AZD1390 + SBRT for Metastatic Cancer
Recruiting in Palo Alto (17 mi)
+4 other locations
Age: 18+
Sex: Any
Travel: May be covered
Time Reimbursement: Varies
Trial Phase: Phase 1
Waitlist Available
Sponsor: Memorial Sloan Kettering Cancer Center
No Placebo Group
Trial Summary
What is the purpose of this trial?This trial is testing a new drug called AZD1390 combined with a precise form of radiation therapy to treat people with cancer that has spread to other parts of the body. The goal is to see if this combination is safe and effective. AZD1390 helps make cancer cells more vulnerable to radiation, potentially improving treatment outcomes.
Do I have to stop taking my current medications for the trial?
The trial protocol does not specify if you must stop all current medications. However, you cannot take strong inhibitors or inducers of CYP3A4 within 2 weeks before starting AZD1390, and you should avoid certain medications like prazosin, cimetidine, simvastatin, dofetilide, metformin, dabigatran, digoxin, and fexofenadine while on the study.
What data supports the idea that AZD1390 + SBRT for Metastatic Cancer is an effective treatment?
The available research shows that Stereotactic Body Radiation Therapy (SBRT) is effective in treating spinal metastases, which are cancerous growths that spread to the spine. One study found that SBRT improved pain relief for patients with spinal metastases compared to traditional radiation therapy. Another study suggests that using SBRT along with standard treatments for certain cancers with bone metastases could lead to longer periods without the cancer getting worse. This indicates that SBRT, when combined with other treatments, can be a promising option for managing metastatic cancer.
12345What safety data is available for AZD1390 + SBRT treatment?
The provided research articles focus on the safety and efficacy of stereotactic body radiotherapy (SBRT) and stereotactic ablative radiotherapy (SABR) for various types of metastases, including spinal, lung, renal cell carcinoma, and skeletal metastases. These studies generally evaluate the tolerability and toxicities associated with SBRT/SABR, indicating that safety data exists for the radiotherapy component of the treatment. However, specific safety data for the combination of AZD1390 with SBRT is not directly addressed in these articles.
26789Is the treatment AZD1390 and SBRT a promising treatment for metastatic cancer?
Yes, AZD1390 combined with SBRT is a promising treatment for metastatic cancer. SBRT is effective in controlling pain and targeting cancer in specific areas like the spine and lungs. It offers long-lasting relief and can sometimes aim for a cure, especially in patients with fewer cancer spread areas.
136910Eligibility Criteria
Adults with confirmed metastatic solid tumor cancer, suitable for SBRT treatment to two disease sites, and meeting specific health criteria (e.g., adequate blood counts, liver function). Must not be pregnant or breastfeeding and willing to use contraception. Excludes those with severe medical conditions, brain metastases treatments ongoing, recent heart issues, certain lung diseases, high risk of heart rhythm problems.Participant Groups
The trial is testing the safety of a new drug called AZD1390 when given alongside Stereotactic Body Radiotherapy (SBRT) in adults with various types of advanced cancers that have spread to other parts of the body.
8Treatment groups
Experimental Treatment
Group I: Arm B, Dose Level 4Experimental Treatment2 Interventions
Participants have peripheral metastasis with bowel and lung in SBRT treatment planning target
Group II: Arm B, Dose Level 3Experimental Treatment2 Interventions
Participants have peripheral metastasis with bowel and lung in SBRT treatment planning target
Group III: Arm B, Dose Level 2Experimental Treatment2 Interventions
Participants have peripheral metastasis with bowel and lung in SBRT treatment planning target
Group IV: Arm B, Dose Level 1Experimental Treatment2 Interventions
Participants have peripheral metastasis with bowel and lung in SBRT treatment planning target
Group V: Arm A, Dose Level 4Experimental Treatment2 Interventions
Participants have peripheral metastases only, without bowel and lung in SBRT treatment planning target. Once 2 dosing cohorts of safety data are available from concomitant dosing of AZD1390 with SBRT in Arm A, and provided that Arm A is advancing to Cohort 3, Arm B (with bowel and lung in SBRT treatment planning target \[PTV\]) may be triggered at the initial dose level).
Group VI: Arm A, Dose Level 3Experimental Treatment2 Interventions
Participants have peripheral metastases only, without bowel and lung in SBRT treatment planning target. Once 2 dosing cohorts of safety data are available from concomitant dosing of AZD1390 with SBRT in Arm A, and provided that Arm A is advancing to Cohort 3, Arm B (with bowel and lung in SBRT treatment planning target \[PTV\]) may be triggered at the initial dose level).
Group VII: Arm A, Dose Level 2Experimental Treatment2 Interventions
Participants have peripheral metastases only, without bowel and lung in SBRT treatment planning target. Once 2 dosing cohorts of safety data are available from concomitant dosing of AZD1390 with SBRT in Arm A, and provided that Arm A is advancing to Cohort 3, Arm B (with bowel and lung in SBRT treatment planning target \[PTV\]) may be triggered at the initial dose level).
