MucositisPhase 2NCT05658016
Phase 2a Study to Evaluate Suppression of Radiotherapy-induced Mucositis by TK112690
A Phase 2 study testing TK-112690 in people with Mucositis, run by Tosk, Inc. at 5 sites in India.
Trial summary
Patients expected to receive a continuous course of radiation as single daily fractions of 2.0 Gy treatment with a cumulative radiation dose of 70 Gy. The radiation can be 2DRT, 3DRT,IMRT etc. Read more about this study
- Who is it for?
- Ages 18 to 75 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
- 24 participants
- Where
- 5 sitesIndia
- Study dates
- 17 Jun 2022to Sep 2023
- Phase
- Phase 2
- Are there results?
- None posted in the registry
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 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Participants must meet ALL of the following criteria at the time of screening unless otherwise specified:
- Patient must sign study specific informed consent prior to study entry.
- Male or Female patient aged 18 - 75 years.
- Pathologically (histologically or cytologically) proven (from primary lesion and/or lymph nodes) diagnosis of squamous cell carcinoma of the oral cavity (Refer Definition in 10.13.1), oropharynx or hypopharynx.
- Patients must have at least 1 mucosal site of the oral cavity/oropharynx/hypopharynx mucosa assessable by visual transoral inspection that will receive cumulative radiation dose of 70 Gy.
- Note: Unavoidable doses of at least 60 Gy, to include entrance, exit, and scatter doses, still constitutes planned radiation.
Show all 22Show fewer
- Patients with tumors of the larynx or hypopharynx are eligible only if it is anticipated that at least 1 index site in the oral cavity/oropharynx/hypopharynx mucosa (Refer section 10.13.1) will receive cumulative radiation dose of 70 Gy.
- Selected Stage I to III or IVA-B per AJCC, Cancer Imaging Manual, 8th edition, at study entry, including no distant metastases other than non- metastatic SCCHN, based upon the following minimum diagnostic workup:
- History/physical examination, including documentation of tobacco/alcohol use and current medications (including opioids/dosing), within 8 weeks prior to randomization.
- Chest CT scan within 8 weeks prior to randomization.
- MRI or CT scan with contrast of tumor site within 8 weeks prior to randomization.
- Mucositis Grade ≤ 1 per WHO Scale and Xerostomia of Grade ≤ 2 per CTCAE version 5.0
- ECOG Performance Status ≤ 2.
- Adequate bone marrow function as per CTCAE V 5, defined as follows (within 2 weeks prior to randomization):
- Absolute neutrophil count ≥ 1500cells/mm3 based upon CBC/differential obtained within 2 weeks prior to randomization.
- Platelets ≥ 100,000 cells/mm3 based upon CBC/differential obtained within 2 weeks prior to randomization.
- Hemoglobin ≥ 8.0 g/dl based upon CBC/differential obtained within 2 weeks prior to randomization (Note: The use of transfusion or other intervention to achieve Hgb> 8.0 g/dl is acceptable).
- Adequate hepatic function with bilirubin ≤ 1.5 x upper-normal limit (ULN), AST or ALT ≤3 x ULN within 2 weeks prior to randomization.
- Adequate renal function with serum creatinine < 1.5 mg/dl and creatinine clearance (CrC) ≥ 50 ml/min determined by 24-hour collection or estimated by Cockcroft-Gault formula. CrC male = [(140 - age) x (wt in kg)] / [(Serum Cr mg/dl) x (72)]. CrC female = 0.85 x (CrCl male) within 2 weeks prior to randomization.
- Normal serum calcium or normal corrected serum calcium within 2 weeks prior to randomization; formula for corrected calcium if albumin valued is below normal range: Corrected calcium (mg/dl) = (4 - [Patient's albumin (g/dl)] x 0.8) + Patient's measured calcium (mg/dl).
- Negative serum pregnancy test for women of childbearing potential.
- Women of childbearing potential and male participants with female partners of childbearing potential must practice adequate contraception.
Who cannot join
- Patients who meet any of the following criteria at the time of screening will be excluded:
- Stage IVC (Any T, Any N, M1) per AJCC Cancer Staging Manual. 8th ed, or distant metastases at protocol study entry other than metastatic SCCHN.
