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

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ClinicalTrials.gov Identifier: NCT02454972
Recruitment Status : Active, not recruiting
First Posted : May 27, 2015
Last Update Posted : March 13, 2020
Sponsor:
Information provided by (Responsible Party):
PharmaMar

Tracking Information
First Submitted Date  ICMJE May 6, 2015
First Posted Date  ICMJE May 27, 2015
Last Update Posted Date March 13, 2020
Actual Study Start Date  ICMJE August 12, 2015
Estimated Primary Completion Date January 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: September 26, 2018)
Overall response rate (ORR) [ Time Frame: Change in each patient: every 2/3 cycles from cycle 6 (cycle duration: 3 weeks) until progression disease or start of a new anti-cancer therapy or death or end of study (12 months after last enrolled cohort patient or until death in SCLC cohort) ]
Overall response rate (ORR), defined as the percentage of evaluable patients with a confirmed response, either complete (CR) or partial (PR).
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: March 11, 2020)
  • Duration of response (DR) [ Time Frame: Change in each patient: every 2/3 cycles from cycle 6 (cycle duration: 3 weeks) until progression disease or start of a new anti-cancer therapy or death or end of study (12 months after last enrolled cohort patient or until death in SCLC cohort) ]
    Duration of response (DR), 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: Change in each patient: every 2/3 cycles from cycle 6 (cycle duration: 3 weeks) until progression disease or start of a new anti-cancer therapy or death or end of study (12 months after last enrolled cohort patient or until death in SCLC cohort) ]
    Clinical benefit defined as patients with ORR or SD>=4 months
  • Progression free survival (PFS) [ Time Frame: Change in each patient: every 2/3 cycles from cycle 6 (cycle duration: 3 weeks) until progression disease or start of a new anti-cancer therapy or death or end of study (12 months after last enrolled cohort patient or until death in SCLC cohort) ]
    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.
  • Overall survival (OS) in each cohort of advanced solid tumors [ Time Frame: infusion up to 12 months after last enrolled cohort patient received the first ]
    Defined as the period of time from the date of first infusion to the date of death
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 Active, not recruiting
Actual Enrollment  ICMJE
 (submitted: December 20, 2018)
345
Original Estimated Enrollment  ICMJE
 (submitted: May 21, 2015)
225
Estimated Study Completion Date  ICMJE January 2021
Estimated Primary Completion Date January 2021   (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
Responsible Party PharmaMar
Study Sponsor  ICMJE PharmaMar
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account PharmaMar
Verification Date March 2020

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