Pharmacokinetic Study of Lurbinectedin in Combination With Irinotecan in Patients With Selected Solid Tumors

Part of paid clinical trials in Santa Monica, California.

Sponsor
PharmaMar
Study ID
NCT02611024
Phase
PHASE1/PHASE2
Status
Completed

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Lurbinectedin — DRUG
    lurbinectedin (PM01183) 4 mg vials
  • Irinotecan — DRUG
    irinotecan 40 mg, 100 mg or 300 mg vials

Study Details

Prospective, open-label, dose-ranging, uncontrolled phase I/II study of Lurbinectedin in combination with irinotecan. The study will be divided into two stages: a Phase I dose escalation stage and a Phase II expansion stage.

Key Dates

Start date
May 6, 2016
Status verified
Jul 2025
Primary completion
Jul 1, 2025
Completion
Jul 1, 2025

Study Design

Enrollment
316 participants (actual)
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Lurbinectedin Escalation Group
    Irinotecan 75 mg/m\^2 as a 90-min (-5-min/+30-min) intravenous (i.v.) infusion, followed by Lurbinectedin with starting dose of 1.0 mg/m\^2 as a 60-min (-5-min/+20-min) i.v. infusion followed by Irinotecan alone on Day 8 (at the same dose as Day 1 and as a 90-min \[-5-min/+30-min\] i.v. infusion)
  • Experimental: Irinotecan Escalation Group
    Starting dose of Irinotecan 15 mg/m\^2 as a 90-min (-5-min/+30-min) i.v. infusion, followed by Lurbinectedin 3.0 mg/m\^2 as a 60-min (-5-min/+20-min) i.v. infusion followed by Irinotecan alone on Day 8 (at the same dose as Day 1 and as a 90-min \[-5-min/+30-min\] i.v. infusion).
  • Experimental: Intermediate Escalation Group
    Starting dose of Irinotecan 50 mg/m\^2 as a 90-min (-5-min/+30-min) i.v. infusion, followed by Lurbinectedin 2.6 mg/m\^2 as a 60-min (-5-min/+20-min) i.v. infusion. No Irinotecan dose will be administered on Day 8 in this group.

Primary Outcome Measure

Maximum Tolerated Dose (MTD) [ Time Frame: 66 months ]

Locations (4)

FacilityCityStateZIPSite coordinators
Sarcoma Oncology CenterSanta MonicaCalifornia90403-
Beth Israel Deaconess Medical CenterBostonMassachusetts02215-
Massachusetts General Hospital -BostonMassachusetts02114-
The University of Texas MD Anderson Cancer CenterHoustonTexas77030-

Find similar trials in Santa Monica, CA

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OncologyGI oncologyGynecologic oncologyWomen's healthNeuro-oncologyLung oncologyLung disease
By research site
Sarcoma Oncology Center· Santa Monica, CABeth Israel Deaconess Medical Center· Boston, MAMassachusetts General Hospital· Boston, MAThe University of Texas MD Anderson Cancer Center· Houston, TX

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