Trials / Terminated
TerminatedNCT00907517
Study of SCH 900776 (MK-8776) With and Without Cytarabine in Participants With Acute Leukemias (P05247)
A Phase 1 Dose-Escalation Study of SCH 900776 in Combination With Cytarabine in Subjects With Acute Leukemias (Protocol No. P05247)
- Status
- Terminated
- Phase
- Phase 1
- Study type
- Interventional
- Enrollment
- 24 (actual)
- Sponsor
- Merck Sharp & Dohme LLC · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
This study of SCH 900776 (MK-8776) will evaluate its safety and tolerability when given in combination with cytarabine to participants with acute leukemias. Participants in the Dose-Escalation Part will be enrolled in cohorts that will receive sequentially higher doses of MK-8776 in combination with standard doses of cytarabine. Only one combination treatment cycle of approximately 4 to 6 weeks is anticipated, but participants may receive additional cycles if clinically indicated after discussion between the Investigator and the Sponsor. The recommended combination doses for a Phase 2 trial (RP2D) will be determined based on safety and biological activity. Up to 10 to 15 additional participants will be studied at the combination RP2D.
Conditions
- Myelogenous Leukemia, Acute
- Leukemia, Lymphocytic, Acute
- Leukemia, Lymphoblastic, Acute, Philadelphia-Positive
- Myelogenous Leukemia, Chronic, Aggressive Phase
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | MK-8776 | IV infusion |
| DRUG | Cytarabine | IV infusion |
Timeline
- Start date
- 2009-07-29
- Primary completion
- 2011-06-13
- Completion
- 2011-06-13
- First posted
- 2009-05-22
- Last updated
- 2018-08-27
- Results posted
- 2017-01-25
Source: ClinicalTrials.gov record NCT00907517. Inclusion in this directory is not an endorsement.