Clinical Trial of Lurbinectedin (PM01183) in Platinum Resistant Ovarian Cancer Patients (CORAIL)

March 25, 2020 updated by: PharmaMar

Phase III Randomized Clinical Trial of Lurbinectedin (PM01183) Versus Pegylated Liposomal Doxorubicin or Topotecan in Patients With Platinum-resistant Ovarian Cancer (CORAIL Trial)

Multicenter, open-label, randomized, controlled phase III clinical trial to evaluate the activity and safety of PM01183 versus PLD or topotecan as control arm in patients with platinum-resistant ovarian cancer. PM01183 will be explored as single agent in the experimental arm (Arm A) versus PLD or topotecan in the control arm (Arm B).

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

442

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Arizona
      • Peoria, Arizona, United States
        • 1112
    • California
      • Greenbrae, California, United States
        • 1102
      • La Jolla, California, United States
        • 1103
      • Los Angeles, California, United States
        • 1116
      • Los Angeles, California, United States
        • 1120
      • Palo Alto, California, United States
        • 1113
      • San Francisco, California, United States
        • 1111
      • Santa Maria, California, United States
        • 1122
      • West Hills, California, United States
        • 1123
    • Georgia
      • Augusta, Georgia, United States
        • 1109
    • Indiana
      • Indianapolis, Indiana, United States
        • 1104
    • Louisiana
      • Covington, Louisiana, United States
        • 1110
    • Maine
      • Scarborough, Maine, United States
        • 1124
    • New Jersey
      • Brick, New Jersey, United States
        • 1121
    • New York
      • Albany, New York, United States
        • 1127
      • New York, New York, United States
        • 1105
    • North Carolina
      • Asheville, North Carolina, United States
        • 1117
      • Charlotte, North Carolina, United States
        • 1101
      • Charlotte, North Carolina, United States
        • 1125
      • Durham, North Carolina, United States
        • 1108
    • Ohio
      • Columbus, Ohio, United States
        • 1107
      • Dayton, Ohio, United States
        • 1118
    • Pennsylvania
      • Pittsburgh, Pennsylvania, United States
        • 1119
    • South Carolina
      • Greenville, South Carolina, United States
        • 1115
    • Tennessee
      • Nashville, Tennessee, United States
        • 1129
    • Texas
      • Fort Worth, Texas, United States
        • 1131
      • Houston, Texas, United States
        • 1128
    • Virginia
      • Charlottesville, Virginia, United States
        • 1106

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

14 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Age >/= 18 years
  • Confirmed diagnosis of unresectable epithelial ovarian, fallopian tube or primary peritoneal cancer.
  • Platinum-resistant disease (PFI: 1-6 months after last platinum-containing chemotherapy).
  • Evaluable disease according to Response Evaluation Criteria in Solid Tumors (RECIST) v.1.1 criteria
  • No more than three prior systemic chemotherapy regimens
  • Eastern Cooperative Oncology Group (ECOG) performance status (PS) (ECOG PS) ≤ 2
  • Adequate hematological, renal, metabolic and hepatic function

Exclusion Criteria:

  • Concomitant diseases/conditions: cardiac disease, immunodeficiency, chronic active hepatitis or cirrhosis, uncontrolled infection, bowel obstruction, any other major illness
  • Prior treatment with PM01183, trabectedin, or with both PLD and topotecan.
  • Requirement of permanent or frequent (i.e., once per week) external drainages within two weeks prior to randomization

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Arm A
lurbinectedin (PM01183)
Drug: Lurbinectedin (PM01183)
Active Comparator: Arm B

pegylated liposomal doxorubicin

OR

topotecan
Drug: Topotecan
Drug: Pegylated liposomal doxorubicin (PLD)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Progression-free Survival by Independent Review Committee
Time Frame: Time from the date of randomization to the date of PD, death (of any cause), or last tumor evaluation, whichever came first, assessed up to 3 years
The primary endpoint was PFS by IRC assessment, defined as the time from the date of randomization to the date of documented progression per RECIST v.1.1 or death (regardless of the cause of death). If the patient received further antitumor therapy or was lost to follow-up before PD, PFS was censored at the date of last tumor assessment before the date of subsequent antitumor treatment.
Time from the date of randomization to the date of PD, death (of any cause), or last tumor evaluation, whichever came first, assessed up to 3 years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Progression-free Survival by Investigator's Assessment
Time Frame: Time from the date of randomization to the date of PD, death (of any cause), or last tumor evaluation, whichever came first, assessed up to 3 years
The primary endpoint was PFS by Investigator's Assessment, defined as the time from the date of randomization to the date of documented progression per RECIST v.1.1 or death (regardless of the cause of death). If the patient received further antitumor therapy or was lost to follow-up before PD, PFS was censored at the date of last tumor assessment before the date of subsequent antitumor treatment.
Time from the date of randomization to the date of PD, death (of any cause), or last tumor evaluation, whichever came first, assessed up to 3 years
Overall Survival (OS)
Time Frame: From the date of randomization to the date of death or last contact, up to 12 months after last patient inclusion, for a maximum of up to 3 years
Calculated from the date of randomization to the date of death (death event) or last contact (in this case, survival was censored on that date).
From the date of randomization to the date of death or last contact, up to 12 months after last patient inclusion, for a maximum of up to 3 years
Overall Response Rate (ORR) by Independent Review Committee
Time Frame: At baseline and every eight weeks from randomization until evidence of PD, assessed up to 3 years

Best antitumor response defined as the best response obtained according to RECIST v.1.1. Tumor assessment were performed at baseline and every 8 weeks from randomization until evidence of PD. Patients who discontinued treatment without PD continued with assessments.