- Prior invasive malignancy (except non-melanomatous skin cancer) unless disease free for a minimum of 3 years.
- Patients who have not fully recovered after prior surgery. (Patients who have had prior surgery and have fully recovered and patients who may have surgery in the future are eligible.).
- Severe, active co-morbidity, defined as follows:
- Symptomatic and/or uncontrolled cardiac disease, New York Heart Association Classification III or IV.
Show all 18Show fewer
- Transmural myocardial infarction within the last 6 months.
- Acute bacterial or fungal infection requiring intravenous antibiotics at the time of screening.
- Chronic Obstructive Pulmonary Disease exacerbation or other respiratory illness requiring hospitalization or precluding study therapy at the time of screening.
- Hepatic insufficiency resulting in clinical jaundice and/or coagulation defects.
- Patients known to be sero-positive for human immunodeficiency virus (HIV), hepatitis B (HBV), hepatitis C (HCV).
- Collagen vascular disease, such as scleroderma.
- Previous treatment with palifermin or other keratinocyte growth factors, such as velafermin or repifermin, within 28 days of randomization.
- Any prohibited therapy 2 weeks prior to randomization (see Section 8.4).
- Pregnancy, breast feeding or women of childbearing potential and men who are sexually active and not willing/able to use medically acceptable forms of contraception.
- Substance abuse, medical, psychological or social conditions that may interfere with the patient's participation in the study or evaluation of the study results.
- Known hypersensitivity study medication or excipients in the formulation.
- Any illness or medical conditions that are unstable or could jeopardize the safety of the patient and his/her compliance in the study.
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
India5 sites
Bangalore Medical college and Research Institute
Bangalore, Karnataka, 560002
Saveetha Medical College and Hospita
Chennai, Tamil Nadu, 602105
Netaji Subhash Chandra Bose Hospital
Kolkata, West Bengal, 700094
Sher-I-Kashmir Institute of Medical Sciences
Srinagar, Jammu and Kashmir, 190011
Apex Hospital
Varanasi, Uttar Pradesh, 221004
About this study
Official title: A Phase 2a, Multi-center, Placebo-Controlled, Randomized, Assessor-blind Study to Assess the Safety & Efficacy of Parenteral TK-90 or Parenteral TK-90 Placebo to Patients Receiving Radiotherapy for Non-Metastatic Squamous Cell Carcinoma of Head and Neck.
Patients expected to receive a continuous course of radiation as single daily fractions of 2.0 Gy treatment with a cumulative radiation dose of 70 Gy. The radiation can be 2DRT, 3DRT,IMRT etc. Prior to each radiation treatment the patients will receive a one-hour infusion of TK-90 or equivalent TK-90 placebo depending on randomization. 6 Hours after the completion of TK-90 infusion or TK-90 placebo dose, the patients will receive another identical TK-90 or TK-90 placebo treatment depending on randomization. This treatment cycle will continue for 7 weeks. The TK112690 dose will be 45 mg/kg.
Read the detailed description
Patients expected to receive a continuous course of radiation as single daily fractions of 2.0 Gy treatment with a cumulative radiation dose of 70 Gy. The radiation can be 2DRT, 3DRT,IMRT etc. Prior to each radiation treatment the patients will receive a one-hour infusion of TK-90 or equivalent TK-90 placebo depending on randomization. 6 Hours after the completion of TK-90 infusion or TK-90 placebo dose, the patients will receive another identical TK-90 or TK-90 placebo treatment depending on randomization. This treatment cycle will continue for 7 weeks. The TK112690 dose will be 45 mg/kg.
- 24 patients will be randomized equally into 2 different groups: TK-90 treated or TK-90 placebo treated.
- Screening must be completed within 2 weeks.
- The treatment period for the study is 7 weeks.
- Study follow-up will be scheduled post two weeks of completion of last dose of radiation or early termination through up to 4 weeks.
- Blinding: The study will be partially blinded. The patient and investigator as well as site personnel will be blinded as to whether TK-90 or TK-90 placebo is administered. The CRO, sponsor, and site pharmacist will know whether the patient was administered active drug or TK-90 placebo.
- Conditions
- Mucositis
- Being tested
- TK-112690, Placebo
- Keywords
- Mucositis, Uridine Phosphorylase Inhibitor, Head and Neck Cancer, Radiation
- 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
TK112690 treatment Pre \& Post Radiation
PlaceboDrug
TK112690 Placebo treatment Pre \& Post Radiation
| Study group | Role | What they receive |
|---|---|---|
| TK112690 | Experimental | TK112690 treatment Receives: Drug: TK-112690 |
| Placebo | Placebo comparator | TK112690 formulation Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mucositis
- SOM (Severe Oral Mucositis) - Comparison of incidences of Grade 3 or 4 mucositis (WHO scale) in the treatment and placebo groups.
- Duration of SOM (Severe Oral Mucositis). Days patients suffer Grades 3 and 4 oral mucositis measured by WHO scale from the start of treatment.
- Calculate Number of days from the first occurrence of WHO Grade 3 or 4 oral mucositis through the first occurrence of non-severe (≤ Grade 2) without a subsequent instance of ≥ Grade 3 oral mucositis.
- Subjects with complete study follow-up for SOM who do not develop severe oral mucositis (grade 0-2) will be considered to have duration of 0 days.
Measured: 7 weeks
Secondary outcomes (2)
Secondary efficacy/outcome mucositis
- Mucositis status in the patients will also be evaluated using two different published and validated mucositis scales: NCI/CTCAE/mucositis, and PROMS.
- Comparison of WHO scale values of treated patients at each point of evaluation.
NCI/CTCAE=National Cancer Institute/Common Terminology Criteria for Adverse Events and WHO=World Health Organization PROMS=Patient Reported oral Mucositis Symptom Scale
As per WHO:Grade 0 to Grade 5 \& NCI CTCAE: Grade 1 to Grade 5
Measured: 7 weeks
Incidence Adverse Events That Are Related to Treatment
Tolerance
Measured: 7 Weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Dec 2022
- Study start17 Jun 2022
- Primary completionSep 2023 (estimated)
- Study completionSep 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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 24 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
- 24 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Tosk, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- SIRO Clinpharm Private Limited
- Responsible party
- Sponsor
- Investigators
- Emile Youssef, MD, PhD, Study director, Tosk, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05658016
- Sponsor's protocol ID
- CLP-2690-0004
- Status last verified
- Aug 2023
- First submitted
- 1 Dec 2022
- Last updated
- 14 Aug 2023
- Results posted
- No
- Data monitoring committee
- Yes
- 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 14 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 2a, Multi-center, Placebo-Controlled, Randomized, Assessor-blind Study to Assess the Safety & Efficacy of Parenteral TK-90 or Parenteral TK-90 Placebo to Patients Receiving Radiotherapy for Non-Metastatic Squamous Cell Carcinoma of Head and Neck.
- ClinicalTrials.gov ID
- NCT05658016
- Acronym / sponsor ID
- CLP-2690-0004
- Conditions
- Mucositis
- Keywords
- Mucositis, Uridine Phosphorylase Inhibitor, Head and Neck Cancer, Radiation
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 24 participants (estimated)
- Lead sponsor
- Tosk, Inc.Industry (pharma, biotech, devices)
- Collaborators
- SIRO Clinpharm Private Limited
- Study start
- 17 Jun 2022 (actual)
- Primary completion
- Sep 2023 (estimated)
- Study completion
- Sep 2023 (estimated)
- First posted
- 20 Dec 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Patients expected to receive a continuous course of radiation as single daily fractions of 2.0 Gy treatment with a cumulative radiation dose of 70 Gy. The radiation can be 2DRT, 3DRT,IMRT etc. Prior to each radiation treatment the patients will receive a one-hour infusion of TK-90 or equivalent TK-90 placebo depending on randomization. 6 Hours after the completion of TK-90 infusion or TK-90 placebo dose, the patients will receive another identical TK-90 or TK-90 placebo treatment depending on randomization. This treatment cycle will continue for 7 weeks. The TK112690 dose will be 45 mg/kg.
Detailed description
Patients expected to receive a continuous course of radiation as single daily fractions of 2.0 Gy treatment with a cumulative radiation dose of 70 Gy. The radiation can be 2DRT, 3DRT,IMRT etc. Prior to each radiation treatment the patients will receive a one-hour infusion of TK-90 or equivalent TK-90 placebo depending on randomization. 6 Hours after the completion of TK-90 infusion or TK-90 placebo dose, the patients will receive another identical TK-90 or TK-90 placebo treatment depending on randomization. This treatment cycle will continue for 7 weeks. The TK112690 dose will be 45 mg/kg.
