EP0057 in Combination With Olaparib in Relapsed Advanced Gastric Cancer and Small Cell Lung Cancer
NCT ID: NCT05411679
Last Updated: 2023-06-12
Study Results
Results pending
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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Recruitment Status
WITHDRAWN
Clinical Phase
PHASE2
Study Classification
INTERVENTIONAL
Study Start Date
2023-04-30
Study Completion Date
2024-12-31
Brief Summary
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The aim of EP0057 - 202 is to assess the safety and efficacy of EP0057 in combination with Olaparib (a PARP inhibitor) in two cancers where there is a high unmet need: extensive stage small cell lung cancer (SCLC) and ATM-negative gastric cancer (GC).
EP0057-202 is a non-comparative, multi-arm, multi-centre, open label, Phase 2 study to determine the efficacy, safety, and tolerability of EP0057 in combination with olaparib (an approved PARP inhibitor) in defined patient populations with relapsed\* GC and SCLC.
\*(see Eligibility Criteria for definition of "relapse" for each tumour type/population) The treatment cohorts will open sequentially at the Sponsor's discretion and patients may be enrolled into each cohort concurrently.
EP0057 is an investigational nanoparticle-drug conjugate administered intravenously. The rationale for developing EP0057 is to enable selective entry of EP0057 into tumour tissue and as a result create preferential accumulation of EP0057, and therefore of the payload Camptothecin, to translate into maximum tumour cell killing.
EP0057-202 is a non-comparative, multi-arm, multi-centre, open label, Phase 2 study to determine the efficacy, safety, and tolerability of EP0057 in combination with olaparib (an approved PARP inhibitor) in defined patient populations with relapsed\* GC and SCLC.
\*(see Eligibility Criteria for definition of "relapse" for each tumour type/population) The treatment cohorts will open sequentially at the Sponsor's discretion and patients may be enrolled into each cohort concurrently.
EP0057 is an investigational nanoparticle-drug conjugate administered intravenously. The rationale for developing EP0057 is to enable selective entry of EP0057 into tumour tissue and as a result create preferential accumulation of EP0057, and therefore of the payload Camptothecin, to translate into maximum tumour cell killing.
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Detailed Description
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EP0057 - 202 is a Phase 2 multi arm, open label study in defined populations of patients with SCLC and GC.
The Primary objectives of Arm 1 will be to investigate the efficacy, as defined by best Objective Response Rate (ORR) of EP0057 in combination with Olaparib in patients with ataxia-telangiectasia mutated protein (ATM)-negative relapsed, advanced GC.
The Primary objectives of Arm 2 will be to investigate the efficacy, as defined by the best ORR of EP0057 in combination with Olaparib in patients with relapsed extensive stage SCLC.
The secondary objectives of both arms will be to further investigate the efficacy of EP0057 in combination with olaparib in the target patient population of each arm by assessment of the following:
* Progression-free survival (PFS)
* Overall survival (OS)
* Duration of overall response (DoR)
* Disease control rate (DCR)
Secondary objectives of arms 1 and 2 also include exploring the safety and tolerability of EP0057 when combined with olaparib in patients with GC and SCLC.
Exploratory objectives may or may not be performed during the course of the study, but if so, where available at the time of publication, results from these analyses will be reported in the clinical study report (CSR). Exploratory objectives are to:
* Examine the PK characteristics of EP0057 in combination with olaparib
* Investigate the impact of HRD (homologous recombination deficiency) status on primary and secondary endpoints, as analysed by sub-groups of HRD status.
It is estimated that approximately 115 patients will be enrolled into the study. The study will aim to recruit 34 patients across both arms of the study in stage 1. The study will then aim to recruit an additional 81 patients across both arms in the second stage.
The Primary objectives of Arm 1 will be to investigate the efficacy, as defined by best Objective Response Rate (ORR) of EP0057 in combination with Olaparib in patients with ataxia-telangiectasia mutated protein (ATM)-negative relapsed, advanced GC.
