MucositisPhase 2TK112690NCT04046250
Phase 2a Study to Evaluate Suppression of Methotrexate-induced Mucositis by TK112690
A Phase 2 study testing TK-112690 in people with Mucositis, run by Tosk, Inc. at 3 sites in India.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Mucositis
- What is being tested?
- TK-112690
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 22 participants
- Where
- 3 sitesIndia
- Study dates
- 15 May 2019to 31 Mar 2020
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male and female subjects over 18 years old with a histologically or cytological confirmed diagnosis of locally residual, recurrent or metastatic SCCHN.
- Subject must have failed at least one courses of non-MTX chemotherapy, or one course of non-MTX chemotherapy and chemo radiation for treating their SCCHN.
- No prior systemic treatments for cancer (chemotherapy and/or radiotherapy) 4 weeks prior to screening.
- No other concurrent, active, invasive malignancies.
- An Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2.
- Must have a life expectancy of at least 6 months.
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- History of brain metastases allowed if disease has stabilized or improved after radiation and/or craniotomy.
- No active angina or uncontrolled arrhythmia.
- No detectable infection including hepatitis B/C and HIV.
- Not pregnant or nursing. Women of childbearing potential must have a negative urine pregnancy test at screening and on the day before dosing and must use medically acceptable methods of birth control. Acceptable methods of birth control include oral or transdermal contraceptives, condoms, spermicidal foam, IUD, progestin implant or injection, abstinence, vaginal ring, or sterilization of partner. The reason for non-childbearing potential, such as bilateral tubal ligation, bilateral oophorectomy, hysterectomy, or post-menopausal for ≥ 1 year, must be specified in the patient's medical history file and CRF.
- Must have adequate organ and immune function as indicated by the following laboratory values:
- Parameter Laboratory Values Serum creatinine ≤1.5 x ULN Est. creatinine clearance ≥45 mL/min Total bilirubin ≤2.0 mg/dL (≤34.2 μmol/L) AST \& ALT ≤3 x ULN Absolute granulocytes ≥1.5 x 109 cells/L Platelets ≥100,000/µL
- ● Be able to read and understand, and provide a signature or thumb impression on the Informed Consent Form (ICF) before entering the study.
Who cannot join
- Subject has not failed at least one courses of non-MTX chemotherapy or one course of non-MTX chemotherapy and chemo radiation for treating their SCCHN.
- Uncontrolled active infection.
- Current mucositis (>Grade 1).
- Pregnant or nursing mother.
- Prior history of a cerebrovascular accident or hemorrhage.
- Congestive heart failure, as defined by New York Heart Association class III or IV.
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- Uncontrolled hypertension.
- Active psychiatric/mental illness making informed consent or useful clinical follow-up unlikely.
- Subjects who have previously been enrolled into this study and subsequently withdrew.
- Subject receiving other investigational agent(s).
- Any systemic immunosuppressive medication/therapy (eg, other chemotherapy, steroids).
- Any significant systemic illness, unstable or severe medical condition(s) that could put the subject at risk during the study, interfere with outcome measures, or affect compliance with the protocol procedures such as intercurrent infection and/or autoimmune disease, ie, any condition that compromises the immune system.
- Known or suspected intolerance or hypersensitivity to the study materials (TK-112690 and/or excipients or closely related compounds).
- Subjects, who have received, or plan to receive, radiation or chemotherapy within 4 weeks of screening.
- Subjects that have a history of poor compliance in clinical research studies.
- Subjects that have participated in any other investigative clinical trial in the past 4 weeks.
Trial locations and contacts
3 sites in 1 country.
India3 sites
Bangalore Cancer
Bangalore, Karnataka, 560091
Netaji Subhash Chandra Bose Cancer Hospital
Kolkata, West Bengal, 700094
Karnatak Cancer Therapy and Research Institute
Navanagar, Karnataka, 580025
About this study
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
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.
Read the 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.
