TumorPhase 1NCT03453034
Tolerance and Pharmacokinetics of TQ-B3233
A Phase 1 study testing TQ-B3233 in people with Tumor, run by Chia Tai Tianqing Pharmaceutical Group Co., Ltd. at 1 site in China.
Trial summary
Study of Tolerance and Pharmacokinetics of TQ-B3233 Capsule, phase I,single arm. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Tumor
- What is being tested?
- TQ-B3233
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteChina
- Study dates
- 22 Nov 2017to 31 Dec 2018
- 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
- Patients definitely diagnosed by pathology and/or cytology as BRAF mutation advanced malignant melanoma.
- 18-70 years old, ECOG PS:0-1,Life expectancy of more than 3 months;
- Patients treated with chemotherapy agents or surgery before being enrolled into the study need waiting for 4 weeks, 6 weeks will be needed if agents were nitrocarbamide and mitomycin C;
- Main organs function is normal;
- Women of childbearing potential should agree to use and utilize an adequate method of contraception (such as intrauterine device，contraceptive and condom) throughout treatment and for at least 6 months after study is stopped；the result of serum or urine pregnancy test should be negative within 7 days prior to study enrollment，and the patients required to be non-lactating；Man participants should agree to use and utilize an adequate method of contraception throughout treatment and for at least 6 months after study is stopped;
- Patients should be voluntary and sign the informed consent before taking part in the study;
Who cannot join
- Patients with Malignant tumors within 5 years, except for non-melanoma skin cancer and in situ cancer;
- Patients who had previously received specific BRAF inhibitors;
- A variety of factors that affect oral medication (such as inability to swallow, gastrointestinal resection, chronic diarrhea, intestinal obstruction, etc.)
- Patients who participated in other anticancer drug clinical trials within 4 weeks ;
- Blood pressure unable to be controlled ideally by one drug(systolic pressure≥150 mmHg，diastolic pressure≥90 mmHg);
- Patients with Grade 1 or higher myocardial ischemia, myocardial infarction or malignant arrhythmias or cardiac insufficiency (including QTc≥480ms) and patients with Grade 3 or higher congestive heart failure (NYHA Classification);
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- Patients with non-healing wounds or fractures;
- Patients with brain metastasis, spinal cord compression, cancerous meningitis, CT or MRI examination reminds patients with cerebral or soft meningeal diseases in the screening phase;
- Patients with drug abuse history or unable to get rid of drugs or Patients with mental disorders;
- Coagulation function abnormality: haemorrhagic tendencies (e.g. active digestive tract ulcer), or are receiving thrombolytic or anticoagulant therapy;
- Patients with immunodeficiency, including HIV positive or other acquired, congenital immunodeficiency disease, or organ transplant history;
- Patients with thyroid dysfunction;
- Patients with concomitant diseases which could seriously endanger themselves or those who won't complete the study according to investigators;
- Parents with hepatitis b surface antigen positive or HCV;
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Beijing cancer hospital
Beijing, 100142
Jun Guo, doctor, 010-88196317, guoj307@126.com
About this study
Official title: To Study the Pharmacokinetic Characteristics of TQ-B233 in the Human Body, Recommend a Reasonable Regimen for Subsequent Research
Study of Tolerance and Pharmacokinetics of TQ-B3233 Capsule, phase I,single arm.
Read the detailed description
The maximum tolerated dose (MTD) of TQ-B3233 [ Time Frame: 48 weeks ] [ Designated as safety issue: Yes ]The highest dose at which no more than 33% of the subjects experience a dose-limiting toxicity (DLT) during treatment.
Pharmacokinetics of TQ-B3233 (in whole blood):In the study of single-dose, full PK profiles will be obtained at H0/H0.5/H1/H2/H3/H5/H8/H10/H12/H24/H48/H72（H means Hour）.In the study of multiple-dose,full PK profiles will be obtained at D0/D1/D2/D8/D15/D22/D28（D means Day）.
- Conditions
- Tumor
- Being tested
- TQ-B3233
- Keywords
- TQ-B3233, tumor, toleration, pharmacokinetics
- Medical subject headings
- Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TQ-B3233Drug
QD or BID in different stage of this research
| Study group | Role | What they receive |
|---|---|---|
| TQ-B3233 capsule | Experimental | QD or BID; patients are given the doses according to the protocal, and a cycle is 28 days. Receives: Drug: TQ-B3233 |
What is being measured
The primary outcome is the main question the study is designed to answer.
maximum tolerated dose(MTD)
Measured: 28 Days
dose-limiting toxicity(DLT)
Measured: 28 Days
Peak Plasma Concentration(Cmax)
Measured: up to 28 Days
Peak time(Tmax)
Measured: up to 28 Days
Half life(t1/2)
Measured: up to 28 Days
Area under the plasma concentration versus time curve (AUC)
Measured: up to 28 Days
Secondary outcomes (1)
Objective Response Rate (ORR)
Measured: up to 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Mar 2018
- Study start22 Nov 2017
- Primary completion31 Dec 2018 (estimated)
- Study completion31 Dec 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for TumorStudies of the same condition, open and under way.
