Status:
COMPLETED
Study of ABT-700 in Subjects With Advanced Solid Tumors
Lead Sponsor:
AbbVie (prior sponsor, Abbott)
Conditions:
Advanced Solid Tumors
Eligibility:
All Genders
18-99 years
Phase:
PHASE1
Brief Summary
This is a Phase 1/1b open-label study evaluating the safety, pharmacokinetics (PK), and preliminary efficacy of ABT-700 in subjects with advanced solid tumors that may have MET amplification or c-Met ...
Eligibility Criteria
Inclusion
- Subject with advanced solid tumors; Dose-expansion: evidence for MET gene amplification.
- Subject must have disease: a) that is not amenable to surgical resection, or b) that has progressed or recurred despite standard therapy, or c) that has failed to respond to standard therapy, or d) for which no effective therapy exists.
- Subject cannot tolerate or must not be eligible for other approved therapeutic options with known survival advantage.
- Subjects enrolled on the combination therapy phase must satisfy the above inclusion criteria and also the following: Subjects must have inoperable, locally advanced or metastatic cancer and be eligible to receive docetaxel or FOLFIRI/cetuximab or erlotinib in combination with ABT-700.
Exclusion
- Subject 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 ABT-700.
- Subjects with uncontrolled metastases of the central nervous system. Subjects with brain metastases are eligible provided they have shown clinical and radiographic stable disease after definitive therapy and have not used steroids for at least 1 month prior to first dose of ABT-700.
- Subject has unresolved adverse events \> Grade 1 from prior anticancer therapy except for alopecia or anemia.
- Subject has had major surgery within 21 days prior to the first dose of ABT-700.
- Subjects enrolled on the combination therapy phase must not meet the above exclusion criteria and must be eligible to receive docetaxel or FOLFIRI/cetuximab or erlotinib per most current prescribing information, or at the discretion of the Investigator. Subjects with K-Ras mutation-positive colorectal cancer will be excluded from receiving FOLFIRI/cetuximab.
Key Trial Info
Start Date :
October 6 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 27 2017
Estimated Enrollment :
74 Patients enrolled
Trial Details
Trial ID
NCT01472016
Start Date
October 6 2011
End Date
April 27 2017
Last Update
November 21 2017
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