Your session is about to expire
← Back to Search
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Age ≥ 18 years
Histologically or cytologically documented, incurable or metastatic solid tumor or B cell NHL that is refractory to or intolerant of all standard therapy or for which no standard therapy is available
Timeline
Screening 3 weeks
Treatment Varies
Follow Up pk samples are collected at pre-dose and post-dose at 1, 2, 3, 5, 8, and 24 hours on days 1 and 5 of cycle 1 (each cycle is 28 days).
Awards & highlights
Study Summary
This trial is designed to study the safety and effectiveness of BTX-A51 in people with advanced solid tumors or NHL. The trial will have two parts: in the first part, the dose of BTX-A51 will be increased until the maximum tolerated dose is found; in the second part, the safety and effectiveness of BTX-A51 will be studied in people with MYC genomic amplified/overexpressed tumors.
Who is the study for?
Adults with advanced solid tumors or B cell Non-Hodgkin Lymphoma that's resistant to standard treatments can join. They must have measurable disease, not be pregnant, agree to use contraception, and have good organ function. Those with MYC amplified/overexpressed tumors are eligible for the expansion phase.Check my eligibility
What is being tested?
The trial is testing BTX-A51, an oral drug given on a weekly schedule (5 days on/2 days off). It has two phases: Phase 1a finds the safest dose by slowly increasing amounts; Phase 1b expands this dose to more patients focusing on those with specific genetic tumor features.See study design
What are the potential side effects?
Possible side effects of BTX-A51 include reactions related to the maximum tolerated dose which could involve fatigue, digestive issues or other organ-related symptoms based on previous similar trials. Specific side effects will be monitored during the first cycle of treatment.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am 18 years old or older.
Select...
My cancer is advanced, cannot be cured with standard treatments, or I cannot tolerate them.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ pk samples are collected at pre-dose and post-dose at 1, 2, 3, 5, 8, and 24 hours on days 1 and 5 of cycle 1 (each cycle is 28 days).
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~pk samples are collected at pre-dose and post-dose at 1, 2, 3, 5, 8, and 24 hours on days 1 and 5 of cycle 1 (each cycle is 28 days).
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Defining the maximum tolerated dose (MTD) or recommended Phase 2 dose (RP2D) of BTX-A51
Safety and tolerability of BTX-A51
Secondary outcome measures
Area under the plasma concentration of BTX-A51
Duration of response (DoR)
Half-life of BTX-A51
+4 moreTrial Design
6Treatment groups
Experimental Treatment
Group I: BTX-A51 Dose Cohort 6Experimental Treatment1 Intervention
Up to 10-times the SD of BTX-A51 administered orally 5 times per week in a 28-day cycle
Group II: BTX-A51 Dose Cohort 5Experimental Treatment1 Intervention
Up to 7-times the SD of BTX-A51 administered orally 5 times per week in a 28-day cycle
Group III: BTX-A51 Dose Cohort 4Experimental Treatment1 Intervention
Up to 5-times the SD of BTX-A51 administered orally 5 times per week in a 28-day cycle
Group IV: BTX-A51 Dose Cohort 3Experimental Treatment1 Intervention
Up to 3.5-times the SD of BTX-A51 administered orally 5 times per week in a 28-day cycle
Group V: BTX-A51 Dose Cohort 2Experimental Treatment1 Intervention
Up to 2-times the SD of BTX-A51 administered orally 5 times per week in a 28-day cycle
Group VI: BTX-A51 Dose Cohort 1Experimental Treatment1 Intervention
Starting dose (SD) of BTX-A51 administered orally 5 times per week in a 28-day cycle
Find a Location
Who is running the clinical trial?
Edgewood Oncology Inc.Lead Sponsor
1 Previous Clinical Trials
80 Total Patients Enrolled
BioTheryX, Inc.Lead Sponsor
2 Previous Clinical Trials
88 Total Patients Enrolled
Zung Thai, MDStudy DirectorEdgewood Oncology Inc.
5 Previous Clinical Trials
668 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I haven't taken more than 10 mg of steroids daily in the last month.I have a serious heart condition.I have not had major surgery or serious injury in the last 4 weeks.I do not have any ongoing serious infections.My organs are functioning well.My cancer can be measured using scans.I am 18 years old or older.I have had serious brain-related side effects from drugs or have brain disease.My cancer shows MYC gene changes in tests.I have another cancer that has been in remission for less than 3 years.I have active hepatitis B or C.I haven't had cancer treatment in the last 3 weeks.My side effects from previous cancer treatments are mild, except for hair loss or thyroid issues.My cancer is advanced, cannot be cured with standard treatments, or I cannot tolerate them.I am not pregnant and will use birth control during and up to 3 months after treatment.I agree to use birth control methods if I'm sexually active with a woman who can have children, during and up to 3 months after the study.
Research Study Groups:
This trial has the following groups:- Group 1: BTX-A51 Dose Cohort 1
- Group 2: BTX-A51 Dose Cohort 5
- Group 3: BTX-A51 Dose Cohort 3
- Group 4: BTX-A51 Dose Cohort 4
- Group 5: BTX-A51 Dose Cohort 2
- Group 6: BTX-A51 Dose Cohort 6
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.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
What is the capacity of participants in this research endeavor?
"Affirmative. Per clinicaltrials.gov, this study has been actively seeking participants since June 7th 2021 and the most recent update was on September 8th 2022. The research team is looking for 116 people to participate at three different sites."
Answered by AI
Is recruitment for this research opportunity still open?
"This research effort is still searching for participants, as evidenced by clinicaltrials.gov's listing that was first published on June 7th 2021 and amended most recently on September 8th 2022."
Answered by AI
Is BTX-A51 a secure remedy for individuals?
"The safety of BTX-A51 can be rated as a 1 since it is currently in its first phase, with limited evidence for both efficacy and risk factors."
Answered by AI
What is the primary aim of this medical trial?
"This clinical trial will assess the maximum tolerated dose (MTD) or recommended Phase 2 dose (RP2D) of BTX-A51. It's primary outcome measure is overall survival, which is calculated from first dose to death due to any cause. Other metrics include area under the curve plasma concentration and objective response rate as determined by specific disease criteria. The duration of this study spans 30 days after last BTX-A51 treatment with continued access until progression or toxicity occurs."
Answered by AI
Recent research and studies
Other Trials to Consider
Popular Categories
Share this study with friends
Copy Link
Messenger