Ignite Creation Date:
2024-05-06 @ 9:28 AM
Last Modification Date:
2024-10-26 @ 12:14 PM
Study NCT ID:
NCT02984683
Status:
TERMINATED
Last Update Posted:
2021-09-08
First Post:
2016-12-04
Brief Title:
Study Evaluating Efficacy and Safety of SAR566658 Treatment in Patients With CA6 Positive Metastatic Triple Negative Breast Cancer
Sponsor:
Sanofi
Organization:
Sanofi
Study Overview
Official Title:
Open-label Phase 2 Study Evaluating Efficacy and Safety of SAR566658 Treatment in Patients With CA6 Positive Metastatic Triple Negative Breast Cancer
Status:
TERMINATED
Status Verified Date:
2021-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Study discontinued considering the limited clinical benefit combined with a higher than expected rate of known non-serious ophthalmological event
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Primary Objective
To evaluate the tumor Objective Response Rate ORR according to the Response Evaluation Criteria in Solid Tumors RECIST 11 of SAR566658 in participants with anti-carbonic anhydrase 6 CA6-positive metastatic triple negative breast cancer TNBC Part 1 To select the SAR566658 dose based on ORR and safety of 2 dose levels of SAR566658 Part 2 Part 2a To demonstrate the activity of SAR566658 based on ORR in participants overexpressing CA6 membrane intensity of 2 3 in greater than or equal to 30 of tumor cells treated at the selected dose in an expanded cohort in addition to the participants treated in Part 1 - Part 2b To assess the efficacy in participants with metastatic TNBC and mild CA6 expression
Secondary Objectives
To assess
Disease Control Rate DCR Duration of Response DOR Progression-Free Survival PFS and Time To Progression TTP
The impact of ocular primary prophylaxis on the incidence of keratopathies
The potential immunogenicity of SAR566658
To evaluate the global safety profile
To evaluate the tumor Objective Response Rate ORR according to the Response Evaluation Criteria in Solid Tumors RECIST 11 of SAR566658 in participants with anti-carbonic anhydrase 6 CA6-positive metastatic triple negative breast cancer TNBC Part 1 To select the SAR566658 dose based on ORR and safety of 2 dose levels of SAR566658 Part 2 Part 2a To demonstrate the activity of SAR566658 based on ORR in participants overexpressing CA6 membrane intensity of 2 3 in greater than or equal to 30 of tumor cells treated at the selected dose in an expanded cohort in addition to the participants treated in Part 1 - Part 2b To assess the efficacy in participants with metastatic TNBC and mild CA6 expression
Secondary Objectives
To assess
Disease Control Rate DCR Duration of Response DOR Progression-Free Survival PFS and Time To Progression TTP
The impact of ocular primary prophylaxis on the incidence of keratopathies
The potential immunogenicity of SAR566658
To evaluate the global safety profile
Detailed Description:
The duration of the study for 1 participant included a screening period of up to 21 days prior to first study drug administration 3-week treatment cycles until 30 days after last SAR566658 administration and a follow-up period Each participant was treated until radiological disease progression unacceptable toxicity or participants refusal of further study treatment
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
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
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 2016-001962-27 | EUDRACT_NUMBER | None | None |
| U1111-1182-7044 | OTHER | UTN | None |