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A Study of ABT-414 in Subjects With Solid Tumors

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
AbbVie ( AbbVie (prior sponsor, Abbott) )
ClinicalTrials.gov Identifier:
NCT01741727
First received: September 19, 2012
Last updated: February 7, 2016
Last verified: February 2016
  Purpose
A study of ABT-414 in subjects with solid tumors.

Condition Intervention Phase
Squamous Cell Tumors
Drug: ABT-414
Phase 1

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
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)

Resource links provided by NLM:


Further study details as provided by AbbVie:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: Yes ]
    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 1 - Pharmacokinetic profile [ Time Frame: Multiple timepoints Week 1 and Week 7 ] [ Designated as safety issue: Yes ]
    Cmax, Cmin, and half-life

  • Phase 2 - Efficacy [ Time Frame: Every 6-9 weeks for an average of 20 weeks ] [ Designated as safety issue: No ]
    Objective response per Response Evaluation Criteria in Solid Tumors, version 1.1 (RECIST)


Secondary Outcome Measures:
  • Phase 2- Safety (Scheduled study visits occurring on average every 3 weeks) [ Time Frame: Followed on average every 3 weeks for approximately 20 weeks ] [ Designated as safety issue: Yes ]
    Evaluation of vital signs, clinical lab testing, and adverse event monitoring, physical exam, and electrocardiogram (periodic)

  • Phase 2- Pharmacokinetic profile [ Time Frame: Multiple timepoints Week 1 ] [ Designated as safety issue: Yes ]
    Cmax, Cmin, and half-life

  • Phase 1&2 - QT assessment [ Time Frame: Week 1 ] [ Designated as safety issue: Yes ]
    Triplicate electrocardiograms


Enrollment: 57
Study Start Date: October 2012
Study Completion Date: November 2015
Primary Completion Date: November 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: ABT-414
Subjects with solid tumors (Phase 1) and squamous non-small cell lung cancer (NSCLC) (Phase 2)
Drug: ABT-414
ABT-414 will be administered by intravenous infusion.

  Eligibility

Ages Eligible for Study:   18 Years to 99 Years   (Adult, Senior)
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01741727

Locations
United States, Arizona
Site Reference ID/Investigator# 90333
Scottsdale, Arizona, United States, 85258
United States, Illinois
Site Reference ID/Investigator# 83156
Chicago, Illinois, United States, 60637
United States, Massachusetts
Site Reference ID/Investigator# 117516
Boston, Massachusetts, United States, 02215
Site Reference ID/Investigator# 83154
Boston, Massachusetts, United States, 02215
United States, Texas
Site Reference ID/Investigator# 83155
San Antonio, Texas, United States, 78229
Canada
Site Reference ID/Investigator# 89035
Ottawa, Canada, K1H 8L6
Sponsors and Collaborators
AbbVie (prior sponsor, Abbott)
Investigators
Study Director: Christopher Ocampo, MD AbbVie
  More Information

Responsible Party: AbbVie (prior sponsor, Abbott)
ClinicalTrials.gov Identifier: NCT01741727     History of Changes
Other Study ID Numbers: M13-379 
Study First Received: September 19, 2012
Last Updated: February 7, 2016
Health Authority: United States: Food and Drug Administration
Canada: Health Canada

Additional relevant MeSH terms:
Neoplasms, Squamous Cell
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms

ClinicalTrials.gov processed this record on September 27, 2016