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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 : March 2, 2023
Sponsor:
Information provided by (Responsible Party):
PharmaMar

Study Description
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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

Condition or disease Intervention/treatment Phase
Advanced Solid Tumors Drug: lurbinectedin (PM01183) Phase 2

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 Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 345 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Multicenter Phase II Clinical Trial of Lurbinectedin (PM01183) in Selected Advanced Solid Tumors
Actual Study Start Date : August 25, 2015
Actual Primary Completion Date : September 18, 2020
Actual Study Completion Date : September 18, 2020

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: lurbinectedin (PM01183)
lurbinectedin (PM01183) 4 mg vials of powder for concentrate for solution for infusion
 Drug: lurbinectedin (PM01183)


Outcome Measures
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Primary Outcome Measures :
  1. 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

  2. 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.



Secondary Outcome Measures :
  1. 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.

  2. 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)

  3. 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

  4. 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


  5. 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

  6. 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

  7. 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.

  8. 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

  9. 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


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02454972


Locations
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Sponsors and Collaborators
PharmaMar
  Study Documents (Full-Text)

Documents provided by PharmaMar:
Study Protocol  [PDF] June 5, 2020
Statistical Analysis Plan  [PDF] November 11, 2020

More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: PharmaMar
ClinicalTrials.gov Identifier: NCT02454972    
Other Study ID Numbers: PM1183-B-005-14
First Posted: May 27, 2015    Key Record Dates
Results First Posted: November 22, 2021
Last Update Posted: March 2, 2023
Last Verified: February 2023
Additional relevant MeSH terms:
Layout table for MeSH terms
Neoplasms