The Primary objectives of Arm 2 will be to investigate the efficacy, as defined by the best ORR of EP0057 in combination with Olaparib in patients with relapsed extensive stage SCLC.
The secondary objectives of both arms will be to further investigate the efficacy of EP0057 in combination with olaparib in the target patient population of each arm by assessment of the following:
* Progression-free survival (PFS)
* Overall survival (OS)
* Duration of overall response (DoR)
* Disease control rate (DCR)
Secondary objectives of arms 1 and 2 also include exploring the safety and tolerability of EP0057 when combined with olaparib in patients with GC and SCLC.
Exploratory objectives may or may not be performed during the course of the study, but if so, where available at the time of publication, results from these analyses will be reported in the clinical study report (CSR). Exploratory objectives are to:
* Examine the PK characteristics of EP0057 in combination with olaparib
* Investigate the impact of HRD (homologous recombination deficiency) status on primary and secondary endpoints, as analysed by sub-groups of HRD status.
It is estimated that approximately 115 patients will be enrolled into the study. The study will aim to recruit 34 patients across both arms of the study in stage 1. The study will then aim to recruit an additional 81 patients across both arms in the second stage.
Conditions
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Gastric Cancer
Small-cell Lung Cancer
Study Design
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Allocation Method
NON_RANDOMIZED
Intervention Model
PARALLEL
Primary Study Purpose
TREATMENT
Blinding Strategy
NONE
Study Groups
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Arm 1
patients with ataxia-telangiectasia mutated protein (ATM)-negative relapsed, advanced GC.
Group Type
EXPERIMENTAL
EP0057
Intervention Type
DRUG
EP0057 is an investigational nanoparticle-drug conjugate with a Camptothecin payload, that is administered intravenously
Olaparib tablets
Intervention Type
DRUG
Olaparib is a PARP inhibitor (poly \[adenosine diphosphate-ribose\] polymerase inhibitor) Other names: Lynparza
Arm 2
patients with relapsed extensive stage SCLC.
Group Type
EXPERIMENTAL
EP0057
Intervention Type
DRUG
EP0057 is an investigational nanoparticle-drug conjugate with a Camptothecin payload, that is administered intravenously
Olaparib tablets
Intervention Type
DRUG
Olaparib is a PARP inhibitor (poly \[adenosine diphosphate-ribose\] polymerase inhibitor) Other names: Lynparza
Interventions
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EP0057
EP0057 is an investigational nanoparticle-drug conjugate with a Camptothecin payload, that is administered intravenously
Intervention Type
DRUG
Olaparib tablets
Olaparib is a PARP inhibitor (poly \[adenosine diphosphate-ribose\] polymerase inhibitor) Other names: Lynparza
Intervention Type
DRUG
Eligibility Criteria
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Inclusion Criteria
Applicable to both arms:
1. Patients aged≥ 18 years (or legal age of majority in the jurisdiction) of age at the time of informed consent
2. Ability to understand and provide written informed consent prior to undergoing any study procedures
3. Life expectancy of \> 3 months, as estimated by the Investigator
4. Presence of at least 1 measurable lesion using CT/MRI as defined by RECIST v1.1
5. Adequate haematological and organ function
* Haemoglobin ≥9.0 g/dL
* ANC ≥1.5 x 10\^9/L
* Lymphocyte count ≥0.5 x 10\^9/L
* Platelet count ≥100 x 10\^9/L
* Total bilirubin ≤1.5 institutional ULN
* Serum albumin ≥2.5 g/dL
* Aspartate transaminase (AST)and alanine transaminase (ALT) ≤2.5 x ULN, unless liver metastases are present in which case, they must be ≤5xULN
* Creatinine clearance \>50 mL/min (calculated using the Cockcroft-Gault formula) for patients with creatinine levels above institutional normal
* Patients not receiving anti-coagulant medication must have an INR of ≤1.5 and an aPTT ≤1.5xULN
6. In the opinion of the Investigator, all other relevant medical conditions must be well-managed and stable for ≥28days prior to first administration of study drug
7. Willing and able to participate in all required evaluations and procedures in this study protocol
8. Contraception:
For female subjects: each female subject of childbearing potential must agree to use two highly effective methods of contraception (ie, a method with less than 1% failure rate per year \[eg, sterilization, hormone implants, hormone injections, some intrauterine devices, vasectomized partner, or combined birth control pills\]) from screening until 6 months after the last dose of EP0057 or olaparib, whichever was taken last. Females of childbearing potential must have a negative serum pregnancy test at Screening and a negative serum or urine pregnancy test within 24 hours before each dose of EP0057 (and must not be lactating). Each female subject will be considered to be of childbearing potential unless she has been surgically sterilized by hysterectomy or bilateral tubal ligation/salpingectomy or has been postmenopausal for ≥1 year. For male subjects: Sexually active male patients must be willing to use barrier contraception (ie, condoms with spermicide) with all sexual partners for the duration of the study and for 6months after the last EP0057 administration. Where a sexual partner of a male participant is a 'woman of child-bearing potential', she must use a highly effective method contraceptive measures (see above definition) during her partner's participation in the study and for 6 months after her partner has received his last dose of EP0057. Men must not donate sperm for 6 months after the last dose of EP0057.
