TriangleNCT02454972 · CITED IN SOURCE DOCUMENTS
Clinical Trial of Lurbinectedin (PM01183) in Selected Advanced Solid Tumors
An NCI or FDA source cites this study. A citation does not establish that it applies to an individual diagnosis.
- Phase
- PHASE2
- Status at capture
- COMPLETED
- Registry last update
- 2023-03-02
Multicenter, open-label, exploratory, phase II clinical trial to evaluate the efficacy and safety of PM01183 in previously treated patients with advanced solid tumors
Open the original ClinicalTrials.gov record → · Download preserved record
What did the study report?
Outcomes, safety and baseline populations are separate source sections. Quality-of-life measures appear under their original outcome titles.
Participant flow
Baseline characteristics
Overall Response Rate (ORR)
Response by Investigator Assessment
Duration of Response
Clinical Benefit
Disease Control Rate
Progression Free Survival (PFS)
Progression-free Survival at 4 Months
Progression-free Survival at 6 Months
Overall Survival (OS)
Overall Survival at 6 Months
Overall Survival at 12 Months
Adverse events
Limitations, agreements, and source contact
Who could take part
- eligibility Criteria
- Inclusion Criteria: * Age ≥ 18 years. * Voluntary signed informed consent (IC) * Pathologically proven diagnosis of any of the following malignancies: * Small cell lung cancer (SCLC). * Head and neck carcinoma (H\&N). Salivary glands tumors are excluded. * Neuroendocrine tumors (NETs), grade 2 and grade 3 according to World Health Organization classification. * Biliary tract carcinoma. * Endometrial carcinoma. * BRCA 1/2- associated metastatic breast carcinoma * Carcinoma of unknown primary site. * Germ cell tumor (GCTs), excluding immature teratoma, or teratoma with malignant transformation. * Ewing's family of tumors (EFTs) * Prior treatment. Patients must have received: * SCLC, endometrial carcinoma: one prior chemotherapy-containing line. * H\&N, NETs, biliary tract, CUP: one or two prior chemotherapy-containing lines * GCTs: no limit of prior therapy * EFTs: no more than two prior chemotherapy-containing lines in the metastatic/recurrent setting. * BRCA 1/2-associated metastatic breast carcinoma: at least one but no more than three prior chemotherapy-containing lines. * Performance status ≤ 2 \[Eastern Cooperative Oncology Group (ECOG)\] * Adequate major organ function * At least three weeks since the last chemotherapy * Women of childbearing potential must have pregnancy excluded by appropriate testing before study entry Exclusion Criteria: * Prior treatment with PM01183 or trabectedin * Prior or concurrent malignant disease unless in complete remission for more than five years * Known central nervous system (CNS) involvement * Relevant diseases or clinical situations which may increase the patient's risk * Pregnant or breastfeeding women and fertile patients (men and women) who are not using an effective method of contraception
- healthy Volunteers
- false
- minimum Age
- 18 Years
- sex
- ALL
- std Ages
- ADULT
- OLDER_ADULT
Treatment arms and interventions
- arm Groups
- description
- lurbinectedin (PM01183) 4 mg vials of powder for concentrate for solution for infusion
- intervention Names
- Drug: lurbinectedin (PM01183)
- label
- lurbinectedin (PM01183)
- type
- EXPERIMENTAL
- interventions
- arm Group Labels
- lurbinectedin (PM01183)
- name
- lurbinectedin (PM01183)
- type
- DRUG
Study design
- allocation
- NA
- intervention Model
- SINGLE_GROUP
- masking Info
- masking
- NONE
- primary Purpose
- TREATMENT
Enrollment
- count
- 345
- type
- ACTUAL
Registered outcome plans (not posted results)
- primary Outcomes
- description
- 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
- measure
- Overall Response Rate (ORR)
- time Frame
- 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)
- description
- 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.
- measure
- Response by Investigator Assessment
- time Frame
- 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)
- secondary Outcomes
- description
- 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.
- measure
- Duration of Response
- time Frame
- 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)
- description
- Clinical Benefit Rate was defined as Overall Response Rate or Stable Disease lasting over four months (SD ≥ 4 months)
- measure
- Clinical Benefit
- time Frame
- 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)
- description
- Disease Control Rate was defined as Overall Response Rate or Stable Disease
- measure
- Disease Control Rate
- time Frame
- 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
- description
- 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
- measure
- Progression Free Survival (PFS)
- time Frame
- 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
- description
- 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
- measure
- Progression-free Survival at 4 Months
- time Frame
- At 4 months
- description
- 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
- measure
- Progression-free Survival at 6 Months
- time Frame
- At 6 months
- description
- 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.
- measure
- Overall Survival (OS)
- time Frame
- From the date of first infusion to the date of death or last contact, up to an average of 5 years
- description
- Overall Survival at 6 months defined as the probability of being alive after the first infusion at 6 months
- measure
- Overall Survival at 6 Months
- time Frame
- At 6 months
- description
- Overall Survival at 12 months defined as the probability of being alive after the first infusion at 12 months
- measure
- Overall Survival at 12 Months
- time Frame
- At 12 months
Full study description
- brief Summary
- Multicenter, open-label, exploratory, phase II clinical trial to evaluate the efficacy and safety of PM01183 in previously treated patients with advanced solid tumors
- detailed Description
- Patients with relapsed small cell lung cancer (SCLC), head and neck carcinoma (H\&N), neuroendocrine tumors (NETs), biliary tract carcinoma, endometrial carcinoma, BRCA 1/2-associated metastatic breast carcinoma, carcinoma of unknown primary site, germ cell tumors (GCTs), and Ewing's family of tumors (EFTs) will be enrolled in nine different cohorts. Up to 25 evaluable patients are planned to be enrolled in each cohort (50 in the endometrial carcinoma and 100 in the SCLC cohort).
