A Study to Evaluate the Safety, Tolerability, Preliminary Efficacy of KRC-01

Condition(s) studied

Investigational drug(s) / intervention(s)

KRC-01: 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: * 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: * 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: * BT treatment planning will be based on 3D-image-guided BT by MRI. * Low-dose-rate, pulsed-dose-rate, or high-dose-rate BT

Study summary

This is a seamless Phase 1/2 study consisting of two components. Phase 1 component is a dose-escalation, single arm, open label study in 10 patients to evaluate the safety and tolerability of KRC 01. Phase 2 component is a randomized, open label, controlled, multi-center study in 60 patients to evaluate the preliminary antitumor effect of KRC-01 in combination with CRT.

Eligibility

Primary outcome measure(s)

• Adverse Events — 36 month
  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.
• AEs of special interest — 36 month
  (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)
• Physical examination — at the time of Screening and at Week 6 and partial examination will be done weekly in between to document relevant changes.
  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.
• Tolerance — week 1 to 6
  • Number of patients who have a significant treatment delays/interruption (total duration \> 59 days)

Trial sites (4)

Other trials for the same condition