A Study Evaluating the Safety and Pharmacokinetics of ABBV-075 in Subjects With Cancer



Status:Active, not recruiting
Conditions:Breast Cancer, Lung Cancer, Prostate Cancer, Cancer, Cancer, Cancer, Cancer, Blood Cancer, Lymphoma, Hematology
Therapuetic Areas:Hematology, Oncology
Healthy:No
Age Range:18 - Any
Updated:2/17/2019
Start Date:April 14, 2015
End Date:October 22, 2019

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A Phase 1 Study Evaluating the Safety and Pharmacokinetics of ABBV-075 in Subjects With Advanced Cancer

This is a Phase 1, first-in-human, dose escalation study in participants with advanced solid
tumors to determine the pharmacokinetics, maximum tolerated dose and the recommended Phase 2
dose of ABBV-075 at different monotherapy dosing schedules. In addition the study will
evaluate the safety. tolerability and the pharmacokinetics of ABBV-075 monotherapy or
combination therapy in disease specific expansion cohorts.


Inclusion Criteria:

1. Participant in the dose escalation cohorts must have histological confirmation of
locally advanced or metastatic solid tumor that is either refractory after standard of
care therapy for the disease or for which standard of care therapy or does not exist.

2. Participants in the expansion cohorts must have histological confirmation of AML,
Multiple Myeloma, breast cancer, NSCLC, prostate cancer, SCLC, or NHL that is either
refractory after standard of care therapy or for which standard of care therapy does
not exist.

3. Participant must have an Eastern Cooperative Oncology Group (ECOG) Performance status
of: 0 - 1 (dose escalation cohorts) or 0 - 2 (expansion cohorts)

4. Participants in the dose escalation cohort must have a serum albumin of ≥ 3.2 g/dL at
screening.

5. Adequate bone marrow, renal, and hepatic function.

6. QTc interval < 480 milliseconds (msec) on the baseline electrocardiogram.

Exclusion Criteria:

1. Participant has untreated brain or meningeal metastases.

2. Participant has received anti-cancer therapy including chemotherapy, immunotherapy,
biologic or any investigational therapy within a period of 21 days prior to Study Day
1.

3. Participant has active peptic ulcer disease or other hemorrhagic
esophagitis/gastritis.

4. Symptoms of gross hematuria or gross hemoptysis.

5. Exhibits symptomatic or persistent, uncontrolled hypertension (BP > or = to 140 and/or
diastolic pressure of > or = to 90 mm Hg).

6. History of long QT syndrome.

7. Peripheral neuropathy greater than or equal to grade 2.
We found this trial at
10
sites
Chicago, Illinois 60637
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Chicago, IL
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Dallas, TX
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Duarte, California 91010
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Duarte, CA
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2301 Erwin Road
Durham, North Carolina 27710
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Durham, NC
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Houston, Texas 77030
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Houston, TX
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Houston, TX
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340 West 10th Street
Indianapolis, Indiana 46202
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Indianapolis, IN
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New Haven, Connecticut 06510
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New Haven, CT
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Sacramento, California 95817
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Sacramento, CA
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Scottsdale, Arizona 85258
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Scottsdale, AZ
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