NUC-1031 in Patients With Platinum-Resistant Ovarian Cancer
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|ClinicalTrials.gov Identifier: NCT03146663|
Recruitment Status : Terminated (Despite the clinical activity observed, the study was stopped due to reduced dose intensity in this heavily pre-treated population with complex comorbidities)
First Posted : May 10, 2017
Last Update Posted : January 14, 2020
|Condition or disease||Intervention/treatment||Phase|
|Ovarian Cancer||Drug: NUC-1031 500 mg Drug: NUC-1031 750mg||Phase 2|
Up to 20 patients will be treated at each dose in Part I of the study. In Part II of the study, one of the treatment dose levels will be selected for further evaluation. The dose selection will be based on clinical and laboratory assessments of patients recruited in Part I. Patients will only participate in either Part I or II. A total of 64 patients will be treated in Part I and Part II combined.
Eligible consenting patients will receive NUC-1031 by IV infusion on days 1, 8 and 15 of each 28-day cycle. Patients will continue to receive NUC-1031 until the occurrence of disease progression. Patients will undergo imaging every 8 weeks. After disease progression, patients will be followed for overall survival.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||51 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Phase II Open-Label Study of NUC-1031 in Patients With Platinum-Resistant Ovarian Cancer|
|Actual Study Start Date :||September 28, 2017|
|Actual Primary Completion Date :||December 31, 2019|
|Actual Study Completion Date :||December 31, 2019|
Experimental: NUC-1031 500 mg/m2
NUC-1031 500 mg/m2 on days 1, 8, and 15
Drug: NUC-1031 500 mg
NUC-1031 500 mg/m2 on Days 1, 8 and 15 of a 28-day cycle.
Experimental: NUC-1031 750 mg/m2
NUC-1031 750 mg/m2 on Days 1, 8, and 15
Drug: NUC-1031 750mg
NUC-1031 750 mg/m2 on Days 1, 8, and 15 of a 28-day cycle
- Objective Response Rate (ORR) [ Time Frame: Assessed at approximately 24 weeks following the last patient enrolled ]ORR is defined as the number of patients achieving a confirmed response (CR or PR).
- Change from baseline in tumor size [ Time Frame: Assessed every 8 weeks for up to 36 months ]The percentage change in the total measurement of target lesions from the pre-treatment scan to the total measurement of target lesions at each scheduled scan
- Progression-Free Survival (per RECIST) [ Time Frame: Assessed every 8 weeks for up to 36 months ]Progression-free survival will be calculated from the start of treatment to the date of progression or death from any cause
- Overall Survival [ Time Frame: Assessed every 12 weeks following disease progression for up to 36 months ]Overall survival will be calculated from the start of treatment to the date of death from any cause
- Treatment-emergent adverse events (per NCI CTCAE v4), changes in vitals signs and laboratory parameters [ Time Frame: Assessed from the time of consent until 30 days following the last NUC-1031 dose administration ]Evaluation of safety and tolerability of NUC-1031
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03146663
|Study Director:||Christopher B Wood, MD PhD||NuCana plc|