Group VIII: Arm A, Dose Level 1Experimental Treatment2 Interventions
Participants have peripheral metastases only, without bowel and lung in SBRT treatment planning target. Once 2 dosing cohorts of safety data are available from concomitant dosing of AZD1390 with SBRT in Arm A, and provided that Arm A is advancing to Cohort 3, Arm B (with bowel and lung in SBRT treatment planning target \[PTV\]) may be triggered at the initial dose level).
Find A Clinic Near You
Research locations nearbySelect from list below to view details:
Memorial Sloan Kettering Monmouth (All Protocol Activities)Middletown, NJ
Memorial Sloan Kettering Suffolk - Commack (All Protocol Activities)Commack, NY
University of Washington (Data Collection AND Data Analysis)Seattle, WA
Memorial Sloan Kettering Westchester (All Protocol Activities)Harrison, NY
More Trial Locations
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Who is running the clinical trial?
Memorial Sloan Kettering Cancer CenterLead Sponsor
AstraZenecaIndustry Sponsor
References
Efficacy and safety of SBRT for spine metastases: A systematic review and meta-analysis for preparation of an ESTRO practice guideline. [2023]Advances in characterizing cancer biology and the growing availability of novel targeted agents and immune therapeutics have significantly changed the prognosis of many patients with metastatic disease. Palliative radiotherapy needs to adapt to these developments. In this study, we summarize the available evidence for stereotactic body radiotherapy (SBRT) in the treatment of spinal metastases.
Stereotactic body radiotherapy as a primary treatment for spinal metastasis: a single institution experience. [2021]To investigate the clinical outcome including efficacy and safety of stereotactic body radiotherapy (SBRT) in management of spinal metastasis.
Mature Local Control and Reirradiation Rates Comparing Spine Stereotactic Body Radiation Therapy With Conventional Palliative External Beam Radiation Therapy. [2022]Stereotactic body radiation therapy (SBRT) improves complete pain response for painful spinal metastases compared with conventional external beam radiation therapy (cEBRT). We report mature local control and reirradiation rates in a large cohort of patients treated with SBRT versus cEBRT enrolled previously in the Canadian Clinical Trials Group Symptom Control 24 phase 2/3 trial.
Efficacy of extracranial stereotactic body radiation therapy (SBRT) added to standard treatment in patients with solid tumors (breast, prostate and non-small cell lung cancer) with up to 3 bone-only metastases: study protocol for a randomised phase III trial (STEREO-OS). [2021]Stereotactic Body Radiation Therapy (SBRT) is an innovative modality based on high precision planning and delivery. Cancer with bone metastases and oligometastases are associated with an intermediate or good prognosis. We assume that prolonged survival rates would be achieved if both the primary tumor and metastases are controlled by local treatment. Our purpose is to demonstrate, via a multicenter randomized phase III trial, that local treatment of metastatic sites with curative intent with SBRT associated of systemic standard of care treatment would improve the progression-free survival in patients with solid tumor (breast, prostate and non-small cell lung cancer) with up to 3 bone-only metastases compared to patients who received systemic standard of care treatment alone.
Dosimetric analysis of varying cord planning organ at risk volume in spine stereotactic body radiation therapy. [2020]Spine stereotactic body radiation therapy (SBRT) is becoming widely accepted as first-line treatment of oligometastatic spine disease as well as in the postoperative setting. The reported incidence of myelopathy is very low and guidelines vary widely on the maximum tolerable dose of the spinal cord and thecal sac.
Multi-institutional phase I/II trial of stereotactic body radiation therapy for lung metastases. [2022]To evaluate the efficacy and tolerability of high-dose stereotactic body radiation therapy (SBRT) for the treatment of patients with one to three lung metastases.
Phase I dose-escalation study of stereotactic body radiotherapy (SBRT) for poor surgical candidates with localized renal cell carcinoma. [2022]To evaluate the tolerability of escalating doses of stereotactic body radiotherapy (SBRT) for primary treatment of localized renal cell carcinoma (RCC) in poor surgical candidates.
Utilization of stereotactic ablative radiotherapy in oligometastatic & oligoprogressive skeletal metastases: Results and pattern of failure. [2019]To evaluate the outcome and toxicities of stereotactic ablative radiotherapy (SABR) for skeletal metastasis in a tertiary cancer center.
Comparison of Clinical Outcomes Stratified by Target Delineation for Patients Undergoing Stereotactic Body Radiotherapy for Spinal Metastases. [2020]Stereotactic body radiotherapy (SBRT) is an effective treatment of spinal metastases in the vertebral body. However, variation has existed between practitioners regarding the appropriate target delineation. As such, we compared the tumor control, rates of compression fractures, and pain control for patients who had undergone SBRT for spinal metastases to either the lesion only (LO) or the full vertebral body (FVB).
Spinal metastases: Is stereotactic body radiation therapy supported by evidences? [2022]Stereotactic body radiotherapy (SBRT) is becoming widely adopted in the treatment of primary and secondary tumors. Spinal bone metastases are frequently discovered in cancer patients, and in the past have been usually treated with a palliative goal. Nevertheless, in some particular clinical settings, such as oligometastatic patients and/or those with a long life expectancy, spinal SBRT could be considered a valid therapeutic option to obtain long-lasting palliation and, when possible, with a curative goal. This review aims to summarize available clinical and dosimetric data of published studies about spinal SBRT.