Open Label Trial of Perifosine in Patients Currently Being Treated on Perifosine Trials in Solid Tumors or Multiple Myeloma

NCT ID: NCT00847366

Last Updated: 2018-03-15

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 10 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2008-05-31
• Study Completion Date: 2012-12-31

Brief Summary

This is an open label trial for patients currently enrolled in other perifosine trials.

Detailed Description

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.

Conditions

Non Small Cell Lung Cancer; Solid Tumors; Metastatic Breast Cancer; Sarcomas

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

Perifosine

Intervention Type: DRUG

All patients should continue therapy on their current regimen until disease progression. The trial specific intervention is specified in the arms descriptions.

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.

Group Type: EXPERIMENTAL

Perifosine

Intervention Type: DRUG

All patients should continue therapy on their current regimen until disease progression. The trial specific intervention is specified in the arms descriptions.

Trastuzumab

Intervention Type: DRUG

Trastuzumab was given 6mg/kg i.v. daily or 2 mg/kg i.v. on day 1, 8 and 15.

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.

Group Type: EXPERIMENTAL

Perifosine

Intervention Type: DRUG

All patients should continue therapy on their current regimen until disease progression. The trial specific intervention is specified in the arms descriptions.

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.

Group Type: EXPERIMENTAL

Perifosine

Intervention Type: DRUG

All patients should continue therapy on their current regimen until disease progression. The trial specific intervention is specified in the arms descriptions.

Tamoxifen

Intervention Type: DRUG

Endocrine therapy with tamoxifen will be evaluated in combination with perifosine to determine if the combination overcomes resistance to endocrine therapy .

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).

Group Type: EXPERIMENTAL

Perifosine

Intervention Type: DRUG

All patients should continue therapy on their current regimen until disease progression. The trial specific intervention is specified in the arms descriptions.

Interventions

Perifosine

All patients should continue therapy on their current regimen until disease progression. The trial specific intervention is specified in the arms descriptions.

Intervention Type: DRUG

Trastuzumab

Trastuzumab was given 6mg/kg i.v. daily or 2 mg/kg i.v. on day 1, 8 and 15.

Intervention Type: DRUG

Tamoxifen

Endocrine therapy with tamoxifen will be evaluated in combination with perifosine to determine if the combination overcomes resistance to endocrine therapy .

Intervention Type: DRUG

Other Intervention Names

D-21266; KRX-0401

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

AEterna Zentaris

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Eric Grossman, MD

Role: STUDY_CHAIR

Keryx Biopharmaceuticals, Inc., NY 10022-9819

Other Identifiers

Perifosine 534

Identifier Type: -

Identifier Source: org_study_id