Brain Metastases Clinical Trial
Official title:
Efficacy and Safety of X-396 (Ensartinib) in ALK-Positive NSCLC Patients With Brain Metastases: A Phase Ⅱ, Open-Label, Single Arm, Multicenter Study
To assess efficacy and safety of oral X-396 (Ensartinib) capsule in Chinese ALK-positive NSCLC patients with brain metastases, eligible patients will be enrolled with objective responses being primary outcome measures.
Status | Recruiting |
Enrollment | 37 |
Est. completion date | June 2021 |
Est. primary completion date | December 2020 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility |
Inclusion Criteria: 1. Female or male, 18 years of age or older 2. Histologically or cytologically confirmed locally advance or recurrent/metastatic NSCLC that was positive for ALK mutations. 3. Contrast-enhanced MRI or CT confirmed parenchymal brain metastases with at least one measurable lesion (according to RANO and RECIST 1.1), which was not previously treated with radiotherapy. 4. At most once treated with chemotherapy, which must have been completed at least 4 weeks before the initiation of study treatment. Any adverse events related to previous chemotherapy treatment have disappeared. 5. A Karnofsky Performance Status score of at least 60. 6. An expected survival time of at least 12 weeks. 7. Adequate organ functions. 8. Drug related toxicities has been relieved to grade 1 (based on NCI CTCAE v4.03), except for hair loss. 9. Being willing and able to comply with scheduled visits, treatment plans, laboratory tests and other study procedures. 10. Signed and dated informed consent. Exclusion Criteria: 1. Currently under treatment of other systemic anti-cancer therapies. 2. Evidence of active malignancy within last 5 years. 3. Patients who participated in other clinical trials within last 4 weeks before the initiation of study treatment. 4. Patients who received surgery or immunotherapy within last 4 weeks before the initiation of study treatment. 5. Patients who need to receive drugs which are potent CYP3A4 inhibitors or inducers within last 2 weeks before the initiation of study treatment and during the study. 6. Patients who previously received organ transplantation or stem cell transplantation. 7. Patients with clinically significant cardiovascular diseases. 8. Patients with active gastrointestinal diseases or other conditions that will interfere significantly with the absorption, distribution, metabolism or excretion of study medication. 9. Patients with interstitial lung disease history or signs of active interstitial lung disease. 10. Patients with known allergy or delayed hypersensitivity reaction to study drug or its excipients. 11. Pregnant and lactating women. 12. Patients with other illness or medical conditions potentially interfering with the study treatment. |
Country | Name | City | State |
---|---|---|---|
China | Fudan University Shanghai Cancer Center | Shanghai |
Lead Sponsor | Collaborator |
---|---|
Betta Pharmaceuticals Co., Ltd. | Fudan University |
China,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Intracranial objective response rate (iORR) based on investigator assessment according to RNAO-BM. | iORR per RANO-BM calculated as the proportion of patients with a best intracranial overall response defined as complete response (CR) or partial response (PR), based on investigator assessment. | 12 weeks | |
Secondary | Disease control rate based on intracranial response (iDCR) according to RANO-BM. | Defined as the percentage of patients who have achieved intracranial overall response of CR, PR and stable disease (SD), assessed by investigator. | 12 weeks | |
Secondary | Progression-free survival based on intracranial response (iPFS) according to RANO-BM | Defined as time from first dose of X-396 capsule to intracranial disease progression or death due to any causes, assessed by investigator. | 36 months | |
Secondary | Time to progression based on intracranial response (iTTP) according to RANO-BM. | Defined as time from first dose of X-396 capsule to intracranial disease progression, assessed by investigator. | 36 months | |
Secondary | Duration of response based on intracranial response (iDOR) according to RANO-BM. | Defined as time from documentation of intracranial response (CR or PR) to intracranial disease progression or death, assessed by investigator. | 36 months | |
Secondary | Intracranial objective response rate (iORR) based on intracranial response according to RECIST 1.1. | iORR per RECIST 1.1 calculated as the proportion of patients with a best intracranial overall response defined as complete response (CR) or partial response (PR), based on investigator assessment. | 12 weeks | |
