Study of Perifosine + Capecitabine for Colon Cancer Patients

AEterna Zentaris

Status and phase

Completed

Phase 1

Conditions

Colon Cancer

Treatments

Drug: Capecitabine

Drug: Perifosine

Study type

Interventional

Funder types

Other

Industry

Identifiers

NCT01048580

Perifosine 141

Details and patient eligibility

About

This is a Phase I study of Perifosine + Capecitabine for patients with advanced colon cancer.

Full description

This study is a Phase I trial. A total of 3 - 9 patients will be enrolled. Three patients will initially be enrolled. There will be no dose escalation in this study as only one dose for perifosine (50 mg) in combination with one dose of capecitabine (1000 mg/m2 BID) will be evaluated. The maximum tolerated dose (MTD) is defined in which fewer than 33% of patients experienced DLT attributable to the study drug(s), when at least six patients have been treated at that dose and are evaluable for toxicity. Pharmacokinetic (PK) data will also be evaluated from all enrolled patients.

Enrollment

10 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Patients with 3rd line or > metastatic colon cancer
Patients must have received or not be candidates for regimens containing 5- FU, oxaliplatin, irinotecan, bevacizumab, and cetuximab or panitumumab
No prior exposure to perifosine
Adequate bone marrow, liver, and renal function
Patients must have at least one measurable lesion
Patients must agree to have extra blood drawn for PK analyses

Exclusion criteria

Patients with prior exposure to perifosine.
Patients 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).
Patients with known dipyrimidine dehydrogenase (DPD) deficiency or prior severe reaction to 5-FU.
Patients with known central nervous system CNS metastases.
Patients with known HIV, Hepatitis B, or Hepatitis C seropositivity.
Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection and psychiatric illness/social situations that would limit compliance with study requirements.
Patients with a history of unstable or newly diagnosed angina pectoris, recent myocardial infarction (within 6 months of enrollment), or New York Heart Association class II-IV congestive heart failure.
Female patients who are pregnant or lactating are ineligible.