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Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
≥ 18 years of age the time of signing the informed consent form (ICF)
Histological or cytological evidence of advanced and/or metastatic cancer,
Timeline
Screening 3 weeks
Treatment Varies
Follow Up through study completion, an average of 6 months
Awards & highlights
Study Summary
This trial will investigate the safety of ON 123300 by testing it at increasing doses. The goal is to find the best dose to use in future clinical trials.
Who is the study for?
Adults with advanced/metastatic cancer, who've failed at least one treatment or lack options, can join. They must be able to take oral meds, have a life expectancy over 3 months, and use effective birth control. Excluded are those with certain blood disorders, recent treatments or surgeries, heart issues that could lead to Torsades de pointes (a type of heart rhythm problem), active infections like HIV/Hepatitis B/C, or expecting/nursing mothers.Check my eligibility
What is being tested?
The trial is testing the safety of ON123300 at various doses to find the optimal dose for future studies. It's for patients whose cancers haven't responded well to other treatments and involves taking this new drug orally.See study design
What are the potential side effects?
While specific side effects aren't listed here, common ones from drugs like ON123300 may include nausea, fatigue, risk of infection due to lowered immunity from chemotherapy-like agents; liver function changes; and potential allergic reactions.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am 18 years old or older.
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My cancer is advanced or has spread to other parts of my body.
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My cancer is advanced or has spread to other parts of my body.
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My liver function tests are within the required limits.
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I can do most activities without help.
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My blood, liver, and kidney functions are within the required ranges.
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I can swallow pills.
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I am 18 years old or older.
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I can swallow pills.
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My kidney function, measured by creatinine levels or clearance, is within the required range.
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I can do most of my daily activities without help.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ through study completion, an average of 6 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~through study completion, an average of 6 months
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Abnormal Laboratory Test results
Incidence of Dose Limiting Toxicities (DLT)
Incidence of adverse events (AE)
Secondary outcome measures
Establish the recommended phase 2 dose (RP2D)
Pharmacokinetics of ON 123300 and 2 metabolites - AUClast
Pharmacokinetics of ON 123300 and 2 metabolites - CL/F
+4 moreOther outcome measures
Preliminary efficacy of ON 123300
Trial Design
1Treatment groups
Experimental Treatment
Group I: ON 123300Experimental Treatment1 Intervention
ON 123300 capsules at increasing doses per cohort, starting at 40 mg
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Who is running the clinical trial?
Onconova Therapeutics, Inc.Lead Sponsor
31 Previous Clinical Trials
1,625 Total Patients Enrolled
Michael E Saunders, MDStudy DirectorOnconova Therapeutics
1 Previous Clinical Trials
60 Total Patients Enrolled
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Eligibility Criteria:
This trial includes the following eligibility criteria:- I have received a live vaccine within the last 28 days.My blood calcium level is higher than 12.5 mg/dL.My disease can be measured by tests.I am 18 years old or older.My heart's electrical cycle is longer than normal.My cancer can be measured by tests or scans.My cancer is advanced or has spread to other parts of my body.I am currently on medication that affects my heart's electrical cycle.My disease can be measured by medical tests.I have tried at least one treatment for my condition without success, or there are no suitable treatments available for me.I have not had major surgery in the last 14 days.I have a blood cancer diagnosis, but it's not non-Hodgkin's lymphoma.I have moderate to severe diarrhea before starting treatment.I do not have any severe illnesses that could interfere with the study.I have risk factors for a specific heart rhythm problem (like heart failure or low potassium).I am not currently on, nor have I recently taken, strong medication that affects liver enzymes.I understand the study's risks and can communicate with the research team.My organs are functioning well.My cancer is advanced or has spread to other parts of my body.My liver function tests are within the required limits.I had a blood clot in the past 6 months and am currently on treatment.I can do most activities without help.I am allergic to medications similar to ON 123300.I understand the study's risks and can communicate with the research team.I am willing and able to follow all study requirements.My blood, liver, and kidney functions are within the required ranges.I can swallow pills.I am 18 years old or older.I have tried at least one treatment for my condition without success, or there are no suitable treatments available.Your doctor expects you to live for at least three more months.I can swallow pills.I haven't had cancer treatment or experimental therapy in the last 14 days.I am at risk for a specific type of abnormal heart rhythm.My kidney function, measured by creatinine levels or clearance, is within the required range.I can do most of my daily activities without help.I do not have any active infections like HIV or Hepatitis B/C.My cancer can be measured by tests or it cannot.
Research Study Groups:
This trial has the following groups:- Group 1: ON 123300
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.
Are patients currently being accepted into this research program?
"That is correct. As of right now, this study is still trying to recruit patients. The original posting was on May 13th, 2021 and the latest update was on January 27th, 2022. They need a total of 36 individuals from 3 different locations."
Answered by AI
What do researchers hope to achieve through this clinical trial?
"The primary objective of this study, which will follow patients for up to one month after their last dose, is to track the incidence of Dose Limiting Toxicities (DLT). Additionally, data on the pharmacokinetics of ON 123300 and its two metabolites - CL/F and Tmax - as well as Vss, or the steady state volume of distribution."
Answered by AI
How many individuals are enrolled in this experiment?
"In order for this trial to be valid, 36 patients who match the pre-determined inclusion criteria must participate. Locations where potential participants can access this trial include Mary Crowley Cancer Research in Dallas, Texas and Greenville Health System, Institute for Oncology Clinical Research in Greenville, South carolina."
Answered by AI
Is ON123300 a safe drug for patients to take?
"ON123300 is still in the early stages of testing, so it only received a 1 for safety."
Answered by AI
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