9. ECOG Performance Status Grade 0-2
10. Confirmed histological (cytological diagnosis excluded) of gastric adenocarcinoma or gastro-oesophageal junction adenocarcinoma with archival tumour sample available. In the absence of an archival tumour biopsy sample, a tumour biopsy will need to be collected
11. HER2status known with no HER2 expression.PDL-1 status known (this does not need to be known prior to enrolment)
12. ATM protein expression known by investigational use only immunohistochemical Ventana ATM (Y170) assay, with ATM-negative status confirmed (defined as \<25% nuclear staining)
13. Relapse, defined as: clear, documented evidence of locally advanced or metastatic, unresectable disease progression following: -two prior lines of systemic therapy, providing patients have not received irinotecan in the second line setting OR One prior line of therapy if considered to be unwilling or unsuitable for current standard of care treatment options
14. Confirmed histological (cytological diagnosis excluded) SCLC with archival tumour sample available. In the absence of an archival tumour biopsy sample, a tumour biopsy will need to be collected. Note: Patients are eligible irrespective of prior assessment of limited or extensive disease
15. PDL-1 status known (this does not need to be known prior to enrolment)
16. Relapse, defined as: clear, documented evidence of disease progression following at least one (and no more than two) lines of previous therapy. Patients must have received all available standard of care treatment options or be unsuitable or unwilling to receive the current standard of care treatment
1. Patients aged≥ 18 years (or legal age of majority in the jurisdiction) of age at the time of informed consent
2. Ability to understand and provide written informed consent prior to undergoing any study procedures
3. Life expectancy of \> 3 months, as estimated by the Investigator
4. Presence of at least 1 measurable lesion using CT/MRI as defined by RECIST v1.1
5. Adequate haematological and organ function
* Haemoglobin ≥9.0 g/dL
* ANC ≥1.5 x 10\^9/L
* Lymphocyte count ≥0.5 x 10\^9/L
* Platelet count ≥100 x 10\^9/L
* Total bilirubin ≤1.5 institutional ULN
* Serum albumin ≥2.5 g/dL
* Aspartate transaminase (AST)and alanine transaminase (ALT) ≤2.5 x ULN, unless liver metastases are present in which case, they must be ≤5xULN
* Creatinine clearance \>50 mL/min (calculated using the Cockcroft-Gault formula) for patients with creatinine levels above institutional normal
* Patients not receiving anti-coagulant medication must have an INR of ≤1.5 and an aPTT ≤1.5xULN
6. In the opinion of the Investigator, all other relevant medical conditions must be well-managed and stable for ≥28days prior to first administration of study drug
7. Willing and able to participate in all required evaluations and procedures in this study protocol
8. Contraception:
For female subjects: each female subject of childbearing potential must agree to use two highly effective methods of contraception (ie, a method with less than 1% failure rate per year \[eg, sterilization, hormone implants, hormone injections, some intrauterine devices, vasectomized partner, or combined birth control pills\]) from screening until 6 months after the last dose of EP0057 or olaparib, whichever was taken last. Females of childbearing potential must have a negative serum pregnancy test at Screening and a negative serum or urine pregnancy test within 24 hours before each dose of EP0057 (and must not be lactating). Each female subject will be considered to be of childbearing potential unless she has been surgically sterilized by hysterectomy or bilateral tubal ligation/salpingectomy or has been postmenopausal for ≥1 year. For male subjects: Sexually active male patients must be willing to use barrier contraception (ie, condoms with spermicide) with all sexual partners for the duration of the study and for 6months after the last EP0057 administration. Where a sexual partner of a male participant is a 'woman of child-bearing potential', she must use a highly effective method contraceptive measures (see above definition) during her partner's participation in the study and for 6 months after her partner has received his last dose of EP0057. Men must not donate sperm for 6 months after the last dose of EP0057.
