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Mucositis

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Methotrexate

TK112690 treatment pre-methotrexate treatment

TK-112690

Placebo TK-112690

Emile Youssef, MD, PhD

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.

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: TK112690 treated or placebo treated.

The study will be partially blinded. The patient and investigator will be blinded as to whether TK112690 or placebo is administered. The clinical research organization, sponsor, and site pharmacist will know whether the patient was administered active drug or placebo.

Phase 2a Study to Evaluate Suppression of Methotrexate-induced Mucositis by TK112690

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

Mucositis Evaluation Using Established Scoring Systems: NCI/CTCAE at 4 WKs (Primary) and WHO at 4 WKs (Primary).

NCI/CTCAE=National Cancer Institute/Common Terminology Criteria for Adverse Events and WHO=World Health Organization

NCI Grades- 0= No mucositis, 1=Mild mucositis (Painless ulcers, erythema, or mild soreness in the absence of lesions), 2=Moderate mucositis (Painful erythema, edema, or ulcers but eating or swallowing possible), 3= Severe mucositis (Painful erythema, edema, or ulcers requiring IV hydration), 4=Life threatening, 5=Death WHO Grades- 0=No mucositis, 1= Mild (Oral soreness, erythema), 2=Moderate (Oral erythema, ulcers, solid diet tolerated), 3=Severe (Oral ulcers, liquid diet only), 4=Life-threatening (Oral alimentation impossible).

For both the scales above, a higher score implies greater mucositis.

Scale specific mean values for patients in each group (placebo or treated) are calculated and compared by Student's t-test.

Crystal Life Sciences

Tosk, Inc.

TK112690 treatment

TK-112690: TK112690 treatment pre-methotrexate treatment

TK112690

TK112690 formulation

Placebo TK-112690: Placebo

Placebo

Total

Age, Continuous

Sex: Female, Male

Ethnicity (NIH/OMB)

India

Region of Enrollment

NCI/CTCAE at 4 WKs

WHO at 4 WKs

Patients with SCCHN who have failed at least one prior treatment of chemotherapy and/or radiation

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
Phase 2a Study to Evaluate Suppression of Methotrexate-induced Mucositis by TK112690	NCT04046250	Mucositis	TK-112690 Placebo TK-1126...	18 Years - 80 Years	Tosk, Inc.
Phase 2a Study to Evaluate Suppression of Methotrexate-induced Mucositis by TK112690	NCT04046250	Mucositis	TK-112690 Placebo TK-1126...	18 Years - 80 Years	Tosk, Inc.

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