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 (IV) Once Weekly in Subjects With Advanced Malignant Solid Tumors.

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00195325
• Other study ID #: 3162K1-100
• Status: Terminated
• Phase: Phase 1
• First received: September 12, 2005
• Last updated: March 22, 2007
• Start date: August 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 MTD (maximum tolerated dose) of TTI-237 for the treatment of subjects with advanced malignant solid tumors.

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 (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

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety Study, Intervention Model: Factorial Assignment, Masking: Open Label, Primary Purpose: Educational/Counseling/Training

Related Conditions & MeSH terms

• Neoplasms
• Tumors

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	To determine safety, tolerability, and MTD of TTI-237 - patients are monitored during the duration of their participation on the trial.
Secondary	Preliminary pharmacokinetics (during cycle 1) and anti-tumor activity of TTI-237 (approximately every 8 weeks).