Study Escalating Doses of PM01183 in Combination With Fixed Doxorubicin in Patients With Specific Advanced Unresectable Solid Tumors

Sponsor
PharmaMar
Study ID
NCT01970540
Phase
PHASE1
Status
Completed

Conditions

  • Endometrial Adenocarcinomas
  • Neuroendocrine Tumors
  • Small-cell Lung Cancer With Less Than 2 Prior Cytotoxic-containing Lines of Therapy

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.
  • Doxorubicin — DRUG
    Commercially available presentations of vials containing doxorubicin will be provided as appropriate.

Study Details

Phase I Multicenter, Open-label, Clinical and Pharmacokinetic Study of PM01183 in Combination with Fixed Doxorubicin 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 doxorubicin, to characterize the safety profile and feasibility of this combination, to characterize the pharmacokinetics (PK) of this combination, to obtain preliminary information on the clinical antitumor activity,to explore the feasibility, safety and efficacy of a potential improvable dose of this combination in selected tumor types \[i.e. small cell lung cancer (SCLC) and endometrial cáncer\] and to evaluate the pharmacogenomics (PGx) in tumor samples of patients exposed to PM01183 and doxorubicin at the RD in order to assess potential markers of response and/or resistance.

Key Dates

Start date
May 25, 2011
Status verified
Jan 2020
Primary completion
Aug 9, 2017
Completion
Aug 9, 2017

Study Design

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

Arms

  • Experimental: lurbinectedin (PM01183) / doxorubicin

Primary Outcome Measure

Maximum Tolerated Dose (MTD) [ Time Frame: During the first cycle of treatment, up to 28 days ]

Related Studies