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Study Evaluating TTI-237 in Advanced Malignant Solid Tumors.

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.
ClinicalTrials.gov Identifier: NCT00195325
Recruitment Status : Terminated
First Posted : September 19, 2005
Last Update Posted : March 26, 2007
Sponsor:
Information provided by:

Study Description
Brief Summary:
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 or disease Intervention/treatment Phase
Tumors Neoplasms Drug: TTI-237 Phase 1

Study Design

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 45 participants
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.
Study Start Date : August 2005
Arms and Interventions


Outcome Measures

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

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

Eligibility Criteria

Information from the National Library of Medicine

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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 Posted: September 19, 2005    Key Record Dates
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