Study Evaluating MST-997 in Advanced Malignant Solid Tumors

A Phase 1 Dose-Escalation Study of Intravenous MST-997 Formulated in Intralipid 20% Administered Weekly in Subjects With Advanced Malignant Solid Tumors

The primary objective of this clinical research study is to evaluate the safety, tolerability, and maximum tolerated dose (MTD) of intravenous (IV) MST-997 formulated in Intralipid 20% administered on a weekly schedule to subjects with advanced malignant solid tumors.

Study Overview

• Status: Terminated
• Conditions: Neoplasms
• Intervention / Treatment: Drug: MST-997

• Study Type: Interventional
• Phase: Phase 1

Contacts and Locations

Study Locations

• United States
  • New York
    • New York, New York, United States, 10016
  • Ohio
    • Cleveland, Ohio, United States, 44195
  • Tennessee
    • Nashville, Tennessee, United States, 37232

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Documented histological or cytological diagnosis confirming the presence of malignant solid tumor
• Tumor progression after conventional therapy for cancer or a malignant solid tumor for which no conventional therapy exists
• Subjects enrolled in the MTD confirmation cohort should have a documented histologic and/or cytologic diagnosis of metastatic breast cancer or non-small cell lung cancer (NSCLC) and should not have received more than 2 prior chemotherapy regimens for metastatic disease (adjuvant and neoadjuvant chemotherapy will not be included in the maximum of 2 prior regimens described above)

Exclusion Criteria:

• Subjects with symptomatic or clinically active central nervous system (CNS) metastases. Subjects who have had prior treatment with radiotherapy or surgical resection for CNS metastases will be permitted if CNS metastases have remained stable and have not required any treatment for at least 3 months prior to first dose of test article
• History of any other primary malignancy with less than 5 years documentation of a disease-free state (Subjects with a history of basal cell or squamous cell carcinomas of the skin or cervical carcinoma in situ, which have been successfully treated, are not excluded)
• Recent major surgery (within 14 days before the first dose) or chemotherapy within 28 days before the first dose of MST-997 (42 days if the previous chemotherapy included nitrosoureas or mitomycin C)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Factorial Assignment
• Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
To evaluate the safety, tolerability and MTD of IV MST-997 throughout patients participation on trial.

Secondary Outcome Measures

Outcome Measure
To obtain preliminary information on the pharmacokinetics (during cycle 1) and antitumor activity of MST-997 (approximately every 8 weeks).

Collaborators and Investigators

• Sponsor: Wyeth is now a wholly owned subsidiary of Pfizer

Study record dates

Study Registration Dates

• First Submitted: July 30, 2004
• First Submitted That Met QC Criteria: July 30, 2004
• First Posted (Estimate): August 2, 2004

Study Record Updates

• Last Update Posted (Estimate): December 8, 2006
• Last Update Submitted That Met QC Criteria: December 7, 2006
• Last Verified: December 1, 2006

More Information

Terms related to this study

• Keywords: breast cancer; advanced malignant solid tumors
• Additional Relevant MeSH Terms: Neoplasms
• Other Study ID Numbers: 3161K1-100