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Advanced CancerPhase 1NCT03645200

Treatment of Carrying TP53 Harmful Mutations

A Phase 1 study testing Fluzoparib combined with Apatinib in people with Advanced Cancer, run by Tianjin Medical University Second Hospital at 1 site in China.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

Assessment of the safety and tolerability of Fluzoparib combined with Apatinib in the treatment of advanced refractory solid tumors with TP53 harmful mutations. Read more about this study

Who is it for?
Ages 18 to 70 years
Conditions the study is for
Advanced Cancer
What is being tested?
Fluzoparib combined with Apatinib
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
60 participants
Where
1 siteChina
Study dates
1 Jul 2019to 1 Jun 2020
Phase
Phase 1
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 70 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Age is 18≥years ≤70 years .
  • ECOG body State is 0~1 score.
  • The estimated survival period are greater than 3 months .
  • Histologic or cytological diagnosis of advanced refractory tumors that are ineffective or without standard treatment by standard multi-line therapy. The definition of treatment invalidity: progression of disease after multiple line therapy.
  • With the relevant qualification agencies NGS (second generation sequencing) report, and the molecular Oncology Expert Committee identified TP53 as the main harmful mutation.
  • The patient has at least one measurable lesion that can be assessed by CT or MRI (RECIST 1.1).
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  • Previous treatment of any anti-tumor therapy (including radiotherapy, chemotherapy, hormone therapy, surgery, or molecular targeting therapy) ended with the Thou Yan ≥4 weeks (to the first medication) in this trial.
  • Urine routine display urine protein <2+, if urine protein qualitative ≥2+, should accept 24 hour urine protein quantitative detection, ≤ 1g can be entered into a group.
  • Good organ function level ( no blood transfusion, no use of G-CSF in the first 7 days of screening ; no drug correction;7 days without loss ALB):ANC≥ 1.5x109/L;WBC≥ 3x109 /L;PLT≥80x109/L ;Hb≥90g/l; TBIL≤1.5xULN;ALT and AST≤2.5xULN; ALB≥29g/l ;BUN and Cr ≤1. 5xULN ;LVEF ≥50%;Fridericia method to correct QT Inter-period (QTcF ) Male <450 ms , Women <470 ms .
  • Women of childbearing age are required to take effective contraceptive measures at least 8 weeks after taking part in the study and after the last drug delivery .
  • Can follow the test plan according to the judgment of the investigator.
  • Volunteer to participate in this clinical trial, have the ability to understand the research requirements, can give written informed consent.

Who cannot join

  • Anticancer drugs, including Fluzoparib that used or were using PARP as a target.
  • Antineoplastic agents used or using VEGFR targets, including Apatinib.
  • As a participant in the clinical trial, and the signing of the informed consent of the last clinical trial at the end of the interval of less than days.
  • Has a blood system-related tumor.
  • Receive any anti-tumor treatment (including radiotherapy, chemotherapy, hormone therapy, surgery or molecular targeting therapy) within 4 weeks before delivery;
  • Double phosphate drug treatment was received in the first 4 weeks of the drug delivery;
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  • There is a CTCAE grade II toxicity caused by previous treatment.
  • Hypertension is not controlled (systolic pressure is greater than 150mmHg, or diastolic pressure is greater than 90 mmHg); or a history of congestive heart failure (American Heart Association heart function grade ≥2 Level).
  • Clinically significant heart disease, including but not limited to: congestive heart failure, symptomatic coronary artery disease, arrhythmia, myocardial infarction, QTc period ≥470ms.
  • Intestinal obstruction or CTCAE 3 or 4 upper digestive tract bleeding in the first 4 weeks before the drug delivery.
  • Inability to swallow, inflammatory bowel disease or uncontrollable nausea, vomiting, diarrhea or other gastrointestinal disorders that seriously affect drug use and absorption.
  • The tumor metastasis of central nervous system was diagnosed by the researchers.
  • A history of severe venous thrombosis or pulmonary embolism.
  • There is a third interstitial fluid (such as large pleural effusion and ascites) that cannot be controlled by drainage or other means.
  • There is still an electrolyte disorder that cannot be corrected when the group is given a drug.
  • In the first 7 days before the group received a strong CYP3A4 inhibitor treatment, or in the first day of the group received a strong effect CYP3A4 Inducer therapy.
  • Active HBV, HCV infection (HBV copy number ≥104 copies/ml, the number of copies of HCV virus ≥103 copies /ml).
  • There is a history of immune deficiency, including HIV testing positive, or other acquired, congenital immunodeficiency disease, or a history of organ transplantation.
  • Pregnancy, breast-feeding female patients.
  • In patients with bone metastases, palliative radiotherapy (radiotherapy area,5% bone marrow region) was received within 4 weeks before the group's entry.
  • According to the researchers ' judgment, there are serious, uncontrollable risks to patients ' safety, or associated diseases (such as severe diabetes, thyroid disease, infection, spinal cord compression, superior vena cava syndrome, neurological or psychiatric disorders) that affect the patient's completion of the study.

