Celgene terminated its collaboration agreement with MethylGene for the development of MGCD0103. All Celgene-sponsored trials with MGCD0103 will be closed.
Study to Evaluate Combination Treatment of MGCD0103 and Docetaxel (Taxotere®) for Subjects With Advanced Cancer Tumors
A Phase 1, Open-Label, Dose-Escalation Trial to Evaluate the Safety, Pharmacokinetics, and Pharmacodynamics of MGCD0103 (MG-0103) in Combination With Docetaxel (Taxotere®) in Subjects With Advanced Solid Malignancies
This date has not been verified as actual or estimated.
Primary Completion
March 2009
Actual (reported)
Study Completion
March 2009
Actual (reported)
Brief Summary
The purpose of this study is to test the combination of an experimental drug known as MGCD0103 given along with an FDA-approved drug called docetaxel. This is a Phase 1 study that will look at different doses of MGCD0103 given along with docetaxel in order to better understand the effects (positive and negative) of this combination on the subject's body and disease. The study would like to find the following information:
How long MGCD0103 and docetaxel stay in the subject's body;
What effects, good and/or bad, MGCD0103 and docetaxel have on the subject and on his/her cancer; and
If the genetic and chemical make-up of the subject's blood cells and tumor cells play a role in how you respond or do not respond to MGCD0103 and docetaxel.
Registry Overview
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
Recruitment status
terminated
Estimated enrollment
54 participants
Study completion date
March 2009
Actual (reported)
Listed locations
1 countries · 2 sites
Trial Relationships
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Related Scientific Literature
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Study Timeline
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
Study Start
August 2007
Date type not reported
This date has not been verified as actual or estimated.
Advanced or Metastatic Breast CancerBreast CancerAdvanced or Metastatic Non-Small-Cell Lung Cancer (NSCLC)Hormone Refractory Prostate CancerProstate CancerGastric CancerAdvanced Gastric AdenocarcinomaHDAC InhibitorTaxotereDocetaxel
Outcome Measures
Primary Outcomes (4)
To determine the maximum tolerated dose (MTD), dose limiting toxicities (DLTs), and safety profile of escalating doses of orally administered MGCD0103 in combination with two fixed doses (60 mg/m2 and 75 mg/m2) of IV docetaxel.
15 months
To assess the plasma pharmacokinetics (PK) of MGCD0103 (and/or its metabolites) and IV docetaxel administered in combination.
15 months
To evaluate potential pharmacodynamic (PD) effects of orally administered MGCD0103 in combination with IV docetaxel.
15 months
Study Arms (2)
Part 1
ACTIVE COMPARATOR
In Part 1, cohorts of three to six subjects will receive doses of MGCD0103 administered orally three times per week (TIW) in combination with 60 mg/m2 IV docetaxel administered as a 1-hour infusion on Day 1 of each 3-week (21-day) cycle. The starting dose of MGCD0103 in Part 1 will be 50 mg (approximately 25 mg/m2).
Drug: MGCD0103 & Docetaxel
Part 2
ACTIVE COMPARATOR
Part 2 will begin once the MTD for MGCD0103 in combination with 60 mg/m2 IV docetaxel has been determined and further evaluated in the expansion phase. In Part 2, cohorts of three to six subjects will receive escalating doses of MGCD0103 administered orally TIW in combination with 75 mg/m2 docetaxel administered as a 1-hour IV infusion on Day 1 of each cycle. The starting dose of MGCD0103 administered in combination with 75 mg/m2 IV docetaxel will be the MTD from Part 1 minus 25 mg.
Drug: MGCD0103 & Docetaxel
Interventions
MGCD0103 & DocetaxelDrug
In both Parts 1 and 2, subsequent doses of MGCD0103 will be escalated in 25 mg increments until the MTD of MGCD0103 in combination with each fixed dose (60 mg/m2 or 75 mg/m2) ofIV docetaxel is determined.
In both parts 1 and 2, MGCD0103 will be administered orally TIW for 3 weeks beginning on Day 1 at 1 hour prior to the start of the IV docetaxel infusion.
There will be no scheduled break between cycles and no limit to the number of cycles a subject can receive provided they do not have disease progression as defined by RECIST, or a clinically significant drug-related adverse event (AE) that does not resolve or respond to treatment intervention with 3 weeks.
Also known as: MG-0103, Taxotere®
Part 1Part 2
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
Eligibility Criteria
Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
You may qualify if:
Age ≥18 years.
Diagnosis of malignant solid tumor (histologically or cytologically confirmed) where treatment with docetaxel is considered standard of care, or advanced solid malignancy that has failed to respond to standard therapy, or has progressed despite standard therapy, or where there is no reasonable likelihood of achieving clinical benefit with existing therapies.
To determine the overall tumor response of orally administered MGCD0103 in combination with IV docetaxel according to Response Evaluation Criteria in Solid Tumors (RECIST) methodology.
15 months
Eastern Cooperative Oncology Group (ECOG) performance status 0 to 2.
Adequate organ function, including: Hemoglobin (Hgb) ≥8.0g/dL; Absolute neutrophil count (ANC) ≥1.5 x 10\<9\>/L (≥1500/mm\<3\>); Platelets ≥100 x 10\<9\>/L (≥100,000/mm\<3\>); Total bilirubin ≤1.5 x ULN (upper limit of normal); AST (SGOT) and ALT (SGPT) ≤2.5 x ULN; Alkaline phosphatase ≤5.0 x ULN; Serum creatinine ≤2.0 x ULN.
Evidence of measurable disease (ie, at least one lesion that can accurately be measured in at least one dimension as ≥20 mm with conventional techniques or ≥10 mm with spiral CT scan). The requirement for measurable disease will not apply to subjects with prostate cancer.
A minimum of 4 weeks elapsed since any major surgery.
At least 4 weeks elapsed since any prior anticancer therapy (standard or investigational) and full recovery (NCI CTCAE grade 1) from the toxic effects of that treatment. Antiandrogen therapy is permitted for subjects with prostate cancer.
For women of childbearing potential, a negative serum pregnancy test within 10 days of treatment, and use of physician-approved methods of birth control throughout the study.
Written, informed consent, willingness, and ability to comply with all study procedures.
You may not qualify if:
Subjects meeting any of the following criteria will not be included in the study.
Prior taxane and HDAC inhibitor combination therapy.
Previous or concurrent malignancy except adequately treated basal cell or squamous cell skin cancer; in situ carcinoma of the cervix, or other solid tumor treated curatively, and without evidence of recurrence for at least 3 years prior to study entry.
Clinically significant cardiac disease including congestive heart failure (New York Heart Association Class III or IV), including pre-existing ventricular arrhythmia or conduction abnormality requiring medication, or cardiomyopathy.
Active and uncontrolled clinically significant infection.
History of melena, hematemesis, or hemoptysis within the last 3 months.
Known central nervous system metastases controlled ≤3 months.
Pregnant or lactating women. Women of child-bearing potential must have a negative serum pregnancy test within 10 days of starting study drug on Day 1 Cycle 1.
Known hypersensitivity to taxanes, HDAC inhibitors, and/or any components of MGCD0103 capsules or docetaxel formulation components (eg, polysorbate 80).
Known HIV or known active Hepatitis B or C.
Presence of serious illness, medical condition, or other medical history, including abnormal laboratory parameters, which, in the opinion of the Investigator, would be likely to interfere with a subject's participation in the study or with the interpretation of the results.
Any condition that will put the subject at undue risk or discomfort as a result of adherence to study procedures (eg, requirement to take MGCD0103 with a low pH beverage).
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Source: ClinicalTrials.gov.
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