Resistant Ovarian Cancer, Olaparib and Liposomal Doxorubicin

Sponsor
Grupo Español de Investigación en Cáncer de Ovario
Study ID
NCT03161132
Phase
PHASE2
Status
Completed

Conditions

  • Advanced Ovarian Cancer

Eligibility Criteria

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

Interventions

  • Olaparib — DRUG
    Combination of continous olaparib 300mg for oral administration plus Pegylated Liposomal Doxorubicin (PLD), followed by maintenance treatment further described.
  • Pegylated Liposomal Doxorubicin — DRUG
    PLD 40mg/m2 every 28 days intravenous

Study Details

Impact of the combination of Olaparib and Pegylated Liposomal Doxorubicin on improvement of progression-free survival at 6 months in patients with platinum resistant advanced ovarian cancer.

Key Dates

Start date
Dec 13, 2017
Status verified
Jan 2023
Primary completion
Feb 7, 2020
Completion
Dec 31, 2022

Study Design

Enrollment
32 participants (actual)
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Olaparib 300mg
    Olaparib bid orally at 300 mg (tablet formulation) continuously, combined with chemotherapy with Pegylated Liposomal Doxorubicin (up to 6 cycles), then, as monotherapy at the same dose and frequency (300mg bid orally) until progression of disease or unaccepted toxicity.
  • Other: Pegylated Liposomal Doxorubicin (PLD)
    PLD 40mg/m2 every 28 days intravenous for up to 6 cycles. This treatment will be combined with Olaparib (as described earlier).

Primary Outcome Measure

Progression-free Survival [ Time Frame: 6 months ]

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