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Kinase Inhibitor
XRD-0394 + Palliative Radiotherapy for Advanced Cancer
Phase 1
Waitlist Available
Research Sponsored by XRad Therapeutics Inc
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 5 years
Awards & highlights
No Placebo-Only Group
Summary
This trial tests XRD-0394, a new oral drug that blocks proteins helping cancer cells repair, on patients with advanced or recurring cancer receiving radiation therapy. The goal is to see if it is safe and how well it works with radiation.
Eligible Conditions
- Cancer
- Solid Tumors
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 5 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 5 years
Treatment Details
Awards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
4Treatment groups
Experimental Treatment
Group I: XRD-0394 80 mgExperimental Treatment2 Interventions
Subjects will receive a single dose of XRD-0394 capsules approximately 90 minutes before RT on Day 2 of the RT regimen
Group II: XRD-0394 40 mgExperimental Treatment2 Interventions
Subjects will receive a single dose of XRD-0394 capsules approximately 90 minutes before RT on Day 2 of the RT regimen
Group III: XRD-0394 160 mgExperimental Treatment2 Interventions
Subjects will receive a single dose of XRD-0394 capsules approximately 90 minutes before RT on Day 2 of the RT regimen
Group IV: XRD-0394 (Dose TBD)Experimental Treatment2 Interventions
Subjects will receive a single dose of XRD-0394 capsules approximately 90 minutes before RT. A single biopsy will be performed in each subject (either after RT alone or after XRD-0394 and RT).
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
XRD-0394
2021
Completed Phase 1
~20
Palliative radiotherapy
2015
Completed Phase 2
~30
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Who is running the clinical trial?
XRad Therapeutics IncLead Sponsor
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- The cancer has spread to the skin, soft tissues, or other sites where radiation treatment can be given without harming nearby healthy tissues.There may be additional requirements specific to the study that you need to meet.You have a history of trouble swallowing or chronic digestive problems that may affect how well you can take the study drug. You also cannot have a feeding tube called a PEG tube.If you have received any type of cancer treatment like chemotherapy, immunotherapy, hormone therapy, or other medications within the past 14 days, or if you will need to start any of these treatments within the next 14 days, you cannot participate in the study. This includes holding off on these treatments for at least 14 days after completing radiation therapy.
Research Study Groups:
This trial has the following groups:- Group 1: XRD-0394 40 mg
- Group 2: XRD-0394 80 mg
- Group 3: XRD-0394 160 mg
- Group 4: XRD-0394 (Dose TBD)
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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