TumorsPhase 1/2NCT00372437
A Phase I/II Study of MGCD0103 (MG-0103) in Combination With Gemcitabine
A Phase 1/2 study testing MGCD0103 and Gemcitabine in people with Tumors, run by Mirati Therapeutics Inc. at 8 sites in 2 countries.
Trial summary
Inthis study, MGCD0103, a new anticancer drug under investigation, is given three times weekly in combination with gemcitabine to patients with solid tumours. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Tumors
- What is being tested?
- MGCD0103 and Gemcitabine
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 47 participants
- Where
- 8 sitesin 2 countries
- Study dates
- Sep 2006to Dec 2008
- Phase
- Phase 1/2
- 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 must have histologically or cytologically documented cancer: Phase I--solid tumors where gemcitabine is considered standard of care; refractory solid tumor with no reasonable likelihood of achieving clinical benefit with existing therapies, that has failed to respond to standard therapy, has progressed despite standard therapy, or for which no standard therapy exists. Phase II--locally advanced and measurable (non-resectable III) or metastatic (Stage IV) pancreatic cancer.
- Patients with known CNS metastases may be enrolled on Phase I or II only if they meet the following criteria:
- They have received radiotherapy for their CNS disease;
- They have had steroids discontinued for at least 1 month prior to study entry;
- They have had a CT or MRI of the brain within 1 month of study entry that shows stable disease; and d)they are free of neurological symptoms.
- Karnofsky performance status of 70 or greater.
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- Age 18 years and over.
- Laboratory requirements (must be done within 14 days prior to study initiation):
- Hematology: White Blood Cells (WBC)≥3 x 10<9>/L (≥ 3000/mm3);
- Absolute Neutrophil Count (ANC) ≥1.5 x 10<9>/L (≥1500/mm3);
- Platelets ≥100 x 10<9>/L (≥100,000/mm3);
- Chemistry: Total Bilirubin ≤1.5 x Upper Limit of Normal(ULN);
- AST(SGOT)and ALT(SGPT)≤3 x ULN; ≤ 5 x ULN if documented liver metastases;
- Serum Creatinine ≤1.5 x ULN or calculated creatinine clearance ≥50 mL/min;
- Urinalysis: Proteinuria <1 mg/dl or 500 mg protein/24 hours if dipstick ≥2+.
- Patients or their legal representative must be able to read (or have read to them), understand, and sign a written informed consent (approved by the institutional review board/Ethics Committee (IRB/EC)) within 14 days prior to start of treatment.
Who cannot join
- Patients with another active cancer (excluding basal cell carcinoma or cervical intraepithelial neoplasia (CIN/cervical in situ or melanoma in situ). (Phase II portion only)
- Pregnant or lactating women. Women of child bearing potential (WOCBP) must have a negative serum pregnancy test documented within 7 days prior to starting study drug.
- WOCBP and men whose partners are WOCBP must use an acceptable method of contraception while enrolled on this study, and for a period of 3 months following study drug treatment. Patients unwilling or unable to follow this guideline will be excluded. Investigators should follow their Institutional standard regarding acceptable methods of contraception.
- Patients with uncontrolled concomitant illness, active infection requiring i.v. antibiotics, or uncontrolled infections, or a fever >38.5C on the day of scheduled dosing.
- Patients with serious illnesses, medical conditions, or other medical history, including laboratory results, which, in the investigator's opinion, would be likely to interfere with a patient's participation in the study, or with the interpretation of the results.
- Patients who have been treated with any investigational drug within 28 days prior to study initiation (an investigational drug is one for which there is no approved indication), or who are receiving concurrent treatment with other experimental drugs or anti-cancer therapy.
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- Known hypersensitivity to HDAC inhibitors or to any of the components of MG-0103.
- Known hypersensitivity to gemcitabine.
- Prior treatment with gemcitabine (during the expanded phase II portion only).
- Known HIV or known active Hepatitis B or C.
- Any condition (e.g., known or suspected poor compliance, psychological instability, geographical location, etc.) that, in the judgment of the investigator, may affect the patient's ability to sign the informed consent and undergo study procedures.
- Any condition that will put the patient at undue risk or discomfort as a result of adherence to study procedures. For example, consider requirement to take MG-0103 with a low pH drink and recommendation to avoid agents that increase gastric pH.
Trial locations and contacts
8 sites in 2 countries.
8 sites in 2 countries
United States6 sites
Gabrail Cancer Center
Canton, Ohio, 44718
Duke University Medical Center
Durham, North Carolina, 27710
Indiana University Cancer Center
Indianapolis, Indiana, 46202
Veterans Affairs Medical Center
Kansas City, Kansas, 64128
Vanderbilt University Medical Center
Nashville, Tennessee, 37232-6307
Pennsylvania Presbyterian Medical Center
Philadelphia, Pennsylvania, 19104-4283
Canada2 sites
McGill University/Dept Oncology
Montreal, Quebec, H2W 1S6
CHUS Hopital Fleurimont
Sherbrooke, Quebec, J1H 5N4
About this study
Inthis study, MGCD0103, a new anticancer drug under investigation, is given three times weekly in combination with gemcitabine to patients with solid tumours.
