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Trial record 7 of 114 for:    liposarcoma

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT02343172
Recruitment Status : Recruiting
First Posted : January 21, 2015
Last Update Posted : December 18, 2017
Information provided by (Responsible Party):

Study Description
Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Liposarcoma Drug: HDM201 Drug: LEE011 Phase 1 Phase 2

Study Design

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 108 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase Ib/II, Open-label, Multicenter Study of Oral HDM201 in Combination With Oral LEE011 in Adult Patients With Liposarcoma
Actual Study Start Date : March 14, 2015
Estimated Primary Completion Date : December 30, 2018
Estimated Study Completion Date : December 30, 2018

Resource links provided by the National Library of Medicine

Drug Information available for: Ribociclib
U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
Experimental: HDM201+LEE011 Drug: HDM201 Drug: LEE011

Outcome Measures

Primary Outcome Measures :
  1. Phase I: Incidence of Dose Limiting Toxicities (DLTs) [ Time Frame: 21/28 days cycle depending on assigned regimen ]
    DLTs in the first cycle of treatment.

  2. Phase II: Progression free survival (PFS) [ Time Frame: 6/12 weeks assessments until study end ]
    To assess the preliminary anti-tumor activity of HDM201 in combination with LEE011 in liposarcoma

  3. Phase I: Exposure to HDM201 and LEE011 [ Time Frame: 14 days ]
    as measured by AUC0-24h at C1D14

Secondary Outcome Measures :
  1. Number of patients with Adverse events [ Time Frame: 6 months ]
    Number of patients with AEs as a measure of Safety and tolerability of HDM201 in combination with LEE011

  2. Pharmacokinetics (PK) parameters of HDM201 and LEE011 [ Time Frame: up to 18 weeks ]
    PK will be assessed using the composite PK parameters of AUC and Cmax.

  3. Changes from baseline of Pharmacodynamics (PD) markers [ Time Frame: baseline, 14 days ]
    Changes from baseline of PD markers in tumor tissue and in blood. PDdirect targets of p53 and effectors of CD4.

  4. Tumor response [ Time Frame: every 6 weeks up to 9 months ]
    On Phase Ib: To assess the preliminary anti-tumor activity of HDM201 in combination with LEE011 in liposarcoma

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.

Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02343172

Contact: Novartis Pharmaceuticals 1-888-669-6682 Novartis.email@novartis.com
Contact: Novartis Pharmaceuticals +41613241111

Canada, Ontario
Novartis Investigative Site Recruiting
Toronto, Ontario, Canada, M5G 2M9
Novartis Investigative Site Recruiting
Bordeaux, France, 33076
Novartis Investigative Site Recruiting
Lyon Cedex, France, 69373
Novartis Investigative Site Recruiting
Essen, Germany, 45122
Novartis Investigative Site Recruiting
Ulm, Germany, 89081
Novartis Investigative Site Recruiting
Singapore, Singapore, 169610
Novartis Investigative Site Recruiting
Barcelona, Catalunya, Spain, 08035
Novartis Investigative Site Recruiting
Majadahonda, Madrid, Spain, 28222
Novartis Investigative Site Recruiting
Taipei, Taiwan, 10002
Sponsors and Collaborators
Novartis Pharmaceuticals
Study Director: Novartis Pharmaceuticals Novartis Pharmaceuticals
More Information

Responsible Party: Novartis Pharmaceuticals
ClinicalTrials.gov Identifier: NCT02343172     History of Changes
Other Study ID Numbers: CHDM201X2103C
First Posted: January 21, 2015    Key Record Dates
Last Update Posted: December 18, 2017
Last Verified: December 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Plan Description:

Novartis is committed to sharing with qualified external researchers, access to patient-level data and supporting clinical documents from eligible studies. These requests are reviewed and approved by an independent review panel on the basis of scientific merit. All data provided is anonymized to respect the privacy of patients who have participated in the trial in line with applicable laws and regulations.

This trial data availability is according to the criteria and process described on www.clinicalstudydatarequest.com

Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Novartis ( Novartis Pharmaceuticals ):
MDM2 inhibition,
cdk4 inhibition,

Additional relevant MeSH terms:
Neoplasms, Adipose Tissue
Neoplasms, Connective and Soft Tissue
Neoplasms by Histologic Type