Open Label Trial of Perifosine in Patients Currently Being Treated on Perifosine Trials in Solid Tumors or Multiple Myeloma
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| ClinicalTrials.gov Identifier: NCT00847366 |
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Recruitment Status :
Completed
First Posted : February 19, 2009
Last Update Posted : March 15, 2018
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| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Non Small Cell Lung Cancer Solid Tumors Metastatic Breast Cancer Sarcomas | Drug: Perifosine Drug: Trastuzumab Drug: Tamoxifen | Not Applicable |
Perifosine is an oral anticancer agent with limited toxicity and a novel mechanism of action that is distinctly different from cytotoxic chemotherapies. It has been shown to inhibit and otherwise modify signaling through a number of pathways including Akt, p21, and JNK. Perifosine has been tested in Phase I and Phase II settings in a variety of dosing schedules including daily, weekly, and daily following a loading dose. In general, it has been well tolerated with dose-related nausea, vomiting, diarrhea, and fatigue being the most commonly observed toxicities.
Perifosine has induced partial responses or stable disease in solid tumors including but not limited to renal cell, sarcoma, and hepatocellular carcinoma. Perifosine is currently being studied in multiple diseases as a single agent as well as in combination with other cancer therapies. As studies are closed there are patients that have achieved a partial response or stable disease.
| Study Type : | Interventional (Clinical Trial) |
| Actual Enrollment : | 10 participants |
| Allocation: | Non-Randomized |
| Intervention Model: | Crossover Assignment |
| Masking: | None (Open Label) |
| Primary Purpose: | Treatment |
| Official Title: | An Open Label Trial of Perifosine in Patients Currently Being Treated on Perifosine Trials in Solid Tumors or Multiple Myeloma |
| Study Start Date : | May 2008 |
| Actual Primary Completion Date : | December 2012 |
| Actual Study Completion Date : | December 2012 |
| Arm | Intervention/treatment |
|---|---|
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Experimental: Perifosine 201
Perifosine 201: A Phase 1/2 trial of Perifosine in the Treatment of Non-Small Cell Lung Cancer. Perifosine dosage: Arm A: 50 mg p.o. 3 times daily with meals. Arm B: 150 mg p.o. daily at bedtime. Arm C: 300 mg p.o. 3 times a day (900 mg) once a week. |
Drug: Perifosine
All patients should continue therapy on their current regimen until disease progression. The trial specific intervention is specified in the arms descriptions.
Other Names:
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Experimental: Perifosine 206
Perifosine 206: A Randomized Phase II Trial of Three Doses of Perifosine in Combination with Trastuzumab. Arm A: Perifosine 50 mg p.o. daily + 6 mg/kg Trastuzumab on day 1 of a 21-day cycle or 2 mg/kg on days 1, 8 and 15 of a 21 day cycle. Arm B: Perifosine 50 mg p.o three times a day + 6 mg/kg Trastuzumab on day 1 of a 21-day cycle or 2 mg/kg on days 1, 8 and 15 of a 21 day cycle. Arm C: Perifosine 300 mg three times on one day + 6 mg/kg Trastuzumab on day 1 of a 21-day cycle or 2 mg/kg on days 1, 8 and 15 of a 21 day cycle. |
Drug: Perifosine
All patients should continue therapy on their current regimen until disease progression. The trial specific intervention is specified in the arms descriptions.
Other Names:
Drug: Trastuzumab Trastuzumab was given 6mg/kg i.v. daily or 2 mg/kg i.v. on day 1, 8 and 15. |
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Experimental: Perifosine 207
Perifosine 207: a Phase IIA Trial of Two Schedules of Perifosine Arm A: 50 mg daily with food. Arm B: 50 mg twice daily with food.
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Drug: Perifosine
All patients should continue therapy on their current regimen until disease progression. The trial specific intervention is specified in the arms descriptions.
Other Names:
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Experimental: Perifosine 208
Perifosine 208: A Phase II Trial of Two Schedules of Perifosine in Combination with Endocrine Therapy (Tamoxifen) for Patients with Estrogen Receptor or Progesterone Receptor Positive Metastatic Breast Cancer Dosage: Arm A: 50 mg Perifosine /day p.o. .Endocrine therapy continued at same dose and schedule. Arm B: 900 Perifosine weekly. Endocrine therapy continued at same dose and schedule.
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Drug: Perifosine
All patients should continue therapy on their current regimen until disease progression. The trial specific intervention is specified in the arms descriptions.
Other Names:
Drug: Tamoxifen Endocrine therapy with tamoxifen will be evaluated in combination with perifosine to determine if the combination overcomes resistance to endocrine therapy . |
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Experimental: Perifosine 209
Perifosine 209: A Phase II Trial of Perifosine in Patients with Sarcomas. Perifosine 900 mg weekly (This dose should be divided so that the maximum dose rate is 300 mg in any 4-hour interval).
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Drug: Perifosine
All patients should continue therapy on their current regimen until disease progression. The trial specific intervention is specified in the arms descriptions.
Other Names:
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- To evaluate the safety and tolerability [ Time Frame: 12 weeks ]To evaluate the safety and tolerability of perifosine as a single agent as well as in combination with hormonal therapies or trastuzumab.
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
| Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- Patients must be currently receiving treatment with perifosine on a previously approved protocol.
- Patients must have had at least one evaluation following the initiation of treatment and have stable disease, partial response or complete response.
- Patient is willing to sign a new consent Regarding the protocol no exclusion criteria are described.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00847366
| Study Chair: | Eric Grossman, MD | Keryx Biopharmaceuticals, Inc., NY 10022-9819 |
| Responsible Party: | AEterna Zentaris |
| ClinicalTrials.gov Identifier: | NCT00847366 |
| Other Study ID Numbers: |
Perifosine 534 |
| First Posted: | February 19, 2009 Key Record Dates |
| Last Update Posted: | March 15, 2018 |
| Last Verified: | February 2018 |
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Perifosine |
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Multiple Myeloma Neoplasms Neoplasms, Plasma Cell Neoplasms by Histologic Type Hemostatic Disorders Vascular Diseases Cardiovascular Diseases Paraproteinemias Blood Protein Disorders Hematologic Diseases Hemorrhagic Disorders Lymphoproliferative Disorders Immunoproliferative Disorders |
Immune System Diseases Tamoxifen Trastuzumab Antineoplastic Agents, Immunological Antineoplastic Agents Estrogen Antagonists Hormone Antagonists Hormones, Hormone Substitutes, and Hormone Antagonists Physiological Effects of Drugs Antineoplastic Agents, Hormonal Selective Estrogen Receptor Modulators Estrogen Receptor Modulators Bone Density Conservation Agents |