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Sponsored by: |
AOI Pharma, Inc. |
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Information provided by: | AOI Pharma, Inc. |
ClinicalTrials.gov Identifier: | NCT00399126 |
This is a study of the drug perifosine given in combination with paclitaxel. Perifosine is an oral anti-cancer agent that has been used in more than 140 people. Paclitaxel is a standard chemotherapy agent used in many types of cancer. This study is designed to determine the highest dose of perifosine that can be administered to people every day while they are receiving paclitaxel in one of two regimens, without severe or prolonged nausea, vomiting and diarrhea. This study starts with patients taking 50 mg/day and goes up to 150 mg/day.
Condition | Intervention | Phase |
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Neoplasms |
Drug: Perifosine Drug: Paclitaxel |
Phase I |
Study Type: | Interventional |
Study Design: | Treatment, Non-Randomized, Open Label, Dose Comparison, Single Group Assignment, Safety Study |
Official Title: | A Phase 1 Trial of the Combination of Perifosine and Paclitaxel Given Either Weekly or Every 3 Weeks |
Estimated Enrollment: | 30 |
Study Start Date: | November 2004 |
Estimated Study Completion Date: | December 2008 |
Estimated Primary Completion Date: | June 2008 (Final data collection date for primary outcome measure) |
This is a phase 1, open-label trial of perifosine and paclitaxel administered either weekly or every 3 weeks in patients with malignancies for whom single agent paclitaxel is a reasonable treatment option. All patients will receive paclitaxel either at a dose of 80 mg/m2 on days 1, 8 and 15 of a 28-day cycle (Arm A) or at 175 mg/m2 administered on day 8 of a 21 day cycle (Arm B). Patients on both arm A and arm B will receive premedication with diphenhydramine 50 mg IV 30 minutes prior to treatment; ranitidine 50 mg IV 30 minutes prior to treatment and dexamethasone 20 mg IV at 30 minutes prior to treatment. The 1st cohort of patients on Arm A will receive perifosine orally at a dose of 50 mg per day for the first 21 days of the 28-day cycle and on Arm B will receive perifosine orally at a dose of 50 mg per day for the first 14 days of the 21-day cycle. On each arm, the perifosine dose will be escalated in subsequent groups to 50 mg bid and then 50 mg tid as tolerated. (See below) Alternating cohorts of 3 patients will be entered first to Arm A and then to Arm B. The perifosine dose escalation for Arm A and Arm B will be performed separately according to the following algorithm. For each arm, a maximum tolerated dose (MTD) will be defined as a dose that can be given without grade 3/4 non-hematologic toxicity in more than 1/3 patients. If 2/3 patients in any cohort encounter a grade 3/4 non-hematologic toxicity, an additional 3 patients will be added. If the dose is intolerable for >3/6 patients then the previous dose level will be declared the MTD for that arm.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
United States, Tennessee | |
AOI Pharmaceuticals Investigative Site | |
Johnson City, Tennessee, United States, 37604 |
Study Director: | Robert Birch, Ph.D. | AOI Pharma, Inc. |
Study ID Numbers: | Perifosine 104 |
Study First Received: | November 10, 2006 |
Last Updated: | April 4, 2008 |
ClinicalTrials.gov Identifier: | NCT00399126 |
Health Authority: | United States: Food and Drug Administration |
Paclitaxel |
Neoplasms Molecular Mechanisms of Pharmacological Action Antineoplastic Agents Therapeutic Uses Mitosis Modulators |
Tubulin Modulators Antimitotic Agents Antineoplastic Agents, Phytogenic Pharmacologic Actions |