Study of NUC-1031 in Patients with Platinum-Resistant Ovarian Cancer
Research type
Research Study
Full title
A Phase II Open-Label Study of NUC-1031 in Patients with Platinum-Resistant Ovarian Cancer
IRAS ID
223060
Contact name
Charlie Gourley
Contact email
Sponsor organisation
Nucana BioMed Ltd
Eudract number
2016-003287-39
Clinicaltrials.gov Identifier
130348, IND
Duration of Study in the UK
2 years, 3 months, 3 days
Research summary
The purpose of this study is to test the safety of the drug, NUC-1031, and how well it works in patients with ovarian cancer. Laboratory studies carried out have shown that NUC-1031 can stop the growth of ovarian cancer cells. In clinical studies, patients with cancer (including ovarian cancer) have already been given NUC-1031. In these studies, NUC-1031 has been generally well tolerated and has shown a reduction in the size of the tumour or slowing the growth of tumours in some patients.
This study will be divided into two parts. During Part I, patients will be randomly selected to receive one of two different dose levels of NUC-1031 (500 mg/m² or 750mg/m²). Up to 20 patients will be treated at each dose. In Part II, one of the treatment dose levels will be selected for further evaluation. This will be based on clinical and laboratory assessments of patients recruited in Part I. Patients will only participate in either Part I or II.
NUC-1031 will be given once a week for three weeks followed by a week off before starting the next treatment cycle. Patients will continue to receive NUC-1031 until the occurrence of disease progression or drug-related adverse events become unmanageable. This study will be conducted at 24 sites, approximately 16 in the USA and 8 in the UK. About 64 women aged 18 and over with ovarian cancer will take part. Throughout the study subjects will undergo blood tests, ECGs, physical examinations and urine tests. A CT or MRI scan will be taken every 8 weeks to measure the patient’s cancer. If possible, a fresh tumour biopsy will be taken during screening and an optional second biopsy after approx.6 weeks of treatment. In part II enrollment shall continue until 44 evaluable patients are recruited at the selected dose.
REC name
East of Scotland Research Ethics Service REC 2
REC reference
17/ES/0051
Date of REC Opinion
16 May 2017
REC opinion
Favourable Opinion