Trial Title:
A Study of AZD1390 and Stereotactic Body Radiotherapy (SBRT) for People With Metastatic Solid Tumor Cancer
NCT ID:
NCT05678010
Condition:
Solid Tumor
Metastatic Solid Tumor
Solid Carcinoma
Solid Tumor, Adult
Metastatic Tumor
Metastatic Cancer
Conditions: Official terms:
Neoplasms
Neoplasm Metastasis
Conditions: Keywords:
Solid Tumor
Metastatic Solid Tumor
Solid Carcinoma
Metastatic Tumor
Metastatic Cancer
22-042
Memorial Sloan Kettering Cancer Center
AZD1390
Study type:
Interventional
Study phase:
Phase 1
Overall status:
Recruiting
Study design:
Allocation:
Non-Randomized
Intervention model:
Sequential Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Drug
Intervention name:
AZD1390
Description:
Dose level 1: 20 Dose level 2: 40 Dose level 3: 60 Dose level 4: 80
Arm group label:
Arm A, Dose Level 1
Arm group label:
Arm A, Dose Level 2
Arm group label:
Arm A, Dose Level 3
Arm group label:
Arm A, Dose Level 4
Arm group label:
Arm B, Dose Level 1
Arm group label:
Arm B, Dose Level 2
Arm group label:
Arm B, Dose Level 3
Arm group label:
Arm B, Dose Level 4
Intervention type:
Radiation
Intervention name:
Stereotactic Body Radiotherapy
Description:
Participants will receive Stereotactic Body Radiotherapy/SBRT to 2 sites of metastatic
tumors consecutively. The two treatment sites will be randomized to SBRT to one site and
SBRT + AZD1390 to the other site. Both sites will receive 30Gy in 5 fractions.
Arm group label:
Arm A, Dose Level 1
Arm group label:
Arm A, Dose Level 2
Arm group label:
Arm A, Dose Level 3
Arm group label:
Arm A, Dose Level 4
Arm group label:
Arm B, Dose Level 1
Arm group label:
Arm B, Dose Level 2
Arm group label:
Arm B, Dose Level 3
Arm group label:
Arm B, Dose Level 4
Other name:
SBRT
Summary:
The purpose of this study is to find out whether AZD1390 combined with stereotactic body
radiation therapy/SBRT is a safe treatment for people with metastatic solid tumor cancer
Criteria for eligibility:
Criteria:
Inclusion Criteria:
- Willing and able to provide written informed consent
- Aged at least 18 years.
- Karnofsky Performance Score (KPS) of ≥60.
- Histologically confirmed diagnosis of cancer with clear evidence of metastasis on
imaging. Confirmation of metastasis by biopsy is preferred but not required.
- Candidates for SBRT delivered as 6Gy x 5 daily fractions to 2 sites of disease. The
radiation plan should meet departmental guidelines. Patients can have more than 2
sites of disease. If patient requires RT to other sites of disease this can be done
after completion of DLT period.
- Adequate organ system functions, as outlined below:
- Absolute neutrophil count (ANC) ≥1.0 x 109/L
- Platelets ≥75 x 109/L
- Hemoglobin ≥8 g/dL
- Total bilirubin ≤1.5 times the ULN
- Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤2.5 times
the ULN if no liver involvement or ≤5 times the ULN with liver involvement with
metastatic disease.
- Creatinine <1.5 times ULN concurrent with creatinine clearance >50 mL/min
(measured or calculated by Cockcroft and Gault equation); confirmation of
creatinine clearance is only required when creatinine is >1.5 times ULN.
- Lipase within normal limits (WNL)
- Creatine kinase (CK) ≤5 times ULN
- Females of childbearing potential must have a negative pregnancy test during
screening and must not be breastfeeding or intending to become pregnant during the
study. Male patients with female partners of child-bearing potential must be willing
to use two forms of acceptable contraception, including one barrier method, during
their participation in this study and for 16 weeks following the last dose of the
study drug.
- Ability to swallow and retain oral medication.
Exclusion Criteria:
- Prior radiotherapy to the same region within the last 3 months.
