Clinical Trials /

Study of Oral PQR309 in Patients With Advanced Solid Tumors

NCT02483858

Description:

This is an open-label, multi-center, non-randomized, dose escalation Phase 1 study evaluating safety, tolerability, PK (pharmacokinetics) and efficacy of PQR309 in the treatment of selected patients with advanced solid tumors.

Related Conditions:
  • Malignant Solid Tumor
Recruiting Status:

Completed

Phase:

Phase 1

Trial Eligibility

Document

Study of Oral <span class="go-doc-concept go-doc-intervention">PQR309</span> in Patients With Advanced Solid Tumors

Title

  • Brief Title: Study of Oral PQR309 in Patients With Advanced Solid Tumors
  • Official Title: Phase I Study of Oral PQR309 in Patients With Advanced Solid Tumors
  • Clinical Trial IDs

    NCT ID: NCT02483858

    ORG ID: PQR309-003

    Trial Conditions

    Cancer

    Trial Interventions

    Drug Synonyms Arms
    PQR 309 AKT/PI3K/mTOR Inhibitor PQR309

    Trial Purpose

    This is a nonrandomized, dose escalation Phase I study designed to evaluate the safety and
    tolerability of PQR309 in the treatment of selected patients with advanced solid tumors with
    known activation of AKT/PI3K/mTOR.

    Detailed Description

    Trial Arms

    Name Type Description Interventions
    PQR309 Experimental Different dose evaluation PQR 309

    Eligibility Criteria

    Inclusion Criteria:

    - Histologically or cytologically confirmed diagnosis of solid malignancy, for which no
    standard curative or life prolonging therapy is available.

    - Age 18

    - ECOG Performance Status of 1.

    - Male and female subjects of child-bearing potential must agree to use double-barrier
    contraceptive measures, oral contraception, or avoidance of intercourse during the
    study and for 90 days after last investigational drug dose received.

    - Life expectancy of 12 weeks.

    - Signed informed consent.

    Exclusion Criteria:

    - Concomitant anticancer therapy (e.g., chemotherapy, radiotherapy, hormonal,
    immunotherapy).

    - Major surgery within 14 days prior to starting study drug.

    - Patients with poorly controlled diabetes mellitus, steroid-induced diabetes mellitus,
    or HbA1c > 7%.

    - Patient is currently receiving warfarin for treatment, prophylaxis or otherwise.

    - Patients with symptomatic congestive heart failure, myocardial infarction 6 months
    prior to enrolment, unstable angina pectoris, serious uncontrolled cardiac
    arrhythmia, symptomatic pericarditis, QTcB > 480 msec on the screening ECG.

    - Pregnant or nursing (lactating) women.

    - Patients have any of the following mood disorders (active major depressive episode,
    bipolar disorder (I or II), obsessive-compulsive disorder, schizophrenia, a history
    of suicidal attempt or ideation, or homicidal ideation, CTCAE Grade 3 anxiety).

    - Patients with a history of interstitial pneumonitis or patients who require chronic
    oxygen.

    Minimum Eligible Age: 18 Years

    Maximum Eligible Age: N/A

    Eligible Gender: Both

    Primary Outcome Measures

    Number of participants with adverse events as a measure of safety and tolerability

    Secondary Outcome Measures

    Dose-limiting toxicities

    Pharmacokinetics profile of PQR309 Cmax, Tmax, AUC, and T1/2

    Trial Keywords

    oncology, solid tumors