Solid Tumor, AdultPhase 1NCT03175497
Telatinib Safety and Pharmacokinetics Study in China Patients With Advanced Solid Tumors
A Phase 1 study testing Telatinib Mesylate in people with Solid Tumor, Adult, run by Taizhou EOC Pharma Co., Ltd. at 1 site in China.
Trial summary
The purpose of this China Phase I bridging study is to to evaluate the safety, tolerability and pharmacokinetic profile of telatinib in China patients with advanced solid tumor Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Solid Tumor, Adult
- What is being tested?
- Telatinib Mesylate
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15 participants
- Where
- 1 siteChina
- Study dates
- 25 Jul 2017to 15 Aug 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
- For inclusion in the study patients should fulfil the following criteria:
- Provision of informed consent prior to any study specific procedures.
- ≥ 18 and ≤ 70 years of age
- For the 1st phase: histological or cytological confirmed solid malignant tumors in advanced stage, standard regimen failed or intolerable, or no standard regimen available For the 2nd phase: histological or cytological confirmed gastric cancer in advanced stage.
- ECOG performance status of 0-1
- Life expectancy of more than 12 weeks
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- Patients must have adequate organ and bone marrow function as defined by the following laboratory results.
- Neutrophil > 1.5 × 10^9/L
- Platelets >100 × 10^9/L
- Alkaline phosphatase ≤2 times the upper limit of normal (ULN)
- Prothrombin time (PT), international normalized ratio (INR), and partial thromboplastin time (APPT) < 1.5 times ULN
- Hemoglobin ≥ 9 g/dL.
- Creatinine ≤ 1.5 times the upper limit of normal (ULN) for the institution or Creatinine clearance ≥ 60 ml/min
- Total bilirubin ≤ 1.5 times ULN
- Aspartate transaminases (AST/SGOT) or alanine transaminase (ALT/SGPT) ≤ 2.5 times ULN. In HCC patients, those two values should be < 5 times ULN
- Urine protein <2+; if urine protein ≥ 2+, 24-hour urine protein quantity must ≤ 1g
- Patients must be able to swallow tablets, not spit out the drug, and without malabsorption
- Patients must NOT suffer from medical or psychiatric conditions that would interfere with protocol compliance, the ability to provide informed consent, or assessment of response or anticipated toxicities.
Who cannot join
- Patients should NOT enter the study if any of the following exclusion criteria are fulfilled:
- Patients have known central nervous system metastasis except patients who have terminated steroid treatment for brain metastasis or spinal cord compression with remain disease stable for at least 1 month. (a MRI is not required to rule out brain metastases unless there is clinical suspicion)
- Patients with diagnosed lymphoma
- Patients receiving the following therapy or treatment prior to enrollment:
- Mitomycin C or nitroso urea within ≤ 6 weeks immediately prior to C1D1; anticancer drugs, chemotherapy, radiation or immunotherapy within ≤ 4 weeks immediately prior to C1D1, or have not recovered from the prior anticancer therapy that was received 4 weeks ago (Anticancer drug therapy is defined as any drug or drug combination that have demonstrated anticancer activities, and the purpose of application is to directly or indirectly influence cancer. Patients who have ever received the following therapies can be enrolled: adjuvant chemotherapy, chemotherapy, immunotherapy or steroid therapy for metastatic diseases)
- Autologous bone marrow transplantation or stem cell therapy within ≤ 4 weeks immediately prior to C1D1
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- Biological regulators, such as granulocyte colony stimulating factors (G-CSF)
- Patients who need to take anticoagulant medications throughout the study (such as heparin, warfarin, clopidogrel and aspirin)
- Patients who have a history of heart disease: NYHA III or IV grade of congestive heart failure, coronary artery disease; or have been hospitalized due to heart failure, atrial fibrillation, or atrial flutter within ≤ 3 months immediately prior to C1D1
- Patients who suffer from ≥ grade 2 myocardial ischemia and myocardial infarction; poorly controlled cardiac arrhythmia, including QTc : men ≥ 450 ms, women ≥ 470 ms (patients are only allowed to receive beta blockers or dioxin)
- Patients who suffer from hypertension (systolic blood pressure > 140 mmHg or diastolic pressure is 90 mmHg) that cannot be controlled by receiving ≤ two types of antihypertensive drugs
- Patients who have a medical history of HIV infection, active hepatitis B or hepatitis C infection.
