Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
KRC-01 · 1 trial · 1 indication
An AE is any untoward medical occurrence in a patient or clinical investigation subject administered a study drug that does not necessarily have a causal relationship with the treatment.
(local pain, radiation dermatitis, tumor lysis syndrome, superficial soft tissue fibrosis, vaginal stenosis, gastrointestinal/urinary AEs, and severe and medically significant bleeding (requires urgent intervention) after intratumoral injection)
The physical examination will include: * General appearance * Head, eyes, ears, nose, and throat * Respiratory * Cardiovascular * Musculoskeletal * Abdomen * Neurologic * Extremities * Dermatologic * Lymphatic Partial examination, patient will verbally report changes since last week.
• Number of patients who have a significant treatment delays/interruption (total duration \> 59 days)
| Arm | Type | Description |
|---|---|---|
| dose-escalation single arm | EXPERIMENTAL | Dose-escalation single arm, open label study. All eligible subjects will receive external beam radiotherapy (EBRT) with cisplatin (40 mg/m2) intravenously (IV) once weekly for 5 weeks (sixth dose optional) followed by image-guided brachytherapy (BT). KRC-01 will be dosed intratumorally within 2 hours prior to EBRT starting from second week of EBRT. There are two cohorts (n=5 per cohort) Cohort 1: Once-a-week between Monday to Thursday (not necessarily the same day every week) Cohort 2: Twice-a-week with a 1- or 2- day interval (either Mon+Wed, Mon+Thu, or Tue+Thu) |
| Name | Type | Description |
|---|---|---|
| KRC-01 | DRUG | KRC-01 is a solution that contains hydrogen peroxide 3% with sodium hyaluronate 1%. Hydrogen peroxide is the active ingredient for this radiosensitizer. |
| External Beam Radiation Therapy | RADIATION | * Target definition for EBRT will be based on 3D imaging by computed tomography, positron emission tomography with computed tomography, or MRI. * Intensity-modulated radiotherapy (IMRT) must be used. * IMRT should be given once daily Monday-Friday, 5 fractions per week. |
| cisplatin | DRUG | * Weekly concomitant cisplatin (40 mg/m2) during EBRT * Neo-adjuvant chemotherapy or other forms of antineoplastic treatment apart from weekly concomitant cisplatin (40 mg/m2) are not allowed. * Adjuvant chemotherapy (after completion of EBRT+BT) is not allowed. |
| brachytherapy | RADIATION | * BT treatment planning will be based on 3D-image-guided BT by MRI. * Low-dose-rate, pulsed-dose-rate, or high-dose-rate BT |
Inclusion Criteria: * Provide written informed consent before participation. * Female subjects age 18 years or older. * Histologically diagnosed squamous cell carcinoma, adenocarcinoma or adeno-squamous cell carcinoma of the uterine cervix. * FIGO stage II and III locally advanced cervical cancer. ...
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