Study to Evaluate PM01183 in Combination With Olaparib in Advanced Solid Tumors

Sponsor
Poveda, Andrés, M.D.
Study ID
NCT02684318
Phase
PHASE1/PHASE2
Status
Unknown

Conditions

Eligibility Criteria

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

Interventions

Study Details

Phase Ib/II study to evaluate the efficacy and tolerability of PM01183 in combination with olaparib in patients with advanced solid tumors.

Key Dates

Start date
Jul 31, 2015
Status verified
Jun 2017
Primary completion
Jul 31, 2019
Completion
Oct 31, 2019

Study Design

Enrollment
100 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Dose Level 1
    PM01183 + olaparib PM01183: 1 mg/m² IV olaparib 100 mg BID
  • Experimental: Dose Level 2
    PM01183 + olaparib PM01183: 1 mg/m² IV olaparib 150 mg BID
  • Experimental: Dose Level 3
    PM01183 + olaparib PM01183: 1.5 mg/m² IV olaparib 200 mg BID
  • Experimental: Dose Level 4
    PM01183 + olaparib PM01183: 1.5 mg/m² IV olaparib 250 mg BID
  • Experimental: Dose Level 5
    PM01183 + olaparib PM01183: 2 mg/m² IV olaparib 250 mg BID
  • Experimental: Dose Level 6
    PM01183 + olaparib PM01183: 2 mg/m² IV olaparib 300 mg BID
  • Experimental: Dose Level 7
    PM01183 + olaparib PM01183 3 mg/m² IV olaparib 300 mg BID

Primary Outcome Measure

Dose limiting toxicity [ Time Frame: 1 year ]

Central Contacts

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