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Completed

NCT Number: NCT02343172

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

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.

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Key information

Conditions

Liposarcoma Neoplasms Neoplasms by Histologic Type Neoplasms, Adipose Tissue Neoplasms, Connective and Soft Tissue Sarcoma

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Novartis Investigative Site, Toronto, Ontario, Canada

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

HDM201

Drug

LEE011

Drug

Primary outcomes

  1. Phase Ib: Incidence of Dose Limiting Toxicities (DLTs) during the first cycle of treatment.

    Time frame: 5 years

    DLTs in the first cycle of treatment.

  2. Phase Ib: Exposure to HDM201 and LEE011 as measured by AUC 0-24h

    Time frame: 5 years

    as measured by AUC0-24h

  3. Phase II: Progression free survival (PFS)

    Time frame: 5 years

    To assess the preliminary anti-tumor activity of HDM201 in combination with LEE011 in liposarcoma

Secondary outcomes

  1. Phase Ib/II: Incidence and severity of AEs and SAEs

    Time frame: 5 years

    Run-in part to assess safety of HDM201 in combination with LEE011

  2. Phase Ib/II: number of patients with dose interruptions and reduction

    Time frame: 5 years

    Run-in part To assess tolerability of HDM201 in combination with LEE011

  3. Phase Ib/II: dose intensity

    Time frame: 5 years

    Run-in part To assess tolerability of HDM201 in combination with LEE011

  4. Phase Ib/II: Pharmacokinetics (PK) parameters of HDM201 and LEE011: Cmax

    Time frame: 5 years

    Run-in part to evaluate PK parameters of HDM201 and LEE011

  5. Phase Ib/II: Pharmacokinetics (PK) parameters of HDM201 and LEE011: Tmax

    Time frame: 5 years

    Run-in part to evaluate the PK parameters of HDM201 and LEE011

  6. Phase Ib/II: Pharmacokinetics (PK) parameters of HDM201 and LEE011: AUClast

    Time frame: 5 years

    Run-in part to evaluate the PK parameters of HDM201 and LEE011

  7. Phase Ib/II: Pharmacokinetics (PK) parameters of HDM201 and LEE011: AUCtau

    Time frame: 5 years

    Run-in part to evaluate the PK parameters of HDM201 and LEE011

  8. Phase Ib/II: Changes from baseline of Pharmacodynamics (PD) markers in blood (GDF-15)

    Time frame: 5 years

    Run-in part measure of GDF-15 fold-change in protein levels (PD direct targets of p53) to assess PD changes from baseline in blood and a potential relationship with clinical outcome.

  9. Phase Ib/II: Changes from baseline of Pharmacodynamics (PD) markers in tumor tissue (p21, MDM2)

    Time frame: 5 years

    Run-in part measure of p21 and MDM2 protein levels by IHC (H-Score) (p53 and CDK4 pathways) to assess changes from baseline of PD markers in tumor tissue and a potential relationship with clinical outcome.

  10. Phase Ib/II: anti-tumor activity endpoint (BOR, PFS)

    Time frame: 5 years

    Run-in part to assess PD effect of HDM201 and LEE011 and a potential relationship with clinical outcome

  11. Phase Ib: BOR, ORR and PFS as per RECIST v1.1, assessed by investigator

    Time frame: 5 years

    Run-in part to assess the preliminary anti-tumor activity of HDM201 in combination with LEE011 in liposarcoma

  12. Phase II: BOR, ORR and PFS as per RECIST v1.1, assessed by investigator

    Time frame: 5 years

    Run-in part to further assess the anti-tumor activity of HDM201 in combination with LEE011 in liposarcoma

Sponsors and collaborators

Lead sponsor

Novartis Pharmaceuticals

Industry

Registry information

Official study title

A Phase Ib/II, Open-label, Multicenter Study of Oral HDM201 in Combination With Oral LEE011 in Adult Patients With Liposarcoma

Important dates

Study start
2015
Primary completion
2019
Study completion
2019
First posted
Jan 21, 2015
Registry last updated
Dec 9, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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