Status:
COMPLETED
A Study to Evaluate the Safety and Pharmacokinetics ABBV-399 in Japanese Participants With Solid Tumors
Lead Sponsor:
AbbVie
Conditions:
Advanced Solid Tumors Cancer
Eligibility:
All Genders
20+ years
Phase:
PHASE1
Brief Summary
An open-label, dose-escalation study designed to evaluate the safety, pharmacokinetics, and preliminary efficacy of ABBV-399 in participants with advanced solid tumors.
Eligibility Criteria
Inclusion
- Participant with histologically confirmed advanced solid tumor.
- Participant must have advanced solid tumor that is not amenable to surgical resection or other approved therapeutic options that have demonstrated clinical benefit.
- Participant has an Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 to 2.
- Participant must have measurable disease per Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1.
- Participant has archived diagnostic formalin-fixed paraffin embedded (FFPE) tumor tissue available for analysis.
- Participant has adequate bone marrow, renal, and hepatic function.
Exclusion
- Participant has received anticancer therapy including chemotherapy, immunotherapy, radiation therapy, immunotherapy, biologic, or any investigational therapy within a period of 21 days, or herbal therapy within 7 days prior to the first dose of ABBV-399.
- Participant has known uncontrolled metastases to the central nervous system. Participants with brain metastases are eligible after definitive therapy provided they are asymptomatic off systemic steroids and anticonvulsants for at least 2 weeks prior to first dose of ABBV-399.
- Participant has unresolved clinically significant adverse events \>= Grade 2 from prior anticancer therapy except for alopecia or anemia.
- Participant has had major surgery within 21 days prior to the first dose of ABBV-399.
Key Trial Info
Start Date :
November 6 2017
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 4 2019
Estimated Enrollment :
9 Patients enrolled
Trial Details
Trial ID
NCT03311477
Start Date
November 6 2017
End Date
March 4 2019
Last Update
March 14 2019
Active Locations (2)
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1
Shizuoka Cancer Center /ID# 166940
Sunto-gun, Shizuoka, Japan, 411-8777
2
National Cancer Center Hospital /ID# 166939
Chuo-ku, Tokyo, Japan, 104-0045