A Study of ABT-414 in Subjects With Solid Tumors

NCT01741727 | Completed Phase 1

• 1 other identifier: M13-379
• Study Type: interventional
• Target: 57
• Locations: 2 countries
• Sites: 6

Brief Summary

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

Conditions

Squamous Cell Tumors

Outcome Measures

Primary Outcomes (3)

• Phase 1 - Safety (Number of subjects with adverse events and/or dose limiting toxicities)

  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.

  Every 1-3 weeks for an average of 20 weeks

• Phase 1 - Pharmacokinetic profile

  Cmax, Cmin, and half-life

  Multiple timepoints Week 1 and Week 7

• Phase 2 - Efficacy

  Objective response per Response Evaluation Criteria in Solid Tumors, version 1.1 (RECIST)

  Every 6-9 weeks for an average of 20 weeks

Secondary Outcomes (3)

• Phase 2- Safety (Scheduled study visits occurring on average every 3 weeks)

  Followed on average every 3 weeks for approximately 20 weeks

• Phase 2- Pharmacokinetic profile

  Multiple timepoints Week 1

• Phase 1&2 - QT assessment

  Week 1

Study Arms (1)

ABT-414

EXPERIMENTAL

Subjects with solid tumors (Phase 1) and squamous non-small cell lung cancer (NSCLC) (Phase 2)

Drug: ABT-414

Interventions

ABT-414 DRUG

ABT-414 will be administered by intravenous infusion.

ABT-414

Eligibility Criteria

• Age: 18 Years - 99 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Subjects must have a solid tumor type likely to over-express Epidermal Growth Factor Receptor (EGFR) (Phase 1)
• Subjects have an Eastern Cooperative Oncology Group (ECOG) Performance Status of 0-2
• Subjects have available tumor tissue
• 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.
• Subjects in the Phase 2 portion must have squamous cell Non-Small Cell Lung Cancer (NSCLC)
• Eligibility is restricted to subjects with confirmed EGFR amplification in the EGFR amplified cohort

You may not qualify if:

• 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).
• 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.
• 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.
• The subject had had major surgery within 28 days prior to the first dose of ABT-414.
• The subject has a history of immunologic reaction to any Immunoglobulin G (IgG) containing agent.
• 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.

Sponsors & Collaborators

• AbbVie (prior sponsor, Abbott): lead

Study Sites (6)

Site Reference ID/Investigator# 90333

Scottsdale, Arizona, 85258, United States

Location

Site Reference ID/Investigator# 83156

Chicago, Illinois, 60637, United States

Location

Site Reference ID/Investigator# 117516

Boston, Massachusetts, 02215, United States

Location

Site Reference ID/Investigator# 83154

Boston, Massachusetts, 02215, United States

Location

Site Reference ID/Investigator# 83155

San Antonio, Texas, 78229, United States

Location

Site Reference ID/Investigator# 89035

Ottawa, K1H 8L6, Canada

Location

Related Publications (1)

• Munasinghe WP, Mittapalli RK, Li H, Hoffman DM, Holen KD, Menon RM, Xiong H. Evaluation of the effect of the EGFR antibody-drug conjugate ABT-414 on QT interval prolongation in patients with advanced solid tumors likely to over-express EGFR. Cancer Chemother Pharmacol. 2017 May;79(5):915-922. doi: 10.1007/s00280-017-3284-y. Epub 2017 Mar 27.

  PMID: 28349167 RESULT

MeSH Terms

Interventions

ABT-414

Study Officials

• Christopher Ocampo, MD

  AbbVie

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 19, 2012
• First Posted: December 5, 2012
• Study Start: October 1, 2012
• Primary Completion: November 1, 2015
• Study Completion: November 1, 2015
• Last Updated: November 20, 2017

Record last verified: 2016-02

Locations

CA (1); US (5)