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Study Evaluating TTI-237 in Advanced Malignant Solid Tumors.

This study has been terminated.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00195325
First Posted: September 19, 2005
Last Update Posted: March 26, 2007
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Wyeth is now a wholly owned subsidiary of Pfizer
  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
Intervention Model: Factorial Assignment
Masking: None (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.

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

Information from the National Library of Medicine

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, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

ClinicalTrials.gov Identifier: NCT00195325     History of Changes
Other Study ID Numbers: 3162K1-100
First Submitted: September 12, 2005
First Posted: September 19, 2005
Last Update Posted: March 26, 2007
Last Verified: March 2007

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

Additional relevant MeSH terms:
Neoplasms