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

Primary Purpose

Non Small Cell Lung Cancer, Solid Tumors, Metastatic Breast Cancer

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Perifosine
Trastuzumab
Tamoxifen
Sponsored by
AEterna Zentaris
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Non Small Cell Lung Cancer focused on measuring Perifosine

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm 3

    Arm 4

    Arm 5

    Arm Type

    Experimental

    Experimental

    Experimental

    Experimental

    Experimental

    Arm Label

    Perifosine 201

    Perifosine 206

    Perifosine 207

    Perifosine 208

    Perifosine 209

    Arm Description

    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.

    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.

    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.

    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.

    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).

    Outcomes

    Primary Outcome Measures

    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.

    Secondary Outcome Measures

    Full Information

    First Posted
    February 17, 2009
    Last Updated
    March 12, 2018
    Sponsor
    AEterna Zentaris
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    1. Study Identification

    Unique Protocol Identification Number
    NCT00847366
    Brief Title
    Open Label Trial of Perifosine in Patients Currently Being Treated on Perifosine Trials in Solid Tumors or Multiple Myeloma
    Official Title
    An Open Label Trial of Perifosine in Patients Currently Being Treated on Perifosine Trials in Solid Tumors or Multiple Myeloma
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    February 2018
    Overall Recruitment Status
    Completed
    Study Start Date
    May 2008 (undefined)
    Primary Completion Date
    December 2012 (Actual)
    Study Completion Date
    December 2012 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    AEterna Zentaris

    4. Oversight

    Data Monitoring Committee
    No

    5. Study Description

    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Non Small Cell Lung Cancer, Solid Tumors, Metastatic Breast Cancer, Sarcomas
    Keywords
    Perifosine

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Crossover Assignment
    Masking
    None (Open Label)
    Allocation
    Non-Randomized
    Enrollment
    10 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Perifosine 201
    Arm Type
    Experimental
    Arm Description
    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.
    Arm Title
    Perifosine 206
    Arm Type
    Experimental
    Arm Description
    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.
    Arm Title
    Perifosine 207
    Arm Type
    Experimental
    Arm Description
    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.
    Arm Title
    Perifosine 208
    Arm Type
    Experimental
    Arm Description
    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.
    Arm Title
    Perifosine 209
    Arm Type
    Experimental
    Arm Description
    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).
    Intervention Type
    Drug
    Intervention Name(s)
    Perifosine
    Other Intervention Name(s)
    D-21266, KRX-0401
    Intervention Description
    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
    Intervention Name(s)
    Trastuzumab
    Intervention Description
    Trastuzumab was given 6mg/kg i.v. daily or 2 mg/kg i.v. on day 1, 8 and 15.
    Intervention Type
    Drug
    Intervention Name(s)
    Tamoxifen
    Intervention Description
    Endocrine therapy with tamoxifen will be evaluated in combination with perifosine to determine if the combination overcomes resistance to endocrine therapy .
    Primary Outcome Measure Information:
    Title
    To evaluate the safety and tolerability
    Description
    To evaluate the safety and tolerability of perifosine as a single agent as well as in combination with hormonal therapies or trastuzumab.
    Time Frame
    12 weeks

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    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. Patient is willing to sign a new consent Regarding the protocol no exclusion criteria are described.
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Eric Grossman, MD
    Organizational Affiliation
    Keryx Biopharmaceuticals, Inc., NY 10022-9819
    Official's Role
    Study Chair

    12. IPD Sharing Statement

    Learn more about this trial

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

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