Clinical Trials /

Study of Safety and Efficacy of HDM201 in Combination With LEE011 in Patients With Liposarcoma

NCT02343172

Description:

To determine the MTD/RP2D of the HDM201 and LEE011 combination and evaluate whether the combination is safe and has beneficial effects in patients with liposarcoma.

Related Conditions:
  • Liposarcoma
Recruiting Status:

Active, not recruiting

Phase:

Phase 1/Phase 2

Trial Eligibility

Document

Study of Safety and Efficacy of <span class="go-doc-concept go-doc-intervention">HDM201</span> in Combination With LEE011 in Patients With Liposarcoma

Title

  • Brief Title: Study of Safety and Efficacy of HDM201 in Combination With LEE011 in Patients With Liposarcoma
  • Official Title: A Phase Ib/II, Open-label, Multicenter Study of Oral HDM201 in Combination With Oral LEE011 in Adult Patients With Liposarcoma
  • Clinical Trial IDs

    NCT ID: NCT02343172

    ORG ID: CHDM201X2103C

    Trial Conditions

    Liposarcoma

    Trial Interventions

    Drug Synonyms Arms
    HDM201 HDM201+LEE011
    LEE011 HDM201+LEE011

    Trial Purpose

    To determine the MTD/RP2D of the HDM201 and LEE011 combination and evaluate whether the
    combination is safe and has beneficial effects in patients with liposarcoma.

    Detailed Description

    Trial Arms

    Name Type Description Interventions
    HDM201+LEE011 Experimental HDM201, LEE011

    Eligibility Criteria

    Inclusion Criteria:

    - Patients with histologically documented, locally advanced or metastatic WD/DD
    liposarcoma who have received at least one prior systemic therapy

    - Patients with radiologic progression, defined by RECIST v.1.1, occurring while on/or
    within 6 months after last systemic treatment, prior to enrollment

    - ECOG performance status of 0-1

    Exclusion Criteria:

    - Prior treatment with compounds with the same mode of action

    - Patients with TP53 mutated tumors, if the molecular status is known

    - Symptomatic central nervous system metastases

    - Inadequate organ function

    - Previous and concomitant therapy that precludes enrollment, as defined by protocol

    Other protocol-defined inclusion/exclusion criteria may apply.

    Minimum Eligible Age: 18 Years

    Maximum Eligible Age: N/A

    Eligible Gender: Both

    Primary Outcome Measures

    Phase I: Incidence of Dose Limiting Toxicities (DLTs)

    Phase II: Progression free survival (PFS)

    Phase I: Exposure to HDM201 and LEE011

    Secondary Outcome Measures

    Number of patients with Adverse events

    Pharmacokinetics (PK) parameters of HDM201 and LEE011

    Changes from baseline of Pharmacodynamics (PD) markers

    Tumor response

    Trial Keywords

    Liposarcoma,

    MDM2 inhibition,

    cdk4 inhibition,

    HDM201,

    LEE011