- Patients who suffer from severe unhealed damage, bleeding, ulcer and fracture
- Patients who have evidence of severe or poorly controlled systemic disease (e.g., severe liver damage, severe kidney damage, poorly controlled diabetes and acute infection), or unstable current diseases, or decompensated respiratory or cardiac disease (baseline LVEF < 55%), or peripheral vascular disease (including diabetic vascular disease);
- Patients who have gone major surgery ≤ 4 weeks immediately prior to C1D1, including but not limited to hip or knee replacement, or spinal cord injury
- Patients who have a medical history of venous thromboembolism
- Patients who suffer from seizure that needs to be controlled by drug
- Patients who have the high risk of developing coagulation, and are defined as those who meet any two of the following criteria
- Platelets >300 × 10^9/L
- PT reduction >3s (8.8-13.8s)；
- APPT reduction >3s (24.9-36.8s)
- Fibrinogen (FIB) > 0.5 g/L
- D-dimer > 300 μg/L
- Patients who have a medical history of organ transplantation
- Patients who have ever received telatinib treatment
- Patients who have received any investigational agent within ≤ 4 weeks immediately prior to C1D1 or plan to receive other investigational agent during the course of this study
- Patients who have known or suspected allergies to telatinib mesylate tablet, its recipients, and drugs of the similar class
- Women who are breast-feeding, or have positive results of serum pregnancy test within ≤ 7 days immediately prior to C1D1, or sexually active males and pre/perimenopausal women who do not agree to use an accepted and effective method of contraception or to abstain from sexual intercourse for the duration of their participation in the study and for 3 months after discontinuation of therapy
- Patients who suffer from medical or psychiatric conditions that would interfere with protocol compliance, the ability to provide informed consent, or assessment of response or anticipated toxicities.
- Patients are not suitable for the enrollment based on the judgment of Investigators
- People who are involved in the planning and conduct of the study (applies to both Eddingpharm. LTD staff and staff at the investigational site).
- Patients with advanced GI tumor in the 1st phase and all patients in the 2nd phase should be excluded from enrollment if any of the following criteria is met:
- Patients who ever suffer from active gastrointestinal bleeding or occult blood (++) within ≤ 4 weeks immediately prior to C1D1
- Patients who suffer from occult blood (+) and the enteroscopy results assessed by Investigator with the potential of causing gastrointestinal bleeding
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Phase I Study to Evaluate Safety, Tolerability and Pharmacokinetics of Telatinib, a Selective Inhibitor of the Vascular Endothelial Growth Factor (VEGF) Receptor, in Adult Chinese Patients With Advanced Solid Tumors
The purpose of this China Phase I bridging study is to to evaluate the safety, tolerability and pharmacokinetic profile of telatinib in China patients with advanced solid tumor
Read the detailed description
This is an open-label, nonrandomized, phase I, escalating dose study to evaluate the safety, tolerability and pharmacokinetic profile of telatinib. .
This study is comprised of two stages. The 1st stage follows the traditional 3+3 dose-escalation design. Telatinib mesylate tablets will be administrated orally to patient twice daily at a starting dose of 600 mg bid. Patients will be successively enrolled into three cohorts from low-dose to high-dose (600 mg bid, 900 mg bid, and 1200 mg bid). For each cohort, patient will be first enrolled for single-dose PK and safety observation. After one-day interval, patient will then be resumed for a 21-day continuous treatment to assess safety, tolerability and PK profile with multiple dosing.
The dose-limiting toxicity (DLT) observation period will be 23 days, starting from the first day of single dosing till the end of the 21-day continuous treatment.
