Recruiting PHASE1 Childhood Astrocytoma

New treatment option for Childhood Astrocytoma

Official title Testing the Addition of an Anti-Cancer Drug, AZD1390, During Radiation Therapy for Newly Diagnosed High Grade Glioma, Diffuse Midline Glioma, or Diffuse Intrinsic Pontine Glioma

ClinicalTrials.gov ID: NCT06894979

What this study is testing

What is ATM Kinase Inhibitor AZD1390?

ATM Kinase Inhibitor AZD1390 is an investigational medicine, given as an once-daily infusion into a vein, being studied as a potential treatment for childhood astrocytoma.

Also referred to as AZD-1390, AZD1390.

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 phase I clinical trial studies the side effects and best dose of AZD1390 and to see how well it works when given together with radiation therapy for the treatment of pediatric patients with high grade glioma, diffuse midline glioma or diffuse intrinsic pontine glioma. AZD1390 is in a class of medications called kinase inhibitors.

Phase 1: an early, usually small safety study
Time commitment: about 6 weeks

A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.

Who can take part

Ages 12 to 22

You may be able to join if

COHORT A and COHORT B: For the dose escalation phase, patients must be ≥ 12 months and \< 18 years of age at the time of study enrollment
COHORT C and COHORT D: For the disease expansion phase, patients must be ≥ 12 months and \< 22 years of age at the time of study enrollment
Patients with newly diagnosed primary high-grade glioma (HGG), diffuse midline glioma (DMG) (excluding primary spinal tumors), or diffuse intrinsic...
COHORTS A AND C (SUPRATENTORIAL TUMORS):
HGG and non-pontine DMG:

You likely can't join if

Pregnant or breast-feeding women will not be entered on this study due to risks of fetal and teratogenic adverse events as seen in animal/human...
Investigational Drugs: Patients who are currently receiving another investigational drug are not eligible
Anti-cancer Agents: Patients who are currently receiving other anti-cancer agents are not eligible with the exception of corticosteroids
Anti-graft versus host disease (GVHD) agents post-transplant: Patients who are receiving cyclosporine, tacrolimus or other agents to prevent...
CYP-450/Transport Proteins: Patients receiving any medications or substances that are strong inhibitors or inducers of CYP3A4/5 enzyme are...
Enzyme-Inducing Anticonvulsants: Patients must not have received enzyme-inducing anticonvulsants within 14 days prior to enrollment

