Home
Search
Study Topics
Glossary
|
|
|
|
|
|
Sponsored by: |
S*BIO |
---|---|
Information provided by: | S*BIO |
ClinicalTrials.gov Identifier: | NCT00741234 |
This is an open label, dose escalation study with 2 arms (Arm A and Arm B). Arm A will assess the safety and tolerability of escalating doses of SB939 in cohorts of patients with advanced solid tumors. Arm B will assess the safety and tolerability of escalating doses in cohorts of patients with advanced hematologic malignancies.
Condition | Intervention | Phase |
---|---|---|
Solid Tumors Hematologic Malignancies |
Drug: SB939 |
Phase I |
Study Type: | Interventional |
Study Design: | Treatment, Non-Randomized, Open Label, Uncontrolled, Parallel Assignment, Safety Study |
Official Title: | A Phase I Dose Escalation Study of Oral SB939 When Administered Thrice Weekly (Every Other Day) for 3 Weeks in a 4-Week Cycle in Patients With Advanced Malignancies |
Estimated Enrollment: | 60 |
Study Start Date: | April 2007 |
Estimated Study Completion Date: | December 2009 |
Estimated Primary Completion Date: | December 2008 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
---|---|
A: Experimental
Advanced solid tumors
|
Drug: SB939
The starting dose of SB939 will be 10 mg every other day three times a week in a 4-week cycle. Each 4-week cycle consists of three weeks treatment of SB939 followed by a one week rest period.
|
B: Experimental
Advanced hematologic malignancies
|
Drug: SB939
The starting dose of SB939 will be 10 mg every other day three times a week in a 4-week cycle. Each 4-week cycle consists of three weeks treatment of SB939 followed by a one week rest period.
|
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
United States, Texas | |
MD Anderson Cancer Center | Recruiting |
Houston, Texas, United States, 77030 | |
Contact: Moneida Holmes 713-792-0850 moholmes@mdanderson.org | |
Principal Investigator: Guillermo Garcia-Manero, MD | |
United States, Wisconsin | |
University of Wisconsin-Madison | Recruiting |
Madison, Wisconsin, United States, 53792 | |
Contact: Jeffrey D. Bozeman 608-263-6222 jb10@medicine.wisc.edu | |
Contact: Jennifer Heideman | |
Principal Investigator: George Wilding, M.D. | |
Singapore | |
National University Hospital | Recruiting |
Singapore, Singapore, 119074 | |
Contact: Elaine Seah (65)6772-4628 zhu_hui_seah@nuh.com.sg | |
Contact: Lin Htike Zin (65) 6722 4618 Lin_Htike_ZIN@nuh.com.sg | |
Principal Investigator: Boon Cher Goh, M.D. | |
National Cancer Center | Recruiting |
Singapore, Singapore, 160610 | |
Contact: Emily Lin (65) 6436 8411 ctelsa@nccs.com.sg | |
Contact: Noryati A Rahman (65) 6436 8256 nctnor@nccs.com.sg | |
Principal Investigator: Han Chong Toh, M.D. | |
Singapore General Hospital | Recruiting |
Singapore, Singapore, 169608 | |
Contact: Chee Keong Wong (65) 6321 4627 wong.chee.keong01@sgh.com.sg | |
Principal Investigator: Charles Chuah, M.D. |
Principal Investigator: | George Wilding, M.D. | University of Wisconsin, Madison |
Principal Investigator: | Boon Cher Goh, M.D. | National University Hospital, Singapore |
Principal Investigator: | Han Chong Toh, M.D. | National Cancer Center |
Principal Investigator: | Charles Chuah, M.D. | Singapore General Hospital |
Principal Investigator: | Guillermo Garcia-Manero, MD | M.D. Anderson Cancer Center |
Responsible Party: | S*BIO PTE LTD ( Joy Zhu, M.D., Ph.D., Senior Vice President, Global Clinical Development ) |
Study ID Numbers: | SB939-2006-001 |
Study First Received: | August 22, 2008 |
Last Updated: | December 5, 2008 |
ClinicalTrials.gov Identifier: | NCT00741234 |
Health Authority: | United States: Food and Drug Administration; Singapore: Health Sciences Authority |
SB939 Solid malignancies Hematologic malignancies HDAC inhibitor Refractory to standard therapy |
Hematologic Neoplasms Hematologic Diseases |
Neoplasms Neoplasms by Site |