NCT00398697

Brief Summary

This is a study of the drug perifosine in combination with Gemcitabine. Perifosine is an oral anti-cancer agent that has been used in more than 140 people, but has not been combined with other drugs before this study. The study is designed to determine the highest dose of perifosine that can be administered to people every day while they are on a Gemcitabine regimen, without severe or prolonged nausea, vomiting and diarrhea. This study starts with patients taking 50 mg/day and goes up to 150 mg/day. After the highest tolerable dose is found, we will add 10 more patients at that dose.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
19

participants targeted

Target at P25-P50 for phase_1

Timeline
Completed

Started Aug 2004

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2004

Completed
1.4 years until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2006

Completed
10 months until next milestone

First Submitted

Initial submission to the registry

November 10, 2006

Completed
4 days until next milestone

First Posted

Study publicly available on registry

November 14, 2006

Completed
Last Updated

February 13, 2014

Status Verified

January 1, 2007

First QC Date

November 10, 2006

Last Update Submit

February 12, 2014

Conditions

Neoplasms

Keywords

perifosinegemcitabine

Outcome Measures

Primary Outcomes (1)

  • GI Toxicities

Secondary Outcomes (2)

  • Other toxicities

  • Disease progression

Interventions

PerifosineDRUG
GemcitabineDRUG

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients must have histologically or cytologically confirmed diagnosis of cancer for which treatment with single agent gemcitabine would be an appropriate treatment option
  • At least 18 years of age
  • Patients may have received no more than two prior chemotherapy regimens
  • Patients must have a life expectancy of more than 3 months.
  • Patients must have a performance status of 0 to 2 according to the ECOG criteria
  • Patients must have normal organ and marrow function as defined in the protocol.
  • Patients must have recovered from any acute toxicity related to prior therapy, including surgery or radiotherapy.
  • Patients must be able to ingest oral medications.
  • Female patients who are pregnant or lactating are ineligible. All females of childbearing potential must have a negative serum pregnancy test within 72 hours of treatment. Men and women of childbearing potential must agree to employ adequate contraception.
  • Patients must have ability to understand and the willingness to sign a written informed consent document.

You may not qualify if:

  • Patients may not be receiving any other investigational agents or devices.
  • History of allergic reactions attributed to compounds of similar chemical or biologic composition to perifosine (miltefosine or edelfosine).
  • Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection and psychiatric illness/social situations that would limit compliance with study requirements.
  • HIV-positive patients receiving combination anti-retroviral therapy are excluded from the study because of possible pharmacokinetic interactions with perifosine. HIV-positive patients not receiving combination anti-retroviral therapy must be approved by the study chair prior to entry.
  • Patients with a history of unstable or newly diagnosed angina pectoris, recent myocardial infarction (within 6 months of enrollment) or New York Heart Assoc. class II-IV congestive heart failure.
  • Radiation therapy to \> 50% of marrow producing sites.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Unknown Facility

Johnson City, Tennessee, 37604, United States

Location

Related Publications (1)

  • Journal of Clinical Oncology, 2006 ASCO Annual Meeting Proceedings (Post-Meeting Edition). Vol 24, No 18S (June 20 Supplement), 2006: 13084

    RESULT

MeSH Terms

Conditions

Neoplasms

Interventions

perifosineGemcitabine

Intervention Hierarchy (Ancestors)

Heterocyclic CompoundsDeoxycytidineCytidinePyrimidine NucleosidesPyrimidinesHeterocyclic Compounds, 1-Ring

Study Officials

  • Robert Birch, Ph.D.

    Keryx / AOI Pharmaceuticals, Inc.

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

November 10, 2006

First Posted

November 14, 2006

Study Start

August 1, 2004

Study Completion

January 1, 2006

Last Updated

February 13, 2014

Record last verified: 2007-01

Locations

US(1)