Ignite Creation Date:
2025-12-24 @ 5:05 PM
Ignite Modification Date:
2025-12-29 @ 2:50 AM
Study NCT ID:
NCT04046250
Status:
COMPLETED
Last Update Posted:
2023-08-25
First Post:
2019-08-01
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Phase 2a Study to Evaluate Suppression of Methotrexate-induced Mucositis by TK112690
Sponsor:
Tosk, Inc.
Organization:
Study Overview
Official Title:
Phase 2a, Multi-center, Placebo-controlled, Randomized, Partially Blinded, Study Infused TK112690 or or Placebo Administered Along With Methotrexate Weekly for Four Consecutive Weeks to Patients With Recurrent or Residual SCCHN
Status:
COMPLETED
Status Verified Date:
2023-08
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:
TK112690
Brief Summary:
Patients will receive methotrexate at a dose of 45 mg/m2 administered weekly for 4 consecutive weeks as an iv infusion along with a nutritional supplement administered two hours before the methotrexate. One hour before the methotrexate treatment the patients will be administered the first infusion of the day of either TK112690 or placebo depending on randomization. Five hours after the methotrexate treatment the patients will be administered the second treatment of either TK112690 or placebo depending on randomization. The TK112690 dose will be 45 mg/kg.
Detailed Description:
Patients will receive methotrexate at a dose of 45 mg/m2 administered weekly for 4 consecutive weeks as an iv infusion along with a nutritional supplement administered two hours before the methotrexate. One hour before the methotrexate treatment the patients will be administered the first infusion of the day of either TK112690 or placebo depending on randomization infusion. Five hours after the methotrexate treatment the patients will be administered the second treatment of either TK112690 or placebo depending on randomization. The TK112690 dose will be 45 mg/kg.
* A total of 22 patients will be enrolled into one of 2 different dose groups: TK-112690 treated or placebo treated.
* Screening must be within 15 days of subject enrollment.
* Patients will remain for observation at the clinical site for a minimum of 25 hours post initial TK112690 or placebo dose.
* Study follow-up will occur on Week 6, two weeks after the last dosing of methotrexate.
* Blinding: The study will be partially blinded. The patient and investigator will be blinded as to whether TK112690 or placebo is administered. The CRO, sponsor, and site pharmacist will know whether the patient was administered active drug or placebo.
* A total of 22 patients will be enrolled into one of 2 different dose groups: TK-112690 treated or placebo treated.
* Screening must be within 15 days of subject enrollment.
* Patients will remain for observation at the clinical site for a minimum of 25 hours post initial TK112690 or placebo dose.
* Study follow-up will occur on Week 6, two weeks after the last dosing of methotrexate.
* Blinding: The study will be partially blinded. The patient and investigator will be blinded as to whether TK112690 or placebo is administered. The CRO, sponsor, and site pharmacist will know whether the patient was administered active drug or placebo.
Study Oversight
Has Oversight DMC:
False
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?:
True
Is an FDA AA801 Violation?: