Solid Tumors
Conditions
Brief summary
In lung cancer, ensartinib is effective in improving the prognosis of ALK positive /MET exon 14 skipping patients. However, patients with ALK positive /MET14 exon skipping non-lung cancer solid tumors have limited treatment options in the absence of standard treatment. We hope to bring a new effective and safe treatment option to these patients more efficiently.
Interventions
DRUGEnsartinib
ensartinib 225mg ,PO,QD,until disease progression or intolerable toxicity
Sponsors
Nanjing First Hospital, Nanjing Medical University
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
* Advanced/metastatic solid tumors other than primary lung cancer * Alk-positive or MET14 exon skipping mutation by IHC\\FISH\\NGS\\RT-PCR * Have no standard treatment after MDT discussion, or could not tolerate the standard treatment, or the patient refused the standard treatment * Adequate liver and kidney function * Adequate bone marrow function * ECOG PS 0-3 * Female subjects should not be pregnant. All human subjects should able to comply with the required protocol and follow-up procedures, and able to receive oral medications Written informed consent provided
Exclusion criteria
* Active viral, bacterial, or fungal infection detected 2 weeks before enrollment * Pregnancy or lactation * receiving medications or herbal supplements with potent inducers of CYP3A4 (at least 3 weeks prior) * Any severe or uncontrolled systemic illness, including uncontrolled Hypertension and active bleeding, any nonadherence that the investigator considered to be detrimental to study participation or adherence to the protocol, or active infections including hepatitis B, hepatitis C, and human immunodeficiency virus (HIV) * Ineligible cardiac function * Interstitial lung disease, drug-induced interstitial lung disease, previous history of radiation pneumonitis requiring steroid therapy, or any evidence of active interstitial lung disease * Lack of adequate bone marrow reserve or organ function
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| progression-free survival | 2 years | time to progression or Intolerable toxicity occurred |
| Overall responce rate | 1year | Proportion of patients with CR/PR response in the total population |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Disease control rate | 1year | Proportion of patients with CR/PR/SD response in the total population |
| Overall survival | 3 years | time to death |
| Duration of responce | 3 years | time from first assessment of CR or PR to the first assessment of PD or death |
| Number of participants with treatment-related adverse events as assessed by CTCAE v5.0 | 3 years | The safety of Ensartinib treatment will be assessed according to CTCAE v5.0 criteria observed over the whole treatment period. |
Contacts
Primary ContactXiaowei Wei
Outcome results
None listed