Status:
UNKNOWN
An Exploratory Basket Study of Pyrotinib Maleate Tablets in HER2 Mutated or Amplified of Metastatic Solid Tumors
Lead Sponsor:
Zhongshan Hospital Xiamen University
Conditions:
Solid Tumor
Eligibility:
All Genders
18-75 years
Phase:
PHASE2
Brief Summary
A single arm, open-label Phase II clinical study.The subjects were patients with lung, gastric and colorectal cancers.
Detailed Description
Object: 1.The main purpose: T To observe and evaluate the efficacy of pyrotinib in patients with HER2-mutated/amplified metastatic solid tumors after failure of standard therapy; 2. Secondary objectiv...
Eligibility Criteria
Inclusion
- Age:18-75 years old, regardless of gender;
- Disease progression during the previous standard treatment or disease progression within 6 months after the end of treatment, patients with gastric and gastroesophageal junction adenocarcinoma requires previous use of trastuzumab, and other tumors must have received at least first-line standard chemotherapy ± targeted therapy.
- Two or more grade IV hematological toxicity or non-hematological toxicity ≥ grade III or damage to the heart, liver, kidney and other major organs of grade ≥ II occurred during the standard treatment process; Patients who have been confirmed by the doctor to no longer receive standard treatment can be included in the group.
- HER2 mutated non-small cell lung cancer , gastric and gastroesophageal junction adenocarcinoma or Adenocarcinoma of the colon has been confirmed by Pathology.
- Cancer tissue pathology is clearly HER2 positive: including IHC2+/ISH+, IHC 3+ or HER2 mutations (the results obtained by NGS method, PCR method, Sanger method, mass spectrometry sequencing and other measurement methods are all acceptable).
- Eastern Cooperative Oncology Group (ECOG) performance status of 0-1;
- For recurrent or metastatic tumours, according to the RECIST 1.1 standard, the subject has at least one measurable target disease.
- Life expectancy greater than or equal to 12 months;
- The functional level of organs must meet the following requirements:
- (1) Blood routine: ANC ≥ 1.5×10\^9/L; PLT ≥ 90×10\^9/L; Hb ≥ 90 g/L; (2) Blood biochemistry: TBIL\<=1.5×ULN; ALT and AST\<=2×ULN; for subjects with liver metastases, ALT and AST\<=5×ULN; BUN and Cr\<=1.5×ULN and creatinine clearance ≥50mL/min (Cockcroft-Gault formula); (3) Heart color Doppler ultrasound: LVEF≥50%; (4) 12-lead electrocardiogram: The QT interval (QTcF) corrected by Fridericia's method is \<450ms for males and \<470ms for females.
- 10\. Have sufficient bone marrow, liver and kidney functions. 11. Women of childbearing age and their spouses are willing to contraception during treatment and within 1 year after the last medication.
- Volunteer to join the study, sign an informed consent form, have good compliance and are willing to cooperate with follow-up.
Exclusion
- 1\. Left ventricular ejection fraction (LVEF) \< 50% at baseline (measured by echocardiography or MUGA); 2. Patients who have received systemic therapy including immunotherapy, biotherapy and any clinical trial drugs in the past 2 weeks; 3. Patients with uncontrollable central metastases, brain tumor lesions confirmed by brain CT or MRI and need dehydration treatment or radiotherapy (except for patients with stable brain metastases after 1 month of radiotherapy); 4. With \> grade 1 unresolved toxicity due to any previous treatment / procedure (ctc-ae, except alopecia, anemia, and hypothyroidism); 5. Severe infection and other serious systemic diseases; 6. Patients receiving long-term or high-dose corticosteroid treatment (inhaled steroids or short-term oral steroids are allowed to resist vomiting or promote appetite); 7. Evidence or history of coagulation disorders such as bleeding events with grade ≥ 3 (ctc-ae); 8. Patients whom intestinal obstruction and other factors affecting oral administration or absorption of drugs; After the comprehensive judgment of the disease, the researcher thought that it was not suitable to participate in this study.
Key Trial Info
Start Date :
March 4 2022
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
March 15 2024
Estimated Enrollment :
60 Patients enrolled
Trial Details
Trial ID
NCT05274191
Start Date
March 4 2022
End Date
March 15 2024
Last Update
March 10 2022
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