Trial locations and contacts

1 site in 1 country.

Haitao Wang, Ph.D contact

+86-022-88326385

peterrock2000@126.com

China1 site

  • Tianjin Medical Unversity Second Hospital

    Tianjin, Tianjin Municipality, 300200

Other trials in China

About this study

Official title: Fluzoparib Combined With Apatinib for the Treatment of Carrying TP53 Harmful Mutations in Advanced Refractory Solid Tumors of the I Stage Clinical Study

Assessment of the safety and tolerability of Fluzoparib combined with Apatinib in the treatment of advanced refractory solid tumors with TP53 harmful mutations.

Read the detailed description

Results of the clinical trial of the combination of Fluzoparib and Apatinib in the treatment of gastric cancer animal model and the drug PARP inhibitor alone, PARP inhibitor combined with VEGFR inhibitor, Patients with advanced refractory solid tumors with TP53 harmful mutations can be expected to be safe and effective in the treatment of Fluzoparib and Apatinib.

Conditions
Advanced Cancer
Being tested
Fluzoparib combined with Apatinib
Keywords
TP53, Solid tumor, Fluzoparib, Apatinib

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Fluzoparib combined with ApatinibDrug

    Also called Apatinib mesylate tablets

    Fluzoparib :

    40mg.bid, morning and evening each time, interval of 12 hours or so, the first oral administration 72 hours later

    Apatinib :

    250mg or 500mg take one day, 72 hours later, the continuous drug delivery phase (B-C1D1) was entered into the Fluzoparib, that is, the Fluzoparib capsule with 40mg.bid, every morning and evening, each time, interval of 12 hours, the Apatinib tablets daily with the Fluzoparib capsule with the same service, fixed doses of 250mg or 500mg, daily. Continuous drug delivery for 28 days for one cycle

Study groups in NCT03645200
Study groupRoleWhat they receive
Fluzoparib combined with ApatinibExperimentalFluzoparib in the initial dose of 40mg.bid started into the group of participants, group A combined with a fixed dose of Apatinib 250mg.qd for treatment, followed by the 40mg.bid, 60mg.bid, 80mg.bid, 100mg.bid dose increase. Fluzoparib in the initial dose of 40mg.bid started into the group of participants, Group B was treated with a fixed dose of Apatinib 500mg.qd, followed by an increase in doses of 40mg.bid, 60mg.bid, 80mg.bid, 100mg.bid .
Receives: Drug: Fluzoparib combined with Apatinib

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Dosage (provide right dosage for II phase clinical trial)

    provide right dosage for II phase clinical trial

    Measured: 12 months

Secondary outcomes (2)

  1. ORR: objective response rate

    objective response rate

    Measured: 12 months

  2. DCR: disease control rate

    disease control rate

    Measured: 12 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted24 Aug 2018
  2. Study start1 Jul 2019 (estimated)
  3. Primary completion1 Dec 2019 (estimated)
  4. Study completion1 Jun 2020 (estimated)

Resources

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 1
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
60 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03645200
Sponsor's protocol ID
TP53MuToma
Status last verified
Aug 2018
First submitted
22 Aug 2018
Last updated
25 Apr 2019
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing Fluzoparib combined with Apatinib in people with Advanced Cancer, run by Tianjin Medical University Second 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 12 inclusion and 21 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 25 Apr 2019. 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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

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?

Contact Haitao Wang, Ph.D (+86-022-88326385, peterrock2000@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Dosage (provide right dosage for II phase clinical trial) (time frame: 12 months). 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 NCT03645200.

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 25 Apr 2019.

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