CI

At a glance

ClinicalIndex Comparison Record
Phase 2Recruiting· 80 target
Drug / intervention
Carboplatindrug
Likely dose
Not stated in record
Key inclusion· 11
  • Female aged ≥18 years
  • High grade serous or high grade endometrioid carcinoma of ovary, fallopian tube, or peritoneum
  • Prior platinum treatment (cisplatin or carboplatin)
  • Prior PARP inhibitor treatment
Key exclusion· 13
  • Non-epithelial ovarian cancer, carcinosarcoma, low-grade serous/endometrioid, mucinous, clear-cell carcinomas
  • Requiring combination chemotherapy regimens
  • Known hypersensitivity to carboplatin
  • Persisting ≥grade 2 CTCAE v5 adverse events (except alopecia and neuropathy)

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

Search/NCT05080556
NCT05080556Phase 2RecruitingOn TrackUpdated 26mo ago
Long Recruiting

A Multicentre Phase II Randomised Controlled Trial to Evaluate the Efficacy of Adaptive Therapy (AT) With Carboplatin, Based on Changes in CA125, in Patients With Relapsed Platinum-sensitive High Grade Serous or High Grade Endometrioid Ovarian Cancer

University College, London·interventional·Posted Oct 15, 2021·Updated Apr 12, 2024

In Brief

A Phase 2 clinical trial evaluating Carboplatin for Ovarian Cancer and 6 related conditions. Currently recruiting, targeting 80 participants across 1 site.

Detailed Summary

ACTOv will compare standard 3-weekly carboplatin (AUC5), to carboplatin delivered according to an AT regimen. The AT regimen will modify carboplatin dose according to changes in the clinical-standard serum biomarker CA125 as a proxy measure of total tumour burden and an individual patient's response to the most recent chemotherapy treatment. AT could prolong sensitivity to carboplatin and extend tumour control, while simultaneously reducing chemotherapy dose and drug-induced toxicity. Carboplatin is a low cost and low toxicity drug that has an enduring and central role in ovarian cancer treatment.

Study Details

Timeline

Phase 2Recruiting
2022202320242025202620272028
First PostedOct 15, 2021
Enrollment StartMay 24, 2023
Primary CompletionNov 1, 2026
Study CompletionNov 1, 2027
TodayJul 2, 2026
Enrollment to primary: 3.4 yearsPosted 4.7 years agoPrimary completion in 4 months

Interventions

Carboplatindrug

Treatment in both arms will be administered intravenously (IV) every 21 days (q21D) and for a maximum of 6 cycles in Arm 1 and 12 cycles in Arm 2.