See the full eligibility criteria

Who can join

COHORT A and COHORT B: For the dose escalation phase, patients must be ≥ 12 months and \< 18 years of age at the time of study enrollment
COHORT C and COHORT D: For the disease expansion phase, patients must be ≥ 12 months and \< 22 years of age at the time of study enrollment
Patients with newly diagnosed primary high-grade glioma (HGG), diffuse midline glioma (DMG) (excluding primary spinal tumors), or diffuse intrinsic pontine glioma (DIPG) who are eligible to receive 54-59.4 Gray (Gy)...
COHORTS A AND C (SUPRATENTORIAL TUMORS):
HGG and non-pontine DMG:
Patients with newly diagnosed HGG (including diffuse hemispheric glioma, H3 G34-mutant; diffuse pediatric-type high-grade glioma, H3-wildtype and IDH-wildtype; astrocytoma; IDH-mutant; or glioblastoma, IDH-wildtype): or...
COHORT B AND D (INFRATENTORIAL TUMORS):
DIPG/pontine DMG or infratentorial HGG or DMG:
Patients with newly diagnosed typical DIPG, defined as tumors with a pontine epicenter and diffuse involvement of at least 2/3 of the pons on at least 1 axial T2-weighted image, are eligible. No histologic confirmation...
Patients with infratentorial tumors that do not meet radiographic criteria for typical DIPG (e.g., focal tumors or those involving less than 2/3 of the pontine cross-sectional area with or without extrapontine...
Protocol Definitions
Supratentorial tumors are defined as tumors with an epicenter in the cerebral hemispheres, basal ganglia, thalamus, hypothalamus, or pituitary gland.
Infratentorial tumors are defined as tumors with an epicenter in the brainstem, cerebellum
Patients with measurable or non-measurable (following a gross total resection) disease
Karnofsky ≥ 50% for patients \> 16 year of age and Lansky ≥ 50% for patients ≤ 16 years of age.
Note: Patients who are unable to walk because of paralysis, but who are in a wheelchair, will be considered ambulatory for the purpose of assessing the performance score
Prior therapy for any cancer diagnosis (including radiation) is not allowed with the exception of surgery and/or corticosteroids. If receiving corticosteroids, dose must remain stable or decrease after enrollment
Peripheral absolute neutrophil count (ANC) ≥ 1000/uL (must be performed within 7 days prior to enrollment unless otherwise indicated)
Platelet count ≥ 100,000/uL (transfusion independent, defined as not receiving platelet transfusions for at least 7 days prior to enrollment) (must be performed within 7 days prior to enrollment unless otherwise...
Hemoglobin ≥ 8.0 g/dL at baseline (may receive red blood cell [RBC] transfusions) (must be performed within 7 days prior to enrollment unless otherwise indicated)
A creatinine based on age/sex as follows (must be performed within 7 days prior to enrollment unless otherwise indicated):
1 to \< 2 years: Maximum serum creatinine 0.6 mg/dL (male), 0.6 mg/dL (female)
2 to \< 6 years: Maximum serum creatinine 0.8 mg/dL (male), 0.8 mg/dL (female)
6 to \< 10 years: Maximum serum creatinine 1 mg/dL (male), 1 mg/dL (female)
10 to \< 13 years: Maximum serum creatinine 1.2 mg/dL (male), 1.2 mg/dL (female)
13 to \< 16 years: Maximum serum creatinine 1.5 mg/dL (male), 1.4 mg/dL (female)
\>= 16 years: Maximum serum creatinine 1.7 mg/dL (male),1.4 mg/dL (female) OR a 24 hour urine creatinine clearance ≥ 70 mL/min/1.73 m\^2 OR a glomerular filtration rate (GFR) ≥ 70 mL/min/1.73 m\^2. GFR must be performed...
Note: The threshold creatinine values in this Table were derived from the Schwartz formula for estimating GFR (Schwartz et al. J. Peds, 106:522, 1985) utilizing child length and stature data published by the CDC.
Bilirubin (sum of conjugated + unconjugated or total) ≤ 1.5 x upper limit of normal (ULN) for age except in patients diagnosed with Gilbert's disease for which bilirubin must be ≤ 3.0 × ULN (must be performed within 7...
Alanine aminotransferase (ALT) ≤ 3 x ULN, unless attributed to tumor involvement then ALT ≤ 5 x ULN (must be performed within 7 days prior to enrollment unless otherwise indicated)
Aspartate aminotransferase (AST) ≤ 3 x ULN, unless attributed to tumor involvement then AST ≤ 5 x ULN (must be performed within 7 days prior to enrollment unless otherwise indicated)
Albumin ≥ 2 g/dL (must be performed within 7 days prior to enrollment unless otherwise indicated)
No evidence of dyspnea at rest, no exercise intolerance and a pulse oximetry \> 93%
Patients with seizure disorder may be enrolled if on anticonvulsants and well controlled as evidenced by no increase in seizure frequency in the prior 7 days. If needed, evaluate use of enzyme-inducing anticonvulsants
Serum lipase ≤ 1.5 ULN (must be performed within 7 days prior to enrollment unless otherwise indicated)
Prothrombin time (PT)/international normalization rate (INR) \< 1.5 x ULN (must be performed within 7 days prior to enrollment unless otherwise indicated)
Patients must have the ability to swallow whole tablets (AZD1390 may not be administered via nasogastric [NG]/gastric [G]-tubes)

What rules you out

Pregnant or breast-feeding women will not be entered on this study due to risks of fetal and teratogenic adverse events as seen in animal/human studies, OR because there is yet no available information regarding human...
Investigational Drugs: Patients who are currently receiving another investigational drug are not eligible
Anti-cancer Agents: Patients who are currently receiving other anti-cancer agents are not eligible with the exception of corticosteroids
Anti-graft versus host disease (GVHD) agents post-transplant: Patients who are receiving cyclosporine, tacrolimus or other agents to prevent graft-versus-host disease post bone marrow transplant are not eligible for...
CYP-450/Transport Proteins: Patients receiving any medications or substances that are strong inhibitors or inducers of CYP3A4/5 enzyme are ineligible. Moderate inhibitors and inducers of CYP3A4/5 are permitted but...
Enzyme-Inducing Anticonvulsants: Patients must not have received enzyme-inducing anticonvulsants within 14 days prior to enrollment
Patients who have an uncontrolled infection are not eligible
Patients who have received a prior solid organ transplantation are not eligible
Patients who in the opinion of the investigator may not be able to comply with the safety monitoring requirements of the study are not eligible. This includes patients with rapidly declining neurological status
Patients must have the ability to swallow whole tablets (AZD1390 may not be administered via NG/G-tubes). Patients with medical conditions that affect drug absorption, such as short gut syndrome are not eligible
Patients with known macular degeneration, uncontrolled glaucoma, or cataracts are not eligible
Patients with primary spinal cord high grade gliomas are not eligible
Patients with metastatic disease are not eligible; Metastatic disease is defined as distant intracranial or spinal metastasis including leptomeningeal disease, or tumor cells within the CSF. MRI of the spine with and...
Patients with gliomatosis type growth pattern (or diffuse spread) with involvement of at least 3 lobes of the brain are not eligible with the exception of H3 K27M-mutant bithalamic tumors
Patients with infant-type hemispheric high-grade gliomas are excluded
Patients with BRAFV600E mutations are excluded
Patients who are not able to receive protocol specified radiation therapy
Patients with a history of radiotherapy as part of anti-cancer therapy are excluded
Presence of myopathy or raised CK \> 5 x ULN on 2 occasions at screening will result in exclusion.
CK should not be measured following strenuous exercise or in the presence of a plausible alternative cause of CK increase, which may confound interpretation of the results.
If CK levels are significantly elevated at baseline (\>5 x ULN) a confirmatory test should be carried out within 5 - 7 days.
If the repeat test confirms a baseline CK \>5 x ULN, treatment should not be started
HIV-infected patients on effective anti-retroviral therapy with undetectable viral load within 6 months are eligible as long as they are NOT receiving anti-retroviral agents that are strong inhibitors or inducers of...
Evidence of clinically significant cardiac dysfunction or prolonged corrected QT interval (QTc) (\> 450 msec) on baseline electrocardiogram (EKG)
Patients with known hepatitis B or C with detectable viral load
Any significant medical condition that in the medical judgement of the investigator would compromise the patient's ability to tolerate study drug or participate in the study

The study team makes the final eligibility decision.

Where it's taking place

Birmingham, Alabama, United States
Los Angeles, California, United States
Orange, California, United States
San Francisco, California, United States
Aurora, Colorado, United States
Washington D.C., District of Columbia, United States
Atlanta, Georgia, United States
Chicago, Illinois, United States
Indianapolis, Indiana, United States
Ann Arbor, Michigan, United States
Minneapolis, Minnesota, United States
St Louis, Missouri, United States
New York, New York, United States
Cincinnati, Ohio, United States
Philadelphia, Pennsylvania, United States
Pittsburgh, Pennsylvania, United States
Memphis, Tennessee, United States
Houston, Texas, United States
Lubbock, Texas, United States
Seattle, Washington, 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 study runs about 6 weeks per participant, based on its public description. The team confirms the exact schedule and number of visits before you enroll.

Who can join this trial?

This study is enrolling all sexes, 12 months to 22 years. The study team makes the final eligibility decision.

Where is this trial taking place?

Study sites include Birmingham, Alabama, United States; Los Angeles, California, United States; Orange, California, United States; San Francisco, California, United States; Aurora, Colorado, United States; Washington D.C., District of Columbia, United States and 14 more location(s). Enter your location above to see the nearest site and check your eligibility.

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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.