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- Klinische proef NCT04053205
A Study of Gentuximab + Paclitaxel in Patients With Advanced Gastric or Gastroesophageal Junction Cancer
9 augustus 2019 bijgewerkt door: GeneScience Pharmaceuticals Co., Ltd.
An Multi-center, Open-label Phase Ib/II Study of Gentuximab Injection + Paclitaxel in Patients With Advanced Gastric or Gastroesophageal Junction Cancer to Evaluate Tolerability, Safety, Efficacy and Pharmacokinetics.
The objective of the study is to evaluate Tolerability, Safety, and primary Efficacy of Gentuximab Injection at different dosage in combination with Paclitaxel in Advanced Gastric or Gastroesophageal Junction Cancer patients, to ensure adequate treatment dosage for further study.
Meanwhile, the study also evaluate Pharmacokinetics of Gentuximab Injection at different dosage in combination with Paclitaxel.
Studie Overzicht
Toestand
Onbekend
Interventie / Behandeling
Gedetailleerde beschrijving
The study includes dose-limiting toxicity (DLT)observing period and randomization period with two cohorts as low-dose group(Gentuximab Injection 8mg/kg+ paclitaxel) and high-dose group(Gentuximab Injection 12mg/kg+ paclitaxel).
During the study,the anti-cancer efficacy, safety and anti-drug antibody were evaluated in all patients.
DLT observation is only to subjects enrolled in DLT observation period and it lasts one treatment period.
PK were doing in part of subjects.
Studietype
Ingrijpend
Inschrijving (Verwacht)
76
Fase
- Fase 2
- Fase 1
Contacten en locaties
In dit gedeelte vindt u de contactgegevens van degenen die het onderzoek uitvoeren en informatie over waar dit onderzoek wordt uitgevoerd.
Studiecontact
- Naam: Siqin Wang
- E-mail: wangsiqin@gensci-china.com
Studie Contact Back-up
- Naam: Jin Li
- Telefoonnummer: 13761222111
- E-mail: tianyoulijin@163.com
Studie Locaties
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Shanghai, China
- Shanghai First People's Hospital
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Contact:
- Weiyi Huang
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Shanghai, China
- Shanghai East Hospital
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Fujian
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Fuzhou, Fujian, China
- Fujian Tumor Hospital
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Contact:
- Jianwei Yang
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Guangdong
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Guangzhou, Guangdong, China
- The Sixth Hospital of Sun Yat-Sen University
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Heilongjiang
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Harbin, Heilongjiang, China
- The Affiliated Tumor Hospital of Harbin Medical University
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Henan
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Zhengzhou, Henan, China
- The First Affiliated Hospital of Zhengzhou University
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Hubei
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Wuhan, Hubei, China
- Union Hospital of Tongji Medical College, Huazhong University of Science and Technology
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Jiangsu
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Nanjing, Jiangsu, China
- Jiangsu Province Hospital
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Contact:
- Yanhong Gu
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Jilin
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Changchun, Jilin, China
- The First Hospital of Jilin University
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Zhejiang
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Hangzhou, Zhejiang, China
- The First Affiliated Hospital, Zhejiang University School of Medicine
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Contact:
- Nong Xu
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Hangzhou, Zhejiang, China
- Sir Run Run Shaw Hospital, Zhejiang University School of Medicine
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Hangzhou, Zhejiang, China
- Tongji Hospital of Tongji Medical College, Huazhong University of Science and Technology
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Deelname Criteria
Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.
Geschiktheidscriteria
Leeftijden die in aanmerking komen voor studie
18 jaar tot 75 jaar (Volwassen, Oudere volwassene)
Accepteert gezonde vrijwilligers
Nee
Geslachten die in aanmerking komen voor studie
Allemaal
Beschrijving
Inclusion Criteria:
- The subject can understand the process and methods of the study, complete the study in accordance with the protocol and is willing to sign a written informed consent.
- Male or female. aged between 18 and 75 years
- Histopathologically confirmed advanced advanced gastric or gastroesophageal junction cancer, and Documented progression during first-line fluoropyrimidine- and platinum- containing chemotherapy, or during the 3 months following the last cycle of such chemotherapy (or during the 6 months following the last dose of adjuvant therapy or new adjuvant therapy containing fluoropyrimidine and platinium).
- At least one Measurable lesion.
- ECOG Performance status (PS) score, 0-1 level.
- A life expectancy of >3 months.
