NCT00195325

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.

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
45

participants targeted

Target at P50-P75 for phase_1

Geographic Reach
1 country

3 active sites

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2005

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

September 12, 2005

Completed
7 days until next milestone

First Posted

Study publicly available on registry

September 19, 2005

Completed
Last Updated

March 26, 2007

Status Verified

March 1, 2007

First QC Date

September 12, 2005

Last Update Submit

March 22, 2007

Conditions

TumorsNeoplasms

Keywords

Advanced Malignant Solid Tumors

Outcome Measures

Primary Outcomes (1)

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

Secondary Outcomes (1)

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

Interventions

TTI-237DRUG

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • Recent major surgery, radiation therapy or anti-cancer treatment
  • History of any other prior malignancy within the last 5 years

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

Unknown Facility

Lexington, Kentucky, 40536-0098, United States

Location

Unknown Facility

Cleveland, Ohio, 44195, United States

Location

Unknown Facility

Nashville, Tennessee, 37232-6307, United States

Location

MeSH Terms

Conditions

Neoplasms

Interventions

cevipabulin

Study Officials

  • Medical Monitor

    Wyeth is now a wholly owned subsidiary of Pfizer

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
ECT
Intervention Model
FACTORIAL
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

September 12, 2005

First Posted

September 19, 2005

Study Start

August 1, 2005

Last Updated

March 26, 2007

Record last verified: 2007-03

Locations

US(3)