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PCLX-001 for Lymphoma and Cancer
Phase 1
Recruiting
Led By Randeep Sangha
Research Sponsored by Pacylex Pharmaceuticals
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Adequate cardiac function per institutional normal measured by echocardiography or multigated acquisition (MUGA) scan (LVEF ≥ 50%)
Participants with histologically-confirmed advanced solid tumor who have failed at least one prior therapy and/or are not eligible for therapies expected to provide clinical benefit.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up measured during every cycle (cycles 1, 2, 3, 4, etc.) of treatment (cycle length is 28 days)
Awards & highlights
Study Summary
This trial is testing a new drug, PCLX-001, to see if it is safe and effective. The trial has two parts: Part A is testing different doses of the drug to see what is safe, and Part B is testing the drug in different groups of people to see how well it works.
Who is the study for?
Adults with certain advanced cancers (like B-cell lymphomas and solid tumors) who've tried at least one other treatment without success are eligible for this trial. They should have a life expectancy of over 12 weeks, be able to perform daily activities with minimal assistance (ECOG status 0-1), and have organs functioning well enough to meet specific medical tests. Pregnant women can't join, and participants must agree to use contraception.Check my eligibility
What is being tested?
The trial is testing PCLX-001, an oral drug, in two parts: dose escalation to find the safe amount that can be given, followed by expansion cohorts where more patients receive this determined dose. It's open-label meaning everyone knows what treatment they're getting; it's not randomized or controlled against another treatment.See study design
What are the potential side effects?
As a Phase I trial primarily assesses safety and tolerability, potential side effects of PCLX-001 aren't fully known yet but may include typical reactions related to cancer drugs such as nausea, fatigue, liver issues or changes in blood counts leading to increased risk of infections or bleeding.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
My heart functions well, confirmed by a heart scan.
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I have an advanced solid tumor and previous treatments didn’t work or I can't receive beneficial therapies.
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I am fully active or restricted in physically strenuous activity but can do light work.
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I am fully active or can carry out light work.
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I have B-cell lymphoma, failed two treatments, or can't have beneficial therapy.
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My liver is functioning well according to recent tests.
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My kidney function is good, with an eGFR over 50 mL/min or creatinine ≤ 1.5 times the normal upper limit.
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I have advanced cancer and previous treatments didn’t work or I can't receive beneficial therapies.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ measured during every cycle (cycles 1, 2, 3, 4, etc.) of treatment (cycle length is 28 days)
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~measured during every cycle (cycles 1, 2, 3, 4, etc.) of treatment (cycle length 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
To determine the maximum plasma level (Cmax) of PCLX-001
Plasma
To determine, during the dose escalation phase, the recommended dose of PCLX-001 for the dose expansion phase of the trial.
Secondary outcome measures
To evaluate the clinical response rate in patients treated with PCLX-001 with advanced solid malignancies
Other outcome measures
Assess the pharmacodynamic (PD) effects of PCLX-001 in patients with B-cell lymphomas
Trial Design
1Treatment groups
Experimental Treatment
Group I: PCLX-001 interventionExperimental Treatment1 Intervention
The Dose-Escalation phase will follow a standard 3+3 cohort design. Three patients will be treated at each dose level. If 0/3 patients experience DLT, 3 patients will be treated at the next dose level. Escalation will terminate as soon as two or more patients experience any DLT attributable to study drugs, at a given dose level.
Oral PCLX-001 will be provided as continuous daily dosing on a 28-day cycle.
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Who is running the clinical trial?
