CI

At a glance

ClinicalIndex Comparison Record
Phase 3Recruiting· 200 target
Drug / intervention
Olaparib +1 moredrug
Likely dose
Olaparib 300 mgfrom record
Key inclusion· 12
  • ✓Female, age ≥18 years
  • ✓High-grade serous or endometroid ovarian, fallopian tube, or primary peritoneal cancer recurrent or progressive after first line PARPi maintenance
  • ✓Only one previous line of platinum-containing regimen (without bevacizumab)
  • ✓First-line maintenance therapy with PARPi for at least 6 months
Key exclusion· 18
  • ✕Poor medical risk due to serious uncontrolled medical disorder, non-malignant systemic disease, or active uncontrolled infection
  • ✕Unable to swallow oral medication or GI disorders interfering with absorption
  • ✕Eligible for platinum-based chemotherapy doublet and bevacizumab
  • ✕Systemic chemotherapy or radiotherapy within 3 weeks prior (except palliative)

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT05255471
NCT05255471Phase 3RecruitingOn TrackUpdated 39mo ago
Long Recruiting
CompareCT.gov

Olaparib Beyond Progression Compared to Platinum Chemotherapy After Secondary Cytoreductive Surgery in Recurrent Ovarian Cancer Patients. The Phase III Randomized, Open Label MITO 35b Study: a Project of the MITO-MANGO Groups.

National Cancer Institute, Naples·interventional·Posted Feb 24, 2022·Updated Mar 24, 2023

In Brief

A Phase 3 clinical trial evaluating Olaparib and Chemotherapy drug for Ovarian Cancer. Currently recruiting, targeting 200 participants across 1 site.

Detailed Summary

MITO 35b is designed as randomized, open label, phase III trial that aims to assess the efficacy of olaparib maintenance beyond progression compered to standard platinum-based chemotherapy after secondary cytoreductive surgery. The target population of this study are ovarian cancer patients who experience a disease recurrence or progression to a first line maintenance therapy with PARPi; at progression patients must have received a secondary cytoreduction according to clinical practice.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsOvarian Cancer
CountriesItaly
Collaborators--

Timeline

Phase 3Recruiting
2022202320242025202620272028
First PostedFeb 24, 2022
Enrollment StartJan 21, 2022
Primary CompletionJan 21, 2028
TodayJul 2, 2026
Enrollment to primary: 6 yearsPosted 4.4 years agoPrimary completion in 1.6 years

Interventions

Olaparibdrug

Olaparib 300 mg, film-coated tablets, twice daily PO, d1- 28 continuously

Chemotherapy drugdrug

Platinum-based chemotherapy at the Investigator's choice among the following regimens: * Carboplatin (AUC5) plus Pegylated Liposomal Doxorubicin (PLD) 30mg/m2 on day 1 every 28 days for a maximum of 8 cycles; * Carboplatin (AUC4) plus Gemcitabine 1000mg/m2 on day 1, 8 every 21 days for a maximum of 8 cycles; * Carboplatin (AUC5) plus Paclitaxel (175mg/m2) every 21days for a maximum of 8 cycles