Status:
UNKNOWN
Arsenic Trioxide in Refractory Solid Tumors With Rescuable p53 Mutation
Lead Sponsor:
Ruijin Hospital
Conditions:
Refractory Solid Tumors
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
This study is an open, prospective, single arm, multi center exploratory basket clinical study. 20 refractory solid tumors patients with rescuable p53 mutation will be enrolled, and the efficacy and s...
Detailed Description
p53 is the most frequently mutated protein in cancer. It is mutated in about half of all cancers and losses tumor-suppressive function. Yet there is no approved p53-targeted therapy, being one of the ...
Eligibility Criteria
Inclusion
- Male/female patients aged≥18 years.
- Patients with refractory solid tumors were confirmed by histopathology and structural p53 mutations were confirmed by sanger sequence.
- ECOG performance status 0 or 2, expected lifetime≥3 months.
- Adequate organ function: Absolute neutrophil count (ANC) ≥1.5x109/L, White blood count ≥3.5x109/L, Platelets ≥75x109/L, Hemoglobin (Hb) ≥70g/L, ALT/AST ≤2.5x ULN (for patient with liver metastasis ALT/AST ≤5x ULN), Serum bilirubin ≤1.5x ULN, Serum creatinine ≤1.5x ULN.
- HBV infected patients (inactive/asymptomatic carrier, chronic or active) with HBV DNA\<500IU/ml (or 2500 copies/ml).
- Pregnancy test of female patients with fertile activity should be negative within 7 days before enrollment. Patients should keep contraception during treatment.
- Willingness and ability to comply with the protocol for the duration of the study including scheduled visits, examinations, investigations and treatment plans with informed consent form.
Exclusion
- Pregnancy or children bearing potential.
- brain or meningeal metastasis.
- With second primary malignant diseases.
- With uncontrolled auto-immune diseases, interstitial pneumonia, ulcerative colitis, or patients who should receive long-term glucocorticoid treatment (\>10mg/d prednisone).
- With uncontrollable complications
- Inadequate organ function
- Conditions which impact on pill taking (dysphagia, chronic diarrhea, bowel obstruction).
- known hypersensitivity reaction to any of the study drugs or components.
- Other unsuitable conditions determined by investigators.
Key Trial Info
Start Date :
April 20 2021
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
April 30 2024
Estimated Enrollment :
20 Patients enrolled
Trial Details
Trial ID
NCT04869475
Start Date
April 20 2021
End Date
April 30 2024
Last Update
May 13 2021
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Department of Oncology, Ruijin Hospital
Shanghai, China, 200025