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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

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).

Condition or disease Intervention/treatment Phase
Ovarian Cancer Drug: Lurbinectedin (PM01183) Drug: Pegylated liposomal doxorubicin (PLD) Drug: Topotecan Phase 3

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 442 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Phase III Randomized Clinical Trial of Lurbinectedin (PM01183) Versus Pegylated Liposomal Doxorubicin or Topotecan in Patients With Platinum-resistant Ovarian Cancer (CORAIL Trial)
Study Start Date : May 2015
Actual Primary Completion Date : October 12, 2018
Actual Study Completion Date : October 12, 2018


Arm Intervention/treatment
Experimental: Arm A
lurbinectedin (PM01183)
Drug: Lurbinectedin (PM01183)
Active Comparator: Arm B

pegylated liposomal doxorubicin

OR

topotecan

Drug: Pegylated liposomal doxorubicin (PLD)
Drug: Topotecan



Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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.

  2. 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).

  3. 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.


  4. 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.


  5. 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.


  6. 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.


  7. 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.




Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02421588


Locations
Show Show 28 study locations
Sponsors and Collaborators
PharmaMar
  Study Documents (Full-Text)

Documents provided by PharmaMar:
Study Protocol  [PDF] December 4, 2014
Statistical Analysis Plan  [PDF] August 30, 2017

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Responsible Party: PharmaMar
ClinicalTrials.gov Identifier: NCT02421588    
Other Study ID Numbers: PM1183-C-004-14
First Posted: April 20, 2015    Key Record Dates
Results First Posted: March 5, 2020
Last Update Posted: April 3, 2020
Last Verified: February 2020
Additional relevant MeSH terms:
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Ovarian Neoplasms
Carcinoma, Ovarian Epithelial
Endocrine Gland Neoplasms
Neoplasms by Site
Neoplasms
Ovarian Diseases
Adnexal Diseases
Genital Diseases, Female
Genital Neoplasms, Female
Urogenital Neoplasms
Endocrine System Diseases
Gonadal Disorders
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Doxorubicin
Liposomal doxorubicin
Topotecan
Antibiotics, Antineoplastic
Antineoplastic Agents
Topoisomerase II Inhibitors
Topoisomerase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Topoisomerase I Inhibitors