- Adequate hematologic function, as defined by: Absolute neutrophil count (ANC) ≥1.5×109/L; hemoglobin concentration ≥90g/L (allowing blood transfusion); and platelet count ≥80×109/L.
- Adequate hepatic function, as defined by: ALT ≤ 2.5 × ULN, AST ≤ 2.5 × ULN, TBIL ≤ 1.5 × ULN (liver metastases patients ALT ≤ 5 × ULN, AST ≤ 5 × ULN, TBIL ≤ 3 × ULN).
- Adequate renal function, as defined by: serum creatinine level≤ 1.5 × ULN, or creatinine clearance ≥ 50ml / min when serum creatinine level> 1.5 × ULN.
- Adequate coagulation function, as defined by: International normalized ratio (INR) ≤1.5× ULN, activated partial thromboplastin time (aPTT) ≤1.5 x ULN.
- 24-hour urine protein quantitation is <1g(24-hour urine protein quantitative test should be performed when urine protein ≥1+ is found during screening visit).
- Subjects (male and female) who have fertility must agree to use reliable contraceptive methods during the trial and in 3 months after the last administration. Female subjects in childbearing age must be negative for blood pregnancy test prior to enrollment.
Exclusion Criteria:
- Previously administrated with anti-angiogenic drugs or paclitaxel.
- Systematic anti-tumor therapy (non-anti-angiogenic drugs or paclitaxel) such as chemotherapy, radiotherapy, macromolecular targeted therapy, immunotherapy, endocrine therapy, etc. within 4 weeks before the first dose of investigational drug, except for the following: nitrourea or mitomycin C is within 6 weeks before the first dose, oral fluorouracil and small molecule targeted drugs are within 2 weeks or 5 half-life of the drug(whichever is longer) before the first dose,Chinese medicine with anti-cancer indications is within 2 weeks before the first dose.
- Has participated in a clinical study of a non-approved experimental agent within 4 weeks prior to screening visit.
- Has undergone major surgery within 4 weeks before screening visit (not including needle biopsy), or would undergo planned surgery during the study.
- Subject with positive HCV-Ab, Anti-HIV or TP-Ab, or positive HBS-Ag with copies of HBV DNA > ULN.
- Patients with previously confirmed malignant tumors.
- History of arterial thrombosis or deep vein thrombosis within 6 months prior to screening, or a bleeding event no less than Grade level 3 within 2 months prior to screening, or the investigator determines that there is a risk of bleeding.
- History of severe cardiovascular and cerebrovascular diseases.
- Subjects with confirmed brain tumor metastases,but subjects in steady situation can be enrolled.
- Active bleeding confirmed by gastroscopy when fecal occult blood positive (only subjects with primary lesions not removed need to do fecal occult blood test.
- History of abdominal fistula, gastrointestinal perforation, or intra-abdominal abscess within 12 months before screening visit.
- Thoracic,abdominal or pericardial effusion that cannot be controlled by repeated drainage or with obvious symptoms.
- Has a nonhealing wound, serious ulcer, or unrecovered bone fracture.
- Active infections requiring systemic treatment, including but not limited to active tuberculosis.
- Using anticoagulation and antiplatelet drugs.
- Female subjects who is pregnant (confirmed by urine or serum pregnancy test) or lactating.
- Has a known serious allergy reaction to recombination monoclonal antibody (MAb) drug, ,or infusion reaction.
- Has known alcohol or drug dependency.
Studie plan
Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.
Hoe is de studie opgezet?
Ontwerpdetails
- Primair doel: Behandeling
- Toewijzing: Gerandomiseerd
- Interventioneel model: Parallelle opdracht
- Masker: Geen (open label)
Wapens en interventies
Deelnemersgroep / Arm |
Interventie / Behandeling |
---|---|
Experimenteel: 1 Gentuximab+ Paclitaxel
8 mg/kg Gentuximab administered intravenously (IV) on D1 and D15(28 days every cycle)+ 80 mg/m² paclitaxel administered IV on D1, D8 and D15
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Administered intravenously (IV)
Administered intravenously (IV)
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Experimenteel: 2 Gentuximab+ Paclitaxel
12 mg/kg Gentuximab administered intravenously (IV) on D1 and D15(28 days every cycle)+ 80 mg/m² paclitaxel administered IV on D1, D8 and D15
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Administered intravenously (IV)
Administered intravenously (IV)
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Wat meet het onderzoek?
Primaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
---|---|---|
Dose-limiting toxicities (DLT)
Tijdsspanne: Up to 4 Weeks
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Number of Participants With One or More Drug-Related Adverse Events (AEs) defined as DLT in the protocol
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Up to 4 Weeks
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AEs or SAEs
Tijdsspanne: Baseline through Study Completion, about 24 weeks
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Drug-Related Adverse Events (AEs) or Any Serious Adverse Events (SAEs)
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Baseline through Study Completion, about 24 weeks
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Secundaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
---|---|---|
Objective response rate(ORR)
Tijdsspanne: Up to 6 cycles (28 days for every cycle)
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Proportion of Participants With CR and PR
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Up to 6 cycles (28 days for every cycle)
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Progression-free survival (PFS)
Tijdsspanne: Up to 6 cycles (28 days for every cycle)
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The time from randomization to the patient tumor progression or death.
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Up to 6 cycles (28 days for every cycle)
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Disease control rate (DCR)
Tijdsspanne: Up to 6 cycles (28 days for every cycle)
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Proportion of Participants With CR, PR and SD
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Up to 6 cycles (28 days for every cycle)
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Time-to-progress (TTP)
Tijdsspanne: Up to 6 cycles (28 days for every cycle)
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The time from randomization to the patient tumor progression.
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Up to 6 cycles (28 days for every cycle)
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Time-to-failure (TTF)
Tijdsspanne: Up to 6 cycles (28 days for every cycle)
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The time from randomization to the patient withdraw from the study.
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Up to 6 cycles (28 days for every cycle)
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Anti-drug antibody
Tijdsspanne: Up to 6 cycles (28 days for every cycle)
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Number of Participants With Anti-drug Antibodies
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Up to 6 cycles (28 days for every cycle)
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Pharmacokinetics Cmax
Tijdsspanne: Cycle 1(day1-day 15)& Cycle 2(day 15-day26) & Cycle 3(day 1) (28 days for every cycle)
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Maximum Concentration (Cmax)
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Cycle 1(day1-day 15)& Cycle 2(day 15-day26) & Cycle 3(day 1) (28 days for every cycle)
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Area Under the Concentration-Time Curve (AUC)
Tijdsspanne: Cycle 1(day1-day 15)& Cycle 2(day 15-day26) & Cycle 3(day 1) Cycle 1(day1-day 15)& Cycle 2(day 15-day26) & Cycle 3(day 1) (28 days for every cycle)
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Cycle 1(day1-day 15)& Cycle 2(day 15-day26) & Cycle 3(day 1) Cycle 1(day1-day 15)& Cycle 2(day 15-day26) & Cycle 3(day 1) (28 days for every cycle)
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Medewerkers en onderzoekers
Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.
Medewerkers
Studie record data
Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.
Bestudeer belangrijke data
Studie start (Verwacht)
1 augustus 2019
Primaire voltooiing (Verwacht)
1 juni 2020
Studie voltooiing (Verwacht)
1 december 2020
Studieregistratiedata
Eerst ingediend
27 juli 2019
Eerst ingediend dat voldeed aan de QC-criteria
9 augustus 2019
Eerst geplaatst (Werkelijk)
12 augustus 2019
Updates van studierecords
Laatste update geplaatst (Werkelijk)
12 augustus 2019
Laatste update ingediend die voldeed aan QC-criteria
9 augustus 2019
Laatst geverifieerd
1 juli 2019
Meer informatie
Termen gerelateerd aan deze studie
Aanvullende relevante MeSH-voorwaarden
Andere studie-ID-nummers
- GenSci 043 CT
Informatie over medicijnen en apparaten, studiedocumenten
Bestudeert een door de Amerikaanse FDA gereguleerd geneesmiddel
Nee
Bestudeert een door de Amerikaanse FDA gereguleerd apparaatproduct
Nee
Deze informatie is zonder wijzigingen rechtstreeks van de website clinicaltrials.gov gehaald. Als u verzoeken heeft om uw onderzoeksgegevens te wijzigen, te verwijderen of bij te werken, neem dan contact op met register@clinicaltrials.gov. Zodra er een wijziging wordt doorgevoerd op clinicaltrials.gov, wordt deze ook automatisch bijgewerkt op onze website .
Klinische onderzoeken op Gentuximab
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GeneScience Pharmaceuticals Co., Ltd.WervingGemetastaseerde niet-kleincellige longkankerChina
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GeneScience Pharmaceuticals Co., Ltd.WervingAdenocarcinoom van de maagChina
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GeneScience Pharmaceuticals Co., Ltd.Shanghai East HospitalOnbekend