Who is sponsoring NCT03462212?

NCT03462212 is sponsored by Fondazione Policlinico Universitario Agostino Gemelli IRCCS.

What drugs are being tested in NCT03462212?

Interventions in NCT03462212: Carboplatin, Paclitaxel, Bevacizumab, Rucaparib.

Is NCT03462212 still recruiting?

NCT03462212 is currently status unknown. Last updated 27 August 2021.

Last reviewed 2021-08-27 · How we verify

NCT03462212: MITO25

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

Carboplatin-Paclitaxel-Bevacizumab vs Carbo-Pacli-Beva-Rucaparib vs Carbo-Pacli-Ruca, Selected According to HRD Status, in Patients With Advanced Ovarian, Primary Peritoneal and Fallopian Tube Cancer, Preceded by a Phase I Dose Escalation Study on Ruca-Beva Combination

Status unknown Phase 1, PHASE2 Last updated 27 August 2021

What this trial tests

Phase 1, PHASE2 trial testing Carboplatin in Advanced (Stage IIIB-C-IV) Ovarian, Primary Peritoneal and Fallopian Tube Cancer in 290 participants. Status unknown.

Timeline

17 March 2021

Primary endpoint
1 March 2025

1 March 2025

Quick facts

Lead sponsor	Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Phase	Phase 1, PHASE2
Status	Status unknown
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	none
Primary purpose	treatment
Enrollment	290
Start date	17 March 2021
Primary completion	1 March 2025
Estimated completion	1 March 2025
Sites	7 locations across Italy

Drugs / interventions tested

Carboplatin (Carboplatin) — full drug profile →
Paclitaxel — full drug profile →
Bevacizumab (Bevacizumab-Bvzr) — full drug profile →
Rucaparib (RUCAPARIB) — full drug profile →

Conditions studied

Advanced (Stage IIIB-C-IV) Ovarian, Primary Peritoneal and Fallopian Tube Cancer — all drugs for Advanced (Stage IIIB-C-IV) Ovarian, Primary Peritoneal and Fallopian Tube Cancer →

Sponsor

Fondazione Policlinico Universitario Agostino Gemelli IRCCS

Who can join

18 and older, female only, with Advanced (Stage IIIB-C-IV) Ovarian, Primary Peritoneal and Fallopian Tube Cancer. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

This trial is a randomized, open-label Phase I-2 multi-center study designed to evaluate the effect of Carboplatin-Paclitaxel-Bevacizumab (in combination and maintenance) vs Carboplatin-Paclitaxel-Bevacizumab-Rucaparib (Rucaparib only in maintenance) vs Carboplatin-Paclitaxel-Rucaparib (Rucaparib only in maintenance) on progression-free survival in patients with advanced high grade ovarian cancer treated according to HRD status . The trial will test the hypothesis that Carboplatin-Paclitaxel-Bevacizumab-Rucaparib and the Carboplatin-Paclitaxel-Rucaparib arms will improve the progression-free survival in comparison to standard Carboplatin-Paclitaxel-Bevacizumab in HRD negative (HR proficient) patients and that Carboplatin-Paclitaxel-Bevacizumab-Rucaparib will improve PFS with respect to Carboplatin-Paclitaxel-Rucaparib in HRD positive patients. The randomized phase of the study will be preceded by a single arm Phase I study which will be conducted only in the National Cancer Institute of Milan, aiming at evaluating the MTD of the combination Rucaparib-Bevacizumab. Once the MTD has been reached, the randomized study will start.

Publications & conference data

8 peer-reviewed publications reference this trial (live from Europe PMC):

Exploring and comparing adverse events between PARP inhibitors.
LaFargue CJ, Dal Molin GZ, Sood AK, Coleman RL. · · 2019 · cited 367× · PMID 30614472 · DOI 10.1016/s1470-2045(18)30786-1
Tumor Microenvironment in Ovarian Cancer: Function and Therapeutic Strategy.
Yang Y, Yang Y, Yang J, Zhao X, et al · · 2020 · cited 168× · PMID 32850861 · DOI 10.3389/fcell.2020.00758
Targeted therapies in gynecological cancers: a comprehensive review of clinical evidence.
Wang Q, Peng H, Qi X, Wu M, et al · · 2020 · cited 114× · PMID 32728057 · DOI 10.1038/s41392-020-0199-6
Targeting DNA repair pathway in cancer: Mechanisms and clinical application.
Wang M, Chen S, Ao D. · · 2021 · cited 84× · PMID 34977872 · DOI 10.1002/mco2.103
Current status and future prospects of PARP inhibitor clinical trials in ovarian cancer.
Jiang X, Li W, Li X, Bai H, et al · · 2019 · cited 75× · PMID 31191001 · DOI 10.2147/cmar.s200524
Bevacizumab use in the frontline, maintenance and recurrent settings for ovarian cancer.
Haunschild CE, Tewari KS. · · 2020 · cited 72× · PMID 31746224 · DOI 10.2217/fon-2019-0042
Current Ovarian Cancer Maintenance Strategies and Promising New Developments.
Gogineni V, Morand S, Staats H, Royfman R, et al · · 2021 · cited 58× · PMID 33391401 · DOI 10.7150/jca.49406
Treatment of patients with recurrent epithelial ovarian cancer for whom platinum is still an option.
Buechel M, Herzog TJ, Westin SN, Coleman RL, et al · · 2019 · cited 58× · PMID 30887020 · DOI 10.1093/annonc/mdz104

Verify or expand the search:

Other trials of Carboplatin

Trials testing the same drug.

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Other Fondazione Policlinico Universitario Agostino Gemelli IRCCS trials

Trials by the same sponsor.

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Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT03462212 (US National Library of Medicine, public domain)
Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Last refreshed: 27 August 2021

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT03462212.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing