Ovarian CancerPhase 3CORAILNCT02421588
Clinical Trial of Lurbinectedin (PM01183) in Platinum Resistant Ovarian Cancer Patients
A Phase 3 study testing Lurbinectedin (PM01183), Pegylated liposomal doxorubicin (PLD) and Topotecan in people with Ovarian Cancer, run by PharmaMar at 28 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Ovarian Cancer
- What is being tested?
- Lurbinectedin (PM01183), Pegylated liposomal doxorubicin (PLD) and Topotecan
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 442 participants
- Where
- 28 sitesUnited States
- Study dates
- May 2015to 12 Oct 2018
- Phase
- Phase 3
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
28 sites in 1 country.
28 sites in 1 country
United States28 sites
1127
Albany, New York
1117
Asheville, North Carolina
1109
Augusta, Georgia
1121
Brick, New Jersey
1101
Charlotte, North Carolina
1125
Charlotte, North Carolina
1106
Charlottesville, Virginia
1107
Columbus, Ohio
1110
Covington, Louisiana
1118
Dayton, Ohio
1108
Durham, North Carolina
1131
Fort Worth, Texas
1102
Greenbrae, California
1115
Greenville, South Carolina
1128
Houston, Texas
1104
Indianapolis, Indiana
1103
La Jolla, California
1116
Los Angeles, California
1120
Los Angeles, California
1129
Nashville, Tennessee
1105
New York, New York
1113
Palo Alto, California
1112
Peoria, Arizona
1119
Pittsburgh, Pennsylvania
1111
San Francisco, California
1122
Santa Maria, California
1124
Scarborough, Maine
1123
West Hills, California
About this study
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)
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).
- Conditions
- Ovarian Cancer
- Being tested
- Lurbinectedin (PM01183), Pegylated liposomal doxorubicin (PLD), Topotecan
- Medical subject headings
- Ovarian Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Lurbinectedin (PM01183)Drug
Pegylated liposomal doxorubicin (PLD)Drug
TopotecanDrug
| Study group | Role | What they receive |
|---|---|---|
| Arm A | Experimental | lurbinectedin (PM01183) Receives: Drug: Lurbinectedin (PM01183) |
| Arm B | Active comparator | pegylated liposomal doxorubicin
OR
topotecan Receives: Drug: Pegylated liposomal doxorubicin (PLD); Drug: Topotecan |
What is being measured
The primary outcome is the main question the study is designed to answer.
Progression-free Survival by Independent Review Committee
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.
Measured: 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 outcomes (7)
Progression-free Survival by Investigator's Assessment
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.
Measured: 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)
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).
Measured: 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
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.
Measured: At baseline and every eight weeks from randomization until evidence of PD, assessed up to 3 years
Overall Response Rate by Investigator's Assessment
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.
Measured: At baseline and every eight weeks from randomization until evidence of PD, assessed up to 3 years
Duration of Response by Independent Review Committee
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.
Measured: 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
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.
Measured: 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)
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:
- 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.
Measured: At baseline and every eight weeks from randomization until evidence of PD, up to 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Apr 2015 (estimated)
- Study startMay 2015
- Primary completion12 Oct 2018
- Study completion12 Oct 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Ovarian CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 442 participants (actual)
Sponsor and investigators
- Lead sponsor
- PharmaMar
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02421588
- Sponsor's protocol ID
- PM1183-C-004-14
- Acronym
- CORAIL
- Status last verified
- Feb 2020
- First submitted
- 10 Apr 2015
- Last updated
- 3 Apr 2020
- Results posted
- Yes, on ClinicalTrials.gov
Publications
Newhouse R, Nelissen E, El-Shakankery KH, Rogozinska E, Bain E, Veiga S, Morrison J. Pegylated liposomal doxorubicin for relapsed epithelial ovarian cancer. Cochrane Database Syst Rev. 2023 Jul 5;7(7):CD006910. doi: 10.1002/14651858.CD006910.pub3.
PubMed 37407274Gaillard S, Oaknin A, Ray-Coquard I, Vergote I, Scambia G, Colombo N, Fernandez C, Alfaro V, Kahatt C, Nieto A, Zeaiter A, Aracil M, Vidal L, Pardo-Burdalo B, Papai Z, Kristeleit R, O'Malley DM, Benjamin I, Pautier P, Lorusso D. Lurbinectedin versus pegylated liposomal doxorubicin or topotecan in patients with platinum-resistant ovarian cancer: A multicenter, randomized, controlled, open-label phase 3 study (CORAIL). Gynecol Oncol. 2021 Nov;163(2):237-245. doi: 10.1016/j.ygyno.2021.08.032. Epub 2021 Sep 11.
PubMed 34521554
Study at a glance
From the registry record, last updated by the sponsor on 3 Apr 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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)
- ClinicalTrials.gov ID
- NCT02421588
- Acronym / sponsor ID
- CORAIL / PM1183-C-004-14
- Conditions
- Ovarian Cancer
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 442 participants (actual)
- Lead sponsor
- PharmaMarIndustry (pharma, biotech, devices)
- Study start
- May 2015
- Primary completion
- 12 Oct 2018 (actual)
- Study completion
- 12 Oct 2018 (actual)
- First posted
- 20 Apr 2015 (estimated)
- Results
- Posted 5 Mar 2020
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Arm A | Experimental | Drug: Lurbinectedin (PM01183)lurbinectedin (PM01183) |
| Arm B | Active comparator | Drug: Pegylated liposomal doxorubicin (PLD), Drug: Topotecanpegylated liposomal doxorubicin OR topotecan |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Lurbinectedin (PM01183) | Drug | Arm A |
| Pegylated liposomal doxorubicin (PLD) | Drug | Arm B |
| Topotecan | Drug | Arm B |
Primary outcome
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.
7 secondary outcomes
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
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
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
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
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 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
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
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Apr 2020.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 37407274Newhouse R, Nelissen E, El-Shakankery KH, Rogozinska E, Bain E, Veiga S, Morrison J. Pegylated liposomal doxorubicin for relapsed epithelial ovarian cancer. Cochrane Database Syst Rev. 2023 Jul 5;7(7):CD006910. doi: 10.1002/14651858.CD006910.pub3.
- Derived from this study: PubMed 34521554Gaillard S, Oaknin A, Ray-Coquard I, Vergote I, Scambia G, Colombo N, Fernandez C, Alfaro V, Kahatt C, Nieto A, Zeaiter A, Aracil M, Vidal L, Pardo-Burdalo B, Papai Z, Kristeleit R, O'Malley DM, Benjamin I, Pautier P, Lorusso D. Lurbinectedin versus pegylated liposomal doxorubicin or topotecan in patients with platinum-resistant ovarian cancer: A multicenter, randomized, controlled, open-label phase 3 study (CORAIL). Gynecol Oncol. 2021 Nov;163(2):237-245. doi: 10.1016/j.ygyno.2021.08.032. Epub 2021 Sep 11.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
28 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Lurbinectedin (PM01183), Pegylated liposomal doxorubicin (PLD) and Topotecan in people with Ovarian Cancer, run by PharmaMar at 28 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 Apr 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 28 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 5 Mar 2020). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02421588, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Apr 2020.