Secondary | Disease control rate based on intracranial response (iDCR) according to RECIST 1.1 | Defined as the percentage of patients who have achieved intracranial overall response of CR, PR and stable disease (SD), assessed by investigator. | 12 weeks | |
Secondary | Progression-free survival based on intracranial response (iPFS) according to RECIST 1.1 | Defined as time from first dose of X-396 capsule to intracranial disease progression or death due to any causes, assessed by investigator. | 36 months | |
Secondary | Time to progression based on intracranial response (iTTP) according to RECIST 1.1 | Defined as time from first dose of X-396 capsule to intracranial disease progression, assessed by investigator. | 36 months | |
Secondary | Objective response rate (ORR) based on overall response according to RECIST 1.1. | ORR per RECIST 1.1 calculated as the proportion of patients with a best overall response defined as complete response (CR) or partial response (PR), based on investigator assessment. | 12 weeks | |
Secondary | Disease control rate based on overall response (DCR) according to RECIST 1.1 | Defined as the percentage of patients who have achieved overall response of CR, PR and stable disease (SD), assessed by investigator. | 12 weeks | |
Secondary | Progression-free survival based on overall response (PFS) according to RECIST 1.1 | Defined as time from first dose of X-396 capsule to overall disease progression or death due to any causes, assessed by investigator. | 36 months | |
Secondary | Time to progression based on overall response (TTP) according to RECIST 1.1 | Defined as time from first dose of X-396 capsule to overall disease progression, assessed by investigator. | 36 months | |
Secondary | Overall survival (OS) | Defined as time from first dose of X-396 to death due to any causes. | 36 months | |
Secondary | Incidence of patients experiencing adverse events. | Incidence of adverse events occurred during the study (from the timeoint of signing a informed consent form to 30days after the end of trial) . | 36 months |
Status | Clinical Trial | Phase | |
---|---|---|---|
Active, not recruiting |
NCT04074096 -
Binimetinib Encorafenib Pembrolizumab +/- Stereotactic Radiosurgery in BRAFV600 Melanoma With Brain Metastasis
|
Phase 2 | |
Recruiting |
NCT04474925 -
Pre- Versus Post-operative SRS for Resectable Brain Metastases
|
Phase 3 | |
Recruiting |
NCT05358340 -
Dual Perfusion Imaging for Characterizing Vascular Architecture of Brain Lesions
|
N/A | |
Recruiting |
NCT05559853 -
Developing a New MRI Technique to Understand Changes in Brain Tumors After Treatment
|
||
Completed |
NCT03189381 -
Pilot Phase 2 Study Whole Brain Radiation Therapy With Simultaneous Integrated Boost for Patients With Brain Metastases
|
N/A | |
Completed |
NCT02082587 -
Toronto BNB Pilot Study
|
N/A | |
Terminated |
NCT01551680 -
A Trial Evaluating Concurrent Whole Brain Radiotherapy and Iniparib in Multiple Non Operable Brain Metastases
|
Phase 1 | |
Terminated |
NCT00717275 -
Study of Temozolomide to Treat Newly Diagnosed Brain Metastases
|
Phase 2 | |
Recruiting |
NCT05048212 -
A Phase II Study of Nivolumab With Ipilimumab and Cabozantinib in Patients With Untreated Renal Cell Carcinoma Brain Metastases
|
Phase 2 | |
Recruiting |
NCT03714243 -
Blood Brain Barrier Disruption (BBBD) Using MRgFUS in the Treatment of Her2-positive Breast Cancer Brain Metastases
|
N/A | |
Recruiting |
NCT05573815 -
Evaluation of Clinical Decision Support System for Brain Metastasis Using Brain MR Images
|
N/A | |
Recruiting |
NCT04899908 -
Stereotactic Brain-directed Radiation With or Without Aguix Gadolinium-Based Nanoparticles in Brain Metastases
|
Phase 2 | |
Completed |
NCT04507217 -
Tislelizumab Combined With Pemetrexed/ Carboplatin in Patients With Brain Metastases of Non-squamous NSCLC
|
Phase 2 | |
Recruiting |
NCT05452005 -
Fluorine-18-AlphaVBeta6-Binding Peptide Positron Emission Tomography in Metastatic Non-Small Cell Lung Cancer
|
Phase 1 | |
Recruiting |
NCT06457906 -
SRS/SRT/Hypo-RT Versus HA-WBRT for No More Than 10 Brain Metastases in SCLC
|
Phase 3 | |
Completed |
NCT04170777 -
Perfexion Registration Using CBCT
|
||
Recruiting |
NCT03027544 -
Tomotherapy for Refractory Brain Metastases
|
N/A | |
Completed |
NCT04178330 -
Tomotherapy as Primary Radiotherapy for Multipule Brain Metastases
|
N/A | |
Terminated |
NCT02187822 -
Fractionated Stereotactic Radiotherapy (FSRT) in Treatment of Brain Metastases
|
Phase 1 | |
Terminated |
NCT00538343 -
RTA 744 in Breast Cancer Patients With Progression of Previously Irradiated Brain Metastases
|
Phase 2 |