Ignite Creation Date:
2024-05-06 @ 5:43 PM
Last Modification Date:
2024-10-26 @ 2:34 PM
Study NCT ID:
NCT05408845
Status:
RECRUITING
Last Update Posted:
2024-02-07
First Post:
2022-06-02
Brief Title:
Testing the Use of Ado-Trastuzumab Emtansine Compared to the Usual Treatment Chemotherapy With Docetaxel Plus Trastuzumab for Recurrent Metastatic or Unresectable HER2-Positive Salivary Gland Cancer
Sponsor:
NRG Oncology
Organization:
NRG Oncology
Study Overview
Official Title:
A Controlled Randomized Phase II Trial of Docetaxel Plus Trastuzumab Versus Ado-Trastuzumab Emtansine for Recurrent Metastatic or Treatment-Naive Unresectable HER2-Positive Salivary Gland Cancer
Status:
RECRUITING
Status Verified Date:
2024-02
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 tests whether ado-trastuzumab emtansine works to shrink tumors in patients with HER2-positive salivary gland cancer that has come back recurrent spread to other places in the body metastatic or cannot be removed by surgery unresectable Trastuzumab emtansine is a monoclonal antibody called trastuzumab linked to a chemotherapy drug called emtansine Trastuzumab attaches to HER2 positive cancer cells in a targeted way and delivers emtansine to kill them Trastuzumab emtansine may work better compared to usual treatment of chemotherapy with docetaxel and trastuzumab in treating patients with salivary gland cancer
Detailed Description:
PRIMARY OBJECTIVE
I To determine if trastuzumab emtansine ado-trastuzumab emtansine T-DM1 shows better progression-free survival PFS when compared to docetaxel plus trastuzumab TH in recurrent andor metastatic RM HER2-positive salivary gland cancer SGC patients who have not previously received HER2 therapy for unresectable or recurrent andor metastatic disease as determined by local assessment
SECONDARY OBJECTIVES
I To compare the overall response rate ORR by Response Evaluation Criteria in Solid Tumors RECIST version v11 criteria between arms
II To compare overall survival OS between arms III To compare toxicity using Common Terminology Criteria for Adverse Events CTCAE v50 criteria between arms
IV To assess patient-reported toxicity as measured by the patient reported outcome PRO-CTCAE between arms and explore patient-reported symptomatic adverse events AEs for tolerability of each treatment arm as measured by the PRO-CTCAE
EXPLORATORY OBJECTIVES
I To assess the ORR in patients who receive crossover treatment to T-DM1TH following disease progression on the TH armT-DM1 arm
II To collect blood and tissue specimens for future translational science studies to examine how tumor genetics HER2 signaling outputexpression and HER2 tumoral heterogeneity impact TH and T-DM1 efficacy
OUTLINE Patients are randomized to 1 of 2 arms
ARM I Patients receive docetaxel intravenously IV over 60 minutes on day 1 of each cycle Treatment repeats every 21 days for up to 6 cycles in the absence of disease progression or unacceptable toxicity Patients also receive trastuzumab IV over 90 minutes on day 1 of each cycle Cycles repeat every 21 days in the absence of disease progression or unacceptable toxicity
ARM II Patients receive trastuzumab emtansine IV over 90 minutes on day 1 of each cycle Cycles repeat every 21 days in the absence of disease progression or unacceptable toxicity
After completion of study treatment patients are followed up every 3 months for 2 years and then every 6 months for 3 years
I To determine if trastuzumab emtansine ado-trastuzumab emtansine T-DM1 shows better progression-free survival PFS when compared to docetaxel plus trastuzumab TH in recurrent andor metastatic RM HER2-positive salivary gland cancer SGC patients who have not previously received HER2 therapy for unresectable or recurrent andor metastatic disease as determined by local assessment
SECONDARY OBJECTIVES
I To compare the overall response rate ORR by Response Evaluation Criteria in Solid Tumors RECIST version v11 criteria between arms
II To compare overall survival OS between arms III To compare toxicity using Common Terminology Criteria for Adverse Events CTCAE v50 criteria between arms
IV To assess patient-reported toxicity as measured by the patient reported outcome PRO-CTCAE between arms and explore patient-reported symptomatic adverse events AEs for tolerability of each treatment arm as measured by the PRO-CTCAE
EXPLORATORY OBJECTIVES
I To assess the ORR in patients who receive crossover treatment to T-DM1TH following disease progression on the TH armT-DM1 arm
II To collect blood and tissue specimens for future translational science studies to examine how tumor genetics HER2 signaling outputexpression and HER2 tumoral heterogeneity impact TH and T-DM1 efficacy
OUTLINE Patients are randomized to 1 of 2 arms
ARM I Patients receive docetaxel intravenously IV over 60 minutes on day 1 of each cycle Treatment repeats every 21 days for up to 6 cycles in the absence of disease progression or unacceptable toxicity Patients also receive trastuzumab IV over 90 minutes on day 1 of each cycle Cycles repeat every 21 days in the absence of disease progression or unacceptable toxicity
ARM II Patients receive trastuzumab emtansine IV over 90 minutes on day 1 of each cycle Cycles repeat every 21 days in the absence of disease progression or unacceptable toxicity
After completion of study treatment patients are followed up every 3 months for 2 years and then every 6 months for 3 years
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 |
|---|---|---|---|
| U10CA180868 | NIH | CTEP | httpsreporternihgovquickSearchU10CA180868 |
| NCI-2022-04353 | REGISTRY | None | None |
| NRG-HN010 | OTHER | None | None |
| NRG-HN010 | OTHER | None | None |