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New treatment option for Malignant Solid Tumors
Official title Phase II Study of Asciminib for Second-line Treatment of Chronic Phase Chronic Myeloid Leukemia
ClinicalTrials.gov ID: NCT06629584
What this study is testing
What is Asciminib?
Asciminib is an investigational medicine, given as an once-daily, being studied as a potential treatment for malignant solid tumors.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- This is an open label, phase 2 study investigating asciminib in patients previously treated with one line of TKI therapy.
- Phase 2: a mid-size study of how well it works
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- Age ≥ 18 years.
- Diagnosis of Ph-positive (by cytogenetics or FISH) or BCR-ABL-positive (by PCR) CML in chronic phase and have received one prior line of therapy with...
- History of treatment failure defined as either:
- BCR::ABL1 \>0.1% for patients with intolerance to first-line TKI
- Less than complete hematologic response (CHR) at ≥3 months
You likely can't join if
- Patients with a history of T315I mutation.
- Patients with New York Heart Association (NYHA) Class III or IV congestive heart failure or LVEF \< 40% by echocardiogram or multi-gated acquisition...
- Patients with a history of myocardial infarction within the last 6 months or unstable/uncontrolled angina pectoris or history of severe and/or...
- Corrected QT interval (QTc) of \> 450 milliseconds (ms) on baseline electrocardiogram (ECG or EKG) (using the Fridericia Formula)
- Long QT syndrome, family history of idiopathic sudden death or congenital long QT syndrome, or any of the following:
- Risk factors for Torsades de Pointes (TdP) including uncorrected hypokalemia or hypomagnesemia, history of cardiac failure, or history of clinically...
See the full eligibility criteria
Who can join
- Age ≥ 18 years.
- Diagnosis of Ph-positive (by cytogenetics or FISH) or BCR-ABL-positive (by PCR) CML in chronic phase and have received one prior line of therapy with a TKI.
- History of treatment failure defined as either:
- BCR::ABL1 \>0.1% for patients with intolerance to first-line TKI
- Less than complete hematologic response (CHR) at ≥3 months
- No partial cytogenetic response at ≥3 months
- BCR::ABL1 ≥ 10% at if 3-6 months
- BCR::ABL1 ≥ 1% at ≥6 months
- Loss of CCyR or development of mutations or other clonal chromosomal abnormalities at any time during TKI treatment
- ECOG performance status ≤ 2.
- Adequate end organ function within 12 days before the first dose of asciminib treatment. Patients with mild to moderate renal and hepatic impairment are eligible if:
- Total bilirubin ≤ 3.0 x ULN without AST/ALT increase
- Aspartate transaminase (AST) ≤ 5.0 x ULN
- Alanine transaminase (ALT) ≤ 5.0 x ULN
- Serum lipase ≤ 1.5 x ULN. For serum lipase \> ULN and ≤ 1.5 x ULN, value should be considered not clinically significant and not associated with risk factors for acute pancreatitis
- Alkaline phosphatase ≤ 2.5 x ULN
- Creatinine clearance ≥ 30 mL/min as calculated using Cockcroft-Gault formula
- The effects of Asciminib on the developing human fetus are unknown. For this reason, women of child-bearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control...
- Total abstinence (when this is in line with the preferred and usual lifestyle of the subject). Periodic abstinence (e.g., calendar, ovulation, symptothermal, post-ovulation methods) and withdrawal are not acceptable...
- Female sterilization (have had surgical bilateral oophorectomy with or without hysterectomy), total hysterectomy, or tubal ligation at least six weeks before the start of study treatment. In case of oophorectomy alone...
- Male sterilization (at least 6 months prior to screening). The vasectomized male partner should be the sole partner for that subject.
- Use of oral, injected or implanted hormonal methods of contraception or placement of an intrauterine device (IUD) or intrauterine system (IUS), or other forms of hormonal contraception that have comparable how well it...
- Sexually active males must use a condom during intercourse while taking the drug and for 30 days after stopping treatment and should not father a child in this period. A condom is required to be used also by...
What rules you out
- Patients with a history of T315I mutation.
- Patients with New York Heart Association (NYHA) Class III or IV congestive heart failure or LVEF \< 40% by echocardiogram or multi-gated acquisition (MUGA) scan.
- Patients with a history of myocardial infarction within the last 6 months or unstable/uncontrolled angina pectoris or history of severe and/or uncontrolled ventricular arrhythmias. Clinically significant cardiac...
- Corrected QT interval (QTc) of \> 450 milliseconds (ms) on baseline electrocardiogram (ECG or EKG) (using the Fridericia Formula)
- Long QT syndrome, family history of idiopathic sudden death or congenital long QT syndrome, or any of the following:
- Risk factors for Torsades de Pointes (TdP) including uncorrected hypokalemia or hypomagnesemia, history of cardiac failure, or history of clinically significant/symptomatic bradycardia.
- Concomitant medication(s) with a known risk to prolong the QT interval and/or known to cause Torsades de Pointes that cannot be discontinued or replaced 7 days prior to starting study drug by safe alternative medication.
- Patients with known active infection with human immunodeficiency virus (HIV) or Hepatitis B or C.
- Patients with known conditions that would significantly affect the ingestion or gastrointestinal absorption of drugs administered orally.
- Nursing women, women of childbearing potential (WOCBP) with positive blood or urine pregnancy test, or women of childbearing potential who are not willing to maintain adequate contraception (see inclusion criteria 8)
- History of acute pancreatitis within 1 year of study entry or past medical history of chronic pancreatitis.
- ANC \< 500/mm3, platelet count \< 50,000 mm3.
- History of other active malignancy within 2 years prior to study entry except for previous or concomitant basal cell skin cancer and previous carcinoma in situ treated curatively.
- Subject has any other significant medical or psychiatric history that in the opinion of the investigator would adversely affect participation in this study. Patients should have discontinued therapy with imatinib...
The study team makes the final eligibility decision.
Where it's taking place
- Houston, Texas, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Houston, Texas, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.