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Ribociclib (Ribociclib (LEE-011)) With Platinum-based Chemotherapy in Recurrent Platinum Sensitive Ovarian Cancer

NCT03056833 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 35

Last updated 2022-09-07

No results posted yet for this study

Summary

Investigators hypothesize that concurrent ribociclib treatment and chemotherapy will enhance the response to platinum-based therapy and maintenance therapy will slow ovarian cancer tumor growth leading to prolongation in progression free survival.

Conditions

Interventions

DRUG

ribociclib

Ribociclib (LEE-011) will be given on days 1-4, 8-11, and 15-18 of a 28 day cycle at 200, 400, or 600mg/day during the dose escalation phase. During the maintenance phase, ribociclib (LEE-011) will be given at 600mg/day, 3 weeks on, 1 week off until progression.

DRUG

Paclitaxel

During the escalation phase Paclitaxel will be given on days 1, 8, and 15 of a 28 day cycle.

DRUG

Carboplatin

During the escalation phase Carboplatin will be given on days 1, 8, and 15 of a 28 day cycle.

Sponsors & Collaborators

  • Ronald Buckanovich

    lead OTHER

Principal Investigators

  • Lan G Coffman, M.D. · University of Pittsburgh Medical Center

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-06-10
Primary Completion
2020-06-01
Completion
2022-08-01
FDA Drug
Yes

Countries

  • United States

Study Locations

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Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03056833 on ClinicalTrials.gov