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LP-108 + Azacitidine for Leukemia
Phase 1
Recruiting
Research Sponsored by Newave Pharmaceutical Inc
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
UK and EU only: Estimated glomerular filtration rate (GFR) ≥ 30 mL/min/1.73m2 using the modification of diet in renal disease (MDRD) equation.
Calculated creatinine clearance (Cr Cl) ≥ 30 mL/min using 24-hour CrCl OR Cockcroft-Gault formula (using actual body weight)
Timeline
Screening 3 weeks
Treatment Varies
Follow Up at cycle 1 day 1 (24 h pk), cycle 1 day 8, cycle 1 day 15, cycle 1 day 22, cycle 2 day 1 (24 h pk)
Awards & highlights
Study Summary
This trial is testing a new cancer drug, LP-108, to see if it is safe and works well against leukemia.
Who is the study for?
This trial is for adults with certain advanced blood cancers like MDS, CMML, or AML that have come back or didn't respond to treatment. They should have functioning kidneys and liver, no serious heart issues, and a blast count under control. It's not for those who've had recent cancer treatments they haven't recovered from, stem cell transplants within the last 60 days, active brain involvement by leukemia, or are on strong drugs affecting liver enzymes.Check my eligibility
What is being tested?
The study tests LP-108 alone and combined with azacitidine in pill form to see how safe it is and how well it works against specific blood cancers. The doses will be increased slowly to find the highest dose patients can take without bad side effects.See study design
What are the potential side effects?
Possible side effects include reactions related to the immune system since these drugs can affect infection-fighting cells. There might also be typical chemotherapy-related issues like nausea, fatigue, bleeding problems due to low platelets, liver function changes and potential drug interactions.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
My kidney function, measured by GFR, is adequate.
Select...
My kidney function, measured by creatinine clearance, is adequate.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ at cycle 1 day 1 (24 h pk), cycle 1 day 8, cycle 1 day 15, cycle 1 day 22, cycle 2 day 1 (24 h pk)
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~at cycle 1 day 1 (24 h pk), cycle 1 day 8, cycle 1 day 15, cycle 1 day 22, cycle 2 day 1 (24 h pk)
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Maximum Tolerated Dose (MTD)
Recommended Phase 2 dose (RP2D)
The PK profile of LP-108: Area Under the Curve [AUC]
+2 moreSecondary outcome measures
Duration of Response (DOR)
Event-Free Survival (EFS)
ORR for CMML
+4 moreTrial Design
2Treatment groups
Experimental Treatment
Group I: Dose Expansion Phase: LP-108 in combination with azacitidineExperimental Treatment1 Intervention
Three to 6 subjects per treatment cohort will be assigned to receive sequentially higher oral doses of LP-108 on a once daily schedule for 28 days (a "Cycle") starting at a dose of 100 mg in combination with azacitidine at 75 mg/m2.
Group II: Dose Escalation Phase: LP-108 monotherapyExperimental Treatment1 Intervention
Three to 6 subjects per treatment cohort will be assigned to receive sequentially higher oral doses of LP-108 on a once daily schedule for 28 days (a "Cycle") starting at a dose of 100 mg.
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Who is running the clinical trial?
Newave Pharmaceutical IncLead Sponsor
3 Previous Clinical Trials
234 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I haven't had a fever over 38.5°C without a known cause during the screening or on the first day of the study drug.I don't have active brain involvement from my cancer, or if I did, it's now under control.I do not have active or uncontrolled HIV, hepatitis B, or C.I am not taking any acid-reducing medications.You are currently receiving experimental treatment.My blood cancer cell count is low enough to start the trial treatment.My blood clotting, kidney, and liver functions are all within normal ranges.I had CAR-T treatment over 28 days ago without severe side effects.I haven't had cancer treatments except for low-dose steroids or hydroxyurea.I do not have severe, life-threatening complications from leukemia like uncontrolled bleeding or pneumonia.I have a severe type of anemia called RAEB or my MDS is high-risk and not responding to treatment.I am not taking strong CYP3A4 inhibitors, or if I am, I understand the need for close monitoring.I have not had a stem cell transplant in the last 60 days and am not on strong immune-suppressing drugs.I haven't taken any excluded medications recently or still have side effects.I haven't taken certain medications or therapies within a specific time before starting the study drug.I have stopped taking statins for the required washout period.I am not taking any medications that affect drug transport in cells.My leukemia is specifically diagnosed as promyelocytic.I am not taking strong immunosuppressive drugs for autoimmune or rheumatologic conditions.I have basal cell or localized squamous cell skin cancer.My AML has returned or didn't respond to treatment, or I'm considered unfit for intensive therapy.I have previously been treated with BCL2 inhibitors or HMA agents.I am not taking medications like rifampin, carbamazepine, phenytoin, or St. John's wort.I have breast or prostate cancer, am on hormone therapy, and my cancer hasn't grown.My cervical cancer was treated while still in its early stages.I do not have an untreated infection.I am not taking medications like montelukast or paclitaxel.My condition is an advanced blood cancer.My kidney function, measured by GFR, is adequate.My CMML has returned or isn't responding to treatment and needs new therapy.My kidney function, measured by creatinine clearance, is adequate.I need continuous treatment.You are experiencing other serious medical conditions that are not under control.I had a cancer that was removed or treated without spreading.I have had cancer other than blood cancer in the last year, except for certain types.
Research Study Groups:
This trial has the following groups:- Group 1: Dose Escalation Phase: LP-108 monotherapy
- Group 2: Dose Expansion Phase: LP-108 in combination with azacitidine
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.
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