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Clinical Trial of Lurbinectedin (PM01183) in Selected Advanced Solid Tumors

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ClinicalTrials.gov Identifier: NCT02454972
Recruitment Status : Completed
First Posted : May 27, 2015
Results First Posted : November 22, 2021
Last Update Posted : November 22, 2021
Sponsor:
Information provided by (Responsible Party):
PharmaMar

Tracking Information
First Submitted Date  ICMJE May 6, 2015
First Posted Date  ICMJE May 27, 2015
Results First Submitted Date  ICMJE September 17, 2021
Results First Posted Date  ICMJE November 22, 2021
Last Update Posted Date November 22, 2021
Actual Study Start Date  ICMJE August 25, 2015
Actual Primary Completion Date September 18, 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: October 21, 2021)
  • 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) ]
    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
  • 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) ]
    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.
Original Primary Outcome Measures  ICMJE
 (submitted: May 21, 2015)
Overall response rate (ORR) [ Time Frame: Every two cycles until Cycle 6 or evidence of progression disease (1 cycle duration: 3 weeks) ]
Overall response rate (ORR), defined as the percentage of evaluable patients with a confirmed response, either complete (CR) or partial (PR).
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: October 21, 2021)
  • 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) ]
    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.
  • 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) ]
    Clinical Benefit Rate was defined as Overall Response Rate or Stable Disease lasting over four months (SD ≥ 4 months)
  • 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 ]
    Disease Control Rate was defined as Overall Response Rate or Stable Disease
  • 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 ]
    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
  • Progression-free Survival at 4 Months [ Time Frame: 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
  • Progression-free Survival at 6 Months [ Time Frame: 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
  • 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 ]
    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.
  • Overall Survival at 6 Months [ Time Frame: At 6 months ]
    Overall Survival at 6 months defined as the probability of being alive after the first infusion at 6 months
  • Overall Survival at 12 Months [ Time Frame: At 12 months ]
    Overall Survival at 12 months defined as the probability of being alive after the first infusion at 12 months
Original Secondary Outcome Measures  ICMJE
 (submitted: May 21, 2015)
  • Duration of response (DR) [ Time Frame: Every two cycles until Cycle 6 or evidence of progression disease (1 cycle duration: 3 weeks) ]
  • Progression free survival (PFS) [ Time Frame: Every two cycles until Cycle 6 or evidence of progression disease (1 cycle duration: 3 weeks) ]
  • 1 year overall survival (1y-OS) [ Time Frame: Every two cycles until Cycle 6 or evidence of progression disease (1 cycle duration: 3 weeks) ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Clinical Trial of Lurbinectedin (PM01183) in Selected Advanced Solid Tumors
Official Title  ICMJE A Multicenter Phase II Clinical Trial of Lurbinectedin (PM01183) in Selected Advanced Solid Tumors
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).
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Advanced Solid Tumors
Intervention  ICMJE Drug: lurbinectedin (PM01183)
Study Arms  ICMJE Experimental: lurbinectedin (PM01183)
lurbinectedin (PM01183) 4 mg vials of powder for concentrate for solution for infusion
Intervention: Drug: lurbinectedin (PM01183)
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: December 20, 2018)
345
Original Estimated Enrollment  ICMJE
 (submitted: May 21, 2015)
225
Actual Study Completion Date  ICMJE September 18, 2020
Actual Primary Completion Date September 18, 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Belgium,   France,   Germany,   Italy,   Spain,   Sweden,   Switzerland,   United Kingdom,   United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02454972
Other Study ID Numbers  ICMJE PM1183-B-005-14
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Current Responsible Party PharmaMar
Original Responsible Party Same as current
Current Study Sponsor  ICMJE PharmaMar
Original Study Sponsor  ICMJE Same as current
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account PharmaMar
Verification Date October 2021

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP