Reprab Study: PLD + Trabectedin Rechallenge | NCT04887961

Studies
Reprab Study: PLD + Trabectedin Rechallenge

NCT04887961

Sponsor

Fondazione Policlinico Universitario Agostino Gemelli IRCCS

Status

Unknown status

Last Update Posted

Aug 9, 2021Actual

Enrollment

64Estimated

Phase

Phase 2

Conditions

Relapsed Ovarian Cancer

Interventions

PLD and Trabectedin rechallenge

Countries

Italy

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Aug 2021

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Oct 1, 2020Actual

Primary Completion Date

Apr 1, 2022Estimated

Completion Date

Apr 1, 2022Estimated

First Submitted Date

Mar 3, 2021

First Submission Date that Met QC Criteria

May 12, 2021

First Posted Date

May 14, 2021Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Aug 5, 2021

Last Update Posted Date

Aug 9, 2021Actual

Description Module

Brief Summary

RECHALLENGE WITH PEGYLATED LIPOSOMAL DOXORUBICIN ADDED TO TRABECTEDIN IN RECURRENT OVARIAN CANCER: A MULTICENTER, PROSPECTIVE TRIAL

Detailed Description

To demonstrate that rechallenge with pegylated liposomal doxorubicin (PLD) with the combination of trabectedin (Yondelis®) is active (objective response rate) in relapsed ovarian cancer patients who have already received pegylated liposomal doxorubicin and progress within 6-12 months after the end of last platinum or in fully platinum sensitive patients not able to receive or not willing to receive other platinum treatments

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 2

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

64Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Single Arm	Experimental	PLD 30 mg/mq 1 h iv + Trabectedin 1.1 mg/mq 3 h iv d1q21 up to 6 cycles or PD.	Drug: PLD and Trabectedin rechallenge

Interventions

Name	Type	Description	Arm Group Labels	Other Names
PLD and Trabectedin rechallenge	Drug	Platinum partially sensitive patients i.e. patients who recur with a platinum free interval between 6 and 12 months, who have previously received pegylated liposomal doxorubicin and are suitable for rechallenge with pegylated liposomal doxorubicin (PLD) with the combination of trabectedin (Yondelis®) and relapsed ovarian cancer fully platinum sensitive patients not able to receive or not willing to receive other platinum treatments

Measure	Description	Time Frame
Objective Response Rate		30 months

Eligibility Module

Eligibility Criteria

Inclusion criteria:

Female aged ≥ 18 years.
Histologically or cytologically documented invasive epithelial ovarian cancer, primary peritoneal carcinoma, or fallopian tube cancer
Platinum partially sensitive patients or fully platinum sensitive patients not able to receive or not willing to receive other platinum treatments, who have previously received pegylated liposomal doxorubicin (carboplatin- pegylated liposomal doxorubicin or pegylated liposomal doxorubicin alone).
Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) 0- 1.
Subject has radiographically-documented measurable disease, as per RECIST 1.1 at study entry (CA-125 rise not supported by radiological evidence of disease is not accepted as criteria for defining progression).
Be able to receive IV dexamethasone or an equivalent IV corticosteroid.
Have all of the following:

hemoglobin ≥9 g/dL (without transfusion in the prior 7 days). Subjects may be enrolled into the study while receiving recombinant erythropoietin provide they have received recombinant erythropoietin for at least 4 weeks. before the first dose of study drug.

albumin >25 g/L absolute neutrophil count (ANC) >1,500/μL platelet count >100,000/μL (without transfusion in the prior 7 days) either a serum creatinine <=1.5 mg/dL or a calculated glomerular filtration rate >60 mL/min/1.73 m2 (Cockcroft-Gault) CPK <2.5 x upper limit of normal (ULN) Have total bilirubin <xULN. If total bilirubin is > 1,5xULN, measure direct and indirect bilirubin to evaluate for Gilbert's syndrome (if direct bilirubin is within normal range, subject may be eligible).

Have alkaline phosphatase (ALP) 2.5xULN; if the ALP is >2.5xULN, then an ALP liver fraction or 5' nucleotidase must be \

Accepts Healthy Volunteers

Sex

Female

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

ID	Term
D004701	Endocrine Gland Neoplasms
D009371	Neoplasms by Site
D009369	Neoplasms
D010049	Ovarian Diseases