A Study Evaluating the Safety and Pharmacokinetics of ABBV-744 in Subjects With Advanced Prostate Cancer (CRPC) and Relapsed/Refractory Acute Myeloid Leukemia (AML) Cancer
This is an open-label, Phase 1, dose-escalation (Segment 1) and expansion (Segment 2) study to determine the maximum tolerated dose (MTD) and the recommended phase two dose (RPTD), and to assess the safety, preliminary efficacy, and pharmacokinetic (PK) profile of ABBV-744 for participants with metastatic Castrate Resistant Prostate Cancer (CRPC) and relapsed/refractory Acute Myeloid Leukemia (AML).
June 29, 2018
Cancer (Hematology) - Acute Myeloid Leukemia,
Cancer - Prostate,
Raya Mawad, MD
Swedish Cancer Institute
|Ages Eligible for Study:
||18 Years and older (Adult, Older Adult)
|Sexes Eligible for Study:
|Accepts Healthy Volunteers:
- Participant must have metastatic CRPC or AML not amenable to curative therapy, refractory to standard of care therapy or for which standard of care therapy does not exist. Participants with AML who are candidates for stem cell transplantation must have been offered this therapeutic option. Must meet additional criteria specific for each diagnosis, metastatic CRPC and relapsing/remitting AML, as described in the protocol.
- Must consent to provide biomarker analyses as described in the protocol.
- Must have an Eastern Cooperative Oncology Group (ECOG) Performance status of:
- Dose Escalation (Segment 1): 0 - 1
- Dose Expansion (Segment 2): 0 - 2
- Dose Escalation: Must have a serum albumin during Screening of >= 3.2 g/dL.
- Participant has adequate bone marrow, renal and hepatic function.
- Participant has untreated brain or meningeal metastases.
- Participant has received anti-cancer traditional medicine or anti-cancer herbal remedies within 14 days prior to ABBV-744 dosing. Saw palmetto is considered anti-cancer herbal remedy. Participant with CRPC who has received anti-cancer therapy including chemotherapy, immunotherapy, radiotherapy, biologic or any investigational therapy within a period of 21 days prior to Study Day 1. Participant with AML has received anti-cancer therapy within a period of 14 days or 5 half-lives (whichever is longer; except for immunotherapy where a period of 21 days will be acceptable) prior to Study Day 1. Except for hydroxyurea which will be allowed during screening and treatment for controlling leukocytosis for AML subjects.
- Participant has been previously treated with a Bromodomain and Extra-Terminal (BET) inhibitor
- Participant has unresolved clinically significant toxicities from most recent prior anti-cancer therapy, defined as any Common Terminology Criteria for Adverse Events (CTCAE v 4.03) grade 2 or higher clinically significant toxicity (excluding alopecia).
- Participant has received the following within 7 days prior to the first dose of study drug: corticosteroid therapy, CYP3A inhibitors, CYP3A inducers.
- Participant consumed grapefruit or grapefruit products within 3 days prior to the first dose of study drug.
- Participant had major surgery within 28 days prior to Study Day 1.
- Participant is unable to swallow or absorb oral tablets.
- Participant has known infection with hepatitis B or hepatitis C.
- Participant has active peptic ulcer disease or other hemorrhagic esophagitis/gastritis, enteritis, colitis.
- Participant has symptoms of gross hematuria or gross hemoptysis
- Has electrocardiogram with a QT interval corrected for heart rate using Fridericia's formula (QTcF) > 470 msec or ECG with second degree type 2 or third degree atrioventricular block.