abbv-744 in patients with aml - abbvie oncology · to learn more about these studies, please visit...
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To learn more about these studies, please visit https://ClinicalTrials.gov or email [email protected]
©2018 AbbVie Inc. North Chicago, IL 60064 May 2018 Printed in U.S.A.
ABBV-744 is an investigational agent not approved by FDA or any regulatory health agencies. Safety and Efficacy have not been established.
https://clinicaltrials.gov/ct2/show/NCT03360006 (accessed April 2018)
To learn more about our pipeline, please visit www.abbviescience.com/oncology
Phase 1 (M16-415)ABBV-744 in Patients with AML
Endpoints
Primary Endpoints• Dose Limiting Toxicity (AE / DLT) • Maximum Tolerated
Dose / Recommended Phase 2 Dose (MTD / R2PD)
• Pharmacokinetics (PK) Secondary Endpoints• Objective Response Rate (ORR)• Duration of Response (DOR)• Progression-free Survival (PFS)
Key Inclusion Criteria
• AML, relapsed or refractory to standard of care therapy, or for which standard of care therapy does not exist
• ECOG 0-1• Adequate hepatic and
renal function
Key Exclusion Criteria
• Unresolved clinically significant toxicities from previous treatments, e.g., GVHD
• Active CNS disease• History of prolonged QT interval• Active peptic ulcer disease,
esophagitis, gastritis, enteritis, colitis
N=20Dose
EscalationN=20
Dose Expansion
N=TBD
A Phase 1 Study Evaluating the Safety and Pharmacokinetics of ABBV-744 in Subjects With Metastatic Castrate-Resistant Prostate Cancer (CRPC) and Relapsed / Refractory Acute Myeloid Leukemia (AML)
ABBV-US-00003-E