Description:
Multicenter, open-label, exploratory, phase II clinical trial to evaluate the efficacy and
safety of PM01183 in previously treated patients with advanced solid tumors
Title
- 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
Clinical Trial IDs
- ORG STUDY ID:
PM1183-B-005-14
- NCT ID:
NCT02454972
Conditions
Interventions
| Drug | Synonyms | Arms |
|---|
| lurbinectedin (PM01183) | | lurbinectedin (PM01183) |
Purpose
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).
Trial Arms
| Name | Type | Description | Interventions |
|---|
| lurbinectedin (PM01183) | Experimental | lurbinectedin (PM01183) 4 mg vials of powder for concentrate for solution for infusion | |
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
| Maximum Eligible Age: | N/A |
| Minimum Eligible Age: | 18 Years |
| Eligible Gender: | All |
| Healthy Volunteers: | No |
Primary Outcome Measures
| Measure: | 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) |
| Safety Issue: | |
| Description: | Overall response rate (ORR), defined as the percentage of evaluable patients with a confirmed response, either complete (CR) or partial (PR). |
Secondary Outcome Measures
| Measure: | 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) |
| Safety Issue: | |
| Description: | 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. |
| Measure: | 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) |
| Safety Issue: | |
| Description: | Clinical benefit defined as patients with ORR or SD>=4 months |
| Measure: | 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) |
| Safety Issue: | |
| Description: | 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. |
| Measure: | 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 |
| Safety Issue: | |
| Description: | Defined as the period of time from the date of first infusion to the date of death |
Details
| Phase: | Phase 2 |
| Primary Purpose: | Interventional |
| Overall Status: | Active, not recruiting |
| Lead Sponsor: | PharmaMar |
Last Updated
March 13, 2020
