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 2 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 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?
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.