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Safety and Efficacy Study of Nuc-1031 and Carboplatin Combination to Treat Recurrent Ovarian Cancer — ProGem2  

Recurrent Ovarian Cancer Clinical Trial

Official title:
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.

Clinical Trial Summary

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.

Clinical Trial Description

Nuc-1031 and carboplatin combination is a new experimental treatment for ovarian cancer which reappear after standard chemotherapy. Chemotherapy is the name for drug treatments to kill or control the growth of cancer cells. Although there is some evidence from laboratory and clinical studies that Nuc-1031 is effective in the treatment of ovarian cancer, it has not yet been tested in combination with another chemotherapy drug. So this combination treatment is classed as a first in human study(Phase1B). The aim of the study is to investigate whether adding Nuc-1031 to carboplatin can improve the benefits of chemotherapy. Other purposes are to find out whether Nuc-1031 is safe to give with carboplatin, to identify the correct dose of Nuc-1031 when given with carboplatin and establish how effective the combination is at treating ovarian cancer. This study is also designed to enable us to find out whether Nuc-1031 adds further benefit, over and above that achieved by carboplatin alone, when treating ovarian cancer. and carboplatin combination will be given in six cycles. Each cycle is 3 weeks long. On first day of first week of each cycle (day1), selected study participants will receive one dose of both Nuc-1031 and Carboplatin chemotherapy. Following this, the study participant will receive a second dose of Nuc-1031 alone on first day of second week (day 8). This schedule will be repeated every 3 weeks for 6 cycles. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT02303912
Study type Interventional
Source Imperial College Healthcare NHS Trust
Contact
Status Completed
Phase Phase 1
Start date November 2014
Completion date January 23, 2017
View Details
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