Trial · NCT02454972
Clinical Trial of Lurbinectedin (PM01183) in Selected Advanced Solid Tumors
NCT02454972, Phase 2, Completed, PharmaMar; results first posted 2021-11-22
3 sourcestrials-2026-11-12-0.5.0
Download JSON
Cite this record
ConductScience Library. Clinical Trial of Lurbinectedin (PM01183) in Selected Advanced Solid Tumors. Trials, record NCT02454972. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02454972
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Clinical Trial of Lurbinectedin (PM01183) in Selected Advanced Solid Tumors
- NCT number
- NCT02454972
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 345 participants, actual
- Lead sponsor
- PharmaMar
- Conditions
- Advanced Solid Tumors
- Interventions
- lurbinectedin (PM01183)
- First posted
- 2015-05-27
- Last updated
- 2023-03-02
- Results first posted
- 2021-11-22
Source ClinicalTrials.gov
Registered outcomes11
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Overall Response Rate (ORR) | From the start of treatment to the date of progression or the start of a subsequent therapy or end of patient's follow-up, until Cycle 6 (21-day cycle) | Overall Response Rate was defined as the percentage of patients with a confirmed response, either CR or PR, according to the RECIST v.1.1. Complete Response (CR): Disappearance of all target lesions; Partial Response (PR): ≥30% decrease in the sum of the longest diameters of target lesions compared with baseline; Progressive disease: ≥20% increase in the sum of the longest diameter of target lesions compared with the smallest-sum longest; diameter recorded or the appearance of one or more new lesions; Stable Disease: Neither PR or PD |
| Primary | Response by Investigator Assessment | From the start of treatment to the date of progression or the start of a subsequent therapy or end of patient's follow-up, until Cycle 6 (21-day cycle) | When response is the primary endpoint, and thus all patients must have measurable disease to enter the trial, all patients included in the study must be accounted for in the report of the results, even if there are major protocol treatment deviations or if they are not evaluable. Each patient will be assigned one of the following: Complete Response: Disappearance of all target lesions; Partial Response: ≥30% decrease in the sum of the longest diameters of target lesions; Progressive disease: ≥20% increase in the sum of the longest diameter of target lesions; diameter recorded or the appearance of one or more new lesions; Stable Disease: Neither PR or PD; Inevaluable for response: specify reasons (for example: early death, malignant disease, toxicity; tumour assessments not repeated/incomplete; other). Normally, all eligible patients should be included in the denominator for the calculation of the response rate for phase II trials. |
| Secondary | Duration of Response | From the start of treatment to the date of progression or the start of a subsequent therapy or end of patient's follow-up, until Cycle 6 (21-day cycle) | Duration of Response by Investigator's Assessment, defined as the time between the date when the response criteria (PR or CR, whichever one is first reached) are fulfilled to the first date when disease progression (PD), recurrence or death is documented. |
| Secondary | Clinical Benefit | From the start of treatment to the date of progression or the start of a subsequent therapy or end of patient's follow-up, until Cycle 6 (21-day cycle) | Clinical Benefit Rate was defined as Overall Response Rate or Stable Disease lasting over four months (SD ≥ 4 months) |
| Secondary | Disease Control Rate | From the start of treatment to the date of progression or the start of a subsequent therapy or end of patient's follow-up, until Cycle 6 | Disease Control Rate was defined as Overall Response Rate or Stable Disease |
| Secondary | Progression Free Survival (PFS) | From the date of first infusion to the date of progression disease, death (of any cause), or last tumor evaluation, up to an average of 5 years | Progression-free Survival (PFS), defined as the period of time from the date of first infusion to the date of PD, death (of any cause), or last tumor evaluation. Progressive disease: ≥20% increase in the sum of the longest diameter of target lesions compared with the smallest-sum longest |
| Secondary | Progression-free Survival at 4 Months | At 4 months | Progression-free Survival at 4, defined as the probability of being free from progression and death after the first infusion at 4 months. Progressive disease: ≥20% increase in the sum of the longest diameter of target lesions compared with the smallest-sum longest |
| Secondary | Progression-free Survival at 6 Months | At 6 months | Progression-free Survival at 6, defined as the probability of being free from progression and death after the first infusion at 6 months. Progressive disease: ≥20% increase in the sum of the longest diameter of target lesions compared with the smallest-sum longest |
| Secondary | Overall Survival (OS) | From the date of first infusion to the date of death or last contact, up to an average of 5 years | Overall survival defined as the period of time from the date of first infusion to the date of death or last contact in case of patients lost to follow-up or alive at the clinical cutoff established for the cohort. |
| Secondary | Overall Survival at 6 Months | At 6 months | Overall Survival at 6 months defined as the probability of being alive after the first infusion at 6 months |
1 to 10 of 11Source ClinicalTrials.gov
See all 11 registered outcomesOutcomes11
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Overall Response Rate (ORR) | From the start of treatment to the date of progression or the start of a subsequent therapy or end of patient's follow-up, until Cycle 6 (21-day cycle) | Treated patients and with disease measurement | percentage of participants | NUMBER |
