Study of Lurbinectedin (PM01183) in Combination With Cisplatin in Patients With Solid Tumors

Sponsor
PharmaMar
Study ID
NCT01980667
Phase
PHASE1
Status
Completed

Conditions

  • Advanced Solid Tumors

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
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.
  • Cisplatin — DRUG
    vials containing 1 mg/ml concentrate for solution for infusion

Study Details

Clinical and Pharmacokinetic Study of Lurbinectedin (PM01183) in Combination with Cisplatin in Patients with Advanced Solid Tumors to determine the recommended dose (RD) of PM01183 in combination with cisplatin, to characterize the safety profile, the pharmacokinetics (PK) of this combination, to obtain preliminary information on the clinical antitumor activity and to conduct an exploratory pharmacogenomic (PGx) analysis.

Key Dates

Start date
Jul 30, 2014
Status verified
Jan 2017
Primary completion
Jan 5, 2017
Completion
Jan 5, 2017

Study Design

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

Arms

  • Experimental: lurbinectedin (PM01183) / cisplatin
    Patients will receive cisplatin as a 90-min i.v. infusion. In addition, patients will receive PM01183 as an i.v. infusion over 1-hour.

Primary Outcome Measure

Recommended dose (RD) of the combination PM01183 and cisplatin [ Time Frame: 30 months ]

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