Phase 2
N=345
Clinical Trial of Lurbinectedin (PM01183) in Selected Advanced Solid Tumors
Advanced Solid Tumors
Bottom Line
View on ClinicalTrials.gov: NCT02454972 ↗Enrolled (actual)
345
Serious AEs
40.6%
Results posted
Nov 2021
Primary outcome: Primary: Overall Response Rate (ORR) — 5.6; 0.0; 11.3; 14.3 percentage of participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- lurbinectedin (PM01183) (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- PharmaMar
- Primary completion
- Sep 2020
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Overall Response Rate (ORR) |
5.6; 0.0; 11.3; 14.3; 4.3; 0.0 | — |
| PRIMARY Response by Investigator Assessment |
0; 0; 2; 0; 0; 0 | — |
| SECONDARY Duration of Response |
3.4; 9.2; 4.2; 10.6; 8.6; 4.7 | — |
| SECONDARY Clinical Benefit |
11.1; 36.8; 35.2; 39.3; 26.1; 15.4 | — |
| SECONDARY Disease Control Rate |
33.3; 57.9; 52.1; 57.1; 39.1; 23.1 | — |
| SECONDARY Progression Free Survival (PFS) |
1.3; 2.7; 2.6; 2.7; 1.5; 1.3 | — |
| SECONDARY Progression-free Survival at 4 Months |
13.7; 38.9; 39.7; 46.2; 30.7; 15.4 | — |
| SECONDARY Progression-free Survival at 6 Months |
13.7; 22.2; 29.0; 23.1; 30.7; 7.7 | — |
| SECONDARY Overall Survival (OS) |
7.3; 7.7; 9.3; 12.0; 9.2; 5.7 | — |
| SECONDARY Overall Survival at 6 Months |
58.2; 55.6; 62.8; 88.2; 55.0; 38.5 | — |
| SECONDARY Overall Survival at 12 Months |
21.8; 36.5; 45.8; 48.5; 34.4; 30.8 | — |
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
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
Data sourced from ClinicalTrials.gov (NCT02454972). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.