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Sponsored by: |
Eisai Inc. |
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Information provided by: | Eisai Inc. |
ClinicalTrials.gov Identifier: | NCT00268905 |
The purpose of this study is to determine the maximum tolerated dose (MTD) and to explore the safety and anti-tumor activity of E7389 in combination with carboplatin in patients with advanced solid tumors.
Condition | Intervention | Phase |
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Cancer |
Drug: E7389 + carboplatin AUC 5 Drug: E7389 + carboplatin AUC 6 |
Phase I |
Study Type: | Interventional |
Study Design: | Treatment, Non-Randomized, Open Label, Uncontrolled, Parallel Assignment, Safety Study |
Official Title: | A Phase Ib Open-Label, Two-Arm, Dose-Finding Study of E7389 in Combination With Carboplatin in Patients With Solid Tumors |
Estimated Enrollment: | 85 |
Study Start Date: | October 2006 |
Estimated Study Completion Date: | November 2010 |
Estimated Primary Completion Date: | May 2010 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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1: Experimental |
Drug: E7389 + carboplatin AUC 5
Patients will receive E7389 before (Schedule A) or after (Schedule B) carboplatin AUC 5 infusion. E7389 will be administered as a 2-5 minute intravenous (IV) bolus infusion at a starting dose of 0.7 mg/m^2 on Days 1 and 8 every 21 days. Carboplatin 5 AUC will be administered as a 30-minute IV infusion on Day 1 every 21 days. Dose escalation will be performed in cohorts of three patients per dose level per schedule.
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2: Experimental |
Drug: E7389 + carboplatin AUC 6
After MTD is reached with carboplatin AUC 5, dose escalation of E7389 in combination with carboplatin at AUC 6 will begin at one dose level below MTD, using the preferred schedule (A or B). If carboplatin AUC 6 with E7389 is tolerated, the MTD reached will be used to enroll 20 additional patients with Stage IIIB or IV non-small cell lung cancer (NSCLC). If carboplatin AUC 6 is not tolerated, these patients will be enrolled at the MTD determined with the combination of E7389 and carboplatin AUC 5.
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This is a Phase Ib open-label, two-arm, dose-finding study of E7389 in combination with carboplatin in patients with solid tumors.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Patients with adequate bone marrow function as evidenced by absolute neutrophil count (ANC) ≥ 1.5 × 10^9/L, hemoglobin ≥ 10.0 g/dL (this may have been corrected by transfusion or growth factors) and platelet count ≥ 100
For patients in the dose finding phase, the following additional inclusion criteria must be fulfilled:
For NSCLC patients at the MTD, the following additional inclusion criteria must be fulfilled:
Exclusion Criteria:
For NSCLC patients at the MTD, the following additional exclusion criterion must be fulfilled:
1. Patients who have had a prior malignancy, other than carcinoma in situ of the cervix, or non-melanoma skin cancer, unless the prior malignancy was diagnosed and definitively treated ≥ five years previously with no subsequent evidence of recurrence.
Contact: Eisai Medical Services | 1-888-422-4743 |
United States, New Jersey | |
Cancer Institute of New Jersey | Recruiting |
New Brunswick, New Jersey, United States | |
United States, New York | |
Columbia University Medical Center | Recruiting |
New York, New York, United States | |
Albert Einstein Cancer Center | Recruiting |
Bronx, New York, United States |
Study Director: | Dale Shuster, Ph.D | Eisai Inc. |
Responsible Party: | Eisai Medical Research Inc. ( Dale Shuster, Ph.D ) |
Study ID Numbers: | E7389-A001-104 |
Study First Received: | December 21, 2005 |
Last Updated: | September 1, 2009 |
ClinicalTrials.gov Identifier: | NCT00268905 History of Changes |
Health Authority: | United States: Food and Drug Administration |
Signs and Symptoms Carboplatin |
Antineoplastic Agents Therapeutic Uses Carboplatin Pharmacologic Actions |