Home
Search
Study Topics
Glossary
|
|
|
|
|
|
Sponsors and Collaborators: |
M.D. Anderson Cancer Center Taiho Pharmaceutical Co., Ltd. |
---|---|
Information provided by: | M.D. Anderson Cancer Center |
ClinicalTrials.gov Identifier: | NCT00752011 |
Primary Objectives:
Secondary Objectives:
Condition | Intervention | Phase |
---|---|---|
Cancer Solid Tumors |
Drug: TAS-106 Drug: Carboplatin |
Phase I |
Study Type: | Interventional |
Study Design: | Treatment, Open Label, Single Group Assignment, Safety/Efficacy Study |
Official Title: | Phase I Dose Escalating Study Of Tas-106 In Combination With Carboplatin In Patients With Solid Tumors |
Estimated Enrollment: | 18 |
Study Start Date: | September 2008 |
Estimated Primary Completion Date: | September 2010 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
---|---|
1: Experimental
Day 1 of each 3 week cycle, carboplatin by vein over 60 minutes followed by TAS-106 by vein over 24 hours.
|
Drug: TAS-106
Starting dose of TAS-106 2.0 mg/m^2 administered by vein over 24 hours, Day 1 of 3 Week Cycle
Drug: Carboplatin
Escalating doses, starting target AUC of carboplatin is 4, administered at each individual dose level by vein over 60 minutes, Day 1 of 3 Week Cycle
|
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contact: Aung Naing, MD | 713-563-0181 |
United States, Texas | |
U.T. M.D. Anderson Cancer Center | Recruiting |
Houston, Texas, United States, 77030 |
Principal Investigator: | Aung Naing, MD | U.T. M.D. Anderson Cancer Center |
Responsible Party: | U.T. M.D. Anderson Cancer Center ( Aung Naing, MD/Assistant Professor ) |
Study ID Numbers: | 2007-0623 |
Study First Received: | September 10, 2008 |
Last Updated: | September 11, 2008 |
ClinicalTrials.gov Identifier: | NCT00752011 |
Health Authority: | United States: Food and Drug Administration |
Cancer Solid Tumors Carboplatin |
TAS-106 Antitumor Activity Pharmacokinetics |
Carboplatin |
Antineoplastic Agents Therapeutic Uses Pharmacologic Actions |