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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: Active Phase 2 study of Soft Tissue Sarcoma, sponsored by Fox Chase Cancer Center.
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. According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
Progression free rate
Conditions Studied
Interventions
- DRUG Everolimus
- DRUG Ribociclib
Study Locations (2)
Massachusetts
- Dana-Farber Cancer Institute - Boston
Pennsylvania
- Fox Chase Cancer Center - Philadelphia
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 48 participants |
| Start Date | 2017-08-08 |
| Est. Completion | 2025-12 |
| Phase | Phase 2 |
What the registry record for NCT03114527 still lists
NCT03114527 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 48 participants, a relatively small participant target, below the 78-participant average among 55 other Soft Tissue Sarcoma trials with a reported enrollment target (38% lower).
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 a single indexed study location in 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.
Learn More About Clinical Trials
Similar trials for Soft Tissue Sarcoma
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT03114527's enrollment target sits among peer trials
48 22nd of 55 higher than 33 of 55 other Soft Tissue Sarcoma trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Soft Tissue Sarcoma trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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