Arsenic Trioxide for Structural p53 Mutations

Phase 2

• Conditions: Refractory Cancer; p53 Mutations; Intractable Cancer; Arsenic Trioxide
• Interventions: Drug: Arsenic Trioxide

• Registration Number: NCT04695223
• Lead Sponsor: Shanghai Changzheng Hospital

Brief Summary

TP53 is the most frequently mutated gene in cancer, but these mutations remain therapeutically non-actionable. Previous study reported arsenic trioxide could rescue structural p53 mutations, endowing p53 mutations with thermostability and transcriptional activity. Under Vivo and Vitro experiments, arsenic trioxide could reactivate mutated p53 to inhibit tumo...

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Status Verified: 2021-01
• Study Start: 2021-01-01
• Study First Submitted: 2021-01-01
• Study First Submitted QC: 2021-01-01
• Last Update Submitted: 2021-01-04
• Study First Posted: 2021-01-05
• Last Update Posted: 2021-01-06
• Primary Completion: 2021-08-31
• Study Completion: 2021-10-31

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 30

Inclusion Criteria

• Malignant solid tumors diagnosed histologically;
• Solid tumor patients have no any standard choice after multiple line of therapy;
• Next-generation Sequence showed TP53 mutation;
• Expected survival ≥ 1 month;
• ECOG / PS score: 0-2, and the main organ function to meet the following criteria: HB ≥ 90g / L, ANC ≥ 1.5 × 109 / L, PLT ≥ 80 × 109 / L,BIL <1.5 times the upper limit of normal (ULN); Liver ALT and AST <2.5 × ULN and if liver metastases, ALT and AST <5 × ULN; Serum Cr ≤ 1 × ULN, endogenous creatinine clearance ≥50ml/min
• normal cardiac function
• obtain informed consent

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Exclusion Criteria

• Patient still has standard treatment therapy based on NCCN guidance;
• Patient can not comply with research program requirements or follow-up;
• woman who are pregnant or breastfeeding;
• allergic to any drug in protocol or with contraindications;
• cannot understand or obey the protocol;
• with a history of allergies or intolerability;
• participate in other clinical trials meanwhile;
• any situations that hinder trial existed;

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Arsenic Trioxide	Arsenic Trioxide	Arsenic Trioxide (0.16mg/kg,d1-5,ivgtt,28days as a duration) for injection

Primary Outcome Measures

Name	Time	Method
Progress Free Survival	Evaluation of tumor burden based on RECIST criteria until first documented progress through study completion, an average of 2 months	Time from treatment beginning until disease progression
Objective Response Rate	Evaluation of tumor burden based on RECIST criteria through study completion, an average of 2 months	Proportion of patients with reduction in tumor burden of a predefined amount, including complete remission and partial remission

Secondary Outcome Measures

Name	Time	Method
Adverse Effect	Through study completion, an average of 1 months	Incidence of Treatment-related adverse Events
Overall Survival	From date of treatment beginning until the date of death from any cause, through study completion, an average of 1 months	Time from treatment beginning until death from any cause

Trial Locations

Locations (1)

Department of Medical Oncology, Shanghai Changzheng Hospital; 🇨🇳 Shanghai, China