9. ECOG Performance Status Grade 0-2
10. Confirmed histological (cytological diagnosis excluded) of gastric adenocarcinoma or gastro-oesophageal junction adenocarcinoma with archival tumour sample available. In the absence of an archival tumour biopsy sample, a tumour biopsy will need to be collected
11. HER2status known with no HER2 expression.PDL-1 status known (this does not need to be known prior to enrolment)
12. ATM protein expression known by investigational use only immunohistochemical Ventana ATM (Y170) assay, with ATM-negative status confirmed (defined as \<25% nuclear staining)
13. Relapse, defined as: clear, documented evidence of locally advanced or metastatic, unresectable disease progression following: -two prior lines of systemic therapy, providing patients have not received irinotecan in the second line setting OR One prior line of therapy if considered to be unwilling or unsuitable for current standard of care treatment options
14. Confirmed histological (cytological diagnosis excluded) SCLC with archival tumour sample available. In the absence of an archival tumour biopsy sample, a tumour biopsy will need to be collected. Note: Patients are eligible irrespective of prior assessment of limited or extensive disease
15. PDL-1 status known (this does not need to be known prior to enrolment)
16. Relapse, defined as: clear, documented evidence of disease progression following at least one (and no more than two) lines of previous therapy. Patients must have received all available standard of care treatment options or be unsuitable or unwilling to receive the current standard of care treatment
Exclusion Criteria
* Applicable to both arms:
1. Unresolved or unstable serious toxic side-effects of prior chemotherapy or radiotherapy, ie, Grade≥2 per CTCAE (v5.0) except fatigue, alopecia, infertility, or palliative radiotherapy within 6 weeks prior to start of study treatment
2. Known cerebral metastases or CNS involvement including leptomeningeal disease. SCLC patients should not have imaging older than 2 weeks prior to start of screening to exclude brain disease. For GC patients, imaging should not be older than 12 weeks prior to start of screening to exclude brain disease. Note: Any abnormal findings on brain imaging should be discussed with the Medical Monitor as part of the screening process
• Subjects with previously treated brain metastases are eligible to participate if: a) they are stable (no evidence of progression by imaging; same imaging modality \[MRI or computed tomography (CT) scan\] must be used for each assessment) for at least 28 days prior to the first dose of study drug; b) any neurologic symptoms returned to baseline; c) they have no evidence of new or enlarging brain metastases; d) they are not using corticosteroids for at least 7 days prior to the first dose of study drug.
