Trial · NCT02421588

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

NCT02421588, Phase 3, Completed, PharmaMar; results first posted 2020-03-05

3 sourcestrials-2026-11-12-0.5.0

Cite this record

ConductScience Library. Clinical Trial of Lurbinectedin (PM01183) in Platinum Resistant Ovarian Cancer Patients. Trials, record NCT02421588. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02421588

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Trial

As registered on ClinicalTrials.gov, in the graph's capture of the registry.

Title: Clinical Trial of Lurbinectedin (PM01183) in Platinum Resistant Ovarian Cancer Patients
NCT number: NCT02421588
Status: Completed
Phases: Phase 3
Enrollment: 442 participants, actual
Lead sponsor: PharmaMar
Conditions: Ovarian Cancer
Interventions: Lurbinectedin (PM01183), Pegylated liposomal doxorubicin (PLD), Topotecan
First posted: 2015-04-20
Last updated: 2020-04-03
Results first posted: 2020-03-05

Source ClinicalTrials.gov

Registered outcomes8

Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.

List	Outcome	Time frame	Description
Primary	Progression-free Survival by Independent Review Committee	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	Progression-free Survival by Investigator's Assessment	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.
Secondary	Overall Survival (OS)	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).
Secondary	Overall Response Rate (ORR) by Independent Review Committee	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.
Secondary	Overall Response Rate by Investigator's Assessment	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.
Secondary	Duration of Response by Independent Review Committee	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.
Secondary	Duration of Response by Investigator's Assessment	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.
Secondary	Best Response According to Tumor Marker Evaluation (CA-125)	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.

Source ClinicalTrials.gov

Outcomes8

Each outcome the trial posted results for, in ClinicalTrials.gov's words.

Type	Outcome	Time frame	Population	Units	Measured as
PRIMARY	Progression-free Survival by Independent Review Committee	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		months	MEDIAN
SECONDARY	Progression-free Survival by Investigator's Assessment	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		months	MEDIAN
SECONDARY	Overall Survival (OS)	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		months	MEDIAN
SECONDARY	Overall Response Rate (ORR) by Independent Review Committee	At baseline and every eight weeks from randomization until evidence of PD, assessed up to 3 years		Participants	COUNT_OF_PARTICIPANTS
SECONDARY	Overall Response Rate by Investigator's Assessment	At baseline and every eight weeks from randomization until evidence of PD, assessed up to 3 years		Participants	COUNT_OF_PARTICIPANTS
SECONDARY	Duration of Response by Independent Review Committee	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	Patients who have CR or PR	months	MEDIAN
SECONDARY	Duration of Response by Investigator's Assessment	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	Patients who have CR or PR	months	MEDIAN
SECONDARY	Best Response According to Tumor Marker Evaluation (CA-125)	At baseline and every eight weeks from randomization until evidence of PD, up to 3 years		Participants	COUNT_OF_PARTICIPANTS

Source ClinicalTrials.gov

Results by group40

Each measurement the trial posted, group by group, in the words and numbers it posted.

Outcome	Group	Category	Value	Spread	Units
Progression-free Survival by Independent Review Committee	Lurbinectedin		3.5	95% Confidence Interval 2.1 to 3.7	months
Progression-free Survival by Independent Review Committee	Control (PLD or Topotecan)		3.6	95% Confidence Interval 2.7 to 3.8	months
Progression-free Survival by Investigator's Assessment	Lurbinectedin		3.7	95% Confidence Interval 3.6 to 3.9	months
Progression-free Survival by Investigator's Assessment	Control (PLD or Topotecan)		3.7	95% Confidence Interval 3.5 to 4.0	months
Overall Survival (OS)	Lurbinectedin		11.4	95% Confidence Interval 9.0 to 14.2	months
Overall Survival (OS)	Control (PLD or Topotecan)		10.9	95% Confidence Interval 9.3 to 12.5	months
Overall Response Rate (ORR) by Independent Review Committee	Lurbinectedin	Complete response	3		Participants
Overall Response Rate (ORR) by Independent Review Committee	Control (PLD or Topotecan)	Complete response	3		Participants
Overall Response Rate (ORR) by Independent Review Committee	Lurbinectedin	Partial response	29		Participants
Overall Response Rate (ORR) by Independent Review Committee	Control (PLD or Topotecan)	Partial response	25		Participants

1 to 10 of 40Source ClinicalTrials.gov

See all 40 results by group

Participant flow6

How many started, completed or left each group, period by period.

