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| Sponsor: | Keryx / AOI Pharmaceuticals, Inc. |
|---|---|
| Collaborator: |
Sarcoma Alliance for Research through Collaboration |
| Information provided by (Responsible Party): | Keryx / AOI Pharmaceuticals, Inc. |
| ClinicalTrials.gov Identifier: | NCT00401388 |
Purpose
This is a phase II study of perifosine in patients with chondrosarcomas, alveolar soft part sarcomas and extra-skeletal myxoid chondrosarcomas. Patients will receive perifosine 100 mg orally qhs with food until disease progression. The goals of this study include:
| Condition | Intervention | Phase |
|---|---|---|
|
Chondrosarcomas Alveolar Soft Part Sarcomas Extra Skeletal Myxoid Chondrosarcomas |
Drug: Perifosine |
Phase 2 |
| Study Type: | Interventional |
| Study Design: | Allocation: Non-Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | Sarcoma Alliance for Research Through Collaboration (SARC) Multicenter Trial: A Phase II Trial of Perifosine in Patients With Chemo-Insensitive Sarcomas |
| Enrollment: | 72 |
| Study Start Date: | November 2006 |
| Study Completion Date: | October 2011 |
| Primary Completion Date: | January 2011 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: chondrosarcoma
Patients with confirmed chondrosarcoma.
|
Drug: Perifosine
Perifosine is available in 50 mg tablets. Patients will take two perifosine 50 mg tablets orally once a day at bedtime with food.
Other Name: perifosine
Drug: Perifosine
Patients will take two perifosine 50 mg tablets orally once a day at bedtime with food.
Other Name: perifosine
|
|
Experimental: myxoid chondrosarcoma
Patients with confirmed extra-skeletal myxoid chondrosarcoma.
|
Drug: Perifosine
Perifosine is available in 50 mg tablets. Patients will take two perifosine 50 mg tablets orally once a day at bedtime with food.
Other Name: perifosine
Drug: Perifosine
Patients will take two perifosine 50 mg tablets orally once a day at bedtime with food.
Other Name: perifosine
|
|
Experimental: alveolar soft part sarcoma
Patients with confirmed alveolar soft part sarcoma.
|
Drug: Perifosine
Perifosine is available in 50 mg tablets. Patients will take two perifosine 50 mg tablets orally once a day at bedtime with food.
Other Name: perifosine
Drug: Perifosine
Patients will take two perifosine 50 mg tablets orally once a day at bedtime with food.
Other Name: perifosine
|
This is a phase II study of perifosine in patients with chondrosarcomas, alveolar soft part sarcomas and extra-skeletal myxoid chondrosarcomas. Patients will receive perifosine 100 mg orally qhs with food until disease progression.
Perifosine is available in 50 mg tablets. Patients will take two perifosine 50 mg tablets orally once a day at bedtime with food. Administering the drug qhs has been shown to decrease gastrointestinal toxicity in some patients. Patients may need anti-emetics and/or anti-diarrheals. All patients may continue therapy unless disease progression is documented on two occasions at least 4 weeks apart. Patients who experience toxicity may continue on treatment with doses delayed or reduced. Evaluation of all lesions for progression or response will be made at 3-month intervals.
STUDY KEY POINTS
Eligibility| Ages Eligible for Study: | 13 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Patients must have normal organ and marrow function, unless in the opinion of the treating investigator, the abnormality is related to tumor, and the study chairman agree the abnormality is unlikely to affect the safety of perifosine use. Normal organ and marrow function is described below:
Exclusion Criteria:
Contacts and Locations
More Information
| Responsible Party: | Keryx / AOI Pharmaceuticals, Inc. |
| ClinicalTrials.gov Identifier: | NCT00401388 History of Changes |
| Obsolete Identifiers: | NCT00411502 |
| Other Study ID Numbers: | Perifosine 214 |
| Study First Received: | November 17, 2006 |
| Last Updated: | February 7, 2012 |
| Health Authority: | United States: Food and Drug Administration |
|
Chemo Insensitive Sarcomas Chondrosarcomas Alveolar soft part sarcomas Extra skeletal myxoid chondrosarcomas Perifosine |
|
Chondrosarcoma Sarcoma, Alveolar Soft Part Sarcoma Neoplasms, Connective Tissue |
Neoplasms, Connective and Soft Tissue Neoplasms by Histologic Type Neoplasms Neoplasms, Muscle Tissue |