Arsenic Trioxide in Refractory Solid Tumors With Rescuable p53 Mutation

Phase 2

• Conditions: Refractory Solid Tumors
• Interventions: Drug: Arsenic trioxide

• Registration Number: NCT04869475
• Lead Sponsor: Ruijin Hospital

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 safety of arsenic trioxide in those patients will be evaluated.

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 most unmet clinical needs. At least 45 approaches/agents were identified to kill cancer cells via p53 mutations by 2017, with at least 17 agents reported to fun...

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study Start: 2021-04-20
• Study First Submitted: 2021-04-28
• Study First Submitted QC: 2021-04-28
• Status Verified: 2021-05
• Study First Posted: 2021-05-03
• Last Update Submitted: 2021-05-11
• Last Update Posted: 2021-05-13
• Primary Completion: 2022-04-30
• Study Completion: 2024-04-30

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 20

Inclusion Criteria

1. Male/female patients aged≥18 years.
2. Patients with refractory solid tumors were confirmed by histopathology and structural p53 mutations were confirmed by sanger sequence.
3. ECOG performance status 0 or 2, expected lifetime≥3 months.
4. 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.
5. HBV infected patients (inactive/asymptomatic carrier, chronic or active) with HBV DNA<500IU/ml (or 2500 copies/ml).
6. Pregnancy test of female patients with fertile activity should be negative within 7 days before enrollment. Patients should keep contraception during treatment.
7. 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.

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Exclusion Criteria

1. Pregnancy or children bearing potential.
2. brain or meningeal metastasis.
3. With second primary malignant diseases.
4. With uncontrolled auto-immune diseases, interstitial pneumonia, ulcerative colitis, or patients who should receive long-term glucocorticoid treatment (>10mg/d prednisone).
5. With uncontrollable complications
6. Inadequate organ function
7. Conditions which impact on pill taking (dysphagia, chronic diarrhea, bowel obstruction).
8. known hypersensitivity reaction to any of the study drugs or components.
9. Other unsuitable conditions determined by investigators.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Experimental	Arsenic trioxide	arsenic trioxide 7mg/m2 ivgtt d1-14, q3w

Primary Outcome Measures

Name	Time	Method
Disease control rate (DCR)	12 months

Secondary Outcome Measures

Name	Time	Method
Duration of response (DOR)	12 months
Progression free survival (PFS)	12 months
Overall response rate (ORR)	12 months
Safety: adverse events as assessed by CTCAE v5.0	36 months

Trial Locations

Locations (1)

Department of Oncology, Ruijin Hospital; 🇨🇳 Shanghai, China