Antitumor activity was assessed using the RECIST v.1.1 by the appropriate method [computed tomography scan or magnetic resonance imaging]: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Stable Disease (SD): Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum diameters; Progressive Disease (PD): At least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum; Overall Response (OR)=CR+PR.
At baseline and every eight weeks from randomization until evidence of PD, assessed up to 3 years
Overall Response Rate by Investigator's Assessment
Time Frame: At baseline and every eight weeks from randomization until evidence of PD, assessed up to 3 years

Best antitumor response defined as the best response obtained according to RECIST v.1.1. Tumor assessment were performed at baseline and every 8 weeks from randomization until evidence of PD. Patients who discontinued treatment without PD continued with assessments.

Antitumor activity was assessed using the RECIST v.1.1 by the appropriate method [computed tomography scan or magnetic resonance imaging]: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Stable Disease (SD): Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum diameters; Progressive Disease (PD): At least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum; Overall Response (OR)=CR+PR.
At baseline and every eight weeks from randomization until evidence of PD, assessed up to 3 years
Duration of Response by Independent Review Committee
Time Frame: The time from the date when the response criteria (PR or CR, whichever was reached first) were fulfilled, to the first date when PD, recurrence or death was documented, up to 3 years

Duration of response (DR): calculated from the date of first documentation of response per RECIST v.1.1 (CR or PR, whichever came first) to the date of documented PD or death. The censoring rules defined above for PFS were used for duration of response.

Best antitumor response defined as the best response obtained according to RECIST v.1.1. Tumor assessment were performed at baseline and every 8 weeks from randomization until evidence of PD. Patients who discontinued treatment without PD continued with assessments.

Antitumor activity was assessed using the RECIST v.1.1 by the appropriate method [computed tomography scan or magnetic resonance imaging]: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR)=CR+PR.
The time from the date when the response criteria (PR or CR, whichever was reached first) were fulfilled, to the first date when PD, recurrence or death was documented, up to 3 years
Duration of Response by Investigator's Assessment
Time Frame: The time from the date when the response criteria (PR or CR, whichever was reached first) were fulfilled, to the first date when PD, recurrence or death was documented, up to 3 years

Duration of response (DR): calculated from the date of first documentation of response per RECIST v.1.1 (CR or PR, whichever came first) to the date of documented PD or death. The censoring rules defined above for PFS were used for duration of response.

Best antitumor response defined as the best response obtained according to RECIST v.1.1. Tumor assessment were performed at baseline and every 8 weeks from randomization until evidence of PD. Patients who discontinued treatment without PD continued with assessments.

Antitumor activity was assessed using the RECIST v.1.1 by the appropriate method [computed tomography scan or magnetic resonance imaging]: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR)=CR+PR.
The time from the date when the response criteria (PR or CR, whichever was reached first) were fulfilled, to the first date when PD, recurrence or death was documented, up to 3 years
Best Response According to Tumor Marker Evaluation (CA-125)
Time Frame: At baseline and every eight weeks from randomization until evidence of PD, up to 3 years

Best response according to tumor marker evaluation (CA-125): defined as the best response obtained according to GCIG criteria. Tumor marker assessments were performed at baseline and every eight weeks from randomization until evidence of PD. Progression based on serum CA-125 levels was defined on the basis of a progressive serial elevation of serum CA-125 according to:

A. Patients with elevated CA-125 pretreatment and normalization of CA-125 must show evidence of CA-125 greater than, or equal to, 2 times the upper limit of the reference range on 2 occasions at least 1 week apart or B. Patients with elevated CA-125 before treatment, which never normalizes, must show evidence of CA-125 greater than, or equal to, 2 times the nadir value on 2 occasions at least 1 week apart or C. Patients with CA-125 in the reference range before treatment must show evidence of CA-125 greater than, or equal to, 2 times the upper limit of the reference range on 2 occasions at least 1 week apart.
At baseline and every eight weeks from randomization until evidence of PD, up to 3 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

PharmaMar

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2015

Primary Completion (Actual)

October 12, 2018

Study Completion (Actual)

October 12, 2018

Study Registration Dates

First Submitted

April 10, 2015

First Submitted That Met QC Criteria

April 15, 2015

First Posted (Estimate)

April 20, 2015

Study Record Updates

Last Update Posted (Actual)

April 3, 2020

Last Update Submitted That Met QC Criteria

March 25, 2020

Last Verified

February 1, 2020

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PM1183-C-004-14

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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