A Study of ABT-414 in Subjects With Solid Tumors

Phase 1

Completed

• Conditions: Squamous Cell Tumors
• Interventions: Drug: ABT-414

• Registration Number: NCT01741727
• Lead Sponsor: AbbVie (prior sponsor, Abbott)

Brief Summary

A study of ABT-414 in subjects with solid tumors.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2012-09-19
• Study Start: 2012-10
• Study First Submitted QC: 2012-12-03
• Study First Posted: 2012-12-05
• Primary Completion: 2015-11
• Study Completion: 2015-11
• Status Verified: 2016-02
• Last Update Submitted: 2017-11-16
• Last Update Posted: 2017-11-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 57

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
ABT-414	ABT-414	Subjects with solid tumors (Phase 1) and squamous non-small cell lung cancer (NSCLC) (Phase 2)

Primary Outcome Measures

Name	Time	Method
Phase 1 - Safety (Number of subjects with adverse events and/or dose limiting toxicities)	Every 1-3 weeks for an average of 20 weeks	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.
Phase 2 - Efficacy	Every 6-9 weeks for an average of 20 weeks	Objective response per Response Evaluation Criteria in Solid Tumors, version 1.1 (RECIST)
Phase 1 - Pharmacokinetic profile	Multiple timepoints Week 1 and Week 7	Cmax, Cmin, and half-life

Secondary Outcome Measures

Name	Time	Method
Phase 2- Pharmacokinetic profile	Multiple timepoints Week 1	Cmax, Cmin, and half-life
Phase 2- Safety (Scheduled study visits occurring on average every 3 weeks)	Followed on average every 3 weeks for approximately 20 weeks	Evaluation of vital signs, clinical lab testing, and adverse event monitoring, physical exam, and electrocardiogram (periodic)
Phase 1&2 - QT assessment	Week 1	Triplicate electrocardiograms

Trial Locations

Locations (6)

Site Reference ID/Investigator# 117516; 🇺🇸 Boston, Massachusetts, United States

Site Reference ID/Investigator# 90333; 🇺🇸 Scottsdale, Arizona, United States

Site Reference ID/Investigator# 83156; 🇺🇸 Chicago, Illinois, United States

Site Reference ID/Investigator# 83154; 🇺🇸 Boston, Massachusetts, United States

Site Reference ID/Investigator# 83155; 🇺🇸 San Antonio, Texas, United States

Site Reference ID/Investigator# 89035; 🇨🇦 Ottawa, Canada