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Study Evaluating MST-997 in Advanced Malignant Solid Tumors

Last updated on May 11, 2018

FOR MORE INFORMATION
Study Location
New York, New York, 10016 United States
Contact
1-800-718-1021
Eligibility criteria
Condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Neoplasms
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
18+ years
Inclusion criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

- 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
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details

- 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)

NCT00088647
Pfizer
Terminated
Study Evaluating MST-997 in Advanced Malignant Solid Tumors

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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.
Not Provided
Interventional
Phase 1
Allocation: Non-Randomized
Intervention Model: Factorial Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Neoplasms
Drug: MST-997
Not Provided
Not Provided


*   Includes publications given by the data provider as well as publications
identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Terminated
Not Provided
Not Provided
Not Provided

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)
Sexes Eligible for Study: All
18 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT00088647
3161K1-100
Not Provided
Not Provided
Not Provided
Not Provided
Wyeth is now a wholly owned subsidiary of Pfizer
Not Provided
Study Director: Medical Monitor, MD Wyeth is now a wholly owned subsidiary of Pfizer
Wyeth is now a wholly owned subsidiary of Pfizer
December 2006

ICMJE     Data element required by the

International Committee of Medical Journal Editors
and the
World Health Organization ICTRP

FOR MORE INFORMATION

Contact a representative by phone, email, or visiting thte study website. To get updates and notications about this trail, sign up using the form below.

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1-800-718-1021

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[email protected]



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