Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00847366
Recruitment Status : Completed
First Posted : February 19, 2009
Last Update Posted : March 15, 2018
Sponsor:
Information provided by (Responsible Party):
AEterna Zentaris

Tracking Information
First Submitted Date  ICMJE February 17, 2009
First Posted Date  ICMJE February 19, 2009
Last Update Posted Date March 15, 2018
Study Start Date  ICMJE May 2008
Actual Primary Completion Date December 2012   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: March 6, 2018)
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.
Original Primary Outcome Measures  ICMJE
 (submitted: February 17, 2009)
To evaluate the safety and tolerability of perifosine as a single agent as well as in combination with hormonal therapies or trastuzamab. [ Time Frame: 12 weeks ]
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Open Label Trial of Perifosine in Patients Currently Being Treated on Perifosine Trials in Solid Tumors or Multiple Myeloma
Official Title  ICMJE An Open Label Trial of Perifosine in Patients Currently Being Treated on Perifosine Trials in Solid Tumors or Multiple Myeloma
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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Non Small Cell Lung Cancer
  • Solid Tumors
  • Metastatic Breast Cancer
  • Sarcomas
Intervention  ICMJE
  • 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:
    • D-21266
    • KRX-0401
  • Drug: Trastuzumab
    Trastuzumab was given 6mg/kg i.v. daily or 2 mg/kg i.v. on day 1, 8 and 15.
  • Drug: Tamoxifen
    Endocrine therapy with tamoxifen will be evaluated in combination with perifosine to determine if the combination overcomes resistance to endocrine therapy .
Study Arms  ICMJE
  • 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.

    Intervention: Drug: Perifosine
  • 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.

    Interventions:
    • Drug: Perifosine
    • Drug: Trastuzumab
  • 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.
    Intervention: Drug: Perifosine
  • 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.
    Interventions:
    • Drug: Perifosine
    • Drug: Tamoxifen
  • 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).
    Intervention: Drug: Perifosine
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: March 6, 2018)
10
Original Estimated Enrollment  ICMJE
 (submitted: February 17, 2009)
50
Actual Study Completion Date  ICMJE December 2012
Actual Primary Completion Date December 2012   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Not Provided
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00847366
Other Study ID Numbers  ICMJE Perifosine 534
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party AEterna Zentaris
Study Sponsor  ICMJE AEterna Zentaris
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Chair: Eric Grossman, MD Keryx Biopharmaceuticals, Inc., NY 10022-9819
PRS Account AEterna Zentaris
Verification Date February 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP