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

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

    NCT ID: NCT01741727

    ORG ID: M13-379

    Trial Conditions

    Squamous Cell Tumors

    Trial Interventions

    Drug Synonyms Arms
    ABT-414 ABT-414

    Trial Purpose

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

    Detailed Description

    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) 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.

    Minimum Eligible Age: 18 Years

    Maximum Eligible Age: N/A

    Eligible Gender: Both

    Primary Outcome Measures

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

    Phase 1 - Pharmacokinetic profile

    Phase 2 - Efficacy

    Secondary Outcome Measures

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

    Phase 2- Pharmacokinetic profile

    Phase 1&2 - QT assessment

    Trial Keywords