Clinical Trials Directory

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UnknownNCT03467178

Study on Decitabine Plus Carboplatin Versus Physician's Choice Chemotherapy in Recurrent, Platinum-resistant Ovarian Cancer.

Randomized Phase II Study on Decitabine Plus Carboplatin Versus Physician's Choice Chemotherapy in Recurrent, Platinum-resistant Ovarian Cancer.

Status
Unknown
Phase
Phase 2
Study type
Interventional
Enrollment
119 (estimated)
Sponsor
Fondazione IRCCS Istituto Nazionale dei Tumori, Milano · Academic / Other
Sex
Female
Age
18 Years
Healthy volunteers
Not accepted

Summary

Multicenter Phase II study on Decitabine-Carboplatin combination in platinum resistant ovarian cancer patients. Patients will receive study treatment until disease progression is documented, extraordinary medical circumstances occur, intolerable toxicities occur, or the patient withdraws consent.

Detailed description

This is an open-label, prospective, multicenter, randomized Phase II, clinical trial evaluating the efficacy and safety of Decitabine-Carboplatin combination in recurrent, platinum resistant ovarian cancer patients in comparison to physician' choice chemotherapy: Arm A: Carboplatin AUC (Area Under Curve) 5 d 8 q 28 Plus Decitabine 10 mg/mq iv d1-5 q 28 Arm B: Pegylated Liposomal Doxorubicin 40 mg/mq q 28 or Gemcitabine 1000 mg/mq dd 1, 8, 15 q 28 or Weekly Paclitaxel 80 mg/mq gg 1, 8, 15 q 28 Patients will be randomly assigned in a 1:1 ratio to treatment arms.

Conditions

Interventions

TypeNameDescription
DRUGDecitabineNucleic Acid Synthesis Inhibitor
DRUGCarboplatinChemotherapy medication
DRUGPegylated Liposomal DoxorubicinChemotherapy medication
DRUGGemcitabineChemotherapy medication
DRUGPaclitaxelChemotherapy medication

Timeline

Start date
2018-07-30
Primary completion
2021-12-01
Completion
2021-12-01
First posted
2018-03-15
Last updated
2021-09-05

Locations

1 site across 1 country: Italy

Source: ClinicalTrials.gov record NCT03467178. Inclusion in this directory is not an endorsement.