Maintenance Study of Niraparib/Placebo in Patients with Ovarian Cancer
Research type
Research Study
Full title
A Phase 3 Randomised Double-blind Trial of Maintenance with Niraparib versus Placebo in Patients with Platinum Sensitive Ovarian Cancer
IRAS ID
134646
Contact name
Jonathan Ledermann
Contact email
Sponsor organisation
TESARO Inc.
Eudract number
2013-000685-11
Clinicaltrials.gov Identifier
Research summary
Summary of Research
Ovarian cancer is a cancer affecting women of all ages. Despite the progress of treatment in ovarian cancer, majority of patients relapse (cancer reoccurs) and the management of relapsed cancer is difficult.Ovarian cancer is usually treated with surgery to remove the cancer followed a combination of chemotherapy and platinum-containing drugs. Patients who respond for an extended time to this type of treatment are referred to as ‘platinum sensitive’. If the cancer reoccurs, they can receive the same combination.
There is a need to develop treatment for relapsing cancer. It’s been suggested that treatment with Poly (ADP-Ribose) Polymerase (PARP-1 and -2) inhibitors can help target and kill cancer cells. PARP-1 and -2 are proteins which play a vital role in DNA repair, by stopping these proteins the cells will die.
Niraparib is an orally active PARP1/2 inhibitor (stops PARP -1 and -2 working) being developed to prolong the time patients relapse after chemotherapy and delay the time that the patient requires further chemotherapy. In clinical trials, PARP inhibitors have shown a significant increase in progression free survival (longer between re-occurrence of cancer). It has also been shown that patients who are impaired DNA repair are shown to have a greater effect when given PARP inhibitors.TESARO Inc. is sponsoring a study to collect information about the effectiveness of niraparib. Patients with platinum-sensitive ovarian cancer, who have previously received treatment will be randomised to receive either Niraparib or placebo (a drug with no medical effect). The chance of getting niraparib will be 67% and the chance of getting placebo will be 33%. Neither the patient nor the study doctor will know which medication will be given. This is a multi-centre study which will take place across Europe, Israel, Canada and the USA. It’s anticipated that 360 patients will be recruited worldwide.
Summary of Results
Plain Language Summary or Lay Summary of Results is out of scope for this study.REC name
North East - Tyne & Wear South Research Ethics Committee
REC reference
13/NE/0269
Date of REC Opinion
18 Oct 2013
REC opinion
Further Information Favourable Opinion