Trials / Terminated
TerminatedNCT00798213
SCH 727965 in Patients With Acute Myelogenous Leukemia and Acute Lymphoblastic Leukemia (P04717AM2)(TERMINATED)
A Phase 2 Study of SCH 727965 in Subjects With Relapsed and Refractory Acute Myelogenous Leukemia and Acute Lymphoblastic Leukemia
- Status
- Terminated
- Phase
- Phase 2
- Study type
- Interventional
- Enrollment
- 29 (actual)
- Sponsor
- Merck Sharp & Dohme LLC · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
Participants with acute myelogenous leukemia (AML) will be randomized to SCH 727965 or gemtuzumab ozogamicin. All participants with acute lymphoblastic leukemia (ALL) will receive SCH 727965. Part 1 of the study will determine the activity of SCH 727965 treatment in participants with AML and participants with ALL. Part 2 of the study will determine the activity of SCH 727965 treatment in participants with AML who experienced disease progression after standard treatment with gemtuzumab ozogamicin during Part 1.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | SCH 727965 | SCH 727965 50 mg/m2 IV on Day 1 of each 21 day cycle until disease progression. |
| DRUG | Gemtuzumab ozogamicin | Gemtuzumab ozogamicin 9 mg/m2 IV on Day 1 and Day 15. |
Timeline
- Start date
- 2009-01-01
- Primary completion
- 2010-04-01
- Completion
- 2010-04-01
- First posted
- 2008-11-26
- Last updated
- 2015-02-04
Source: ClinicalTrials.gov record NCT00798213. Inclusion in this directory is not an endorsement.