- 24 patients will be randomized equally into 2 different groups: TK-90 treated or TK-90 placebo treated.
- Screening must be completed within 2 weeks.
- The treatment period for the study is 7 weeks.
- Study follow-up will be scheduled post two weeks of completion of last dose of radiation or early termination through up to 4 weeks.
- Blinding: The study will be partially blinded. The patient and investigator as well as site personnel will be blinded as to whether TK-90 or TK-90 placebo is administered. The CRO, sponsor, and site pharmacist will know whether the patient was administered active drug or TK-90 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 24 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: PlaceboTK112690 formulation |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (22 listed)
- Participants must meet ALL of the following criteria at the time of screening unless otherwise specified:
- Note: Unavoidable doses of at least 60 Gy, to include entrance, exit, and scatter doses, still constitutes planned radiation.
Key exclusion criteria (18 listed)
- Patients who meet any of the following criteria at the time of screening will be excluded:
- Stage IVC (Any T, Any N, M1) per AJCC Cancer Staging Manual. 8th ed, or distant metastases at protocol study entry other than metastatic SCCHN.
- Prior invasive malignancy (except non-melanomatous skin cancer) unless disease free for a minimum of 3 years.
- Patients who have not fully recovered after prior surgery. (Patients who have had prior surgery and have fully recovered and patients who may have surgery in the future are eligible.).
- Severe, active co-morbidity, defined as follows:
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-112690TK112690 treatment Pre \& Post Radiation | Drug | TK112690 |
| PlaceboTK112690 Placebo treatment Pre \& Post Radiation | Drug | Placebo |
Primary outcome
Mucositis
Time frame: 7 weeks
* SOM (Severe Oral Mucositis) - Comparison of incidences of Grade 3 or 4 mucositis (WHO scale) in the treatment and placebo groups. * Duration of SOM (Severe Oral Mucositis). Days patients suffer Grades 3 and 4 oral mucositis measured by WHO scale from the start of treatment. * Calculate Number of days from the first occurrence of WHO Grade 3 or 4 oral mucositis through the first occurrence of non-severe (≤ Grade 2) without a subsequent instance of ≥ Grade 3 oral mucositis. * Subjects with complete study follow-up for SOM who do not develop severe oral mucositis (grade 0-2) will be considered to have duration of 0 days.
2 secondary outcomes
Secondary efficacy/outcome mucositis
Time frame: 7 weeks
Incidence Adverse Events That Are Related to Treatment
Time frame: 7 Weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Aug 2023.
- Individual participant dataSharing planned: No
Related trials for Mucositis
RecruitingPhase 2
Traditional Chinese Medicine Preparation Alleviates Radiotherapy-induced Oral Mucositis in Head and Neck Cancer Patients.
Radiotherapy-induced Oral Mucositis
RecruitingPhase 3
High-dose Prophylactic Gabapentin (HOPE) vs. Placebo to Prevent Opioid Use for Oral Mucositis Pain During Concurrent Chemoradiation for Head and Neck Cancer
Head and Neck Squamous Cell Carcinoma, Stage I Head and Neck Cutaneous Squamous Cell Carcinoma AJCC v8
RecruitingObservational study
Evaluation of 25(OH)D3 and LL-37 Levels in Periimplant Sulcus Fluid
Peri Implantitis, Peri Implant Mucositis
RecruitingPhase 2
Taurine for the Prevention and Treatment of Radiation-induced Oral Mucositis in Patients With Nasopharyngeal Carcinoma
Oral Mucositis (Ulcerative) Due to Radiation, Nasopharyngeal Carcinoma (NPC)
Recruiting
Home-Use Dual-Light Antibacterial Photodynamic Therapy for Peri-Implant Mucositis in Full-Arch Implant Prostheses
Peri Implant Mucositis, Dental Implant Rehabilitation
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.
5 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 5 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 22 inclusion and 18 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: status not confirmed, as of the sponsor's last update on 14 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 5 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?
Results are not available in the source record.
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: 7 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 14 Aug 2023.