NCT02343172

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.

Trial Health

93
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
74

participants targeted

Target at P75+ for phase_1

Timeline
Completed

Started Mar 2015

Longer than P75 for phase_1

Geographic Reach
6 countries

9 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 5, 2015

Completed
16 days until next milestone

First Posted

Study publicly available on registry

January 21, 2015

Completed
2 months until next milestone

Study Start

First participant enrolled

March 13, 2015

Completed
4.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 16, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 16, 2019

Completed
Last Updated

December 9, 2020

Status Verified

June 1, 2020

Enrollment Period

4.6 years

First QC Date

January 5, 2015

Last Update Submit

December 6, 2020

Conditions

Liposarcoma

Keywords

LiposarcomaMDM2 inhibitioncdk4 inhibitionHDM201LEE011

Outcome Measures

Primary Outcomes (3)

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

    DLTs in the first cycle of treatment.

    5 years

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

    as measured by AUC0-24h

    5 years

  • Phase II: Progression free survival (PFS)

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

    5 years

Secondary Outcomes (12)

  • Phase Ib/II: Incidence and severity of AEs and SAEs

    5 years

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

    5 years

  • Phase Ib/II: dose intensity

    5 years

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

    5 years

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

    5 years

  • +7 more secondary outcomes

Study Arms (1)

HDM201+LEE011

EXPERIMENTAL
Drug: HDM201Drug: LEE011

Interventions

HDM201DRUG
HDM201+LEE011
LEE011DRUG
HDM201+LEE011

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (9)

Novartis Investigative Site

Toronto, Ontario, M5G 2M9, Canada

Location

Novartis Investigative Site

Bordeaux, 33076, France

Location

Novartis Investigative Site

Lyon, 69373, France

Location

Novartis Investigative Site

Essen, 45147, Germany

Location

Novartis Investigative Site

Ulm, 89081, Germany

Location

Novartis Investigative Site

Singapore, 169610, Singapore

Location

Novartis Investigative Site

Barcelona, Catalonia, 08035, Spain

Location

Novartis Investigative Site

Madrid, 28222, Spain

Location

Novartis Investigative Site

Taipei, 10002, Taiwan

Location

Related Links

MeSH Terms

Conditions

Liposarcoma

Interventions

siremadlinribociclib

Condition Hierarchy (Ancestors)

Neoplasms, Adipose TissueNeoplasms, Connective and Soft TissueNeoplasms by Histologic TypeNeoplasmsSarcoma

Study Officials

  • Novartis Pharmaceuticals

    Novartis Pharmaceuticals

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 5, 2015

First Posted

January 21, 2015

Study Start

March 13, 2015

Primary Completion

October 16, 2019

Study Completion

October 16, 2019

Last Updated

December 9, 2020

Record last verified: 2020-06

Locations

SG(1)ES(2)FR(2)DE(2)TW(1)CA(1)