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

NCT00847366 | Completed

• 1 other identifier: Perifosine 534
• Study Type: interventional
• Target: 10
• Locations: 0 countries
• Sites: N/A

Brief Summary

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

Conditions

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

Keywords

Perifosine

Outcome Measures

Primary Outcomes (1)

• To evaluate the safety and tolerability

  To evaluate the safety and tolerability of perifosine as a single agent as well as in combination with hormonal therapies or trastuzumab.

  12 weeks

Study Arms (5)

Perifosine 201

EXPERIMENTAL

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

Perifosine 206

EXPERIMENTAL

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; Drug: Trastuzumab

Perifosine 207

EXPERIMENTAL

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.

Drug: Perifosine

Perifosine 208

EXPERIMENTAL

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.

Drug: Perifosine; Drug: Tamoxifen

Perifosine 209

EXPERIMENTAL

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).

Drug: Perifosine

Interventions

Perifosine DRUG

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

Also known as: D-21266, KRX-0401

Perifosine 201; Perifosine 206; Perifosine 207; Perifosine 208; Perifosine 209

Trastuzumab DRUG

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

Perifosine 206

Tamoxifen DRUG

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

Perifosine 208

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

Sponsors & Collaborators

• AEterna Zentaris: lead

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung; Breast Neoplasms; Sarcoma

Interventions

perifosine; Trastuzumab; Tamoxifen

Condition Hierarchy (Ancestors)

Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases; Neoplasms, Connective and Soft Tissue; Neoplasms by Histologic Type

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins; Stilbenes; Benzylidene Compounds; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals

Study Officials

• Eric Grossman, MD

  Keryx Biopharmaceuticals, Inc., NY 10022-9819

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 17, 2009
• First Posted: February 19, 2009
• Study Start: May 1, 2008
• Primary Completion: December 1, 2012
• Study Completion: December 1, 2012
• Last Updated: March 15, 2018

Record last verified: 2018-02