Period	Milestone	Group	Participants
Overall Study	STARTED	Lurbinectedin	221
Overall Study	STARTED	Control (PLD or Topotecan)	221
Overall Study	COMPLETED	Lurbinectedin	0
Overall Study	COMPLETED	Control (PLD or Topotecan)	0
Overall Study	NOT COMPLETED	Lurbinectedin	221
Overall Study	NOT COMPLETED	Control (PLD or Topotecan)	221

Source ClinicalTrials.gov

Adverse events244

Each adverse event the trial posted, group by group: the participants affected out of those at risk.

Type	Event	Organ system	Group	Affected	At risk	Events
other	Hypertension	Vascular disorders	Lurbinectedin	12	219	22
other	Hypertension	Vascular disorders	Control (PLD or Topotecan)	4	213	9
other	Weight decreased	Investigations	Lurbinectedin	10	219	14
other	Weight decreased	Investigations	Control (PLD or Topotecan)	14	213	16
other	Cough	Respiratory, thoracic and mediastinal disorders	Lurbinectedin	17	219	19
other	Cough	Respiratory, thoracic and mediastinal disorders	Control (PLD or Topotecan)	26	213	33
other	Dyspnoea	Respiratory, thoracic and mediastinal disorders	Lurbinectedin	29	219	37
other	Dyspnoea	Respiratory, thoracic and mediastinal disorders	Control (PLD or Topotecan)	23	213	34
other	Anaemia	Blood and lymphatic system disorders	Lurbinectedin	57	219	155
other	Anaemia	Blood and lymphatic system disorders	Control (PLD or Topotecan)	77	213	201

1 to 10 of 244Source ClinicalTrials.gov

See all 244 adverse events

Adverse event totals6

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	Lurbinectedin	170	219
Total, all-cause mortality	Control (PLD or Topotecan)	171	213
Total, other adverse events	Lurbinectedin	212	219
Total, other adverse events	Control (PLD or Topotecan)	211	213
Total, serious adverse events	Lurbinectedin	92	219
Total, serious adverse events	Control (PLD or Topotecan)	85	213

Source ClinicalTrials.gov

Papers2

The papers the trial lists on ClinicalTrials.gov.

PMID	Listed as	Source
34521554	DERIVED	PubMed
37407274	DERIVED	PubMed

Grants0

The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.

None in this release.

Trial comparisons2

Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.

Comparison	Source
Lurbinectedin vs Control (PLD or Topotecan): deaths from any cause	Trial comparisons
Lurbinectedin vs Control (PLD or Topotecan): serious adverse events	Trial comparisons

Tests0

The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.

None in this release.

Data dates

The day each source was copied for this release.

ClinicalTrials.gov: 2026-11-12; ClinicalTrials.gov
Results, from AACT: 2026-03-23; AACT
NIH grant links: 2026-11-13; NIH RePORTER

Sources 3

ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
ClinicalTrials.govNo license stated
NIH RePORTER's clinical studies and project filesPublic domain

Each source's terms

ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
ClinicalTrials.govnone stated
NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)

ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.

For software

Read this trial from software.

The record and each of its lists are JSON, twenty rows a page. No key.

GET https://conductscience.org/api/trials/v1/NCT02421588

GET https://conductscience.org/api/trials/v1/NCT02421588/results?page=2

API reference For AI assistants