- More trials run by Chia Tai Tianqing Pharmaceutical Group Co., Ltd.The sponsor's other registered studies.
- 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 1
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Chia Tai Tianqing Pharmaceutical Group Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03453034
- Sponsor's protocol ID
- TQ-B3233-I-01
- Status last verified
- Feb 2018
- First submitted
- 23 Dec 2017
- Last updated
- 5 Mar 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Mar 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- To Study the Pharmacokinetic Characteristics of TQ-B233 in the Human Body, Recommend a Reasonable Regimen for Subsequent Research
- ClinicalTrials.gov ID
- NCT03453034
- Acronym / sponsor ID
- TQ-B3233-I-01
- Conditions
- Tumor
- Keywords
- TQ-B3233, tumor, toleration, pharmacokinetics
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Chia Tai Tianqing Pharmaceutical Group Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 22 Nov 2017 (actual)
- Primary completion
- 31 Dec 2018 (estimated)
- Study completion
- 31 Dec 2018 (estimated)
- First posted
- 5 Mar 2018 (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.
Study of Tolerance and Pharmacokinetics of TQ-B3233 Capsule, phase I,single arm.
Detailed description
The maximum tolerated dose (MTD) of TQ-B3233 [ Time Frame: 48 weeks ] [ Designated as safety issue: Yes ]The highest dose at which no more than 33% of the subjects experience a dose-limiting toxicity (DLT) during treatment.
Pharmacokinetics of TQ-B3233 (in whole blood):In the study of single-dose, full PK profiles will be obtained at H0/H0.5/H1/H2/H3/H5/H8/H10/H12/H24/H48/H72（H means Hour）.In the study of multiple-dose,full PK profiles will be obtained at D0/D1/D2/D8/D15/D22/D28（D means Day）.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| TQ-B3233 capsule | Experimental | Drug: TQ-B3233QD or BID; patients are given the doses according to the protocal, and a cycle is 28 days. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Patients definitely diagnosed by pathology and/or cytology as BRAF mutation advanced malignant melanoma.
- 18-70 years old, ECOG PS:0-1,Life expectancy of more than 3 months;
- Patients treated with chemotherapy agents or surgery before being enrolled into the study need waiting for 4 weeks, 6 weeks will be needed if agents were nitrocarbamide and mitomycin C;
- Main organs function is normal;
- Women of childbearing potential should agree to use and utilize an adequate method of contraception (such as intrauterine device，contraceptive and condom) throughout treatment and for at least 6 months after study is stopped；the result of serum or urine pregnancy test should be negative within 7 days prior to study enrollment，and the patients required to be non-lactating；Man participants should agree to use and utilize an adequate method of contraception throughout treatment and for at least 6 months after study is stopped;
Key exclusion criteria (14 listed)
- Patients with Malignant tumors within 5 years, except for non-melanoma skin cancer and in situ cancer;
- Patients who had previously received specific BRAF inhibitors;
- A variety of factors that affect oral medication (such as inability to swallow, gastrointestinal resection, chronic diarrhea, intestinal obstruction, etc.)
- Patients who participated in other anticancer drug clinical trials within 4 weeks ;
- Blood pressure unable to be controlled ideally by one drug(systolic pressure≥150 mmHg，diastolic pressure≥90 mmHg);
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 |
|---|---|---|
| TQ-B3233QD or BID in different stage of this research | Drug | TQ-B3233 capsule |
Primary outcome
maximum tolerated dose(MTD)
Time frame: 28 Days
dose-limiting toxicity(DLT)
Time frame: 28 Days
Peak Plasma Concentration(Cmax)
Time frame: up to 28 Days
Peak time(Tmax)
Time frame: up to 28 Days
Half life(t1/2)
Time frame: up to 28 Days
Area under the plasma concentration versus time curve (AUC)
Time frame: up to 28 Days
1 secondary outcome
Objective Response Rate (ORR)
Time frame: up to 24 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Mar 2018.
- Individual participant dataSharing planned: No
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing TQ-B3233 in people with Tumor, run by Chia Tai Tianqing Pharmaceutical Group Co., Ltd. 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 6 inclusion and 14 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 5 Mar 2018. 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 Guo Jun, doctor (010-88196317, guoj307@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
maximum tolerated dose(MTD) (time frame: 28 Days). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 5 Mar 2018.