Study Evaluating TTI-237 in Advanced Malignant Solid Tumors.

This study has been terminated.
Sponsor:
Information provided by:
Wyeth is now a wholly owned subsidiary of Pfizer
ClinicalTrials.gov Identifier:
NCT00195325
First received: September 12, 2005
Last updated: March 22, 2007
Last verified: March 2007
  Purpose

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


Condition Intervention Phase
Tumors
Neoplasms
Drug: TTI-237
Phase 1

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety Study
Intervention Model: Factorial Assignment
Masking: Open Label
Primary Purpose: Educational/Counseling/Training
Official Title: A Phase 1 Dose Escalation Study of TTI-237 Administered Intravenously (IV) Once Weekly in Subjects With Advanced Malignant Solid Tumors.

Resource links provided by NLM:


Further study details as provided by Wyeth is now a wholly owned subsidiary of Pfizer:

Primary Outcome Measures:
  • To determine safety, tolerability, and MTD of TTI-237 - patients are monitored during the duration of their participation on the trial.

Secondary Outcome Measures:
  • Preliminary pharmacokinetics (during cycle 1) and anti-tumor activity of TTI-237 (approximately every 8 weeks).

Estimated Enrollment: 45
Study Start Date: August 2005
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Documented diagnosis of malignant solid tumor with measurable disease
  • Life expectancy of at least 12 weeks
  • ECOG (The Eastern Cooperative Oncology Group scale) 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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00195325

Locations
United States, Kentucky
Lexington, Kentucky, United States, 40536-0098
United States, Ohio
Cleveland, Ohio, United States, 44195
United States, Tennessee
Nashville, Tennessee, United States, 37232-6307
Sponsors and Collaborators
Wyeth is now a wholly owned subsidiary of Pfizer
Investigators
Study Director: Medical Monitor Wyeth is now a wholly owned subsidiary of Pfizer
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00195325     History of Changes
Other Study ID Numbers: 3162K1-100
Study First Received: September 12, 2005
Last Updated: March 22, 2007
Health Authority: United States: Food and Drug Administration

Keywords provided by Wyeth is now a wholly owned subsidiary of Pfizer:
Advanced Malignant Solid Tumors

Additional relevant MeSH terms:
Neoplasms

ClinicalTrials.gov processed this record on April 17, 2014