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Main
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Note: This record shows only the 20 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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4 March 2013 |
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Main ID: |
NCT00975767 |
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Date of registration:
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10/09/2009 |
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Primary sponsor: |
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Public title:
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A Study of MGCD265 Given With Erlotinib or Docetaxel in Subjects With Advanced Malignancies or Non-Small Cell Lung Cancer
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Scientific title:
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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) |
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Date of first enrolment:
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August 2009 |
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Target sample size:
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150 |
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Recruitment status: |
Recruiting |
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URL:
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http://clinicaltrials.gov/show/NCT00975767 |
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Study type:
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Interventional |
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Study design:
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Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
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Countries of recruitment
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United States
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Contacts
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Name:
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Manal Tawashi |
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Address:
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Telephone:
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514-337-3333 |
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Email:
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tawashim@methylgene.com |
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Affiliation:
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Name:
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Manal Tawashi |
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Address:
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Telephone:
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Email:
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Affiliation:
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MethylGene Inc. |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- 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.
- 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.
Exclusion Criteria:
- 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.
- 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).
Age minimum:
18 Years
Age maximum:
N/A
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Advanced Malignancies, Non-small Cell Lung Cancer
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Intervention(s)
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Drug: MGCD265+docetaxel
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Drug: MGCD265+erlotinib
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Primary Outcome(s)
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Phase I: Safety profile (including maximum tolerated dose and dose limiting toxicities)
[Time Frame: 1 year]
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Phase II: Antitumor activity of MGCD265+erlotinib and MGCD265+docetaxel
[Time Frame: 1 year]
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Secondary Outcome(s)
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Phase I and Phase II: Pharmacodynamic profiles of MGCD265+erlotinib and MGCD265+docetaxel
[Time Frame: 1 year]
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Phase I: Antitumor activity of MGCD265+erlotinib and MGCD265+docetaxel.
[Time Frame: 1 year]
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Phase I: Pharmacokinetic profiles of MGCD265+erlotinib and MGCD265+docetaxel
[Time Frame: 2 months]
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Phase II: Safety profile of MGCD265+erlotinib and MGCD265+docetaxel;
[Time Frame: 1 year]
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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