Ignite Creation Date:
2024-05-06 @ 10:33 AM
Last Modification Date:
2024-10-26 @ 12:31 PM
Study NCT ID:
NCT03284385
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2024-07-03
First Post:
2017-09-14
Brief Title:
Testing AZD1775 in Advanced Solid Tumors That Have a Mutation Called SETD2
Sponsor:
National Cancer Institute NCI
Organization:
National Cancer Institute NCI
Study Overview
Official Title:
A Phase 2 Study of AZD1775 in SETD2-Deficient Advanced Solid Tumor Malignancies
Status:
ACTIVE_NOT_RECRUITING
Status Verified Date:
2024-08
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:
None
Brief Summary:
This phase II trial studies how well adavosertib works in treating patients with SETD2-deficient solid tumors that have spread to other places in the body advancedmetastatic Adavosertib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth
Detailed Description:
PRIMARY OBJECTIVES
I To determine the objective response rate by Response Evaluation Criteria in Solid Tumors RECIST 11 criteria of adavosertib AZD1775 in advanced solid tumor malignancies other than clear cell renal cell carcinoma with evidence of pathogenic loss of SETD2 using next-generation sequencing panel
II To determine the objective response rate by RECIST 11 criteria of AZD1775 in clear cell renal cell carcinoma with evidence of loss of SETD2 using next-generation sequencing panel
SECONDARY OBJECTIVES
I To determine the clinical benefit rate and duration of response of AZD1775 in SETD2-deficient tumors other than clear cell renal cell carcinoma
II To determine the clinical benefit rate and duration of response of AZD1775 in SETD2-deficient clear cell renal cell carcinoma subgroup
III To characterize the safety profile of AZD1775 IV To determine whether H3K36me3 expression by immunohistochemical assay is associated with clinical outcomes
OUTLINE
Patients receive adavosertib orally PO once daily QD on days 1-5 and 8-12 Cycles repeat every 21 days in the absence of disease progression or unacceptable toxicity
After completion of study treatment patients are followed up for 30 days
I To determine the objective response rate by Response Evaluation Criteria in Solid Tumors RECIST 11 criteria of adavosertib AZD1775 in advanced solid tumor malignancies other than clear cell renal cell carcinoma with evidence of pathogenic loss of SETD2 using next-generation sequencing panel
II To determine the objective response rate by RECIST 11 criteria of AZD1775 in clear cell renal cell carcinoma with evidence of loss of SETD2 using next-generation sequencing panel
SECONDARY OBJECTIVES
I To determine the clinical benefit rate and duration of response of AZD1775 in SETD2-deficient tumors other than clear cell renal cell carcinoma
II To determine the clinical benefit rate and duration of response of AZD1775 in SETD2-deficient clear cell renal cell carcinoma subgroup
III To characterize the safety profile of AZD1775 IV To determine whether H3K36me3 expression by immunohistochemical assay is associated with clinical outcomes
OUTLINE
Patients receive adavosertib orally PO once daily QD on days 1-5 and 8-12 Cycles repeat every 21 days in the absence of disease progression or unacceptable toxicity
After completion of study treatment patients are followed up for 30 days
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 |
|---|---|---|---|
| UM1CA186689 | NIH | CTEP | httpsreporternihgovquickSearchUM1CA186689 |
| NCI-2017-01670 | REGISTRY | None | None |
| 10170 | OTHER | None | None |
| 10170 | OTHER | None | None |