Source references
- references
- citation
- Kristeleit R, Leary A, Delord JP, Moreno V, Oaknin A, Castellano D, Shappiro GI, Fernandez C, Kahatt C, Alfaro V, Siguero M, Rueda D, Zeaiter A, Awada A, Santaballa A, Zaman K, Sehouli J, Subbiah V. Lurbinectedin in patients with pretreated endometrial cancer: results from a phase 2 basket clinical trial and exploratory translational study. Invest New Drugs. 2023 Oct;41(5):677-687. doi: 10.1007/s10637-023-01383-2. Epub 2023 Aug 9.
- pmid
- 37556023
- type
- DERIVED
- citation
- Boni V, Pistilli B, Brana I, Shapiro GI, Trigo J, Moreno V, Castellano D, Fernandez C, Kahatt C, Alfaro V, Siguero M, Zeaiter A, Longo F, Zaman K, Anton A, Paredes A, Huidobro G, Subbiah V. Lurbinectedin, a selective inhibitor of oncogenic transcription, in patients with pretreated germline BRCA1/2 metastatic breast cancer: results from a phase II basket study. ESMO Open. 2022 Oct;7(5):100571. doi: 10.1016/j.esmoop.2022.100571. Epub 2022 Aug 28.
- pmid
- 36037567
- type
- DERIVED
- citation
- Longo-Munoz F, Castellano D, Alexandre J, Chawla SP, Fernandez C, Kahatt C, Alfaro V, Siguero M, Zeaiter A, Moreno V, Sanz-Garcia E, Awada A, Santaballa A, Subbiah V. Lurbinectedin in patients with pretreated neuroendocrine tumours: Results from a phase II basket study. Eur J Cancer. 2022 Sep;172:340-348. doi: 10.1016/j.ejca.2022.06.024. Epub 2022 Jul 10.
- pmid
- 35830841
- type
- DERIVED
- citation
- Subbiah V, Brana I, Longhi A, Boni V, Delord JP, Awada A, Boudou-Rouquette P, Sarantopoulos J, Shapiro GI, Elias A, Ratan R, Fernandez C, Kahatt C, Cullell-Young M, Siguero M, Zeaiter A, Chawla SP. Antitumor Activity of Lurbinectedin, a Selective Inhibitor of Oncogene Transcription, in Patients with Relapsed Ewing Sarcoma: Results of a Basket Phase II Study. Clin Cancer Res. 2022 Jul 1;28(13):2762-2770. doi: 10.1158/1078-0432.CCR-22-0696.
- pmid
- 35486638
- type
- DERIVED
- citation
- Fernandez-Teruel C, Fudio S, Lubomirov R. Integrated exposure-response analysis of efficacy and safety of lurbinectedin to support the dose regimen in small-cell lung cancer. Cancer Chemother Pharmacol. 2022 May;89(5):585-594. doi: 10.1007/s00280-021-04366-3. Epub 2021 Nov 5.
- pmid
- 34739582
- type
- DERIVED
- citation
- Subbiah V, Paz-Ares L, Besse B, Moreno V, Peters S, Sala MA, Lopez-Vilarino JA, Fernandez C, Kahatt C, Alfaro V, Siguero M, Zeaiter A, Zaman K, Lopez R, Ponce S, Boni V, Arrondeau J, Delord JP, Martinez M, Wannesson L, Anton A, Valdivia J, Awada A, Kristeleit R, Olmedo ME, Rubio MJ, Sarantopoulos J, Chawla SP, Mosquera-Martinez J, D' Arcangelo M, Santoro A, Villalobos VM, Sands J, Trigo J. Antitumor activity of lurbinectedin in second-line small cell lung cancer patients who are candidates for re-challenge with the first-line treatment. Lung Cancer. 2020 Dec;150:90-96. doi: 10.1016/j.lungcan.2020.10.003. Epub 2020 Oct 10.
- pmid
- 33096421
- type
- DERIVED
- citation
- Trigo J, Subbiah V, Besse B, Moreno V, Lopez R, Sala MA, Peters S, Ponce S, Fernandez C, Alfaro V, Gomez J, Kahatt C, Zeaiter A, Zaman K, Boni V, Arrondeau J, Martinez M, Delord JP, Awada A, Kristeleit R, Olmedo ME, Wannesson L, Valdivia J, Rubio MJ, Anton A, Sarantopoulos J, Chawla SP, Mosquera-Martinez J, D'Arcangelo M, Santoro A, Villalobos VM, Sands J, Paz-Ares L. Lurbinectedin as second-line treatment for patients with small-cell lung cancer: a single-arm, open-label, phase 2 basket trial. Lancet Oncol. 2020 May;21(5):645-654. doi: 10.1016/S1470-2045(20)30068-1. Epub 2020 Mar 27.
- pmid
- 32224306
- type
- DERIVED
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Discovery and provenance
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- ve in IMforte Figure 2: Kaplan-Meier Plot of Overall Survival in IMforte Figure 1 Figure 2 14.2 Metastatic Small Cell Lung Cancer PM1183-B-005-14 (Study B-005; NCT02454972) is a multicenter, open-label, multi-cohort trial evaluating ZEPZELCA as a single agent in patients with advanced or metastatic solid tumors. A cohort of patie
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Preserved source evidence · Not medical advice