Study of Lurbinectedin (PM01183) in Combination With Capecitabine in Patients With Metastatic Breast Cancer (MBC), Pancreatic Cancer (PC) or Metastatic Colorectal Cancer (CRC).

Sponsor
PharmaMar
Study ID
NCT02210364
Phase
PHASE1
Status
Completed

Conditions

Eligibility Criteria

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

Interventions

  • lurbinectedin (PM01183) — DRUG
    lurbinectedin (PM01183) 1 mg and 4 mg vials
  • capecitabine — DRUG
    capecitabine 150 mg tablets

Study Details

Phase I Multicenter, Open-label, Clinical and Pharmacokinetic Study of Lurbinectedin (PM01183) in Combination with Capecitabine in Patients with Unresectable Metastatic Breast Cancer (MBC), Pancreatic Cancer (PC) or Metastatic Colorectal Cancer (CRC) to determine the recommended dose (RD) of PM01183 in combination with capecitabine, to characterize the safety profile, to explore the feasibility of PM01183 dose optimization, to characterize the pharmacokinetics (PK), to obtain preliminary information on the clinical antitumor activity of this combination and to conduct an exploratory pharmacogenomic (PGx) analysis.

Key Dates

Start date
Apr 30, 2013
Status verified
May 2016
Primary completion
Oct 31, 2016
Completion
Oct 31, 2016

Study Design

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

Arms

  • Experimental: lurbinectedin (PM01183) and capecitabine

Primary Outcome Measure

Recommended dose of PM01183 in combination with capecitabine [ Time Frame: 30 months ]

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