If first 3 subjects at a dose level complete a cohort without experiencing any DLT, subjects for the next higher cohort will be recruited. If 1 of the first 3 subjects experiences DLT, then up to three additional subjects (total up to six subjects) will enrolled at that dose level. If more than 2 patients at a dose level experienced DLT, dose escalation will be halted. And the dose level will be declared the toxic dose. The MTD is defined as the previous (lower dose) dose level.
If MTD is not observed even at 1200 mg bid, dose-escalation will not be continued.
- Conditions
- Solid Tumor, Adult
- Being tested
- Telatinib Mesylate
- Keywords
- Gastric Cancer, VEGFR inhibitor
- Medical subject headings
- Stomach Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Telatinib MesylateDrug
Also called BAY 57-9352, TEL0805, EOC315
Telatinib mesylate tablets will be administrated twice a day orally
| Study group | Role | What they receive |
|---|---|---|
| Telatinib mesylate treatment arm | Experimental | Open label, single arm trial. For the 1st phase: three cohorts, and each with 3-6 solid tumor patients who will be treated with telatinib at predetermined dose: 600 mg bid, 900 mg bid, or 1200 mg bid, respectively.
For the 2nd phase, one cohort with 12 GC patients who will be treated with telatinib at 900 mg bid Receives: Drug: Telatinib Mesylate |
What is being measured
The primary outcome is the main question the study is designed to answer.
Dose-limiting toxicity, incidence of treatment-emergent adverse events
Other safety and tolerability parameters including 12-lead ECG, vital signs, blood pressure/pulse, temperature, physical examination, laboratory parameters (hematology, blood biochemistry, coagulant examination, thyroid function test and urine test), and ECOG score.
Measured: single dose, and twice daily continuous dosing for 21 days
Secondary outcomes (2)
Cmax
Peak Plasma Concentration
Measured: single dose, and twice daily continuous dosing for 21 days
AUC
Area under the plasma concentration versus time curve
Measured: single dose, and twice daily continuous dosing for 21 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jun 2017
- Study start25 Jul 2017
- Primary completion15 Aug 2018
- Study completion15 Aug 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Solid Tumor, AdultStudies 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 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- This study is comprised of two stages. The 1st stage will follow the traditional 3+3 dose-escalation design in patients with advanced solid tumor The 2nd phase will be conduced in Gastric cancer patients, primarily for PK data collection
- Masking
- None (open label)
- Enrolment
- 15 participants (actual)
Sponsor and investigators
- Lead sponsor
- Taizhou EOC Pharma Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Fountain Medical Development Co., Ltd.
- Responsible party
- Sponsor
- Investigators
- Tianshu Liu, MD, Principal investigator, Fudan University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03175497
- Sponsor's protocol ID
- EOC315001
- Status last verified
- May 2019
- First submitted
- 25 May 2017
- Last updated
- 13 May 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 May 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I Study to Evaluate Safety, Tolerability and Pharmacokinetics of Telatinib, a Selective Inhibitor of the Vascular Endothelial Growth Factor (VEGF) Receptor, in Adult Chinese Patients With Advanced Solid Tumors
- ClinicalTrials.gov ID
- NCT03175497
- Acronym / sponsor ID
- EOC315001
- Conditions
- Solid Tumor, Adult
- Keywords
- Gastric Cancer, VEGFR inhibitor
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 15 participants (actual)
- Lead sponsor
- Taizhou EOC Pharma Co., Ltd.Industry (pharma, biotech, devices)
- Collaborators
- Fountain Medical Development Co., Ltd.
- Study start
- 25 Jul 2017 (actual)
- Primary completion
- 15 Aug 2018 (actual)
- Study completion
- 15 Aug 2018 (actual)
- First posted
- 5 Jun 2017 (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.
The purpose of this China Phase I bridging study is to to evaluate the safety, tolerability and pharmacokinetic profile of telatinib in China patients with advanced solid tumor
Detailed description
This is an open-label, nonrandomized, phase I, escalating dose study to evaluate the safety, tolerability and pharmacokinetic profile of telatinib. .