| PRIMARY | Response by Investigator Assessment | From the start of treatment to the date of progression or the start of a subsequent therapy or end of patient's follow-up, until Cycle 6 (21-day cycle) | Treated patients with disease measurement | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Duration of Response | From the start of treatment to the date of progression or the start of a subsequent therapy or end of patient's follow-up, until Cycle 6 (21-day cycle) | Patients with response to treatment | months | MEDIAN |
| SECONDARY | Clinical Benefit | From the start of treatment to the date of progression or the start of a subsequent therapy or end of patient's follow-up, until Cycle 6 (21-day cycle) | Treated patients with disease measurement | percentage of participants | NUMBER |
| SECONDARY | Disease Control Rate | From the start of treatment to the date of progression or the start of a subsequent therapy or end of patient's follow-up, until Cycle 6 | Treated patients with disease measurement | percentage of paticipants | NUMBER |
| SECONDARY | Progression Free Survival (PFS) | From the date of first infusion to the date of progression disease, death (of any cause), or last tumor evaluation, up to an average of 5 years | Treated patients with disease measurement | months | MEDIAN |
| SECONDARY | Progression-free Survival at 4 Months | At 4 months | Treated patients with disease measurement | percentage of participants | NUMBER |
| SECONDARY | Progression-free Survival at 6 Months | At 6 months | Treated patients with disease measurement | percentage of participants | NUMBER |
| SECONDARY | Overall Survival (OS) | From the date of first infusion to the date of death or last contact, up to an average of 5 years | Treated patients with disease measurement | months | MEDIAN |
| SECONDARY | Overall Survival at 6 Months | At 6 months | Treated patients with disease measurement | percentage of participants | NUMBER |
1 to 10 of 11Source ClinicalTrials.gov
See all 11 outcomesResults by group133
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Overall Response Rate (ORR) | Biliary Tract Carcinoma Cohort | 5.6 | 95% Confidence Interval 0.1 to 27.3 | percentage of participants | |
| Overall Response Rate (ORR) | Carcinoma of Unknown Primary Site Cohort | 0.0 | 95% Confidence Interval 0.0 to 17.6 | percentage of participants | |
| Overall Response Rate (ORR) | Endometrial Carcinoma Cohort | 11.3 | 95% Confidence Interval 5.0 to 21.0 | percentage of participants | |
| Overall Response Rate (ORR) | Ewing's Family of Tumors Cohort | 14.3 | 95% Confidence Interval 4.0 to 32.7 | percentage of participants | |
| Overall Response Rate (ORR) | Germ Cell Tumors Cohort | 4.3 | 95% Confidence Interval 0.1 to 21.9 | percentage of participants | |
| Overall Response Rate (ORR) | Head and Neck Carcinoma Cohort | 0.0 | 95% Confidence Interval 0.0 to 24.7 | percentage of participants | |
| Overall Response Rate (ORR) | BRCA1/2-associated Metastatic Breast Carcinoma Cohort | 28.6 | 95% Confidence Interval 11.3 to 55.2 | percentage of participants | |
| Overall Response Rate (ORR) | Neuroendocrine Tumors Cohort | 6.5 | 95% Confidence Interval 0.8 to 21.4 | percentage of participants | |
| Overall Response Rate (ORR) | Small Cell Lung Cancer Cohort | 36.2 | 95% Confidence Interval 27.0 to 46.1 | percentage of participants | |
| Response by Investigator Assessment | Biliary Tract Carcinoma Cohort | Complete Response | 0 | Participants |
1 to 10 of 133Source ClinicalTrials.gov
See all 133 results by groupParticipant flow36
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Biliary Tract Carcinoma Cohort | 19 | |
| Overall Study | STARTED | Carcinoma of Unknown Primary Site Cohort | 19 | |
| Overall Study | STARTED | Endometrial Carcinoma Cohort | 76 | |
| Overall Study | STARTED | Ewing's Family of Tumors Cohort | 29 | |
| Overall Study | STARTED | Germ Cell Tumors Cohort | 24 | |
| Overall Study | STARTED | Head and Neck Carcinoma Cohort | 15 | |
| Overall Study | STARTED | BRCA1/2-associated Metastatic Breast Carcinoma Cohort | 21 | |
| Overall Study | STARTED | Neuroendocrine Tumors Cohort | 32 | |
| Overall Study | STARTED | Small Cell Lung Cancer Cohort | 110 | |
| Overall Study | Treated | Biliary Tract Carcinoma Cohort | 19 |
1 to 10 of 36Source ClinicalTrials.gov
See all 36 participant flowAdverse events128
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 | Anaemia | Blood and lymphatic system disorders | Lurbinectedin (PM01183) | 59 | 335 | 100 |
| other | Neutropenia | Blood and lymphatic system disorders | Lurbinectedin (PM01183) | 89 | 335 | 174 |
| other | Abdominal pain | Gastrointestinal disorders | Lurbinectedin (PM01183) | 54 | 335 | 83 |
| other | Abdominal pain upper | Gastrointestinal disorders | Lurbinectedin (PM01183) | 19 | 335 | 21 |
| other | Constipation | Gastrointestinal disorders | Lurbinectedin (PM01183) | 116 | 335 | 189 |
| other | Diarrhoea | Gastrointestinal disorders | Lurbinectedin (PM01183) | 62 | 335 | 104 |
| other | Nausea | Gastrointestinal disorders | Lurbinectedin (PM01183) | 167 | 335 | 276 |
| other | Vomiting | Gastrointestinal disorders | Lurbinectedin (PM01183) | 76 | 335 | 126 |
| other | Asthenia | General disorders | Lurbinectedin (PM01183) | 129 | 335 | 335 |
| other | Chest pain | General disorders | Lurbinectedin (PM01183) | 23 | 335 | 28 |
1 to 10 of 128Source ClinicalTrials.gov
See all 128 adverse eventsAdverse event totals3
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Lurbinectedin (PM01183) | 261 | 335 |
| Total, other adverse events | Lurbinectedin (PM01183) | 330 | 335 |
| Total, serious adverse events | Lurbinectedin (PM01183) | 136 | 335 |
Source ClinicalTrials.gov
Papers7
The papers the trial lists on ClinicalTrials.gov.
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 comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
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.
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/NCT02454972
GET https://conductscience.org/api/trials/v1/NCT02454972/results?page=2