Home
Search
Study Topics
Glossary
|
|
|
|
|
Sponsored by: |
Millennium Pharmaceuticals, Inc. |
---|---|
Information provided by: | Millennium Pharmaceuticals, Inc. |
ClinicalTrials.gov Identifier: | NCT00830869 |
This is an open-label, multicenter, phase 1, dose escalation study of MLN9708. The primary purpose of this study is to determine the safety profile, establish the maximum tolerated dose, and inform the phase 2 dose of MLN9708 administered intravenously in patients with nonhematologic malignancies.
Condition | Intervention | Phase |
---|---|---|
Advanced Non-Hematologic Malignancies |
Drug: MLN9708 |
Phase I |
Study Type: | Interventional |
Study Design: | Treatment, Open Label, Single Group Assignment |
Official Title: | An Open-Label, Dose Escalation, Phase 1 Study of MLN9708, a Second-Generation Proteasome Inhibitor, in Adult Patients With Advanced Nonhematologic Malignancies |
Estimated Enrollment: | 74 |
Study Start Date: | March 2009 |
Estimated Study Completion Date: | December 2010 |
Estimated Primary Completion Date: | November 2010 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
---|---|
1: Experimental
MLN9708
|
Drug: MLN9708
All patients will receive MLN9708 IV injection on Days 1, 4, 8, and 11 of each treatment cycle followed by a rest period of 10 days. The first stage of the study will be initiated at a starting dose of 0.125 mg/m2 Subsequent doses will increase until a maximum tolerated dose (MTD) is established. |
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Each patient must meet all of the following inclusion criteria to be enrolled in the study:
Female patients who are post menopausal, surgically sterile, or agree to practice 2 effective methods of contraception or abstain from heterosexual intercourse.
Male patients who agree to to practice 2 effective methods of contraception or abstain from heterosexual intercourse.
Adequate blood and chemistry values during the screening period:
Exclusion Criteria:
Patients meeting any of the following exclusion criteria are not to be enrolled in the study:
Contact: For an updated listing of recruitment sites contact: Millennium Medical and Drug Information Center | 1-866-835-2233 | medical@mlnm.com |
United States, Florida | |
H. Lee Moffitt Cancer Center and Research | Recruiting |
Tampa, Florida, United States, 33612-9497 | |
United States, Tennessee | |
Sarah Cannon Cancer Center | Recruiting |
Nashville, Tennessee, United States, 37203 |
Study Director: | Medical Monitor | Millennium Pharmaceuticals, Inc. |
Responsible Party: | Millennium Pharmaceuticals, Inc. ( Clinical Research Monitor ) |
Study ID Numbers: | C16001 |
Study First Received: | January 26, 2009 |
Last Updated: | March 26, 2009 |
ClinicalTrials.gov Identifier: | NCT00830869 History of Changes |
Health Authority: | United States: Food and Drug Administration |
Neoplasms |