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| Name | Class |
|---|---|
| Shanghai East Hospital | OTHER |
| Shanghai Zhongshan Hospital | OTHER |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Telatinib | Drug | 300 mg tablets, 900 mg twice daily (BID) at 12h-intervals. |
|
| Measure | Description | Time Frame |
|---|---|---|
| ORR | the proportion of patients with complete response (CR) or partial response (PR) among all patients assessed per RESIST v1.1. | 24 months |
| Measure | Description | Time Frame |
|---|---|---|
| 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). |
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Inclusion Criteria:
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.
Life expectancy of at least 3 months.
Adequate bone marrow function as evidenced by meeting all of the following requirements:
Adequate hepatic function as evidenced by meeting all of the following requirements:
Adequate renal function as evidenced by
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
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Peng Wang, M.S. | Contact | 18606193900 | peng.wang@eocpharma.com | |
| Jie Li, M.S. | Contact | 18951813306 | jie.li@eocpharma.com |
| Name | Affiliation | Role |
|---|---|---|
| Jin Li, M.D. | Shanghai Easter Hospital, Dpt. of Clinical Oncology | Study Chair |
| Tian Shu Liu, M.D. | Shanghai Fudan Zhongshan Hospital, Dpt. of Clinical Oncology | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Shanghai Easter Hospital | Recruiting | Shanghai | China |
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| ID | Term |
|---|---|
| D013274 | Stomach Neoplasms |
| ID | Term |
|---|---|
| D005770 | Gastrointestinal Neoplasms |
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
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| ID | Term |
|---|---|
| C533371 | telatinib |
| D000069287 | Capecitabine |
| D000077150 | Oxaliplatin |
| ID | Term |
|---|---|
| D003841 | Deoxycytidine |
| D003562 | Cytidine |
| D011741 | Pyrimidine Nucleosides |
| D011743 | Pyrimidines |
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| Capecitabine | Drug | 1000 mg/m²,twice daily for 14 days followed by a 7-day rest period (14 days on/7 days off schedule). |
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| Oxaliplatin | Drug | 130 mg/m2, administered intravenously over 2 hours, on Day 1 every 3 weeks (one administration per cycle) for a maximum of 6 cycles. |
|
| Placebos | Drug | 300 mg tablets, 900 mg twice daily (BID) at 12h-intervals. |
|
| 24 months |
| CBR | Clinical Benefit Rate, defined as CR+PR+SD≥ 24 weeks | 24 months |
| DCR | the proportion of patients who had a best response rating of complete response, partial response, or stable disease | 24 months |
| D004066 |
| Digestive System Diseases |
| D005767 | Gastrointestinal Diseases |
| D013272 | Stomach Diseases |
| D006573 |
| Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D005472 | Fluorouracil |
| D014498 | Uracil |
| D011744 | Pyrimidinones |
| D003853 | Deoxyribonucleosides |
| D009705 | Nucleosides |
| D009706 | Nucleic Acids, Nucleotides, and Nucleosides |
| D056831 | Coordination Complexes |
| D009930 | Organic Chemicals |