- Ongoing treatment for brain metastases. Patients with brain metastases may
participate in this trial however, treatment for brain metastases will have to be
completed prior to study enrollment. Treatments can begin or resume two weeks after
completing protocol therapy.
- History of epilectic disorder.
- For Arm B patients with cancers involving the spinal cord, the length of the spinal
cord lesion requiring palliative treatment is greater than 10 cm.
- Past medical history of interstitial lung disease (ILD), drug-induced ILD, radiation
pneumonitis which required steroid treatment, or any evidence of clinically active
interstitial lung disease.
- Evidence of established ILD on screening CT scan.
- Evidence of severe pulmonary infections, as judged by the investigator, based on
clinical findings and investigations.
- Concurrent severe and/or uncontrolled medical condition (e.g., severe COPD).
- Cardiac dysfunction defined as: Myocardial infarction within six months of study
entry, NYHA Class II/III/IV heart failure, unstable angina or unstable cardiac
arrhythmias.
- Any of the following cardiac criteria:
- Mean resting corrected QT interval (QTcF) > 470 msec obtained from 3
electrocardiograms (ECGs) (QTc interval will be calculated using Fridericia's
formula).
- Any clinically important abnormalities in rhythm, conduction or morphology of
resting ECG, e.g., complete left bundle branch block, third degree heart block.
- Any factors that increase the risk of QTc prolongation or risk of arrhythmic
events such as heart failure, hypokalemia, congenital long QT syndrome, family
history of long QT syndrome or unexplained sudden death under 40 years-of-age.
Patients stable on concomitant medications known to prolong the QT interval may
be allowed to participate in the study provided that their mean resting
corrected QT interval \(QTcF) is < 470 msec at baseline.
- History or presence of myopathy or raised CK >5 x ULN on 2 occasions at screening.
- Anticancer therapy within 7 days of first SBRT. These treatments should also be held
for 7 days after last dose of SBRT. Patients who have received an immune checkpoint
inhibitor within 28 days of first administration of study therapy will be excluded.
- History of hypersensitivity to AZD1390 and excipients or drugs with a similar
chemical structure or class to AZD1390.
- Patients receiving treatment with strong inhibitors or inducers of CYP3A4 within 2
weeks before the first dose of AZD1390.
- Patients who require sensitive substrates of BCRP, OATP1B1, MATE1, MATE2K and P-gp
such as prazosin, cimetidine, simvastatin, dofetilide, metformin, dabigatran,
digoxin and fexofenadine should be avoided while on study.
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
Memorial Sloan Kettering Monmouth (All Protocol Activities)
Address:
City:
Middletown
Zip:
07748
Country:
United States
Status:
Recruiting
Contact:
Last name:
Daniel Higginson, MD
Phone:
646-888-3567
Facility:
Name:
Memorial Sloan Kettering Suffolk - Commack (All Protocol Activities)
Address:
City:
Commack
Zip:
11725
Country:
United States
Status:
Recruiting
Contact:
Last name:
Daniel Higginson, MD
Phone:
646-888-3567
Facility:
Name:
Memorial Sloan Kettering Westchester (All Protocol Activities)
Address:
City:
Harrison
Zip:
10604
Country:
United States
Status:
Recruiting
Contact:
Last name:
Daniel Higginson, MD
Phone:
646-888-3567
Facility:
Name:
Memorial Sloan Kettering Cancer Center (All Protocol Activities)
Address:
City:
New York
Zip:
10065
Country:
United States
Status:
Recruiting
Contact:
Last name:
Daniel Higginson, MD
Phone:
646-888-3567
Contact backup:
Last name:
E. Nelson
Facility:
Name:
University of Washington (Data Collection AND Data Analysis)
Address:
City:
Seattle
Zip:
98109
Country:
United States
Status:
Active, not recruiting
Start date:
May 17, 2023
Completion date:
May 17, 2028
Lead sponsor:
Agency:
Memorial Sloan Kettering Cancer Center
Agency class:
Other
Collaborator:
Agency:
AstraZeneca
Agency class:
Industry
Source:
Memorial Sloan Kettering Cancer Center
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05678010
http://www.mskcc.org
