Clinical Trials /

A Study of ABT-414 in Subjects With Solid Tumors

NCT01741727

Description:

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

Related Conditions:
  • Malignant Solid Tumor
  • Squamous Cell Lung Carcinoma
Recruiting Status:

Completed

Phase:

Phase 1

Trial Eligibility

Document

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

  • Squamous Cell Tumors

Interventions

DrugSynonymsArms
ABT-414ABT-414

Purpose

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

Trial Arms

NameTypeDescriptionInterventions
ABT-414ExperimentalSubjects with solid tumors (Phase 1) and squamous non-small cell lung cancer (NSCLC) (Phase 2)
  • ABT-414

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