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Sponsored by: |
EntreMed |
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Information provided by: | EntreMed |
ClinicalTrials.gov Identifier: | NCT00408226 |
To determine the toxicities, maximum tolerated dose (MTD) and recommended phase 2 dose of MKC-1 when administered orally, twice daily for 14 days followed by 7 days without dosing, in combination with pemetrexed (delivered at its recommended single agent dose) to patients with advanced solid tumor malignancies. Also, to determine the antitumor activity, based on the objective response rate and median Progression Free Survival ("PFS"), of oral MKC-1, administered on this schedule in combination with pemetrexed to patients with non small cell lung cancer (NSCLC).
Condition | Intervention | Phase |
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Advanced Cancer Non-Small Cell Lung Cancer |
Drug: MKC-1 Drug: pemetrexed |
Phase I Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study |
Official Title: | Phase 1/2 Study of Oral MKC-1 Administered Twice Daily for 14 Consecutive Days Every 3 Weeks in Combination With Pemetrexed |
Estimated Enrollment: | 60 |
Study Start Date: | October 2006 |
Estimated Study Completion Date: | October 2009 |
Estimated Primary Completion Date: | June 2009 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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1: Experimental |
Drug: MKC-1
capsules, twice daily for 14 days in 21 day cycle
Drug: pemetrexed
standard dosing of 500 mg/m2 infused every 21 days
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Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Patients must satisfy this criteria based on the portion of the study for which they are being considered for enrollment:
Dose Escalating Phase: Patients with advanced solid tumor malignancies for whom single-agent pemetrexed therapy would not be contraindicated.
Measurable disease not required.
Phase 2 portion: Current diagnosis of Stage IIIb (due to malignant pleural effusion or supraclavicular lymph node involvement only) or Stage IV histologically and/or cytologically proven non-small cell lung cancer according to staging system of the American Joint Committee on Cancer.
(i) Patient has received maximally feasible surgical resection and/or radiotherapy for initial disease.
(ii) Either disease progression following treatment with one prior chemotherapy regimen used for the treatment of metastatic disease or disease progression following adjuvant/neoadjuvant therapy within one year of last dose of chemotherapy or (for those patients with disease progression following adjuvant/neoadjuvant therapy >1 year of last dose of chemotherapy) disease progression following one additional chemotherapy regimen for metastatic disease. (iii) Radiographic or physical examination evidence of at least one site of unidimensionally-measurable disease, using the RECIST criteria with disease assessed within 28 days prior to treatment initiation.
The following laboratory results, within 10 days of MKC-1 administration:
Hemoglobin ≥ 9 g/dL Absolute neutrophil count ≥ 1.5 x 109/L Platelet count ≥ 75 x 109/L Serum creatinine ≤ 1.5 x ULN (upper limit of normal) Creatinine clearance ≥ 45 mL/min AST ≤ 2.5 x ULN Serum albumin ≥ LLN (lower limit of normal) or 3.5 g/dL Total bilirubin ≤ ULN
Exclusion Criteria:
Administration of cancer-specific therapy within the following periods prior to study drug initiation:
United States, Indiana | |
Indiana University Cancer Center | |
Indianapolis, Indiana, United States, 46202 | |
United States, Iowa | |
University of Iowa | |
Iowa City, Iowa, United States, 52242 | |
United States, Washington | |
Swedish Cancer Institute | |
Seattle, Washington, United States, 98122 | |
United States, Wisconsin | |
University of Wisconsin Hospital and Clinics | |
Madison, Wisconsin, United States, 53792 |
Principal Investigator: | Nasser H. Hanna, M.D. | Indiana University School of Medicine |
Responsible Party: | EntreMed, Inc. ( Chief Medical Officer ) |
Study ID Numbers: | MKC-102 |
Study First Received: | December 5, 2006 |
Last Updated: | February 25, 2009 |
ClinicalTrials.gov Identifier: | NCT00408226 History of Changes |
Health Authority: | United States: Food and Drug Administration |
Antimetabolites Folic Acid Pemetrexed Thoracic Neoplasms Respiratory Tract Diseases Lung Neoplasms |
Lung Diseases Non-small Cell Lung Cancer Folic Acid Antagonists Carcinoma, Non-Small-Cell Lung Neoplasms, Glandular and Epithelial Carcinoma |
Antimetabolites Thoracic Neoplasms Respiratory Tract Neoplasms Antimetabolites, Antineoplastic Neoplasms by Histologic Type Molecular Mechanisms of Pharmacological Action Antineoplastic Agents Enzyme Inhibitors Folic Acid Antagonists Pharmacologic Actions |
Carcinoma Pemetrexed Neoplasms Neoplasms by Site Respiratory Tract Diseases Lung Neoplasms Therapeutic Uses Lung Diseases Carcinoma, Non-Small-Cell Lung Neoplasms, Glandular and Epithelial |