Gastric CancerPhase 2NCT03817411
Telatinib in Combination With Capecitabine/ Oxaliplatin in 1st Line Gastric or GEJ Cancer
A Phase 2 study testing Telatinib, Capecitabine and Oxaliplatin in people with Gastric Cancer, run by Taizhou EOC Pharma Co., Ltd. at 1 site in China.
Trial summary
The purpose of the trial is to compare the combination regimen of Telatinib and Capecitabine and Oxaliplatin vs. Capecitabine and Oxaplatin to explore superiority of the Telatinib combination in terms of progression-free survival (PFS) in patients previously untreated for advanced HER2 negative advanced gastric or… Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Gastric Cancer
- What is being tested?
- Telatinib, Capecitabine and Oxaliplatin
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 90 participants
- Where
- 1 siteChina
- Study dates
- 25 Jan 2019to 25 Jan 2021
- Phase
- Phase 2
- 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 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male or female at least 18 and <75 years old at the time of screening.
- Histologically or cytologically confirmed unresectable locally advanced or metastatic HER2 negative (or HER2 status unknown), gastric or gastro-oesophageal junction adenocarcinoma.
- Measurable or evaluable lesion as defined by RECIST v1.1.
- No prior treatment for advanced disease. Adjuvant or neoadjuvant chemotherapy must be stopped at least for 6 months.
- Prior surgery and/or radiotherapy stopped for at least 4 weeks.
- ECOG Performance Status 0-1.
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- Life expectancy of at least 3 months.
- Adequate bone marrow function as evidenced by meeting all of the following requirements:
- Absolute neutrophil count > 1.5 × 10 E+9/L without the use of hematopoietic growth factors
- Platelet count > 90 ×10 E+9/L without the need for transfusion in the 2 weeks prior the first dose
- Hemoglobin >90 g/L without the need for transfusion in the 2 weeks prior the first dose
- Adequate hepatic function as evidenced by meeting all of the following requirements:
- Serum total bilirubin ≤1.5 x upper limit of normal (ULN) (biliary drainage is allowed for biliary obstruction)
- Serum albumin levels ≥3.0 g/dL
- Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) and and alkaline phosphatase (ALP): ≤3.0 x upper limit of normal (ULN) (≤5 x ULN if liver metastases are present and if liver and/or bone metastases ALP ≤ 5 × ULN.)
- Adequate renal function as evidenced by
- serum creatinine ≤1.5 x ULN and creatinine clearance of ≥50 mL/min (Cockcroft-Gault formula).
- Urine dipstick for proteinuria of less than 2+ (other ways of urinalysis are also acceptable); if urine dipstick is ≥ 2+, proteinuria must be < 2 g in 24 hours.
- Prothrombin time (PT) or activated partial thromboplastin time (APTT) and International Normalized Ratio (INR) ≤1.5 x ULN.
- Recovered from the effects of any prior surgery, radiotherapy or other anti-neoplastic adjuvant therapy. Unresolved toxicity > Grade 1 (except alopecia) from previous anticancer therapy (including radiotherapy) is accepted
- If female of childbearing potential, the patient must present with a negative urine pregnancy test and agrees to employ adequate birth control measures for at least 90 days after the duration of the study
- Male who are not sterile agrees to take effective contraception for at least 90 days after the last dose of drug and avoid donating sperm at the same time period.
- Ability to swallow pills and no major intestinal surgery.
- Able to understand and sign an informed consent
Who cannot join
- Hypertension and unable to be controlled within normal level following treatment of anti-hypertension agents (systolic blood pressure > 150 mmHg, diastolic blood pressure > 100 mmHg).
- Active and uncontrolled central nervous system (CNS) metastases .
- During the screening and study period, standard dose of anticoagulant or thrombolytic drugs are used for treatment;
- History of any second malignancy in the last 5 years; patients with prior history of in-situ cancer or basal or squamous cell skin cancer are eligible. Patients with other malignancies are eligible if they have been continuously disease free for at least 5 years.
- Evidence of tumor invasion of major blood vessels by images(including complete proximity, surrounding or extending into the main vascular lumen, such as the pulmonary artery or the superior vena cava), and the investigator judged that it was not suitable for enrollment.
- A significant thrombotic or hemorrhagic event ≤ 6 months prior to Screening (includes hemoptysis, gastrointestinal bleeding, hematemesis, CNS hemorrhage, severe epistaxis or vaginal bleeding, cerebral infarction, transient ischemic attacks, myocardial infarction, angina, and uncontrolled coronary artery disease).
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- History of active gastroduodenal ulcer, abdominal fistula as well as nongastrointestinal fistula, gastrointestinal perforation or intraabdominal abscess within 6 months prior to screening.
- Significant cardiac conduction abnormalities, including a history of long QTc syndrome and/or pacemaker.New York Heart Association Class III or IV congestive heart failure, ventricular arrhythmias
- Exposure to any other investigational or commercial anticancer agents or therapies (Chinese herbal medicines e.g) administered with the intention to treat malignancy within 28 days.
- Active infection or an unexplained fever during screening visits or on the first scheduled day of dosing (at the discretion of the Investigator, patients with tumor fever may be enrolled), which in the investigator's opinion might compromise the patient's participation in the trial or affect the trial outcome.
- Positive test or known history of for human immunodeficiency virus (HIV), active hepatitis B (HBsAg) or hepatitis C (anti-HCV antibody) or syphilis (syphilis antibody)
- If female, the patient is pregnant or lactating at the time of enrollment.
- Known hypersensitivity to any of the components of fluoropyrimidines or platinum cmpounds.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Shanghai Easter Hospital
Shanghai
Jin Li, M.D., 021-20334612
About this study
Official title: A Phase II Randomized Trial of Telatinib in Combination With Capecitabine/Oxaliplatin Versus Capecitabine/Oxaliplatin as First-Line Therapy in Patients With HER2-negative Advanced Adenocarcinoma of the Stomach or Gastroesophageal Junction
The purpose of the trial is to compare the combination regimen of Telatinib and Capecitabine and Oxaliplatin vs. Capecitabine and Oxaplatin to explore superiority of the Telatinib combination in terms of progression-free survival (PFS) in patients previously untreated for advanced HER2 negative advanced gastric or Gastroesophageal Junction adenocarcinoma.
Read the detailed description
This trial is a Phase 2, prospective, double-blind, randomized, comparative, multicenter trial in patients with advanced HER2 negative adenocarcinoma of the stomach or Gastroesophageal Junction which has progressed after resection and adjuvant or neoadjuvant therapy, or is unresectable or metastatic at time of first diagnosis. a total of approximately 90 patients will be enrolled and randomized into Telatinib combined with Capecitabine and Oxaliplatin or chemotherapy combined with placebo. All patients will be treated until progressive disease (radiologically documented or symptomatic deterioration) or the occurrence of unacceptable toxicity, withdrawal of consent or investigator's judgment.
- Conditions
- Gastric Cancer
- Being tested
- Telatinib, Capecitabine, Oxaliplatin, Placebos
- Medical subject headings
- Stomach Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TelatinibDrug
Also called EOC315
300 mg tablets, 900 mg twice daily (BID) at 12h-intervals.
CapecitabineDrug
1000 mg/m²,twice daily for 14 days followed by a 7-day rest period (14 days on/7 days off schedule).
OxaliplatinDrug
130 mg/m2, administered intravenously over 2 hours, on Day 1 every 3 weeks (one administration per cycle) for a maximum of 6 cycles.
PlacebosDrug
300 mg tablets, 900 mg twice daily (BID) at 12h-intervals.
| Study group | Role | What they receive |
|---|---|---|
| Telatinib+Capecitabine+Oxaliplatin | Active comparator | Patients receive Telatinib orally (PO) twice daily (bid) on days 1-21 and Capecitabine PO on days 1-14, then stopped for 7 days, and Oxaliplatin by intravenous injection on day 1 of every cycle. Courses repeat every 21 days. Receives: Drug: Telatinib; Drug: Capecitabine; Drug: Oxaliplatin |
| Placebos+Capecitabine+Oxaliplatin | Placebo comparator | Patients receive placebo orally (PO) twice daily (bid) on days 1-21 and Capecitabine PO on days 1-14, then stopped for 7 days, and Oxaliplatin by intravenous injection on day 1 of every cycle. Courses repeat every 21 days. Receives: Drug: Capecitabine; Drug: Oxaliplatin; Drug: Placebos |
What is being measured
The primary outcome is the main question the study is designed to answer.
ORR
the proportion of patients with complete response (CR) or partial response (PR) among all patients assessed per RESIST v1.1.
Measured: 24 months
Secondary outcomes (3)
PFS
Progression free survival of All the Evaluable Participants.Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as at least a 20% increase in the sum of diameters of target lesions, in addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. (Note: the appearance of one or more new lesions is also considered progression).
Measured: 24 months
CBR
Clinical Benefit Rate, defined as CR+PR+SD≥ 24 weeks
Measured: 24 months
DCR
the proportion of patients who had a best response rating of complete response, partial response, or stable disease
Measured: 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jan 2019
- Study start25 Jan 2019
- Primary completion30 Mar 2020 (estimated)
- Study completion25 Jan 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Gastric CancerStudies 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 90 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Taizhou EOC Pharma Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Shanghai East Hospital, Shanghai Zhongshan Hospital
- Responsible party
- Sponsor
- Investigators
- Jin Li, M.D., Study chair, Shanghai Easter Hospital, Dpt. of Clinical OncologyTian Shu Liu, M.D., Study chair, Shanghai Fudan Zhongshan Hospital, Dpt. of Clinical Oncology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03817411
- Sponsor's protocol ID
- EOC315B2101
- Status last verified
- Jan 2019
- First submitted
- 24 Jan 2019
- Last updated
- 7 May 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 7 May 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase II Randomized Trial of Telatinib in Combination With Capecitabine/Oxaliplatin Versus Capecitabine/Oxaliplatin as First-Line Therapy in Patients With HER2-negative Advanced Adenocarcinoma of the Stomach or Gastroesophageal Junction
- ClinicalTrials.gov ID
- NCT03817411
- Acronym / sponsor ID
- EOC315B2101
- Conditions
- Gastric Cancer
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 90 participants (estimated)
- Lead sponsor
- Taizhou EOC Pharma Co., Ltd.Industry (pharma, biotech, devices)
- Collaborators
- Shanghai East Hospital, Shanghai Zhongshan Hospital
- Study start
- 25 Jan 2019 (actual)
- Primary completion
- 30 Mar 2020 (estimated)
- Study completion
- 25 Jan 2021 (estimated)
- First posted
- 25 Jan 2019 (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 the trial is to compare the combination regimen of Telatinib and Capecitabine and Oxaliplatin vs. Capecitabine and Oxaplatin to explore superiority of the Telatinib combination in terms of progression-free survival (PFS) in patients previously untreated for advanced HER2 negative advanced gastric or Gastroesophageal Junction adenocarcinoma.
Detailed description
This trial is a Phase 2, prospective, double-blind, randomized, comparative, multicenter trial in patients with advanced HER2 negative adenocarcinoma of the stomach or Gastroesophageal Junction which has progressed after resection and adjuvant or neoadjuvant therapy, or is unresectable or metastatic at time of first diagnosis. a total of approximately 90 patients will be enrolled and randomized into Telatinib combined with Capecitabine and Oxaliplatin or chemotherapy combined with placebo. All patients will be treated until progressive disease (radiologically documented or symptomatic deterioration) or the occurrence of unacceptable toxicity, withdrawal of consent or investigator's judgment.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Telatinib+Capecitabine+Oxaliplatin | Active comparator | Drug: Telatinib, Drug: Capecitabine, Drug: OxaliplatinPatients receive Telatinib orally (PO) twice daily (bid) on days 1-21 and Capecitabine PO on days 1-14, then stopped for 7 days, and Oxaliplatin by intravenous injection on day 1 of every cycle. Courses repeat every 21 days. |
| Placebos+Capecitabine+Oxaliplatin | Placebo comparator | Drug: Capecitabine, Drug: Oxaliplatin, Drug: PlacebosPatients receive placebo orally (PO) twice daily (bid) on days 1-21 and Capecitabine PO on days 1-14, then stopped for 7 days, and Oxaliplatin by intravenous injection on day 1 of every cycle. Courses repeat every 21 days. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (24 listed)
- Male or female at least 18 and <75 years old at the time of screening.
- Histologically or cytologically confirmed unresectable locally advanced or metastatic HER2 negative (or HER2 status unknown), gastric or gastro-oesophageal junction adenocarcinoma.
- Measurable or evaluable lesion as defined by RECIST v1.1.
- No prior treatment for advanced disease. Adjuvant or neoadjuvant chemotherapy must be stopped at least for 6 months.
- Prior surgery and/or radiotherapy stopped for at least 4 weeks.
Key exclusion criteria (13 listed)
- Hypertension and unable to be controlled within normal level following treatment of anti-hypertension agents (systolic blood pressure > 150 mmHg, diastolic blood pressure > 100 mmHg).
- Active and uncontrolled central nervous system (CNS) metastases .
- During the screening and study period, standard dose of anticoagulant or thrombolytic drugs are used for treatment;
- History of any second malignancy in the last 5 years; patients with prior history of in-situ cancer or basal or squamous cell skin cancer are eligible. Patients with other malignancies are eligible if they have been continuously disease free for at least 5 years.
- Evidence of tumor invasion of major blood vessels by images(including complete proximity, surrounding or extending into the main vascular lumen, such as the pulmonary artery or the superior vena cava), and the investigator judged that it was not suitable for enrollment.
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 |
|---|---|---|
| TelatinibAlso: EOC315300 mg tablets, 900 mg twice daily (BID) at 12h-intervals. | Drug | Telatinib+Capecitabine+Oxaliplatin |
| Capecitabine1000 mg/m²,twice daily for 14 days followed by a 7-day rest period (14 days on/7 days off schedule). | Drug | Placebos+Capecitabine+Oxaliplatin, Telatinib+Capecitabine+Oxaliplatin |
| Oxaliplatin130 mg/m2, administered intravenously over 2 hours, on Day 1 every 3 weeks (one administration per cycle) for a maximum of 6 cycles. | Drug | Placebos+Capecitabine+Oxaliplatin, Telatinib+Capecitabine+Oxaliplatin |
| Placebos300 mg tablets, 900 mg twice daily (BID) at 12h-intervals. | Drug | Placebos+Capecitabine+Oxaliplatin |
Primary outcome
ORR
Time frame: 24 months
the proportion of patients with complete response (CR) or partial response (PR) among all patients assessed per RESIST v1.1.
3 secondary outcomes
PFS
Time frame: 24 months
CBR
Time frame: 24 months
DCR
Time frame: 24 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 May 2019.
- Individual participant dataSharing planned: Undecided
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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.
Jin Li, M.D. study chair
Shanghai Easter Hospital, Dpt. of Clinical Oncology
Tian Shu Liu, M.D. study chair
Shanghai Fudan Zhongshan Hospital, Dpt. of Clinical Oncology
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Telatinib, Capecitabine and Oxaliplatin in people with Gastric Cancer, 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 24 inclusion and 13 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 7 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. Some participants in this study may receive a placebo. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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 Peng Wang, M.S. (18606193900, peng.wang@eocpharma.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
ORR (time frame: 24 months). 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 7 May 2019.