A Study of Gentuximab + Paclitaxel in Patients With Advanced Gastric or Gastroesophageal Junction Cancer

NCT04053205 | Unknown Phase 1

• 1 other identifier: GenSci 043 CT
• Study Type: interventional
• Target: 76
• Locations: 1 country
• Sites: 12

Brief Summary

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.

Conditions

Advanced Gastric or Gastroesophageal Junction Cancer

Outcome Measures

Primary Outcomes (2)

• Dose-limiting toxicities (DLT)

  Number of Participants With One or More Drug-Related Adverse Events (AEs) defined as DLT in the protocol

  Up to 4 Weeks

• AEs or SAEs

  Drug-Related Adverse Events (AEs) or Any Serious Adverse Events (SAEs)

  Baseline through Study Completion, about 24 weeks

Secondary Outcomes (8)

• Objective response rate（ORR）

  Up to 6 cycles (28 days for every cycle)

• Progression-free survival (PFS)

  Up to 6 cycles (28 days for every cycle)

• Disease control rate (DCR)

  Up to 6 cycles (28 days for every cycle)

• Time-to-progress (TTP)

  Up to 6 cycles (28 days for every cycle)

• Time-to-failure (TTF)

  Up to 6 cycles (28 days for every cycle)

Study Arms (2)

1 Gentuximab+ Paclitaxel

EXPERIMENTAL

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

Drug: Gentuximab; Drug: Paclitaxel

2 Gentuximab+ Paclitaxel

EXPERIMENTAL

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

Drug: Gentuximab; Drug: Paclitaxel

Interventions

Gentuximab DRUG

Administered intravenously (IV)

1 Gentuximab+ Paclitaxel; 2 Gentuximab+ Paclitaxel

Paclitaxel DRUG

Administered intravenously (IV)

1 Gentuximab+ Paclitaxel; 2 Gentuximab+ Paclitaxel

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.
• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Changchun GeneScience Pharmaceutical Co., Ltd.: lead
• Shanghai East Hospital: collaborator
• Zhejiang University: collaborator
• Fujian Tumor Hospital: collaborator
• Sir Run Run Shaw Hospital: collaborator
• The Affiliated Tumor Hospital of Harbin Medical University: collaborator
• Union Hospital, Tongji Medical College, Huazhong University of Science and Technology: collaborator
• Sixth Affiliated Hospital, Sun Yat-sen University: collaborator
• Tongji Hospital: collaborator
• Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine: collaborator
• The First Hospital of Jilin University: collaborator
• The First Affiliated Hospital with Nanjing Medical University: collaborator
• The First Affiliated Hospital of Zhengzhou University: collaborator

Study Sites (12)

Fujian Tumor Hospital

Fuzhou, Fujian, China

Location

The Sixth Hospital of Sun Yat-sen University

Guangzhou, Guangdong, China

Location

The Affiliated Tumor Hospital of Harbin Medical University

Harbin, Heilongjiang, China

Location

The First Affiliated Hospital of Zhengzhou University

Zhengzhou, Henan, China

Location

Union Hospital of Tongji Medical College, Huazhong University of Science and Technology

Wuhan, Hubei, China

Location

Jiangsu Province Hospital

Nanjing, Jiangsu, China

Location

The First Hospital of Jilin University

Changchun, Jilin, China

Location

Sir Run Run Shaw Hospital, Zhejiang University School of Medicine

Hangzhou, Zhejiang, China

Location

The First Affiliated Hospital, Zhejiang University School of Medicine

Hangzhou, Zhejiang, China

Location

Tongji Hospital of Tongji Medical College, Huazhong University of Science and Technology

Hangzhou, Zhejiang, China

Location

Shanghai East Hospital

Shanghai, China

Location

Shanghai First People's Hospital

Shanghai, China

Location

MeSH Terms

Interventions

Paclitaxel

Intervention Hierarchy (Ancestors)

Taxoids; Cyclodecanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Diterpenes; Terpenes

Central Study Contacts

Siqin Wang

CONTACT

wangsiqin@gensci-china.com

Jin Li

CONTACT

13761222111; tianyoulijin@163.com

Study Design

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

Study Record Dates

• First Submitted: July 27, 2019
• First Posted: August 12, 2019
• Study Start: August 1, 2019
• Primary Completion: June 1, 2020
• Study Completion: December 1, 2020
• Last Updated: August 12, 2019

Record last verified: 2019-07

Locations

CN (12)