Basic Trial Information
Trial Description
     Summary
     Eligibility Criteria
Trial Contact Information

Basic Trial Information

Phase Type Status Age Sponsor Protocol IDs Phase I Treatment Closed 18 and over Pharmaceutical / Industry 3160A1-100 NCT00195260

Trial Description

Summary

To evaluate the safety and tolerability of oral SKI-606 administered on a daily schedule to subjects with advanced malignant solid tumors and to define a maximum tolerated dose (MTD) in this subject population.

Eligibility Criteria

Inclusion Criteria:

• Advanced or recurrent solid malignancy confirmed histologically or cytologically for which no effective therapy is available

• Eastern Cooperative Oncology Group (ECOG) performance status of 0 - 1

• Measurable disease as outlined by the modified Response Evaluation Criteria in Solid Tumors (RECIST) criteria (Attachment 3)

Other inclusion applies

Exclusion Criteria:

• Use of any systemic antitumor agents or any investigational agent within 28 days before the first dose of test article is administered

• Prior exposure to SKI-606 or any other Src-kinase inhibitor, major surgery or radiotherapy within 14 days before the first dose of test article (recovery from previous surgery should be complete before day 1)

• Active central nervous system (CNS) metastases, as indicated by clinical symptoms, cerebral edema, requirement for corticosteroids and/or progressive growth (Treated CNS metastases must be stable for ≥2 weeks before day 1).

Other exclusion applies.

Trial Contact Information

Trial Lead Organizations/Sponsors

Wyeth Research

Medical Monitor

Study Director

Link to the current ClinicalTrials.gov record.
NLM Identifer NCT00195260
Information obtained from ClinicalTrials.gov on July 16, 2008