3. Malignant disease other than that being treated in this study, with the following exceptions:
* Malignancies that were treated curatively and have not recurred within 2 years prior to study treatment
* Completely resected basal cell and squamous cell skin cancers
* Any malignancy considered to be indolent and that has never required therapy
* Completely resected carcinoma in situ of any type
4. Concurrent treatment with other systemic anti-cancer therapy or investigational anti-cancer drugs within 3 weeks (or 5 half-lives, whichever is longer), or 4 weeks for immunotherapy, prior to the start of study treatment
5. Prior treatment with a topoisomerase I inhibitor
6. History of stroke, transient ischemic attack, or myocardial infarction, within 6 months prior to C1D1
7. Uncontrolled pleural effusion, pericardial effusion or ascites requiring recurrent drainage procedures (as defined as once monthly or more frequently). N. B - patients with indwelling catheters (eg, PleurX) are allowed
8. Confirmed QTcF \> 470 ms on screening ECG or history of Torsades de pointes or history of congenital long QT syndrome
9. Any evidence of severe or uncontrolled systemic conditions (eg, severe hepatic impairment) or current unstable or uncompensated respiratory or cardiac conditions which makes it undesirable for the patient to participate in the study or which could jeopardize compliance with the protocol
10. Any other concurrent severe and/or uncontrolled medical or surgical condition which, in the view of the Investigator, could compromise the patient's participation in the study
11. Patients with active hepatitis infection (defined as having a positive HBsAg test at screening) or hepatitis C. Patients with past HBV infection or resolved HBV infection (defined as having a negative HBsAg test and a positive antibody to hepatitis B core antigen \[anti-HBc\], and surface antigen \[anti-HBs\] antibody test and no HBV DNA detectable without HBV therapy) are eligible. Patients positive for HCV antibody are eligible only if polymerase chain reaction is negative for HCV RNA
12. Active infection with SARS-Cov-2. All patients should be tested for active SARS-Cov-2 infection with an approved diagnostic kit
13. Patients with active HIV infection or known history of HIV infection
14. Active infection requiring IV antibiotics within two weeks prior to treatment
15. Women who are pregnant, likely to become pregnant, breast-feeding or either unable to or refuse to use effective means of contraception during treatment
16. Any major surgical procedure (planned or anticipated) (in the Investigator's judgement) within 2weeks of the first dose of study treatment
17. Known contra-indications, hypersensitivity, or severe intolerance to topoisomerase I inhibitors or Olaparib or the excipients of EP0057 or olaparib
18. Patients with a history, or features suggestive, of bone marrow dysplasia, MDS, or AML
19. The patient is unable to swallow capsules and/or has a surgical or anatomical condition that precludes swallowing and absorbing oral medication on an ongoing basis
20. Concurrent treatment with potent inhibitors or inducers of CYP3A4.
21. Concurrent treatment with Coumadin (Warfarin)
22. Patients considered by the Investigator to be at a higher baseline risk for new onset cystitis (see Section 7.5.4)
23. Palliative radiotherapy (e.g., for pain or bleeding) within 6 weeks prior to enrolment or patients who have not completely recovered (Grade ≥ 2) from the effects of previous radiotherapy
24. Any other condition that would, in the Investigator's judgement, contraindicate the patient's participation in the clinical study due to safety concerns or compliance with clinical study procedures or interpretation of study results
25. Prior irinotecan in the second line setting
1. Unresolved or unstable serious toxic side-effects of prior chemotherapy or radiotherapy, ie, Grade≥2 per CTCAE (v5.0) except fatigue, alopecia, infertility, or palliative radiotherapy within 6 weeks prior to start of study treatment
2. Known cerebral metastases or CNS involvement including leptomeningeal disease. SCLC patients should not have imaging older than 2 weeks prior to start of screening to exclude brain disease. For GC patients, imaging should not be older than 12 weeks prior to start of screening to exclude brain disease. Note: Any abnormal findings on brain imaging should be discussed with the Medical Monitor as part of the screening process
• Subjects with previously treated brain metastases are eligible to participate if: a) they are stable (no evidence of progression by imaging; same imaging modality \[MRI or computed tomography (CT) scan\] must be used for each assessment) for at least 28 days prior to the first dose of study drug; b) any neurologic symptoms returned to baseline; c) they have no evidence of new or enlarging brain metastases; d) they are not using corticosteroids for at least 7 days prior to the first dose of study drug.
