Clinical Trial of Lurbinectedin (PM01183) in Platinum Resistant Ovarian Cancer Patients (CORAIL)
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| ClinicalTrials.gov Identifier: NCT02421588 |
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Recruitment Status :
Completed
First Posted : April 20, 2015
Results First Posted : March 5, 2020
Last Update Posted : April 3, 2020
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| 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 |
|---|---|
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Experimental: Arm A
lurbinectedin (PM01183)
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Drug: Lurbinectedin (PM01183) |
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Active Comparator: Arm B
pegylated liposomal doxorubicin OR topotecan |
Drug: Pegylated liposomal doxorubicin (PLD) Drug: Topotecan |
- 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.
- 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.
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| Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
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
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
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Documents provided by PharmaMar:
| 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 |
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Ovarian Neoplasms Carcinoma, Ovarian Epithelial Endocrine Gland Neoplasms Neoplasms by Site Neoplasms Ovarian Diseases Adnexal Diseases Genital Diseases, Female Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Urogenital Diseases Genital Neoplasms, Female Urogenital Neoplasms Genital Diseases 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 |