Ozmosis Research Inc.Industry Sponsor
20 Previous Clinical Trials
4,955 Total Patients Enrolled
Pacylex PharmaceuticalsLead Sponsor
Randeep SanghaPrincipal InvestigatorCross Cancer Institute
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I do not have serious infections or those not responding to treatment.I am experiencing significant side effects from previous cancer treatments that have not yet stabilized.I have brain or meningeal tumors but have been stable for over 3 months after treatment.My heart functions well, confirmed by a heart scan.I have B-cell lymphoma, failed two treatments, or can't have other beneficial therapies.I have or had brain lymphoma.I have had an organ transplant or stem cell transplant within the last 3 months.I have advanced cancer and previous treatments didn’t work or I can't receive beneficial therapies.I haven't taken strong CYP3A4 inhibitors or inducers in the last 14 days.I have had cancer before, but it was a different type or in a different place and is not active.I have an advanced solid tumor and previous treatments didn’t work or I can't receive beneficial therapies.I am fully active or restricted in physically strenuous activity but can do light work.I have B-cell lymphoma, failed two treatments, and can't have other beneficial therapies.I do not have serious heart problems like recent heart attacks or unstable chest pain.My high blood pressure is not controlled, even with treatment.I am not breastfeeding and will not for 4 months after the last drug dose.I haven't had cancer treatment with chemotherapy or immunotherapy in the last 3 weeks.I am fully active or can carry out light work.I have B-cell lymphoma, failed two treatments, or can't have beneficial therapy.My liver is functioning well according to recent tests.I haven't had a serious bleeding problem in the last month.I have B-cell lymphoma, failed two treatments, and can't have others expected to help.I have not had major surgery or significant injury in the last 4 weeks.You are expected to live for at least 12 more weeks.My cancer can be measured or evaluated using specific criteria.I am taking a high dose of steroids daily.My kidney function is good, with an eGFR over 50 mL/min or creatinine ≤ 1.5 times the normal upper limit.My liver function is significantly impaired.I am currently being treated for active hepatitis B or C.I have a serious wound or fracture that is not healing.I am part of a treatment plan that involves gradually increasing medication doses.I cannot swallow pills.I have advanced cancer and previous treatments didn’t work or I can't receive beneficial therapies.I have an advanced solid tumor and previous treatments haven't worked or I'm ineligible for other beneficial therapies.I do not have any health conditions that could make this study unsafe for me.You have an allergy to the study drugs or any substances used in the study.I am on medication for uncontrolled seizures.You understand the study and agree to sign a document that says you agree to participate before any procedures are done.I am 18 years old or older.You have problems with drug addiction, mental health, or social situations that may affect your ability to take part in the study or affect the study's results.I have a condition that affects how my body absorbs nutrients.I have not had radiation for my cancer within 3 weeks before starting the study drug.
Research Study Groups:
This trial has the following groups:- Group 1: PCLX-001 intervention
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 current enrollment rate for this research project?
"The trial necessitates the enrollment of 60 applicable subjects in a distributed fashion between Cross Cancer Institute (Edmonton, Alberta) and Centre Hospitalier de l'Université de Montréal - CHUM (Montreal, Quebec)."
Answered by AI
Have there been any other investigations that have explored the effects of PCLX-001?
"PCLX-001 was first trialled in 2021 at Princess Margaret Hospital. So far, no clinical trials have been brought to completion; currently there is just one active study that recruits participants predominantly from Edmonton, Alberta."
Answered by AI
Is PCLX-001 a viable treatment option with no known detrimental effects?
"Our internal evaluation at Power rated PCLX-001 as a 1 for safety due to the limited data available from Phase 1 trials, showing only preliminary evidence of efficacy and no long-term proof of its security."
Answered by AI
Does this clinical trial have open enrollment at present?
"Currently, this medical trial is actively sourcing participants. First posted on September 14th 2021, the research was last updated on September 26th 2022 according to details provided by clinicaltrials.gov."
Answered by AI
Does this experimental protocol have any historical precedent?
"Currently, the only active trial for PCLX-001 is hosted in three cities across one country. Commissioned by Pacylex Pharmaceuticals in 2021, the Phase 1 clinical trial was conducted with 60 participants and completed satisfactorily. Since then, no other trials have been finished."
Answered by AI
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