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


Phase 1
18 Years
N/A
Not Enrolling
Both
Neoplasms

Thank you

Trial Information

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


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)

Type of Study:

Interventional

Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety Study, Intervention Model: Factorial Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

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

Principal Investigator

Medical Monitor, MD

Investigator Role:

Study Director

Investigator Affiliation:

Wyeth is now a wholly owned subsidiary of Pfizer

Authority:

United States: Food and Drug Administration

Study ID:

3161K1-100

NCT ID:

NCT00088647

Start Date:

Completion Date:

Related Keywords:

  • Neoplasms
  • advanced malignant solid tumors
  • breast cancer
  • Neoplasms

Name

Location

Albany, New York  12208
Cleveland, Ohio  44195
Nashville, Tennessee  37203-1632