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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
Last Update Posted : October 18, 2018
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

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. Difference in progression-free-survival (PFS) between lurbinectedin (PM01183) and pegylated liposomal doxorubicin (PLD) or topotecan [ Time Frame: 42 months ]

Secondary Outcome Measures :
  1. Overall survival (OS) [ Time Frame: 42 months ]
  2. Patient-reported outcome (PRO) [ Time Frame: 42 months ]
    Using the European Organization for Research and Treatment of Cancer QLQ-C30 and QLQ-OV28 questionnaires

  3. Overall response rate (ORR) [ Time Frame: 42 months ]


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


  Show 28 Study Locations
Sponsors and Collaborators
PharmaMar

Responsible Party: PharmaMar
ClinicalTrials.gov Identifier: NCT02421588     History of Changes
Other Study ID Numbers: PM1183-C-004-14
First Posted: April 20, 2015    Key Record Dates
Last Update Posted: October 18, 2018
Last Verified: October 2018

Additional relevant MeSH terms:
Ovarian Neoplasms
Neoplasms, Glandular and 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
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