- Conditions
- Tumors
- Being tested
- MGCD0103, Gemcitabine
- Keywords
- Refractory solid tumors, Phase I/II, Refractory and solid tumors
- Medical subject headings
- Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MGCD0103Drug
MGCD0103 as an oral dose three times per week.
GemcitabineDrug
Gemcitabine 1000mg/m<2> intravenously days 1, 8, 15 of a 28 day cycle.
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Not described Receives: Drug: MGCD0103; Drug: Gemcitabine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Maximum tolerated dose in combination with azacitidine
Measured: 1 year (anticipated)
Response rate
Measured: 1 year (anticipated)
Secondary outcomes (2)
Objective response.
Measured: 1 year (anticipated)
Pharmacodynamics (histone acetylation, biomarkers)
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 posted7 Sep 2006 (estimated)
- Study startSep 2006
- Primary completionDec 2008
- Study completionDec 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for TumorsStudies 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 1/2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- 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
- Gregory Reid, MSc, MBA, Study director, MethylGene Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00372437
- Sponsor's protocol ID
- 0103-006
- Status last verified
- Jun 2015
- First submitted
- 5 Sep 2006
- Last updated
- 1 Jul 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Jul 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I/II Study of MGCD0103 (MG-0103) in Combination With Gemcitabine
- ClinicalTrials.gov ID
- NCT00372437
- Acronym / sponsor ID
- 0103-006
- Conditions
- Tumors
- Keywords
- Refractory solid tumors, Phase I/II, Refractory and solid tumors
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 47 participants (actual)
- Lead sponsor
- Mirati Therapeutics Inc.Industry (pharma, biotech, devices)
- Study start
- Sep 2006
- Primary completion
- Dec 2008 (actual)
- Study completion
- Dec 2008 (actual)
- First posted
- 7 Sep 2006 (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.
Inthis study, MGCD0103, a new anticancer drug under investigation, is given three times weekly in combination with gemcitabine to patients with solid tumours.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Drug: MGCD0103, Drug: Gemcitabine |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (16 listed)
- Patients must have histologically or cytologically documented cancer: Phase I--solid tumors where gemcitabine is considered standard of care; refractory solid tumor with no reasonable likelihood of achieving clinical benefit with existing therapies, that has failed to respond to standard therapy, has progressed despite standard therapy, or for which no standard therapy exists. Phase II--locally advanced and measurable (non-resectable III) or metastatic (Stage IV) pancreatic cancer.
- Patients with known CNS metastases may be enrolled on Phase I or II only if they meet the following criteria:
- Karnofsky performance status of 70 or greater.
- Age 18 years and over.
- Laboratory requirements (must be done within 14 days prior to study initiation):
Key exclusion criteria (12 listed)
- Patients with another active cancer (excluding basal cell carcinoma or cervical intraepithelial neoplasia (CIN/cervical in situ or melanoma in situ). (Phase II portion only)
- Pregnant or lactating women. Women of child bearing potential (WOCBP) must have a negative serum pregnancy test documented within 7 days prior to starting study drug.
- WOCBP and men whose partners are WOCBP must use an acceptable method of contraception while enrolled on this study, and for a period of 3 months following study drug treatment. Patients unwilling or unable to follow this guideline will be excluded. Investigators should follow their Institutional standard regarding acceptable methods of contraception.
- Patients with uncontrolled concomitant illness, active infection requiring i.v. antibiotics, or uncontrolled infections, or a fever >38.5C on the day of scheduled dosing.
- Patients with serious illnesses, medical conditions, or other medical history, including laboratory results, which, in the investigator's opinion, would be likely to interfere with a patient's participation in the study, or with the interpretation of the results.
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 |
|---|---|---|
| MGCD0103MGCD0103 as an oral dose three times per week. | Drug | 1 |
| GemcitabineGemcitabine 1000mg/m<2> intravenously days 1, 8, 15 of a 28 day cycle. | Drug | 1 |
Primary outcome
Maximum tolerated dose in combination with azacitidine
Time frame: 1 year (anticipated)
Response rate
Time frame: 1 year (anticipated)
2 secondary outcomes
Objective response.
Time frame: 1 year (anticipated)
Pharmacodynamics (histone acetylation, biomarkers)
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 1 Jul 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.
Gregory Reid, MSc, MBA study director
MethylGene Inc.
8 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing MGCD0103 and Gemcitabine in people with Tumors, run by Mirati Therapeutics Inc. at 8 sites in 2 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 16 inclusion and 12 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 1 Jul 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 8 sites in United States, 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 combined 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.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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?
Maximum tolerated dose in combination with azacitidine (time frame: 1 year (anticipated)). 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?
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 1 Jul 2015.