18 and older, any sex, with Myelogenous Leukemia, Acute or Leukemia, Lymphocytic, Acute. Patients with the condition only — healthy volunteers not accepted.
Results — posted to ClinicalTrials.gov
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
Number of Participants Who Experienced a Dose-limiting Toxicity (DLT)Primary· Throughout Cycle 1 (Up to 6 weeks)
Toxicity was assessed according to the Common Terminology Criteria for Adverse Events version 3.0 (CTCAE v 3.0). DLTs in Cycle 1 consisted of any of the following: 1) Selected Grade 4 drug-related nonhematologic toxicities, 2) Selected Grade 3 drug-related nonhematologic toxicities that do not resolve to ≤ Grade 2 within 48 hours: Neurotoxicity of any duration, Nephrotoxicity of any duration, QT interval corrected by Fridericia (QTcF) prolongation of any duration, 3) Inability to administer Day 10 cytarabine therapy due to ongoing, uncontrolled serious or life-threatening toxicity. The number
Group
Value
95% CI
MK-8776 10 mg/m^2 + Cytarabine 2 g/m^2
0
MK-8776 20 mg/m^2 + Cytarabine 2 g/m^2
0
MK-8776 40 mg/m^2 + Cytarabine 2 g/m^2
0
MK-8776 56 mg/m^2 + Cytarabine 2 g/m^2
0
MK-8776 140 mg + Cytarabine 2 g/m^2
3
Number of Participants Who Experienced an Adverse Event (AE)Primary· Up to 45 days after last dose of study treatment (Up to 180 days)
An AE was defined as any untoward medical occurrence in a participant administered a study treatment and which does not necessarily have to have a causal relationship with this treatment. An AE can be any unfavorable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporally associated with the use of a study treatment, whether or not considered related to this study treatment. The number of participants who experienced an AE is summarized.
Group
Value
95% CI
MK-8776 10 mg/m^2 + Cytarabine 2 g/m^2
3
MK-8776 20 mg/m^2 + Cytarabine 2 g/m^2
3
MK-8776 40 mg/m^2 + Cytarabine 2 g/m^2
6
MK-8776 56 mg/m^2 + Cytarabine 2 g/m^2
6
MK-8776 140 mg + Cytarabine 2 g/m^2
6
Number of Participants Who Discontinued Study Treatment Due to an AEPrimary· Up to 135 days
An AE was defined as any untoward medical occurrence in a participant administered a study treatment and which does not necessarily have to have a causal relationship with this treatment. An AE can be any unfavorable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporally associated with the use of a study treatment, whether or not considered related to this study treatment. The number of participants who discontinued study treatment due to an AE is summarized.
Group
Value
95% CI
MK-8776 10 mg/m^2 + Cytarabine 2 g/m^2
0
MK-8776 20 mg/m^2 + Cytarabine 2 g/m^2
0
MK-8776 40 mg/m^2 + Cytarabine 2 g/m^2
0
MK-8776 56 mg/m^2 + Cytarabine 2 g/m^2
0
MK-8776 140 mg + Cytarabine 2 g/m^2
0
Adverse events — posted to ClinicalTrials.gov
Time frame: Up to 45 days after last dose of study treatment (Up to 180 days).
Reporting threshold: 5%.
Adverse-event reports describe events observed during the trial — not all are caused by the drug.
MK-8776 10 mg/m^2 + Cytarabine 2 g/m^2
Serious: 0/3 (0%)
Deaths: —
MK-8776 20 mg/m^2 + Cytarabine 2 g/m^2
Serious: 0/3 (0%)
Deaths: —
MK-8776 40 mg/m^2 + Cytarabine 2 g/m^2
Serious: 1/6 (17%)
Deaths: —
MK-8776 56 mg/m^2 + Cytarabine 2 g/m^2
Serious: 2/6 (33%)
Deaths: —
MK-8776 140 mg + Cytarabine 2 g/m^2
Serious: 1/6 (17%)
Deaths: —
Serious adverse events (12 terms)
Reaction
System
MK-8776 10 mg/m^2 + Cytara…
MK-8776 20 mg/m^2 + Cytara…
MK-8776 40 mg/m^2 + Cytara…
MK-8776 56 mg/m^2 + Cytara…
MK-8776 140 mg + Cytarabin…
FEBRILE NEUTROPENIA
Blood and lymphatic system disorders
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GASTRITIS
Gastrointestinal disorders
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NAUSEA
Gastrointestinal disorders
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VOMITING
Gastrointestinal disorders
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FUNGAL INFECTION
Infections and infestations
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PNEUMONIA
Infections and infestations
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PNEUMONIA FUNGAL
Infections and infestations
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SUBDURAL HAEMATOMA
Injury, poisoning and procedural complications
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HEADACHE
Nervous system disorders
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RENAL FAILURE ACUTE
Renal and urinary disorders
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PULMONARY OEDEMA
Respiratory, thoracic and mediastinal disorders
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HYPERTENSION
Vascular disorders
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—
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—
Other adverse events (164 terms — click to expand)
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.
Publications & conference data
8 peer-reviewed publications reference this trial (live from Europe PMC):
NCT00779584 — A Dose-escalation Study of MK-8776 (SCH 900776) With and Without Gemcitabine in Participants With Solid Tumors or Lympho
· Phase 1
· completed
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Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Merck Sharp & Dohme LLC
Last refreshed: 27 August 2018
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT00907517.