- Conditions
- Mucositis
- Being tested
- TK-112690, Placebo TK-112690
- Keywords
- Mucositis, Methotrexate, Uridine Phosphorylase Inhibitor, Head and Neck Cancer
- Medical subject headings
- Mucositis, Head and Neck Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TK-112690Drug
Also called Treatment
TK112690 treatment pre-methotrexate treatment
Placebo TK-112690Drug
Placebo
| Study group | Role | What they receive |
|---|---|---|
| TK112690 | Experimental | TK112690 treatment Receives: Drug: TK-112690 |
| Placebo | Placebo comparator | TK112690 formulation Receives: Drug: Placebo TK-112690 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mucositis
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.
Measured: up to 4 Weeks
Secondary outcomes (1)
Incidence Adverse Events That Are Related to Treatment
Tolerance
Measured: Measured Weekly Over 4 Weeks of Study
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Aug 2019
- Study start15 May 2019
- Primary completion10 Oct 2019
- Study completion31 Mar 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for MucositisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- A total of 22 patients will be enrolled into one of 2 different: TK112690 treated or placebo treated.
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 22 participants (actual)
Sponsor and investigators
- Lead sponsor
- Tosk, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Crystal Life Sciences
- Responsible party
- Sponsor
- Investigators
- Emile Youssef, MD, PhD, Study director, Tosk, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04046250
- Sponsor's protocol ID
- CLP-2690-0003
- Acronym
- TK112690
- Status last verified
- Aug 2023
- First submitted
- 1 Aug 2019
- Last updated
- 25 Aug 2023
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT04046250
- Acronym / sponsor ID
- TK112690 / CLP-2690-0003
- Conditions
- Mucositis
- Keywords
- Mucositis, Methotrexate, Uridine Phosphorylase Inhibitor, Head and Neck Cancer
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 22 participants (actual)
- Lead sponsor
- Tosk, Inc.Industry (pharma, biotech, devices)
- Collaborators
- Crystal Life Sciences
- Study start
- 15 May 2019 (actual)
- Primary completion
- 10 Oct 2019 (actual)
- Study completion
- 31 Mar 2020 (actual)
- First posted
- 6 Aug 2019 (actual)
- Results
- Posted 3 Jun 2021
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
- Model description
- A total of 22 patients will be enrolled into one of 2 different: TK112690 treated or placebo treated.
| Arm | Type | Receives |
|---|---|---|
| TK112690 | Experimental | Drug: TK-112690TK112690 treatment |
| Placebo | Placebo comparator | Drug: Placebo TK-112690TK112690 formulation |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (13 listed)
- Male and female subjects over 18 years old with a histologically or cytological confirmed diagnosis of locally residual, recurrent or metastatic SCCHN.
- Subject must have failed at least one courses of non-MTX chemotherapy, or one course of non-MTX chemotherapy and chemo radiation for treating their SCCHN.
- No prior systemic treatments for cancer (chemotherapy and/or radiotherapy) 4 weeks prior to screening.
- No other concurrent, active, invasive malignancies.
- An Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2.
Key exclusion criteria (16 listed)
- Subject has not failed at least one courses of non-MTX chemotherapy or one course of non-MTX chemotherapy and chemo radiation for treating their SCCHN.
- Uncontrolled active infection.
- Current mucositis (>Grade 1).
- Pregnant or nursing mother.
- Prior history of a cerebrovascular accident or hemorrhage.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| TK-112690Also: TreatmentTK112690 treatment pre-methotrexate treatment | Drug | TK112690 |
| Placebo TK-112690Placebo | Drug | Placebo |
Primary outcome
Mucositis
Time frame: up to 4 Weeks
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.
1 secondary outcome
Incidence Adverse Events That Are Related to Treatment
Time frame: Measured Weekly Over 4 Weeks of Study
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Aug 2023.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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RecruitingPhase 3
A Clinical Study to Compare BupiZenge With Lidocaine for Pain Due to Oral Mucositis in Patients With Head and Neck Cancer.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Emile Youssef, MD, PhD study director
Tosk, Inc.
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing TK-112690 in people with Mucositis, run by Tosk, Inc. at 3 sites in India.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 13 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 25 Aug 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in India. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 3 Jun 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Mucositis (time frame: up to 4 Weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Aug 2023; AzTrials last refreshed its copy on 3 Nov 2026.