NCT00088647

Brief Summary

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.

Trial Health

35
At Risk

Trial Health Score

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

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

First Submitted

Initial submission to the registry

July 30, 2004

Completed
3 days until next milestone

First Posted

Study publicly available on registry

August 2, 2004

Completed
Last Updated

December 8, 2006

Status Verified

December 1, 2006

First QC Date

July 30, 2004

Last Update Submit

December 7, 2006

Conditions

Neoplasms

Keywords

advanced malignant solid tumorsbreast cancer

Outcome Measures

Primary Outcomes (1)

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

Secondary Outcomes (1)

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

Interventions

MST-997DRUG

Eligibility Criteria

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

You may qualify if:

  • 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)

You may not qualify if:

  • 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)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

Unknown Facility

New York, New York, 10016, United States

Location

Unknown Facility

Cleveland, Ohio, 44195, United States

Location

Unknown Facility

Nashville, Tennessee, 37232, United States

Location

MeSH Terms

Conditions

NeoplasmsBreast Neoplasms

Interventions

MST 997

Condition Hierarchy (Ancestors)

Neoplasms by SiteBreast DiseasesSkin DiseasesSkin and Connective Tissue Diseases

Study Officials

  • Medical Monitor, MD

    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
TREATMENT
Intervention Model
FACTORIAL
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

July 30, 2004

First Posted

August 2, 2004

Last Updated

December 8, 2006

Record last verified: 2006-12

Locations

US(3)