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

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ClinicalTrials.gov Identifier: NCT02421588
Recruitment Status : Completed
First Posted : April 20, 2015
Results First Posted : March 5, 2020
Last Update Posted : April 3, 2020
Sponsor:
Information provided by (Responsible Party):
PharmaMar

Tracking Information
First Submitted Date  ICMJE April 10, 2015
First Posted Date  ICMJE April 20, 2015
Results First Submitted Date  ICMJE February 19, 2020
Results First Posted Date  ICMJE March 5, 2020
Last Update Posted Date April 3, 2020
Study Start Date  ICMJE May 2015
Actual Primary Completion Date October 12, 2018   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: February 19, 2020)
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.
Original Primary Outcome Measures  ICMJE
 (submitted: April 15, 2015)
Difference in progression-free-survival (PFS) between lurbinectedin (PM01183) and pegylated liposomal doxorubicin (PLD) or topotecan [ Time Frame: 42 months ]
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: March 25, 2020)
  • 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.
  • 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).
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
Original Secondary Outcome Measures  ICMJE
 (submitted: April 15, 2015)
  • Overall Survival (OS) [ Time Frame: 42 months ]
  • Patient-reported outcome (PRO) [ Time Frame: 42 months ]
    Using the European Organization for Research and Treatment of Cancer QLQ-C30 and QLQ-OV28 questionnaires
  • Overall response rate (ORR) [ Time Frame: 42 months ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Clinical Trial of Lurbinectedin (PM01183) in Platinum Resistant Ovarian Cancer Patients
Official Title  ICMJE Phase III Randomized Clinical Trial of Lurbinectedin (PM01183) Versus Pegylated Liposomal Doxorubicin or Topotecan in Patients With Platinum-resistant Ovarian Cancer (CORAIL Trial)
Brief Summary 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).
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Ovarian Cancer
Intervention  ICMJE
  • Drug: Lurbinectedin (PM01183)
  • Drug: Pegylated liposomal doxorubicin (PLD)
  • Drug: Topotecan
Study Arms  ICMJE
  • Experimental: Arm A
    lurbinectedin (PM01183)
    Intervention: Drug: Lurbinectedin (PM01183)
  • Active Comparator: Arm B

    pegylated liposomal doxorubicin

    OR

    topotecan

    Interventions:
    • Drug: Pegylated liposomal doxorubicin (PLD)
    • Drug: Topotecan
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: October 16, 2018)
442
Original Estimated Enrollment  ICMJE
 (submitted: April 15, 2015)
420
Actual Study Completion Date  ICMJE October 12, 2018
Actual Primary Completion Date October 12, 2018   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02421588
Other Study ID Numbers  ICMJE PM1183-C-004-14
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party PharmaMar
Study Sponsor  ICMJE PharmaMar
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account PharmaMar
Verification Date February 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP