Telatinib Safety and Pharmacokinetics Study in China Patients With Advanced Solid Tumors

NCT03175497 | Completed Phase 1 FDA Drug

• 1 other identifier: EOC315001
• Study Type: interventional
• Target: 15
• Locations: 1 country
• Sites: 1

Brief 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

Conditions

Solid Tumor, Adult

Keywords

Gastric Cancer, VEGFR inhibitor

Outcome Measures

Primary Outcomes (1)

• 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.

  single dose, and twice daily continuous dosing for 21 days

Secondary Outcomes (2)

• Cmax

  single dose, and twice daily continuous dosing for 21 days

• AUC

  single dose, and twice daily continuous dosing for 21 days

Other Outcomes (1)

• Explore potential predictive and prognostic biomarkers associated with telatinib treatment

  prior to treatment and after 21-day treatment

Study Arms (1)

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

Drug: Telatinib Mesylate

Interventions

Telatinib Mesylate DRUG

Telatinib mesylate tablets will be administrated twice a day orally

Also known as: BAY 57-9352, TEL0805, EOC315

Telatinib mesylate treatment arm

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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
• 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

You may not qualify if:

• 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
• 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

Sponsors & Collaborators

• Taizhou EOC Pharma Co., Ltd.: lead
• Fountain Medical Development Co., Ltd.: collaborator

Study Sites (1)

Fudan University, Zhongshan Hospital

Shanghai, China

Location

MeSH Terms

Conditions

Stomach Neoplasms

Interventions

telatinib

Condition Hierarchy (Ancestors)

Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Stomach Diseases

Study Officials

• Tianshu Liu, MD

  Fudan University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: 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

Study Record Dates

• First Submitted: May 25, 2017
• First Posted: June 5, 2017
• Study Start: July 25, 2017
• Primary Completion: August 15, 2018
• Study Completion: August 15, 2018
• Last Updated: May 13, 2019

Record last verified: 2019-05

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)