A Phase 1 Dose Escalation Study of TTI-237 Administered Intravenously Every 3 Weeks in Subjects With Advanced Malignant Solid Tumors

Study Evaluating TTI-237 in Advanced Malignant Solid Tumors

Sponsors

Lead sponsor: Wyeth is now a wholly owned subsidiary of Pfizer

Source Wyeth is now a wholly owned subsidiary of Pfizer
Brief Summary

The purpose of this study is to evaluate the safety, tolerability, and maximum tolerated dose (MTD) of TTI-237 for the treatment of subjects with advanced malignant solid tumors.

Overall Status Terminated
Start Date May 2005
Phase Phase 1
Study Type Interventional
Primary Outcome
Measure Time Frame
Primary purpose is to address the safety and tolerability of TTI-237. Patient will be assessed on an ongoing basis during their participation on the trial.
Secondary Outcome
Measure Time Frame
Preliminary pharmacokinetics (cycle 1 only) and anti-tumor activity of TTI-237 (approximately every 8 weeks).
Enrollment 45
Condition
Intervention

Intervention type: Drug

Intervention name: TTI-237

Eligibility

Criteria:

Inclusion Criteria:

- Documented diagnosis of malignant solid tumor with measurable disease

- Life expectancy of at least 12 weeks

- ECOG performance status of 0, 1, or 2

Exclusion Criteria:

- Recent major surgery, radiation therapy or anti-cancer treatment

- History of any other prior malignancy within the last 5 years

Gender: All

Minimum age: 18 Years

Maximum age: N/A

Healthy volunteers: No

Overall Official
Last Name Role Affiliation
Medical Monitor Study Director Wyeth is now a wholly owned subsidiary of Pfizer
Location
facility
| Scottsdale, Arizona, 85016, United States
| Los Angeles, California, 90095, United States
| Baltimore, Maryland, 21231, United States
Location Countries

United States

Verification Date

March 2007

Keywords
Condition Browse
Study Design Info

Allocation: Non-Randomized

Intervention model: Factorial Assignment

Primary purpose: Treatment

Masking: None (Open Label)

Source: ClinicalTrials.gov