3. Malignant disease other than that being treated in this study, with the following exceptions:
* Malignancies that were treated curatively and have not recurred within 2 years prior to study treatment
* Completely resected basal cell and squamous cell skin cancers
* Any malignancy considered to be indolent and that has never required therapy
* Completely resected carcinoma in situ of any type
4. Concurrent treatment with other systemic anti-cancer therapy or investigational anti-cancer drugs within 3 weeks (or 5 half-lives, whichever is longer), or 4 weeks for immunotherapy, prior to the start of study treatment
5. Prior treatment with a topoisomerase I inhibitor
6. History of stroke, transient ischemic attack, or myocardial infarction, within 6 months prior to C1D1
7. Uncontrolled pleural effusion, pericardial effusion or ascites requiring recurrent drainage procedures (as defined as once monthly or more frequently). N. B - patients with indwelling catheters (eg, PleurX) are allowed
8. Confirmed QTcF \> 470 ms on screening ECG or history of Torsades de pointes or history of congenital long QT syndrome
9. Any evidence of severe or uncontrolled systemic conditions (eg, severe hepatic impairment) or current unstable or uncompensated respiratory or cardiac conditions which makes it undesirable for the patient to participate in the study or which could jeopardize compliance with the protocol
10. Any other concurrent severe and/or uncontrolled medical or surgical condition which, in the view of the Investigator, could compromise the patient's participation in the study
11. Patients with active hepatitis infection (defined as having a positive HBsAg test at screening) or hepatitis C. Patients with past HBV infection or resolved HBV infection (defined as having a negative HBsAg test and a positive antibody to hepatitis B core antigen \[anti-HBc\], and surface antigen \[anti-HBs\] antibody test and no HBV DNA detectable without HBV therapy) are eligible. Patients positive for HCV antibody are eligible only if polymerase chain reaction is negative for HCV RNA
12. Active infection with SARS-Cov-2. All patients should be tested for active SARS-Cov-2 infection with an approved diagnostic kit
13. Patients with active HIV infection or known history of HIV infection
14. Active infection requiring IV antibiotics within two weeks prior to treatment
15. Women who are pregnant, likely to become pregnant, breast-feeding or either unable to or refuse to use effective means of contraception during treatment
16. Any major surgical procedure (planned or anticipated) (in the Investigator's judgement) within 2weeks of the first dose of study treatment
17. Known contra-indications, hypersensitivity, or severe intolerance to topoisomerase I inhibitors or Olaparib or the excipients of EP0057 or olaparib
18. Patients with a history, or features suggestive, of bone marrow dysplasia, MDS, or AML
19. The patient is unable to swallow capsules and/or has a surgical or anatomical condition that precludes swallowing and absorbing oral medication on an ongoing basis
20. Concurrent treatment with potent inhibitors or inducers of CYP3A4.
21. Concurrent treatment with Coumadin (Warfarin)
22. Patients considered by the Investigator to be at a higher baseline risk for new onset cystitis (see Section 7.5.4)
23. Palliative radiotherapy (e.g., for pain or bleeding) within 6 weeks prior to enrolment or patients who have not completely recovered (Grade ≥ 2) from the effects of previous radiotherapy
24. Any other condition that would, in the Investigator's judgement, contraindicate the patient's participation in the clinical study due to safety concerns or compliance with clinical study procedures or interpretation of study results
25. Prior irinotecan in the second line setting
Minimum Eligible Age
18 Years
Eligible Sex
ALL
Accepts Healthy Volunteers
No
Sponsors
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Ellipses Pharma
