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History of Changes for Study: NCT02454972
Clinical Trial of Lurbinectedin (PM01183) in Selected Advanced Solid Tumors
Latest version (submitted February 1, 2023) on ClinicalTrials.gov
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Study Record Versions
Version A B Submitted Date Changes
1 May 21, 2015 None (earliest Version on record)
2 June 2, 2015 Contacts/Locations and Study Status
3 July 7, 2015 Recruitment Status, Study Status and Contacts/Locations
4 July 13, 2015 Contacts/Locations, Oversight and Study Status
5 August 5, 2015 Study Status and Contacts/Locations
6 September 17, 2015 Study Status
7 October 23, 2015 Study Status
8 November 4, 2015 Contacts/Locations and Study Status
9 November 26, 2015 Contacts/Locations and Study Status
10 December 4, 2015 Contacts/Locations and Study Status
11 February 8, 2016 Contacts/Locations and Study Status
12 February 10, 2016 Contacts/Locations and Study Status
13 May 12, 2016 Study Status
14 January 5, 2017 Contacts/Locations, Study Status, Eligibility, Study Design and Study Description
15 February 8, 2017 Contacts/Locations, Eligibility and Study Status
16 April 24, 2017 Study Status, Contacts/Locations, Eligibility, Outcome Measures, Study Design and Study Description
17 August 22, 2017 Contacts/Locations and Study Status
18 December 4, 2017 Contacts/Locations and Study Status
19 December 12, 2017 Contacts/Locations and Study Status
20 January 26, 2018 Contacts/Locations and Study Status
21 February 2, 2018 Contacts/Locations and Study Status
22 February 8, 2018 Contacts/Locations and Study Status
23 February 15, 2018 Contacts/Locations and Study Status
24 February 16, 2018 Study Status
25 March 2, 2018 Contacts/Locations and Study Status
26 March 6, 2018 Contacts/Locations and Study Status
27 March 13, 2018 Contacts/Locations and Study Status
28 June 28, 2018 Contacts/Locations and Study Status
29 September 26, 2018 Outcome Measures, Study Status, Contacts/Locations and Study Design
30 October 10, 2018 Contacts/Locations and Study Status
31 December 20, 2018 Recruitment Status, Contacts/Locations, Study Status and Study Design
32 March 11, 2020 Study Status, Outcome Measures, Contacts/Locations, Study Description
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Results Submission Events
33 October 21, 2021 Recruitment Status, Study Status, Outcome Measures, Contacts/Locations, Document Section and Results
34 February 1, 2023 Outcome Measures, Document Section, Participant Flow, Study Status and Adverse Events
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Study NCT02454972
Submitted Date:  May 21, 2015 (v1)
Open or close this module Study Identification
Unique Protocol ID: PM1183-B-005-14
Brief Title: Clinical Trial of Lurbinectedin (PM01183) in Selected Advanced Solid Tumors
Official Title: A Multicenter Phase II Clinical Trial of Lurbinectedin (PM01183) in Selected Advanced Solid Tumors
Secondary IDs:
Open or close this module Study Status
Record Verification: May 2015
Overall Status: Not yet recruiting
Study Start: July 2015
Primary Completion: July 2019 [Anticipated]
Study Completion:
First Submitted: May 6, 2015
First Submitted that
Met QC Criteria:		 May 21, 2015
First Posted: May 27, 2015 [Estimate]
Last Update Submitted that
Met QC Criteria:		 May 21, 2015
Last Update Posted: May 27, 2015 [Estimate]
Open or close this module Sponsor/Collaborators
Sponsor: PharmaMar
Responsible Party: Sponsor
Collaborators:
Open or close this module Oversight
U.S. FDA-regulated Drug:
U.S. FDA-regulated Device:
Data Monitoring:
Open or close this module Study Description
Brief Summary: A Multicenter Phase II Clinical Trial of Lurbinectedin (PM01183) in Selected Advanced Solid Tumors to assess the antitumor activity of lurbinectedin (PM01183) in terms of overall response rate (ORR), in the following advanced solid tumors 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)
Detailed Description:
Open or close this module Conditions
Conditions: Advanced Solid Tumors
Keywords:
Open or close this module Study Design
Study Type: Interventional
Primary Purpose: Treatment
Study Phase: Phase 2
Interventional Study Model: Single Group Assignment
Number of Arms: 1
Masking: None (Open Label)
Allocation: N/A
Enrollment: 225 [Anticipated]
Open or close this module Arms and Interventions
Arms Assigned Interventions
Experimental: lurbinectedin (PM01183)
lurbinectedin (PM01183) 4 mg vials of powder for concentrate for solution for infusion
 Drug: lurbinectedin (PM01183)
Open or close this module Outcome Measures
Primary Outcome Measures:
1. 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).
Secondary Outcome Measures:
1. Duration of response (DR)
[ Time Frame: Every two cycles until Cycle 6 or evidence of progression disease (1 cycle duration: 3 weeks) ]
2. Progression free survival (PFS)
[ Time Frame: Every two cycles until Cycle 6 or evidence of progression disease (1 cycle duration: 3 weeks) ]
3. 1 year overall survival (1y-OS)
[ Time Frame: Every two cycles until Cycle 6 or evidence of progression disease (1 cycle duration: 3 weeks) ]
Open or close this module Eligibility
Minimum Age: 18 Years
Maximum Age:
Sex: All
Gender Based:
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 and oropharynx carcinoma are excluded.
    • Neuroendocrine tumors (NETs), excluding carcinoid tumors.
    • Biliary tract carcinoma.
    • Endometrial carcinoma.
    • BRCA 1/2-associated metastatic breast carcinoma.
    • Carcinoma of unknown primary site.
    • Germ cell tumor (GCTs), excluding pure teratocarcinoma.
    • Ewing's family of tumors (EFTs)
  • Prior treatment. Patients must have received:
    • SCLC, NET, biliary tract, endometrial carcinoma: one prior chemotherapy-containing lines
    • H&N, CUP: one or two prior chemotherapy-containing lines
    • BRCA positive MBC: at least one but no more than three prior chemotherapy-containing lines
    • GCTs: no limit of prior therapy
    • Ewing sarcoma: two 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 without appropriate contraception
Open or close this module Contacts/Locations
Central Contact Person: Pharma Mar Clinical Oncology --
Email: clinicaltrials@pharmamar.com
Locations:
Open or close this module IPDSharing
Plan to Share IPD:
Open or close this module References
Links:
Available IPD/Information:
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