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NCT03114527 · ClinicalTrials.gov registry record · Phase 2

Phase II Trial of Ribociclib and Everolimus in Advanced Dedifferentiated Liposarcoma (DDL) and Leiomyosarcoma (LMS)

A Phase 2 study of Soft Tissue Sarcoma, sponsored by Fox Chase Cancer Center.

Active
Registry status
Phase 2
Development phase
48
Enrollment target
2
Study locations

NCT03114527 is a Phase 2 study of Soft Tissue Sarcoma that is active but no longer recruiting, run by Fox Chase Cancer Center. The registered enrollment target is 48 participants, below the 78-participant average among 55 other Soft Tissue Sarcoma trials with a reported enrollment target (38% lower). The trial reports 2 study locations across 2 states.

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The verdict

NCT03114527, a Phase 2 study of Soft Tissue Sarcoma, is active but no longer recruiting, sponsored by Fox Chase Cancer Center.

ACTIVE NOT RECRUITING
Registry status
Phase 2
Development phase
48 participants
Enrollment target
2
Study locations

Study Summary

This is a two center, 2 arm, Phase II study evaluating the combination of Ribociclib and Everolimus in patients with advanced DDL and LMS who have had at least 1 prior systemic therapy. Patients will be enrolled by sarcoma histology into DDL (Arm A) and LMS (Arm B). The purpose of this study is to determine the anti-tumor activity of this doublet therapy in these patient cohorts. Ribociclib will be administered orally at 300 mg/day 3 weeks on/1 week off. Everolimus will be administered 2.5 mg orally on a continuous 28 day cycle. Clinical and laboratory assessments will be made on day 1, d15 of cycle 1 and 2, and day 1 of each subsequent cycle. Tumor response will be assessed by RECIST 1.1 at (CT or MRI) at week 8, 16, 24 and every 12 weeks thereafter. Study drug administration will continue until disease progression, unacceptable toxicity or withdrawal of consent. Patients will be followed until death or are lost to follow-up for analysis of secondary endpoints. There will be a 1 step registration process for dedifferentiated liposarcoma patients while patients with leiomyosarcoma will require a 2 step registration process. For step 1 of registration, patients must meet all the eligibility criteria necessary for step 1. For step 2 registration, patients must meet the inclusion criteria necessary for step 2 to be enrolled into the study.

Conditions Studied

Soft Tissue Sarcoma

Interventions

  • DRUG Everolimus
  • DRUG Ribociclib

Study Locations (2)

Massachusetts

  • Dana-Farber Cancer Institute - Boston

Pennsylvania

  • Fox Chase Cancer Center - Philadelphia

Trial Details

FieldValue
Enrollment Target 48 participants
Start Date 2017-08-08
Est. Completion 2025-12
Phase Phase 2

Sponsor

Fox Chase Cancer Center

183 total trials

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT03114527

The ClinicalTrials.gov registry entry for NCT03114527 describes a study currently listed as active not recruiting, categorized as Phase 2. The registered enrollment target is 48 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 78-participant average among 55 other Soft Tissue Sarcoma trials with a reported enrollment target (38% lower). The listed sponsor is Fox Chase Cancer Center, which has 183 total studies on file at ClinicalTrials.gov.

The record links to 1 condition, with Soft Tissue Sarcoma appearing as the primary indexed condition, and to 2 interventions - of which Everolimus is the first listed.

NCT03114527 reports 2 study locations spanning 2 distinct geographic areas - top geographies include Massachusetts, Pennsylvania.

Frequently Asked Questions

What is clinical trial NCT03114527 about?

NCT03114527 is a clinical study titled "Phase II Trial of Ribociclib and Everolimus in Advanced Dedifferentiated Liposarcoma (DDL) and Leiomyosarcoma (LMS)". This is a two center, 2 arm, Phase II study evaluating the combination of Ribociclib and Everolimus in patients with advanced DDL and LMS who have had at least 1 prior systemic therapy. Patients will be enrolled by sarcoma histology into DDL (Arm A) and LMS (Arm B). The purpose of this study is to d...

What is the current status of trial NCT03114527?

This trial is currently active not recruiting. It is a Phase 2 study. The enrollment target is 48 participants. The study started on 2017-08-08. Estimated completion is 2025-12.

What conditions does trial NCT03114527 study?

This clinical trial studies the following conditions: Soft Tissue Sarcoma.

What interventions are being tested in trial NCT03114527?

The interventions under investigation include: Everolimus (DRUG), Ribociclib (DRUG).

Who is sponsoring clinical trial NCT03114527?

This trial is sponsored by Fox Chase Cancer Center, which has 183 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT03114527 being conducted?

This trial has 2 study locations across Massachusetts, Pennsylvania. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

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Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.