Phase III Study of Apatinib Tablets in the Treatment of Advanced or Metastatic Gastric Cancer

NCT01512745 | Completed Phase 3 Results DMC

• 1 other identifier: HENGRUI 20101208
• Study Type: interventional
• Target: 267
• Locations: 1 country
• Sites: 2

Brief Summary

Apatinib is a tyrosin-inhibitor agent targeting at vascular endothelial growth factor receptor (VEGFR), and it's anti-angiogenesis effect has been viewed in preclinical tests. The investigators' phase I study has shown that the drug's toxicity is manageable and the maximum tolerable daily dose is 850 mg. The purpose of this study is to determine whether apatinib can improve progression free survival or overall survival compared with placebo in patients with metastatic gastric carcinoma who failed two lines of chemotherapy.

Conditions

Advanced or Metastatic Gastric Cancer

Outcome Measures

Primary Outcomes (2)

• Progression Free Survival(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).

  30 months

• Overall Survival(OS)

  Overall Survival of the Participants

  30 months

Secondary Outcomes (3)

• Disease Control Rate(DCR)

  30 months

• Objective Response Rate(ORR)

  30 months

• Percentage of Participants With Adverse Events

  30 months

Study Arms (2)

apatinib

EXPERIMENTAL

Drug: apatinib

placebo

PLACEBO COMPARATOR

Drug: placebo

Interventions

apatinib DRUG

apatinib 850 mg qd p.o. until disease progression or intolerable toxicity or patients withdrawal of consent

apatinib

placebo DRUG

placebo qd p.o. until disease progression or intolerable toxicity or patients withdrawal of consent

placebo

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• ≥ 18 and ≤ 70 years of age
• Histological confirmed advanced or metastatic adenocarcinoma of the stomach
• Have failed for at least 2 lines of chemotherapy
• Life expectancy of at least 12 weeks.
• Eastern Cooperative Oncology Group Performance Status of 0 or 1 within 1 week before randomization.
• At least one measurable lesion beyond stomach (larger than 10 mm in diameter by spiral CT scan)
• Duration from the last therapy is more than 6 weeks for nitroso or mitomycin
• More than 4 weeks for operation or radiotherapy
• More than 4 weeks for cytotoxic agents or growth inhibitors
• Adequate hepatic, renal, heart, and hematologic functions (HB ≥ 90g/L,platelets \> 80 ×10 E+9/L, neutrophil \> 1.5 × 10 E+9/L, serum creatinine ≤ 1× upper limit of normal(ULN), bilirubin \< 1.25× ULN, and serum transaminase ≤ 2.5× ULN).

You may not qualify if:

• Pregnant or lactating women
• History of other malignancies except cured basal cell carcinoma of skin and carcinoma in-situ of uterine cervix Hypertension and unable to be controlled within normal level following treatment of anti-hypertension agents (systolic blood pressure \> 140 mmHg, diastolic blood pressure \> 90 mmHg).
• Any factors that influence the usage of oral administration; Evidence of Central Nerves System(CNS) metastasis
• Intercurrence with one of the following: coronary artery disease, arrhythmia ,heart failure and proteinuria ≥ (+)
• International Normalize Ratio (INR) \> 1.5 and activated partial thromboplastin time（APPT） \> 1.5 × ULN
• Abuse of alcohol or drugs
• Certain possibility of gastric or intestine hemorrhage
• Less than 4 weeks from the last clinical trial
• Prior VEGFR inhibitor treatment
• Disability of serious uncontrolled intercurrence infection Objective evidence of previous or current pulmonary fibrosis history, interstitial pneumonia, Pneumoconiosis, radiation pneumonitis, drug-related pneumonia, Pulmonary function damaged seriously etc.

Sponsors & Collaborators

• Jiangsu HengRui Medicine Co., Ltd.: lead
• Fudan University: collaborator
• The 81 Hospital of PLA: collaborator

Study Sites (2)

The 81 Hosiptal of PLA

Nanjing, Jiangsu, China

Location

Fudan University cancer hospital

Shanghai, Shanghai Municipality, China

Location

MeSH Terms

Conditions

Stomach Neoplasms

Interventions

apatinib

Condition Hierarchy (Ancestors)

Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Stomach Diseases

Results Point of Contact

• Title: Co-Director of Clinical Trials
• Organization: Fudan University Shanghai Cancer Center, Shanghai; PLA Cancer Centre, The 81 Hospital of PLA, Nangjing

fudanlijin@163.com,qinsk@csco.org.cn

021-64433755

Study Officials

• Jin Li, MD, PHD

  Fudan University

  PRINCIPAL INVESTIGATOR

• Shukui Qin, MD

  The 81 Hospital of PLA

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 13, 2012
• First Posted: January 19, 2012
• Study Start: January 1, 2011
• Primary Completion: May 1, 2013
• Study Completion: May 1, 2013
• Last Updated: October 17, 2016
• Results First Posted: June 15, 2016

Record last verified: 2015-04

Locations

CN (2)