Arsenic TrioxidePhase 2NCT04695223
Arsenic Trioxide for Structural p53 Mutations
A Phase 2 study testing Arsenic Trioxide in people with Arsenic Trioxide and p53 Mutations, run by Shanghai Changzheng Hospital at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Arsenic Trioxide, p53 Mutations, Refractory Cancer
- What is being tested?
- Arsenic Trioxide
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteChina
- Study dates
- 1 Jan 2021to 31 Oct 2021
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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;
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Department of Medical Oncology, Shanghai Changzheng Hospital
Shanghai
Xiaodong Jiao, +86-13817797639, 13817797639@139.com
Yuan-Sheng Zang
About this study
Official title: Targeting Structural p53 Mutations With Arsenic Trioxide for Intractable Cancer
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.
- Conditions
- Arsenic Trioxide, p53 Mutations, Refractory Cancer, Intractable Cancer
- Being tested
- Arsenic Trioxide
- Medical subject headings
- Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Arsenic TrioxideDrug
Also called As2O3, Arsenic
Refractory cancer patients without standard-of-care harboring TP53 mutation received Arsenic Trioxide Injection (0.16mg/kg,d1-5,ivgtt,28days as a duration)
| Study group | Role | What they receive |
|---|---|---|
| Arsenic Trioxide | Experimental | Arsenic Trioxide (0.16mg/kg,d1-5,ivgtt,28days as a duration) for injection Receives: Drug: Arsenic Trioxide |
What is being measured
The primary outcome is the main question the study is designed to answer.
Objective Response Rate
Proportion of patients with reduction in tumor burden of a predefined amount, including complete remission and partial remission
Measured: 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
Measured: 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
Time from treatment beginning until death from any cause
Measured: From date of treatment beginning until the date of death from any cause, through study completion, an average of 1 months
Adverse Effect
Incidence of Treatment-related adverse Events
Measured: Through study completion, an average of 1 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jan 2021
- Study start1 Jan 2021 (estimated)
- Primary completion31 Aug 2021 (estimated)
- Study completion31 Oct 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Arsenic TrioxideStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shanghai Changzheng Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Yuan-Sheng Zang, Shanghai Changzheng Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04695223
- Sponsor's protocol ID
- ANTI-P53
- Status last verified
- Jan 2021
- First submitted
- 1 Jan 2021
- Last updated
- 6 Jan 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 35417717
Study at a glance
From the registry record, last updated by the sponsor on 6 Jan 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Targeting Structural p53 Mutations With Arsenic Trioxide for Intractable Cancer
- ClinicalTrials.gov ID
- NCT04695223
- Acronym / sponsor ID
- ANTI-P53
- Conditions
- Arsenic Trioxide, p53 Mutations, Refractory Cancer, Intractable Cancer
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Shanghai Changzheng HospitalUniversity, hospital or other
- Study start
- 1 Jan 2021 (estimated)
- Primary completion
- 31 Aug 2021 (estimated)
- Study completion
- 31 Oct 2021 (estimated)
- First posted
- 5 Jan 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Arsenic Trioxide | Experimental | Drug: Arsenic TrioxideArsenic Trioxide (0.16mg/kg,d1-5,ivgtt,28days as a duration) for injection |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (8 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Arsenic TrioxideAlso: As2O3, ArsenicRefractory cancer patients without standard-of-care harboring TP53 mutation received Arsenic Trioxide Injection (0.16mg/kg,d1-5,ivgtt,28days as a duration) | Drug | Arsenic Trioxide |
Primary outcome
Objective Response Rate
Time frame: 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
Progress Free Survival
Time frame: 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
2 secondary outcomes
Overall Survival
Time frame: From date of treatment beginning until the date of death from any cause, through study completion, an average of 1 months
Adverse Effect
Time frame: Through study completion, an average of 1 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Jan 2021.
- Derived from this study: PubMed 35417717Tang 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.
- Individual participant dataSharing planned: No
Related trials for Arsenic Trioxide
Not yet recruitingPhase 2
Arsenic Trioxide Combined With Chemotherapy for Relapsed SHH-Activated and/or TP53-Mutant Medulloblastoma
Medulloblastoma
Not yet recruitingPhase 1
Arsenic Trioxide to Prevent Relapse in Patients Undergoing Allogeneic Stem Cell Transplantation for Acute Myeloid Leukemia or Myelodysplastic Syndrome
Acute Myeloid Leukemia, Myelodysplastic Syndrome
RecruitingPhase 2
Tretinoin and Arsenic Trioxide With or Without Gemtuzumab Ozogamicin in Treating Patients With Previously Untreated Acute Promyelocytic Leukemia
Acute Promyelocytic Leukemia With PML-RARA
Active, not recruitingPhase 3
Tretinoin and Arsenic Trioxide in Treating Patients With Untreated Acute Promyelocytic Leukemia
Acute Promyelocytic Leukemia With t(15;17)(q24.1;q21.2); PML-RARA
Not yet recruitingPhase 3
A Trial to Investigate Whether Oral Arsenic Trioxide Is Similar to Intravenous Arsenic Trioxide in Pharmacokinetics, Safety, and Efficacy (LATITUDE/SDKARS-301)
Acute Promyelocytic Leukemia (APL), Acute Promyelocytic Leukaemia
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Department of Medical Oncology, Shanghai Changzheng Hospital
Shanghai, China
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Arsenic Trioxide in people with Arsenic Trioxide and p53 Mutations, run by Shanghai Changzheng Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 6 Jan 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Objective Response Rate (time frame: Evaluation of tumor burden based on RECIST criteria through study completion, an average of 2 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04695223, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Jan 2021.