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NCT01946074 | COMPLETED | Advanced Solid Tumors

A Study of ABT-165 in Subjects With Solid Tumors
Sponsor:

AbbVie

Brief Summary:

This is a Phase 1/1b open-label study evaluating the safety, pharmacokinetics (PK), and preliminary efficacy of ABT-165 when administered as monotherapy and in combination with paclitaxel or 5-fluoruracil, folinic acid and irinotecan (FOLFIRI) or ABBV-181 with/without paclitaxel in subjects with advanced solid tumors. Enrollment to Cohorts A, B were completed and for Cohorts C and D are recruiting.

Condition or disease

Advanced Solid Tumors

Intervention/treatment

paclitaxel

FOLFIRI

ABT-165

ABBV-181

Phase

PHASE1

Study Type : INTERVENTIONAL
Estimated Enrollment : 101 participants
Masking : NONE
Primary Purpose : TREATMENT
Official Title : A Multicenter, Phase 1/1b, Open-Label, Dose-Escalation Study of ABT-165, a Dual Variable Domain Immunoglobulin in Subjects With Advanced Solid Tumors
Actual Study Start Date : 2013-08-08
Estimated Primary Completion Date : 2022-09-28
Estimated Study Completion Date : 2022-09-28

Information not available for Arms and Intervention/treatment

Ages Eligible for Study: 18 Years to 99 Years
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers:
Criteria
Inclusion Criteria
  • * Subject must have advanced solid tumor that is not amenable to surgical resection or other approved therapeutic options that have demonstrated clinical benefit.
  • * Subject has adequate bone marrow, renal, hepatic and coagulation function.
  • * Subject must have measurable disease per Response Evaluation Criteria In Solid Tumors (RECIST) version 1.1 or disease evaluable by assessment of tumor antigens including but not limited to cancer antigen (CA-125) and prostate-specific antigen (PSA).
  • * Women of childbearing potential must have a negative serum pregnancy test at the screening visit and a negative urine pregnancy test at baseline prior to the first dose of study drug. Female subject considered not of childbearing potential must be documented as being surgically sterile or post-menopausal for at least 1 year. Women of childbearing potential and men must agree to use adequate contraception.
  • * Subjects in the combination therapy cohorts must meet the above inclusion criteria and be eligible to receive paclitaxel or FOLFIRI per most current prescribing information, or at the discretion of the Investigator. Subjects in the combination therapy cohorts who are to receive ABBV-181, an anti-PD1 antibody, must also meet other criteria described in the Protocol.
Exclusion Criteria
  • * Subject has received anticancer therapy including chemotherapy, radiation therapy, immunotherapy, biologic, or any investigational therapy within a period of 21 days or anti-cancer herbal therapy within 7 days prior to Cycle 1 Day 1 of ABT-165.
  • * Subject has uncontrolled metastases to the central nervous system (CNS).
  • * Subject has unresolved clinically significant toxicities from prior anticancer therapy, defined as any Common Terminology Criteria for Adverse Events (CTCAE) Grade 2 or higher.
  • * Subject has history (within previous 5 years) of clinically significant pulmonary hypertension, uncontrolled systemic hypertension or hypertensive crisis, symptomatic heart failure, cardiomyopathy, myocardial infarction, unstable/severe angina pectoris, cardiac arrhythmia requiring medication, coronary/peripheral artery bypass graft, aneurysm or aneurysm repair, angioplasty, cerebrovascular accident, transient ischemic attack or the left ventricular ejection fraction (LVEF) less than 50%.
  • * Subjects enrolled on the combination therapy phase must not meet the above exclusion criteria and must be eligible to receive paclitaxel or FOLFIRI per most current prescribing information, or at the discretion of the Investigator. Subjects receiving ABBV-181 must not meet other exclusion criteria described in the Protocol.
A Study of ABT-165 in Subjects With Solid Tumors

Location Details

NCT01946074

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How to Participate

Want to participate in this study, select a site at your convenience, send yourself email to get contact details and prescreening steps.

Locations

Not yet recruiting

United States, Arizona

HonorHealth Research Institute - Pima /ID# 105677

Scottsdale, Arizona, United States, 85258-2345

Not yet recruiting

United States, Arizona

Scottsdale Healthcare /ID# 105678

Scottsdale, Arizona, United States, 85258-4566

Not yet recruiting

United States, California

University of California, Los Angeles /ID# 141389

Los Angeles, California, United States, 90095

Not yet recruiting

United States, California

University of California, Davis Comprehensive Cancer Center /ID# 141164

Sacramento, California, United States, 95817

Not yet recruiting

United States, California

Stanford University School of Med /ID# 123758

Stanford, California, United States, 94305-2200

Not yet recruiting

United States, Illinois

Illinois Cancer Care, PC /ID# 151970

Peoria, Illinois, United States, 61615

Not yet recruiting

United States, Indiana

Horizon Oncology Research Center /ID# 138022

Lafayette, Indiana, United States, 47905

Not yet recruiting

United States, North Carolina

Duke Cancer Center /ID# 105679

Durham, North Carolina, United States, 27710-3000

Not yet recruiting

United States, Tennessee

Tennessee Oncology-Nashville Centennial /ID# 143280

Nashville, Tennessee, United States, 37203-1632

Not yet recruiting

United States, Texas

Mary Crowley Cancer Research /ID# 123757

Dallas, Texas, United States, 75230