Ignite Creation Date:
2024-05-06 @ 4:14 PM
Last Modification Date:
2024-10-26 @ 2:06 PM
Study NCT ID:
NCT04921527
Status:
RECRUITING
Last Update Posted:
2023-08-31
First Post:
2021-06-03
Brief Title:
Chiauranib Plus Weekly Paclitaxel in Patients with Platinum-refractory or Platinum-resistant Recurrent Ovarian Cancer
Sponsor:
Chipscreen Biosciences Ltd
Organization:
Chipscreen Biosciences Ltd
Study Overview
Official Title:
A Multi-center Double-blind Randomized Phase III Clinical Trial of Chiauranib Plus Weekly Paclitaxel in Patients with Platinum-refractory or Platinum-resistant Recurrent Ovarian Cancer
Status:
RECRUITING
Status Verified Date:
2024-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
CHIPRO
Brief Summary:
This randomized double-blind 2-arm study will evaluate the efficacy and safety of Chiauranib plus weekly paclitaxel versus placebo plus weekly paclitaxel in patients with Platinum-refractory or Platinum-resistant Recurrent ovarian cancer
Detailed Description:
Chiauranib is a novel orally active multi-target inhibitor that simultaneously inhibits the angiogenesis-related kinases VEGFR2 VEGFR1 VEGFR3 PDGFRa and c-Kit mitosis-related kinase Aurora B and chronic inflammationrelated kinase CSF-1R in a high potency manner with the IC50 at a single-digit nanomolar range In particular Chiauranib showed very high selectivity in the kinase inhibition profile with little activity on off-target non-receptor kinases proteins GPCR and ion channels indicative of a better drug safety profile in terms of clinical relevance
Patients will be randomized to receive treatment with either paclitaxel Chiauranib or paclitaxel placebo Paclitaxel will be repeated every 21 days for a maximum of 6 cycles Patients with objective responsestable disease after completing 6 courses of chemotherapy will continue Chiauranib or placebo until progression
Patients will be randomized to receive treatment with either paclitaxel Chiauranib or paclitaxel placebo Paclitaxel will be repeated every 21 days for a maximum of 6 cycles Patients with objective responsestable disease after completing 6 courses of chemotherapy will continue Chiauranib or placebo until progression
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None