Study Evaluating MST-997 in Advanced Malignant Solid Tumors

Condition(s) targeted: Neoplasms

Intervention: MST-997 (Drug)

Phase: Phase 1

Status: Terminated

Sponsored by: Wyeth

Official(s) and/or principal investigator(s):
Medical Monitor, MD, Study Director, Affiliation: Wyeth

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.

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

Study design: Treatment, Non-Randomized, Open Label, Uncontrolled, Factorial Assignment, Safety Study

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

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

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.

Criteria:

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)

New York, New York 10016, United States

Cleveland, Ohio 44195, United States

Nashville, Tennessee 37232, United States

Last updated: December 7, 2006