MITO 35B: Olaparib Beyond Progression Compared to Platinum Chemotherapy After Secondary Cytoreductive Surgery in Recurrent Ovarian Cancer Patients.

Recruiting Phase 3 Interventional Study
Ovarian Cancer
No Placebo Group Every participant receives an active treatment — no one gets a placebo. Pivotal Trial This treatment is in the last trial phase before FDA approval. Prior Safety Data This treatment has already been tested in at least one earlier human trial.
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At a Glance
Age
18 and older
Sex
Female
Trial phase
Phase 3
Study type
Interventional
Purpose
Treatment
Participants needed
200 (estimated)
Sponsor
National Cancer Institute, Naples · Other
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About This Trial
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 progr…
Trial Locations
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Eligibility Criteria
* Signed informed consent prior to any study specific procedures; * Female, age ≥ 18 years at time of signing informed consent * Patients with high-grade serous or endometroid ovarian, fallopian tube, or primary peritoneal cancer recurrent or progressive after first line PARPi maintenance are allowe…
Contacts

Clorinda Schettino, MD

003908159031791

c.schettino@istitutotumori.na.it

CONTACT

Sandro Pignata, MD

00390815903409

s.pignata@istitutotumori.na.it

CONTACT