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Clinical Trial 21359

Cancer Type: Sarcoma
Study Type: Treatment
NCT#: NCT04979442

Phase: Phase III
Prinicipal Investigator: Druta, Mihaela

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Overview

Study Title

A Randomized Multicenter Phase 3 Study of Milademetan Versus Trabectedin in Patients with Dedifferentiated Liposarcoma

Summary

This study is designed to evaluate the safety and efficacy of milademetan compared to trabectedin in patients with unresectable (i.e., where resection is deemed to cause unacceptable morbidity or mortality) or metastatic DD liposarcoma that progressed on 1 or more prior systemic therapies, including at least 1 anthracycline-based therapy.

Objective

Primary Objective The primary objective is to compare progression-free survival (PFS) between the milademetan treatment arm and trabectedin control arm, as determined by blinded independent central review (BICR), in patients with unresectable or metastatic dedifferentiated (DD) liposarcoma, with or without a well-differentiated (WD) component, who progressed on 1 or more prior systemic therapies including at least 1 anthracycline-based therapy. Secondary Objectives To compare the milademetan treatment arm versus the trabectedin control arm for the following efficacy measures: * Overall survival (OS) * Disease control rate (DCR) * Objective response rate (ORR) * Duration of response (DOR) * PFS by Investigator assessment To assess the safety profile of milademetan To evaluate patient-reported outcomes from health economics and outcomes research

Treatments

Therapies

Chemotherapy (NOS); Therapy (NOS)

Medications

Milademetan (); Not Applicable (); Trabectedin (); Yondelis (Trabectedin)

Inclusion Criteria

  • Histologically confirmed DD liposarcoma, with or without a WD component (WD/DD liposarcoma). Note: Patient must be willing to provide an archival tumor tissue sample that is > Advanced unresectable (i.e., where resection is deemed to cause unacceptable morbidity or mortality) and/or metastatic WD/DD liposarcoma
  • Measurable tumor lesion(s) in accordance with RECIST version 1.1
  • Received 1 or more systemic cancer therapy regimens, including at least 1 anthracycline-based regimen, and had radiographic progressive disease (per RECIST version 1.1) within 6 months before the Screening Visit
  • Resolution of any clinically relevant toxic effects of prior chemotherapy, surgery, radiotherapy, or hormonal therapy
  • ECOG performance status of 0 or 1
  • Adequate bone marrow function as defined by protocol
  • Adequate hepatic function as defined by protocol

  • Exclusion Criteria

  • Prior treatment with any mouse double minute 2 (MDM2) inhibitor or trabectedin
  • Other primary malignancies that have required systemic antineoplastic treatment within the previous 2 years, except for localized cancers that have apparently been cured
  • Gastrointestinal conditions that could affect the absorption of milademetan, in the opinion of the Investigator
  • Uncontrolled infection within the last 7 days requiring IV antibiotics, antivirals, or antifungals
  • Known HIV infection or active Hepatitis B or C
  • Untreated brain metastases. Note: Patients who require steroids for brain metastases must be on a stable or tapering dose of corticosteroids for at least 2 weeks before randomization. If applicable, patients must complete stereotactic radiosurgery 7 days before and whole brain radiotherapy 21 days before their first dose of study drug.
  • Investigational therapy administered within the 28 days or 5 half lives:
  • Cytochrome P450 3A4 isozyme strong inhibitor: 5 elimination half-lives
  • CYP3A strong or moderate inducers: 4 weeks
  • Systemic anticancer therapy or investigational therapy 3 weeks or 5 half-lives,
  • Immunotherapy with checkpoint inhibitor: 4 weeks
  • Curative-intent radiation therapy > Uncontrolled or significant cardiovascular disease as defined by protocol

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