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Advanced CancerPhase 1NCT02944864

A Phase I Study of TQ-B3395 on Tolerance and Pharmacokinetics

A Phase 1 study testing TQ-B3395 in people with Advanced Cancer, run by Chia Tai Tianqing Pharmaceutical Group Co., Ltd. at 1 site in China.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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Trial summary

To study the pharmacokinetic characteristics of TQ-B3395 in the human body, recommend a reasonable regimen for subsequent research. 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?
TQ-B3395
Could I receive a placebo?
No, everyone receives an active treatment
How many people
53 participants
Where
1 siteChina
Study dates
13 Sep 2017to 15 Sep 2022
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

  • Histological documentation of Advanced solid tumors,lack of the standard treatment or treatment failure.In expanding stage,enroll the Non-small Cell Lung Cancer with EGFR+(except exon 20)
  • 18-70 years,ECOG PS:0-1,Life expectancy of more than 3 months
  • 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 participate in the study voluntarily and sign informed consent

Who cannot join

  • 14 Days or more from the last cytotoxic therapy
  • Patients participated in other anticancer drug clinical trials within 4 weeks or Patients participating in other clinical trials now
  • Blood pressure unable to be controlled ideally by one drug(systolic pressure≥140 mmHg，diastolic pressure≥90 mmHg); Patients with Grade 1 or higher myocardial ischemia, myocardial infarction or malignant arrhythmias(including QTc≥470ms) and patients with Grade 3 or higher congestive heart failure (NYHA Classification)
  • Patients with non-healing wounds or fractures
  • Patients with drug abuse history and unable to get rid of or Patients with mental disorders
  • History of immunodeficiency
  • Patients with concomitant diseases which could seriously endanger their own safety or could affect completion of the study according to investigators' judgment

Trial locations and contacts

1 site in 1 country.

China1 site

  • Cancer Institute and Hospital, Chinese Academy of Medical Sciences

    Beijing, Beijing Municipality, 100021

Other trials in China

About this study

Official title: Phase I Study of Tolerance and Pharmacokinetics of TQ-B3395 in Patients With Advanced Cancer

To study the pharmacokinetic characteristics of TQ-B3395 in the human body, recommend a reasonable regimen for subsequent research.

Conditions
Advanced Cancer
Being tested
TQ-B3395

What participants receive

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

  • TQ-B3395Drug

    TQ-B3395 p.o. qd

Study groups in NCT02944864
Study groupRoleWhat they receive
TQ-B3395ExperimentalTQ-B3395 QD po and it should be continued until disease progression or intolerable toxicity or patients withdrawal of consent
Receives: Drug: TQ-B3395

What is being measured

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

  1. The maximum tolerated dose (MTD) of TQ-B3395

    The highest dose at which no more than 33% of the subjects experience a dose-limiting toxicity (DLT) during treatment

    Measured: 48 weeks

  2. The type of dose-limiting toxicity(ies) (DLT[s]) of TQ-B3395

    Subjects within 28 days after treatment appear the following toxicity reaction relate to the drug ：II °or above of kidney damage，III °or above of non-hematological toxicity,IV°hematological toxicity ,Neutropenia associated with fever

    Measured: For 4 weeks for DLTs.

  3. Pharmacokinetics of TQ-B3395 (in whole blood):Peak Plasma Concentration(Cmax)

    Peak Plasma Concentration(Cmax),Cmax in ng/mL.In the study of single-dose, full PK profiles will be obtained at H0/H1/H2/H3/H4/H8/H11/H24/H34/H48/H58/H72（H means Hour）.In the study of multiple-dose,full PK profiles will be obtained at D0/D1/D4/D7/D10/D14/D21（D means Day）.

    Measured: up to 28 Days (endpoint when the two consecutive time points of blood drug concentration <150 DPM/mL)

  4. Pharmacokinetics of TQ-B3395 (in whole blood):Peak time（Tmax）

    Peak time（Tmax）,Tmax in h.In the study of single-dose, full PK profiles will be obtained at H0/H1/H2/H3/H4/H8/H11/H24/H34/H48/H58/H72（H means Hour）.In the study of multiple-dose,full PK profiles will be obtained at D0/D1/D4/D7/D10/D14/D21（D means Day）

    Measured: up to 28 Days (endpoint when the two consecutive time points of blood drug concentration <150 DPM/mL)

  5. Pharmacokinetics of TQ-B3395 (in whole blood):Half life（t1/2）

    Half life（t1/2）,t1/2 in h.In the study of single-dose, full PK profiles will be obtained at H0/H1/H2/H3/H4/H8/H11/H24/H34/H48/H58/H72（H means Hour）.In the study of multiple-dose,full PK profiles will be obtained at D0/D1/D4/D7/D10/D14/D21（D means Day）

    Measured: up to 28 Days (endpoint when the two consecutive time points of blood drug concentration <150 DPM/mL)

  6. Pharmacokinetics of TQ-B3395 (in whole blood):Area under the plasma concentration versus time curve (AUC)

    Area under the plasma concentration versus time curve (AUC), AUC in ng.h/mL.In the study of single-dose, full PK profiles will be obtained at H0/H1/H2/H3/H4/H8/H11/H24/H34/H48/H58/H72（H means Hour）.In the study of multiple-dose,full PK profiles will be obtained at D0/D1/D4/D7/D10/D14/D21（D means Day）

    Measured: up to 28 Days (endpoint when the two consecutive time points of blood drug concentration <150 DPM/mL)

  7. Pharmacokinetics of TQ-B3395 (in whole blood):Clearance（CL）

    Clearance（CL）,CL in L/h.In the study of single-dose, full PK profiles will be obtained at H0/H1/H2/H3/H4/H8/H11/H24/H34/H48/H58/H72（H means Hour）.In the study of multiple-dose,full PK profiles will be obtained at D0/D1/D4/D7/D10/D14/D21（D means Day）

    Measured: up to 28 Days (endpoint when the two consecutive time points of blood drug concentration <150 DPM/mL)

Secondary outcomes (1)

  1. Objective Response Rate (ORR)

    Measured: each 56 days up to intolerance the toxicity or PD (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.

  1. First posted26 Oct 2016 (estimated)
  2. Study start13 Sep 2017
  3. Primary completion23 May 2021
  4. Study completion15 Sep 2022

Why it stopped: Per sponsor request.

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
53 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02944864
Sponsor's protocol ID
TQ-B3395-I-0001
Status last verified
Dec 2016
First submitted
24 Oct 2016
Last updated
23 Sep 2024
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing TQ-B3395 in people with Advanced Cancer, 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 5 inclusion and 7 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: stopped early, as of the sponsor's last update on 23 Sep 2024. 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?

The study was stopped early (reason given: Per sponsor request.). Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

The maximum tolerated dose (MTD) of TQ-B3395 (time frame: 48 weeks). The study lists 7 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 NCT02944864.

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 23 Sep 2024.

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