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Study of Perifosine + Capecitabine for Colon Cancer Patients

This study has been completed.
Sponsor:
Collaborator:
SCRI Development Innovations, LLC
Information provided by (Responsible Party):
AEterna Zentaris
ClinicalTrials.gov Identifier:
NCT01048580
First received: January 9, 2010
Last updated: February 14, 2014
Last verified: November 2011
  Purpose

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


Condition Intervention Phase
Colon Cancer
Drug: Perifosine + Capecitabine
Phase 1

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Phase I Study of Perifosine + Capecitabine for Patients With Advanced Colon Cancer

Resource links provided by NLM:


Further study details as provided by AEterna Zentaris:

Primary Outcome Measures:
  • Safety. Determination of maximum tolerated dose. [ Time Frame: Every 3 weeks ] [ Designated as safety issue: Yes ]

Enrollment: 10
Study Start Date: October 2009
Study Completion Date: October 2011
Primary Completion Date: May 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Arm 1
Perifosine 50 mg qd + Capecitabine 1000 mg/m2 BID x 14 days
Drug: Perifosine + Capecitabine
Perifosine 50 mg qd + Capecitabine 1000 mg/m2 BID x 14 days
Other Name: Xeloda

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01048580

Sponsors and Collaborators
AEterna Zentaris
SCRI Development Innovations, LLC
Investigators
Study Chair: Johanna Bendell,, MD SCRI Development Innovations, LLC
  More Information

No publications provided

Responsible Party: AEterna Zentaris
ClinicalTrials.gov Identifier: NCT01048580     History of Changes
Other Study ID Numbers: Perifosine 141
Study First Received: January 9, 2010
Last Updated: February 14, 2014
Health Authority: United States: Food and Drug Administration

Keywords provided by AEterna Zentaris:
Perifosine
Capecitabine
Colon Cancer

Additional relevant MeSH terms:
Colonic Neoplasms
Colonic Diseases
Colorectal Neoplasms
Digestive System Diseases
Digestive System Neoplasms
Gastrointestinal Diseases
Gastrointestinal Neoplasms
Intestinal Diseases
Intestinal Neoplasms
Neoplasms
Neoplasms by Site
Capecitabine
Fluorouracil
Antimetabolites
Antimetabolites, Antineoplastic
Antineoplastic Agents
Immunologic Factors
Immunosuppressive Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Physiological Effects of Drugs
Therapeutic Uses

ClinicalTrials.gov processed this record on November 25, 2014