AzTrials
AzTrials

MucositisPhase 2NCT05669521

Phase 2a Study to Evaluate Suppression of 5-Fluorouracil -Induced Mucositis by TK112690

A Phase 2 study testing TK-112690 in people with Mucositis, run by Tosk, Inc. at 5 sites in India.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
Search all trials

Trial summary

Patients expected to receive a 500 mg/m2 of Leucovorin by iv \& 500 mg/m2 of Fluorouracil (5FU) by iv bolus for their Colorectal Cancer. The patients will receive a one-hour infusion of TK-90 or equivalent TK-90 placebo depending on randomization at 5 hours \& 11 hours post 5-FU iv bolus. 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
15 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

  • Male and female patients 18 to 75 years old (both inclusive) with a histologically or cytological confirmed diagnosis of colorectal cancer
  • Patient scheduled to receive bolus 5 FU along with LV as first line or subsequent therapy for treating locally advanced or residual or recurrent or metastatic colorectal cancer.
  • No prior systemic treatments for cancer (chemotherapy and/or radiotherapy) 4 weeks prior to screening.
  • Be able to read and understand and provide a signature or thumb impression on the Informed Consent Form (ICF) before entering the study.
  • No other concurrent, active, invasive malignancy.
  • ECOG performance status of 0 to 2.
Show all 15Show fewer
  • Must have a life expectancy of at least 6 months.
  • No active angina or uncontrolled arrhythmia.
  • Not pregnant or nursing. Women of childbearing potential must have a negative serum 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 more than or equal to 1 year, must be specified in the patient's medical history file and CRF.
  • Mucositis Grade less than or equal to 1 per WHO Scale and Xerostomia of Grade less than or equal to 2 per CTCAE
  • Adequate bone marrow function as per CTCAE V5, defined as follows:
  • Absolute neutrophil count more than or equal to 1500 cells/mm3 based upon CBC/differential obtained within 2 weeks prior to randomization ii) Platelets more than or equal to 100,000 cells/mm3 based upon CBC/differential obtained within 2 weeks prior to randomization iii) Hemoglobin more than or equal to 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 more than 8.0 g/dl is acceptable).
  • Adequate hepatic function with bilirubin less than or equal to 1.5 x upper-normal limit (ULN), AST or ALT less than or equal to 3x ULN within 2 weeks prior to randomization
  • Adequate renal function with serum creatinine less than 1.5 mg/dl and creatinine clearance (CrC) more than or equal to 50 ml/min within 2 weeks prior to randomization determined by 24-hour collection or estimated by Cockcroft-Gault formula. CrC male is equal to [(140 - age) x (wt in kg)] / [(Serum Cr mg/dl) x (72)]. CrC female is equal to 0.85 x (CrCl male)
  • 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) is equal to (4 - [patients albumin (g/dl)] x 0.8) + patient measured calcium (mg/dl).

Who cannot join

  • An active infection including HIV/ HBV/ HCV infection.
  • 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.)
  • Unstabilized or symptomatic brain metastasis (History of brain metastases allowed if disease has stabilized or improved after radiation and/or craniotomy).
  • 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.
Show all 16Show fewer
  • Uncontrolled hypertension.
  • Active psychiatric/mental illness making informed consent or useful clinical follow-up unlikely.
  • Patients who have previously been enrolled into this study and subsequently withdrew.
  • Patient receiving other investigational agent(s).
  • Any systemic immunosuppressive medication/therapy (eg, other chemotherapy, steroids).
  • Any prohibited prior or concomitant therapy 2 weeks prior to enrollment.
  • Presence of any significant systemic illness, unstable or severe medical condition(s) that could put the patient 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 90 and/or excipients or closely related compounds).
  • Patients that have a history of poor compliance in clinical research studies.
  • Patients that have participated in any other investigative clinical trial in the past 4 weeks.

Trial locations and contacts

5 sites in 1 country.

5 sites in 1 country

India5 sites

  • Jawaharlal Nehru Cancer Hospital and Research Centre

    Bhopal, Madhya Pradesh, 462001

  • Saveetha Medical college Chennai

    Chennai, Tamil Nadu, 602105

  • Om Sai Onco Surgery Multispecialty Hospital Center

    Kolhāpur, Maharashtra, 416006

  • B. J. Medical College and Sassoon General Hospital

    Pune, Maharashtra, 411001

  • MTES Sanjeevan Hospital

    Pune, Maharashtra, 411001

Other trials in India

About this study

Official title: A Phase 2a, Multi-centre, Placebo Controlled, Randomized, Assessor Blind Study of Bolus 5-fluorouracil and Infused Leucovorin Plus Either Infused TK-90 for Parenteral Use or Infused TK-90 Placebo Administered Weekly for 6 Consecutive Weeks to Patients With Colorectal Cancer.

Patients expected to receive a 500 mg/m2 of Leucovorin by iv \& 500 mg/m2 of Fluorouracil (5FU) by iv bolus for their Colorectal Cancer. The patients will receive a one-hour infusion of TK-90 or equivalent TK-90 placebo depending on randomization at 5 hours \& 11 hours post 5-FU iv bolus. This treatment cycle will continue weekly for 6 weeks. The TK112690 dose will be 45 mg/kg.

Read the detailed description

Patients expected to receive a 500 mg/m2 of Leucovorin by iv \& 500 mg/m2 of Fluorouracil (5FU) by iv bolus for their Colorectal Cancer. The patients will receive a one-hour infusion of TK-90 or equivalent TK-90 placebo depending on randomization at 5 hours \& 11 hours post 5-FU iv bolus. This treatment cycle will continue weekly for 6 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 6 weeks.
  • Study follow-up will be scheduled post two weeks of completion of last dose of Chemotherapy \& TK-90
  • 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, Chemotherapy, 5 FU/ LU, Colorectal cancer
Medical subject headings
Mucositis, Colorectal Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • TK-112690Drug

    TK112690 treatment Post 5-FU chemotherapy

  • PlaceboDrug

    Placebo treatment Post 5-FU chemotherapy

Study groups in NCT05669521
Study groupRoleWhat they receive
TK112690ExperimentalTK112690 treatment
Receives: Drug: TK-112690
PlaceboPlacebo comparatorTK112690 formulation
Receives: Drug: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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. Days patients suffer Grades 3 and 4 oral mucositis measured by WHO scale from the start of treatment. number of days from the first occurrence of WHO Grade 3 or 4 OM through the first occurrence of non-severe (≤ Grade 2) without a subsequent instance of ≥ Grade 3 OM. Subjects with complete study follow-up for severe OM who do not develop severe OM (grade 0-2) will be considered to have durations of 0 days

    Measured: 8 Weeks

Secondary outcomes (1)

  1. Secondary efficacy/outcome mucositis

    1. In addition to the WHO scale, mucositis status in the patients will also be evaluated using two different published and validated mucositis scales: NCI/CTCAE/mucositis, and PROMS.
    2. Comparison of WHO scale values of treated patients at each point of evaluation.

    Measured: 8 Weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted3 Jan 2023
  2. Study start15 Jun 2022
  3. Primary completionSep 2023 (estimated)
  4. Study completionSep 2023 (estimated)

Resources

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)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05669521
Sponsor's protocol ID
CLP-2690-0007
Status last verified
Aug 2023
First submitted
5 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

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 15 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: 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: 8 Weeks). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05669521.

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.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in