abbv-744 in patients with aml - abbvie oncology · to learn more about these studies, please visit...

1
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=20 Dose Escalation N=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

Upload: others

Post on 11-Oct-2020

1 views

Category:

Documents


0 download

TRANSCRIPT

Page 1: ABBV-744 in Patients with AML - AbbVie Oncology · To learn more about these studies, please visit httpslinicalrials.gov or email abbvieclinicaltrialsabbvie.co ©2018 AbbVie Inc

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