This study is comprised of two stages. The 1st stage follows the traditional 3+3 dose-escalation design. Telatinib mesylate tablets will be administrated orally to patient twice daily at a starting dose of 600 mg bid. Patients will be successively enrolled into three cohorts from low-dose to high-dose (600 mg bid, 900 mg bid, and 1200 mg bid). For each cohort, patient will be first enrolled for single-dose PK and safety observation. After one-day interval, patient will then be resumed for a 21-day continuous treatment to assess safety, tolerability and PK profile with multiple dosing.
The dose-limiting toxicity (DLT) observation period will be 23 days, starting from the first day of single dosing till the end of the 21-day continuous treatment.
If first 3 subjects at a dose level complete a cohort without experiencing any DLT, subjects for the next higher cohort will be recruited. If 1 of the first 3 subjects experiences DLT, then up to three additional subjects (total up to six subjects) will enrolled at that dose level. If more than 2 patients at a dose level experienced DLT, dose escalation will be halted. And the dose level will be declared the toxic dose. The MTD is defined as the previous (lower dose) dose level.
If MTD is not observed even at 1200 mg bid, dose-escalation will not be continued.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- This study is comprised of two stages. The 1st stage will follow the traditional 3+3 dose-escalation design in patients with advanced solid tumor The 2nd phase will be conduced in Gastric cancer patients, primarily for PK data collection
| Arm | Type | Receives |
|---|---|---|
| Telatinib mesylate treatment arm | Experimental | Drug: Telatinib MesylateOpen label, single arm trial. For the 1st phase: three cohorts, and each with 3-6 solid tumor patients who will be treated with telatinib at predetermined dose: 600 mg bid, 900 mg bid, or 1200 mg bid, respectively. For the 2nd phase, one cohort with 12 GC patients who will be treated with telatinib at 900 mg bid |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (18 listed)
- Provision of informed consent prior to any study specific procedures.
- ≥ 18 and ≤ 70 years of age
- For the 1st phase: histological or cytological confirmed solid malignant tumors in advanced stage, standard regimen failed or intolerable, or no standard regimen available For the 2nd phase: histological or cytological confirmed gastric cancer in advanced stage.
- ECOG performance status of 0-1
- Life expectancy of more than 12 weeks
Key exclusion criteria (34 listed)
- Patients should NOT enter the study if any of the following exclusion criteria are fulfilled:
- Patients have known central nervous system metastasis except patients who have terminated steroid treatment for brain metastasis or spinal cord compression with remain disease stable for at least 1 month. (a MRI is not required to rule out brain metastases unless there is clinical suspicion)
- Patients with diagnosed lymphoma
- Patients receiving the following therapy or treatment prior to enrollment:
- Patients who need to take anticoagulant medications throughout the study (such as heparin, warfarin, clopidogrel and aspirin)
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 |
|---|---|---|
| Telatinib MesylateAlso: BAY 57-9352, TEL0805, EOC315Telatinib mesylate tablets will be administrated twice a day orally | Drug | Telatinib mesylate treatment arm |
Primary outcome
Dose-limiting toxicity, incidence of treatment-emergent adverse events
Time frame: single dose, and twice daily continuous dosing for 21 days
Other safety and tolerability parameters including 12-lead ECG, vital signs, blood pressure/pulse, temperature, physical examination, laboratory parameters (hematology, blood biochemistry, coagulant examination, thyroid function test and urine test), and ECOG score.
2 secondary outcomes
Cmax
Time frame: single dose, and twice daily continuous dosing for 21 days
AUC
Time frame: single dose, and twice daily continuous dosing for 21 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 May 2019.
- 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.
Tianshu Liu, MD principal investigator
Fudan University
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 Telatinib Mesylate in people with Solid Tumor, Adult, run by Taizhou EOC Pharma 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 18 inclusion and 34 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: finished, as of the sponsor's last update on 13 May 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Dose-limiting toxicity, incidence of treatment-emergent adverse events (time frame: single dose, and twice daily continuous dosing for 21 days). 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 13 May 2019.