Home
Search
Study Topics
Glossary
|
|
|
|
|
|
Sponsored by: |
ZIOPHARM |
---|---|
Information provided by: | ZIOPHARM |
ClinicalTrials.gov Identifier: | NCT00608803 |
The study of safety of ZIO-201-T in combination with doxorubicin in the treatment of advanced cancer.
Condition | Intervention | Phase |
---|---|---|
Advanced Cancer |
Drug: ZIO-201-T and doxorubicin |
Phase I |
Study Type: | Interventional |
Study Design: | Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety Study |
Official Title: | A Phase I Study of ZIO-201-T in Combination With Doxorubicin in Subjects With Advanced, Refractory Solid Tumors for Which no Standard Therapy Exists and for Whom Treatment With Doxorubicin is Considered Medically Acceptable |
Estimated Enrollment: | 30 |
Study Start Date: | January 2008 |
Estimated Study Completion Date: | July 2009 |
Estimated Primary Completion Date: | July 2009 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
---|---|
Single arm: Experimental
Once the maximum tolerated dose (MTD) is determined, an expanded cohort of 20 subjects with advanced, ifosfamide and doxorubicin naive soft-tissue sarcoma subjects will be dosed at the MTD and evaluated for efficacy.
|
Drug: ZIO-201-T and doxorubicin
ZIO-201-T given for 3 consecutive days every 3 weeks. Doxorubicin is given once every 3 weeks. This is a dose escalation arm.
|
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
United States, California | |
Santa Monica, California, United States, 90403 | |
United States, Texas | |
Houston, Texas, United States, 77024 |
Study Director: | Giovanni Abbadessa, MD | ZIOPHARM Oncology, Inc. |
Responsible Party: | ZIOPHARM Oncology, Inc. ( Jon Lewis, Chief Medical Officer ) |
Study ID Numbers: | IPM1002 |
Study First Received: | January 22, 2008 |
Last Updated: | August 25, 2008 |
ClinicalTrials.gov Identifier: | NCT00608803 |
Health Authority: | United States: Food and Drug Administration |
Doxorubicin |
Antineoplastic Agents Therapeutic Uses Antibiotics, Antineoplastic Pharmacologic Actions |