Description:
A study of ABT-414 in subjects with solid tumors.
Title
- Brief Title: A Study of ABT-414 in Subjects With Solid Tumors
- Official Title: A Phase 1/2 Study Evaluating the Safety, Pharmacokinetics and Efficacy of ABT-414 in Subjects With Advanced Solid Tumors Likely to Over-Express the Epidermal Growth Factor Receptor (EGFR)
Clinical Trial IDs
- ORG STUDY ID:
M13-379
- NCT ID:
NCT01741727
Conditions
Interventions
Drug | Synonyms | Arms |
---|
ABT-414 | | ABT-414 |
Purpose
A study of ABT-414 in subjects with solid tumors.
Trial Arms
Name | Type | Description | Interventions |
---|
ABT-414 | Experimental | Subjects with solid tumors (Phase 1) and squamous non-small cell lung cancer (NSCLC) (Phase 2) | |
Eligibility Criteria
Inclusion Criteria:
1. Subjects must have a solid tumor type likely to over-express Epidermal Growth Factor
Receptor (EGFR) (Phase 1)
2. Subjects have an Eastern Cooperative Oncology Group (ECOG) Performance Status of 0-2
3. Subjects have available tumor tissue
4. Subjects have adequate bone marrow, renal, and hepatic function as follows: Bone
marrow: Absolute neutrophil count (ANC) >/= 1,500/mm3 Platelets >/= 100,000/mm3;
Hemoglobin >/= 9.0 g/dL Renal function: Serum creatinine </= 1.5 times the upper limit
of the institution's normal range Hepatic function: Bilirubin, aspartate
aminotransferase (AST), and alanine aminotransferase (ALT) </= 1.5 times the upper
limit of the institution's normal range. Subjects with liver metastasis may have an
AST and ALT of </= 5.0 x the upper limit of normal.
5. Subjects in the Phase 2 portion must have squamous cell Non-Small Cell Lung Cancer
(NSCLC)
6. Eligibility is restricted to subjects with confirmed EGFR amplification in the EGFR
amplified cohort
Exclusion Criteria:
1. The subject has uncontrolled metastases to the central nervous system (CNS). Subjects
with brain metastases are eligible provided they have shown clinical and radiographic
stable disease for at least 28 days after definitive therapy and have not received
prior whole brain radiation (Phase 1 only).
2. The subject has received anticancer therapy including chemotherapy, immunotherapy,
radiotherapy, hormonal, biologic, or any investigational therapy within a period of 28
days prior to the first dose of ABT-414.
3. The subject has unresolved clinically significant toxicities from prior anticancer
therapy, defined as any Common Terminology Criteria for Adverse Events (CTCAE) Grade 2
or higher.
4. The subject had had major surgery within 28 days prior to the first dose of ABT-414.
5. The subject has a history of immunologic reaction to any Immunoglobulin G (IgG)
containing agent.
6. Phase 2 portion only: The subject has previous or concurrent cancer that is distinct
in primary site or histology from NSCLC, except cervical carcinoma in situ,
non-melanoma carcinoma of the skin or in situ carcinoma of the bladder. Any cancer
curatively treated greater than 3 years prior to entry is permitted.
Maximum Eligible Age: | 99 Years |
Minimum Eligible Age: | 18 Years |
Eligible Gender: | All |
Healthy Volunteers: | No |
Primary Outcome Measures
Measure: | Phase 1 - Safety (Number of subjects with adverse events and/or dose limiting toxicities) |
Time Frame: | Every 1-3 weeks for an average of 20 weeks |
Safety Issue: | |
Description: | Evaluation of vital signs, clinical lab testing, adverse event monitoring, physical exam and electrocardiogram (ECG) (periodic) under different dosing schedules, drug infusion times, and manufacturing processes. |
Secondary Outcome Measures
Measure: | Phase 2- Safety (Scheduled study visits occurring on average every 3 weeks) |
Time Frame: | Followed on average every 3 weeks for approximately 20 weeks |
Safety Issue: | |
Description: | Evaluation of vital signs, clinical lab testing, and adverse event monitoring, physical exam, and electrocardiogram (periodic) |
Measure: | Phase 2- Pharmacokinetic profile |
Time Frame: | Multiple timepoints Week 1 |
Safety Issue: | |
Description: | Cmax, Cmin, and half-life |
Measure: | Phase 1&2 - QT assessment |
Time Frame: | Week 1 |
Safety Issue: | |
Description: | Triplicate electrocardiograms |
Details
Phase: | Phase 1 |
Primary Purpose: | Interventional |
Overall Status: | Completed |
Lead Sponsor: | AbbVie (prior sponsor, Abbott) |
Last Updated
November 20, 2017