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Phase 1B Open Label Study to Assess the Safety, Pharmacokinetics and Clinical Activity of Nuc-1031 Given on Days 1 & 8 With Carboplatin on Day 1, q3-weekly for 6 Cycles in Participants With Recurrent Ovarian Cancer. (ProGem2)
A first in human experimental treatment in which an experimental medicine,Nuc-1031, is used in combination with a standard cancer medicine, carboplatin, to treat ovarian cancer which reappear after standard cancer treatment. The aim of the trial is to determine safety, effectiveness, and clinical activity of this combination treatment.
Details
| Lead sponsor | Imperial College Healthcare NHS Trust |
|---|---|
| Phase | Phase 1 |
| Status | COMPLETED |
| Enrolment | 25 |
| Start date | 2014-11 |
| Completion | 2017-01-23 |
Conditions
- Recurrent Ovarian Cancer
Interventions
- Nuc-1031 and Carboplatin
Primary outcomes
- To determine the Recommended Phase II Dose (RP2D) of Nuc-1031 and carboplatin when administered in combination. — 1 year
Countries
United Kingdom