Escalating Doses of PM01183 in Combination With Gemcitabine in Patients With Specific Unresectable Solid Tumors

Sponsor
PharmaMar
Study ID
NCT01970553
Phase
PHASE1
Status
Completed

Conditions

  • Specific Advanced Solid Tumors

Eligibility Criteria

Sex
ALL
Age
18 Years - 75 Years
Healthy Volunteers
Not accepted

Interventions

  • lurbinectedin (PM01183) — DRUG
    lurbinectedin (PM01183) is presented as powder for concentrate for solution for infusion with two strengths, 1-mg and 4-mg vials
  • Gemcitabine — DRUG
    1000 mg vial, powder for injectable solution

Study Details

Phase I multicenter, open-label, clinical and pharmacokinetic study of PM01183 in combination with gemcitabine in non-heavily pretreated patients with selected advanced solid tumors to determine the maximum tolerated dose (MTD) and the recommended dose (RD) of PM01183 in combination with gemcitabine, to characterize the safety profile and feasibility of this combination in patients with selected advanced solid tumors, to characterize the pharmacokinetics (PK), to obtain preliminary information on the clinical antitumor activity in non-heavily pretreated selected solid tumor patients and to evaluate the pharmacogenomics (PGx) in tumor samples of patients exposed, in order to assess potential markers of response and/or resistance.

Key Dates

Start date
May 31, 2011
Status verified
Oct 2013
Primary completion
Oct 31, 2013
Completion
Oct 31, 2013

Study Design

Enrollment
47 participants (actual)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: lurbinectedin (PM01183) / gemcitabine
    Patients will consecutively receive the following on Days 1 and 8 q3wk (three weeks = one treatment cycle): \- Gemcitabine: intravenous infusion of 800 mg/m2/day over 30 minutes, immediately followed by: \- PM01183: intravenous infusion over one hour at a starting dose of 2.5 mg/day, flat dose (FD), both on Days 1 and 8 every 3 weeks

Primary Outcome Measure

Recommended Dose (RD) [ Time Frame: 19 months ]

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