NCT04695223

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 tumor. This trial aimed to explore the efficacy and safety of arsenic trioxide in refractory cancer patients with structural p53 mutations.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
30

participants targeted

Target at P25-P50 for phase_2

Timeline
Completed

Started Jan 2021

Shorter than P25 for phase_2

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 1, 2021

Completed
Same day until next milestone

Study Start

First participant enrolled

January 1, 2021

Completed
4 days until next milestone

First Posted

Study publicly available on registry

January 5, 2021

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 31, 2021

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

October 31, 2021

Completed
Last Updated

January 6, 2021

Status Verified

January 1, 2021

Enrollment Period

8 months

First QC Date

January 1, 2021

Last Update Submit

January 4, 2021

Conditions

Arsenic Trioxidep53 MutationsRefractory CancerIntractable Cancer

Outcome Measures

Primary Outcomes (2)

  • Objective Response Rate

    Proportion of patients with reduction in tumor burden of a predefined amount, including complete remission and partial remission

    Evaluation of tumor burden based on RECIST criteria through study completion, an average of 2 months

  • Progress Free Survival

    Time from treatment beginning until disease progression

    Evaluation of tumor burden based on RECIST criteria until first documented progress through study completion, an average of 2 months

Secondary Outcomes (2)

  • Overall Survival

    From date of treatment beginning until the date of death from any cause, through study completion, an average of 1 months

  • Adverse Effect

    Through study completion, an average of 1 months

Study Arms (1)

Arsenic Trioxide

EXPERIMENTAL

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

Drug: Arsenic Trioxide

Interventions

Arsenic TrioxideDRUG

Refractory cancer patients without standard-of-care harboring TP53 mutation received Arsenic Trioxide Injection (0.16mg/kg,d1-5,ivgtt,28days as a duration)

Also known as: As2O3, Arsenic
Arsenic Trioxide

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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;

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Medical Oncology, Shanghai Changzheng Hospital

Shanghai, China

RECRUITING

Related Publications (1)

  • Tang Y, Song H, Wang Z, Xiao S, Xiang X, Zhan H, Wu L, Wu J, Xing Y, Tan Y, Liang Y, Yan N, Li Y, Li J, Wu J, Zheng D, Jia Y, Chen Z, Li Y, Zhang Q, Zhang J, Zeng H, Tao W, Liu F, Wu Y, Lu M. Repurposing antiparasitic antimonials to noncovalently rescue temperature-sensitive p53 mutations. Cell Rep. 2022 Apr 12;39(2):110622. doi: 10.1016/j.celrep.2022.110622.

    PMID: 35417717DERIVED

MeSH Terms

Conditions

Neoplasms

Interventions

Arsenic TrioxideArsenic

Intervention Hierarchy (Ancestors)

ArsenicalsInorganic ChemicalsOxidesOxygen CompoundsMetalloidsElements

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Department Director

Study Record Dates

First Submitted

January 1, 2021

First Posted

January 5, 2021

Study Start

January 1, 2021

Primary Completion

August 31, 2021

Study Completion

October 31, 2021

Last Updated

January 6, 2021

Record last verified: 2021-01

Data Sharing

IPD Sharing
Will not share

Locations

CN(1)