Study Evaluating TTI-237 in Advanced Malignant Solid Tumors

Neoplasms Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00195247
• Other study ID #: 3162K1-101
• Status: Terminated
• Phase: Phase 1
• First received: September 12, 2005
• Last updated: March 22, 2007
• Start date: May 2005

Study information

• Verified date: March 2007
• Source: Wyeth is now a wholly owned subsidiary of Pfizer
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Other known NCT identifiers

• NCT00112814

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 45
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety Study, Intervention Model: Factorial Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Neoplasms

Intervention

Drug:
• TTI-237

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Wyeth is now a wholly owned subsidiary of Pfizer

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Preliminary pharmacokinetics (cycle 1 only) and anti-tumor activity of TTI-237 (approximately every 8 weeks).