Clinical Trials /

A Dose Escalation Study in Adult Patients With Advanced Solid Malignancies

NCT01004224

Description:

The study will determine the maximum tolerated dose and thus the recommended phase II dose and schedule of the compound and characterize the safety.

Related Conditions:
  • Malignant Solid Tumor
Recruiting Status:

Completed

Phase:

Phase 1

Trial Eligibility

Document

A Dose Escalation Study in Adult Patients With Advanced Solid Malignancies

Title

  • Brief Title: A Dose Escalation Study in Adult Patients With Advanced Solid Malignancies
  • Official Title: A Phase I, Open-label, Multi-center, Dose Escalation Study of Oral BGJ398, a Pan FGF-R Kinase Inhibitor, in Adult Patients With Advanced Solid Malignancies
  • Clinical Trial IDs

    NCT ID: NCT01004224

    ORG ID: CBGJ398X2101

    NCI ID: 2009-010876-73

    Trial Conditions

    Advanced Solid Tumors With Alterations of FGFR1, 2 and/or 3;

    Bladder Cancer With FGFR3 Mutation or Fusion

    Squamous Lung Cancer With FGFR1 Amplification;

    Trial Interventions

    Drug Synonyms Arms
    BGJ398 BGJ398

    Trial Purpose

    The study will determine the maximum tolerated dose and thus the recommended phase II dose
    and schedule of the compound and characterize the safety. The study will also investigate
    preliminary anti-tumor activity of the compound in treated patients.

    Detailed Description

    Trial Arms

    Name Type Description Interventions
    BGJ398 Experimental BGJ398

    Eligibility Criteria

    Inclusion Criteria:

    - Patients with histologically/cytologically confirmed advanced solid tumors with FGFR1
    or FGFR2 amplification or FGFR3 mutation, for which no further effective standard
    anticancer treatment exists

    - Patients with advanced/metastatic urothelial cell carcinoma (UCC) with FGFR3
    mutations or gene fusions progressing after platinum-based chemotherapy or intolerant
    to platinum therapy or for whom platinum is contraindicated

    - No more than 2 prior lines of systemic chemotherapy (not including neoadjuvant or
    adjuvant) for advanced/metastatic disease for UCC patients. UCC patients with more
    than 2 prior lines of systemic chemotherapy may be considered for inclusion on a case
    by case basis after discussion with Novartis. Prior immunotherapy or biological
    therapy is permitted and does not count towards the 2 prior lines.

    - Must be measurable disease for UCC patients

    - A representative tumor sample must be available for molecular testing. The biopsy
    sample must be obtained from an advanced, invasive or metastatic lesion.

    - Adequate bone marrow function

    - Adequate hepatic and renal function

    - Adequate cardiovascular function

    Contraception:

    - For women: Must be surgically sterile, post-menopausal, or compliant with a medically
    approved contraceptive regimen during and for 3 months after the treatment period;
    must have a negative serum or urine pregnancy test and must not be nursing

    - For men: Must be surgically sterile or compliant with a contraceptive regimen during
    and for 3 months after the treatment period

    Exclusion Criteria:

    - Patients with primary CNS tumor or CNS tumor involvement

    - Patients with history and/or current evidence of endocrine alteration of
    calcium-phosphate homeostasis

    - History and/or current evidence of ectopic mineralization / calcification including
    but not limited to the soft tissue, kidneys, intestine, myocard and lung with the
    exception of calcified lymphnodes and asymptomatic coronary calcification

    - Current evidence of corneal or retinal disorder/ keratopathy incl. but not limited to
    bullous/ band keratopathy, corneal abrasion, inflammation/ulceration,
    keratoconjunctivitis etc., confirmed by ophthalmologic examination

    - History or current evidence of cardiac arrhythmia and/or conduction abnormality

    - Women who are pregnant or nursing

    Other protocol-defined inclusion/exclusion criteria may apply.

    Minimum Eligible Age: 18 Years

    Maximum Eligible Age: N/A

    Eligible Gender: Both

    Primary Outcome Measures

    To determine the maximum tolerated dose and thus the recommended phase II dose and schedule of single agent oral study drug in patients with advance solid tumors

    Secondary Outcome Measures

    To characterize the safety and tolerability of the compound at the RPTD

    To determine the pharmacokinetic profiles of the drug including known pharmacologically active metabolites

    To evaluate the pharmacodynamic effect of the drug.

    To further assess any preliminary anti-tumor activity.

    To assess preliminary anti-tumor activity of the compound in patients with advanced/metastatic urothelial cell carcinoma with FGFR3 genetic alterations

    Trial Keywords

    advanced solid tumors

    lung cancer

    bladder cancer

    BGJ398

    FGFR

    kinase inhibitor

    advanced solid malignancies