Study of Perifosine + Capecitabine for Colon Cancer Patients

NCT ID: NCT01048580

Last Updated: 2018-06-28

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 10 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2009-10-31
• Study Completion Date: 2011-10-31

Brief Summary

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

Detailed 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.

Conditions

Colon Cancer

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Perifosine +Capecitabine

One cycle of therapy will be defined as 3 weeks (21 days). Perifosine 50 mg qd (Days 1-21) + Capecitabine 1000 mg/m2 BID (Days 1-14).

Group Type: EXPERIMENTAL

Perifosine

Intervention Type: DRUG

Perifosine 50 mg orally once a day (Days 1-21)

Capecitabine

Intervention Type: DRUG

Capecitabine 1000 mg/m2 orally twice per day (Days 1-14)

Interventions

Perifosine

Perifosine 50 mg orally once a day (Days 1-21)

Intervention Type: DRUG

Capecitabine

Capecitabine 1000 mg/m2 orally twice per day (Days 1-14)

Intervention Type: DRUG

Other Intervention Names

D-21266; KRX-0401; Xeloda

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

SCRI Development Innovations, LLC

OTHER

Sponsor Role: collaborator

AEterna Zentaris

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Johanna Bendell,, MD

Role: STUDY_CHAIR

SCRI Development Innovations, LLC

References

Journal of Oncology, 2010 ASCO Annual Meeting Abstracts. Vol. 28, No. 15_suppl (May 20Supplement), 2010:e14086

Reference Type: RESULT

Other Identifiers

Perifosine 141

Identifier Type: -

Identifier Source: org_study_id