Study Evaluating SKI-606 in Subject With Solid Tumors

October 26, 2009 updated by: Wyeth is now a wholly owned subsidiary of Pfizer

Phase 1 Does-escalation Study of Oral SKI-606 in Subjects With Advanced Malignant Solid Tumors

The purpose of this study is to evaluate the safety and tolerability of oral SKI-606 (100, 200, 300 or 400 mg) administered on a daily schedule to subjects with advanced malignant solid tumors and to define a maximum tolerated dose (MTD) in this subject population. This study will also obtain preliminary information on the pharmacokinetics and antitumor activity of orally administered SKI-606 in subjects with advanced malignant solid tumors

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

28

Phase

  • Phase 1

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years to 74 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  1. Advanced or recurrent solid malignancy confirmed histologically or cytologically for which no effective therapy is available
  2. Recovery from acute adverse effects of prior therapies to £ Grade 1 (excluding alopecia)
  3. Eastern Cooperative Oncology Group (ECOG) performance status of 0 - 1
  4. Adequate hepatic, renal, and bone marrow function
  5. Age 20 to 74 years
  6. Willingness of male and female subjects, who are not surgically sterile or postmenopausal, to use reliable methods of birth control for the duration of the study and for 6 months and 30 days after the last dose of test article for male and female, respectively
  7. Life expectancy of at least 12 weeks

Exclusion Criteria:

  1. Use of any systemic antitumor agents or any investigational agent within 28 days before the enrollment (42 days if the previous chemotherapy included nitrosoureas or mitomycin C)
  2. Ongoing clinical requirement for administration of a strong inhibitor of CYP3A4
  3. Prior exposure to SKI-606 or any other Src-kinase inhibitor
  4. Major surgery or radiotherapy within 2 weeks before the enrollment (recovery from previous surgery should be complete before day 1)
  5. Subjects unable or unwilling to swallow SKI-606 capsules
  6. Active central nervous system (CNS) metastases, as indicated by clinical symptoms, cerebral edema, requirement for corticosteroids and/or progressive growth
  7. Recent or ongoing clinically-significant gastrointestinal disorder
  8. Pregnant or breastfeeding women

  9. Subjects who meet the following criteria:

    • Evidence of serious active infection, significant medical or psychiatric illness
    • History of unexplained syncope or known ventricular arrythmia
    • Known seropositivity to HIV, or current or chronic Hepatitis B or Hepatitis hepatitis C
    • Hypokalemia
    • Unstable concurrent medical conditions
    • Any other condition that, in the investigator's judgment, make the subject inappropriate for this study the subject inappropriate for this study

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 1
Drug: SKI-606

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Safety as measured by AE information. Tolerability as measured by DLT observation.
Time Frame: 2 years
2 years

Secondary Outcome Measures

Outcome Measure
Time Frame
Pharmacokinetics as measured by Taylor Technology Antitumor activity as measured by RECIST
Time Frame: 2 years
2 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Wyeth is now a wholly owned subsidiary of Pfizer

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2006

Primary Completion (Actual)

December 1, 2008

Study Completion (Actual)

December 1, 2008

Study Registration Dates

First Submitted

October 26, 2009

First Submitted That Met QC Criteria

October 26, 2009

First Posted (Estimate)

October 27, 2009

Study Record Updates

Last Update Posted (Estimate)

October 27, 2009

Last Update Submitted That Met QC Criteria

October 26, 2009

Last Verified

October 1, 2009

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 3160A1-102

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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