Home
Search
Study Topics
Glossary
|
|
|
|
|
Sponsored by: |
AOI Pharma, Inc. |
---|---|
Information provided by: | AOI Pharma, Inc. |
ClinicalTrials.gov Identifier: | NCT00399087 |
This is a study of the drug perifosine given in combination with docetaxel. Perifosine is an oral anti-cancer agent that has been used in more than 140 people. Docetaxel 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 docetaxel with or without a steroid called prednisone, 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 |
---|---|---|
Neoplasms |
Drug: Perifosine Drug: Docetaxel Drug: Prednisone |
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 Docetaxel With or Without Prednisone |
Estimated Enrollment: | 30 |
Study Start Date: | November 2004 |
Estimated Study Completion Date: | June 2009 |
Estimated Primary Completion Date: | January 2009 (Final data collection date for primary outcome measure) |
This is a phase 1, open-label trial of perifosine and docetaxel with or without prednisone in patients with malignancies for whom single agent docetaxel is a reasonable treatment option. All patients will receive docetaxel at a dose of 75 mg/m2 on day 8 of a 21-day cycle either without (Arm A) or with prednisone 5 mg bid on days 1 - 21 (Arms B and C). (Patients on all arms will receive premedication with dexamethasone around the time of docetaxel administration either as described in the product insert for arm A or as used in prior prostate cancer phase III studies for arm B and C. The 1st cohort of patients on Arm A and 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. Alternating cohorts of 3 patients will be entered first to Arm A and then to Arm B. At the completion of arms A and B, 3 cohorts of patients will be entered who will receive perifosine weekly at doses of 900, 1200 and 1500 mg. The total dose will be divided into 300 mg doses which will be delivered at least 4 hours apart. The perifosine dose escalation for each arm 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. |
Responsible Party: | AOI Pharmacuticals ( AOI Pharmacuticals ) |
Study ID Numbers: | Perifosine 105 |
Study First Received: | November 10, 2006 |
Last Updated: | February 13, 2009 |
ClinicalTrials.gov Identifier: | NCT00399087 History of Changes |
Health Authority: | United States: Food and Drug Administration |
Anti-Inflammatory Agents Docetaxel Prednisone Antineoplastic Agents, Hormonal |
Hormone Antagonists Hormones, Hormone Substitutes, and Hormone Antagonists Hormones Glucocorticoids |
Anti-Inflammatory Agents Docetaxel Prednisone Neoplasms Antineoplastic Agents, Hormonal Antineoplastic Agents |
Therapeutic Uses Physiological Effects of Drugs Hormones, Hormone Substitutes, and Hormone Antagonists Hormones Glucocorticoids Pharmacologic Actions |