INDUSTRY
Sponsor Role
lead
Responsible Party
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Responsibility Role
SPONSOR
Locations
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Shanghai Chest Hospital
Shanghai, Changning District, 交通大学 邮政编码, China
Site Status
Fudan University Shanghai Cancer Center
Shanghai, Dongan Rd, 270, Xuhui District, China
Site Status
Henan Cancer Hospital
Henan, Jinshui District, Zhengzhou, China
Site Status
Linyi Cancer Hospital
Linyi, Linyi, Lanshan District, Shandong, China
Site Status
The First Affiliated Hospital of Xiamen University
Fujian, Siming District, Xiamen, China
Site Status
Hunan Cancer Hospital & The Affiliated Cancer Hospital of Xiangya School of Medicine, Central South
Changsha, Tongzipo Road, Yuelu District, China
Site Status
Shanxi Cancer Hospital
Shanxi, Xinghualing District, Taiyuan, China
Site Status
Affiliated Hospital of Hebei University
Baoding, Yuhua East Road 212, Lianchi District, China
Site Status
Seoul St. Mary Hospital
Seoul, Banpo-daero 222, Banpo-dong, Seocho-gu, South Korea
Site Status
Dong-A University Hospital
Busan, Daesingongwon-ro 26, Seo-gu, South Korea
Site Status
Seoul National University Bundang Hospital
Seoul, Gumi-ro 82 173(baekchilsipsam)beo, Bundang-gu, Seongnam-si, South Korea
Site Status
Samsung Medical Center
Seoul, Irwon-ro 81, Gangnam-gu, South Korea
Site Status
South Korea University Hospital
Seoul, Jongno-gu, Daehak-ro, 101, South Korea
Site Status
Asan Medical Center
Seoul, Olympic-ro 88 43-gil, Songpa-gu, South Korea
Site Status
Chungbuk National University Hospital
Cheongju-si, Sunhuanro 776 (1), Heungduk-gu, Cheongju-city, South Korea
Site Status
Cha University Bundang Medical Center
Gyeonggi-do, Yatap-ro 59, Bundang-gu, Seongnam, South Korea
Site Status
Kaohsiung Medical University Chung-Ho Memorial Hospital
Kaohsiung City, No. 100號, Ziyou 1st Rd, Sanmin District, Taiwan
Site Status
Changhua Christian Hospital
Changhua, No. 176, Zhonghua Rd, Taiwan
Site Status
Tapei Medical University - Shuang-Ho Hospital Ministry of Health and Welfare
New Taipei City, No. 291, Zhongzheng Rd, Zhonghe District, Taiwan
Site Status
Chang Gung Medical Foundation Linkou
Taoyuan District, No.5, Fuxing St., Guishan Dist, Taiwan
Site Status
Chi Mei Hospital Liouying
Tainan City, Yongkang District, Zhonghua Rd, 710, Taiwan
Site Status
Countries
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China
South Korea
Taiwan
Other Identifiers
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EP0057-202
Identifier Type: -
Identifier Source: org_study_id
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TERMINATED
PHASE2
Phase 2 Study of AMG 386 (20060439) in Combination With Cisplatin & Capecitabine in Subjects With Metastatic Gastric, Gastroesophageal Junction, or Distal Esophageal Adenocarcinoma
NCT00583674
COMPLETED
PHASE2
A Study of GSK5764227 in Participants With. Advanced Solid Tumors (EMBOLD PanTumor-101)
NCT06551142
RECRUITING
PHASE1
Pembrolizumab (MK-3475) Plus Chemotherapy Versus Placebo Plus Chemotherapy in Participants Gastric or Gastroesophageal Junction (GEJ) Adenocarcinoma (MK-3475-859/KEYNOTE-859)
NCT03675737
COMPLETED
PHASE3
A Study of Capecitabine (Xeloda) in Combination Chemotherapy Versus Surgery Alone in Participants With Gastric Cancer
NCT02560974
COMPLETED
PHASE3
Efficacy Study of Nivolumab Plus Ipilimumab or Nivolumab Plus Chemotherapy Against Chemotherapy in Stomach Cancer or Stomach/Esophagus Junction Cancer
NCT02872116
COMPLETED
PHASE3
Efficacy and Safety of AZD4547 Versus Paclitaxel in Patients With Advanced Gastric or Gastro-oesophageal Cancer
NCT01457846
TERMINATED
PHASE2
A Clinical Trial Evaluating the Efficacy and Safety of Dasatinib in Refractory Metastatic GIST
NCT02776878
UNKNOWN
NA
Alpelisib and Paclitaxel in PIK3CA-altered Gastric Cancer
NCT04526470
UNKNOWN
PHASE1/PHASE2
Apatinib Combined With Paclitaxol as Second Line Therapy for Advanced Gastric Cancer.
NCT03144843
UNKNOWN
PHASE2