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.

Trial Health

At Risk

Trial Health Score

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

Trial has exceeded expected completion date

Enrollment

participants targeted

Target at below P25 for phase_2

Timeline

Completed

Started Apr 2021

Typical duration 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

3 years study duration

Study Start

First participant enrolled

April 20, 2021

Completed

8 days until next milestone

First Submitted

Initial submission to the registry

April 28, 2021

Completed

5 days until next milestone

First Posted

Study publicly available on registry

May 3, 2021

Completed

12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 30, 2022

Completed

2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

April 30, 2024

Completed

Last Updated

May 13, 2021

Status Verified

May 1, 2021

Enrollment Period

1 year

First QC Date

April 28, 2021

Last Update Submit

May 11, 2021

Conditions

Refractory Solid Tumors

Outcome Measures

Primary Outcomes (1)

Disease control rate (DCR)
12 months

Secondary Outcomes (4)

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

Study Arms (1)

Experimental

EXPERIMENTAL

arsenic trioxide 7mg/m2 ivgtt d1-14, q3w

Drug: Arsenic trioxide

Interventions

Arsenic trioxideDRUG

This is a single-arm study with all patients receiving arsenci trioxide.

Experimental

Eligibility Criteria

Age18 Years+

Sexall

Healthy VolunteersNo

Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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.

You may not qualify if:

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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Ruijin Hospitallead

Study Sites (1)

Department of Oncology, Ruijin Hospital

Shanghai, 200025, China

RECRUITING

Related Publications (7)

Canon J, Rex K, Saiki AY, Mohr C, Cooke K, Bagal D, Gaida K, Holt T, Knutson CG, Koppada N, Lanman BA, Werner J, Rapaport AS, San Miguel T, Ortiz R, Osgood T, Sun JR, Zhu X, McCarter JD, Volak LP, Houk BE, Fakih MG, O'Neil BH, Price TJ, Falchook GS, Desai J, Kuo J, Govindan R, Hong DS, Ouyang W, Henary H, Arvedson T, Cee VJ, Lipford JR. The clinical KRAS(G12C) inhibitor AMG 510 drives anti-tumour immunity. Nature. 2019 Nov;575(7781):217-223. doi: 10.1038/s41586-019-1694-1. Epub 2019 Oct 30.
PMID: 31666701BACKGROUND
Chen S, Wu JL, Liang Y, Tang YG, Song HX, Wu LL, Xing YF, Yan N, Li YT, Wang ZY, Xiao SJ, Lu X, Chen SJ, Lu M. Arsenic Trioxide Rescues Structural p53 Mutations through a Cryptic Allosteric Site. Cancer Cell. 2021 Feb 8;39(2):225-239.e8. doi: 10.1016/j.ccell.2020.11.013. Epub 2020 Dec 24.
PMID: 33357454BACKGROUND
Kopetz S, Desai J, Chan E, Hecht JR, O'Dwyer PJ, Maru D, Morris V, Janku F, Dasari A, Chung W, Issa JP, Gibbs P, James B, Powis G, Nolop KB, Bhattacharya S, Saltz L. Phase II Pilot Study of Vemurafenib in Patients With Metastatic BRAF-Mutated Colorectal Cancer. J Clin Oncol. 2015 Dec 1;33(34):4032-8. doi: 10.1200/JCO.2015.63.2497. Epub 2015 Oct 12.
PMID: 26460303BACKGROUND
Sabapathy K, Lane DP. Therapeutic targeting of p53: all mutants are equal, but some mutants are more equal than others. Nat Rev Clin Oncol. 2018 Jan;15(1):13-30. doi: 10.1038/nrclinonc.2017.151. Epub 2017 Sep 26.
PMID: 28948977BACKGROUND
Wang H, Liu Y, Wang X, Liu D, Sun Z, Wang C, Jin G, Zhang B, Yu S. Randomized clinical control study of locoregional therapy combined with arsenic trioxide for the treatment of hepatocellular carcinoma. Cancer. 2015 Sep 1;121(17):2917-25. doi: 10.1002/cncr.29456. Epub 2015 May 29.
PMID: 26033499BACKGROUND
Zhang TD, Chen GQ, Wang ZG, Wang ZY, Chen SJ, Chen Z. Arsenic trioxide, a therapeutic agent for APL. Oncogene. 2001 Oct 29;20(49):7146-53. doi: 10.1038/sj.onc.1204762.
PMID: 11704843BACKGROUND
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

Interventions

Arsenic Trioxide

Intervention Hierarchy (Ancestors)

ArsenicalsInorganic ChemicalsOxidesOxygen Compounds

Study Officials

Min Lu, Ph. D
Ruijin Hospital
PRINCIPAL INVESTIGATOR
Jun Zhang, MD & PhD
Ruijin Hospital
PRINCIPAL INVESTIGATOR

Central Study Contacts

Min Shi, MD & Ph. D

CONTACT

+86-21-64370045 sm11998@rjh.com.cn

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: Chief of department of oncology

Study Record Dates

First Submitted

April 28, 2021

First Posted

May 3, 2021

Study Start

April 20, 2021

Primary Completion

April 30, 2022

Study Completion

April 30, 2024

Last Updated

May 13, 2021

Record last verified: 2021-05

Data Sharing

IPD Sharing: Will not share

Locations

CN(1)

Brief Summary

Trial Health

Trial Health Score

Trial Relationships

Related Scientific Literature

Study Timeline

Study Start

First Submitted

First Posted

Primary Completion

Study Completion

Conditions

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (4)

Study Arms (1)

Experimental

Interventions

Eligibility Criteria

You may qualify if:

You may not qualify if:

Sponsors & Collaborators

Study Sites (1)

Related Publications (7)

MeSH Terms

Interventions

Intervention Hierarchy (Ancestors)

Study Officials

Central Study Contacts

Study Design

Study Record Dates

Data Sharing

Locations