Advanced or Metastatic Gastric CancerPhase 3NCT01512745
Phase III Study of Apatinib Tablets in the Treatment of Advanced or Metastatic Gastric Cancer
A Phase 3 study testing apatinib in people with Advanced or Metastatic Gastric Cancer, run by Jiangsu HengRui Medicine Co., Ltd. at 2 sites in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Advanced or Metastatic Gastric Cancer
- What is being tested?
- apatinib
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 267 participants
- Where
- 2 sitesChina
- Study dates
- Jan 2011to May 2013
- Phase
- Phase 3
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- ≥ 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)
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- 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).
Who cannot join
- 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
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- 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.
Trial locations and contacts
2 sites in 1 country.
China2 sites
The 81 Hosiptal of PLA
Nanjing, Jiangsu
Fudan University cancer hospital
Shanghai, Shanghai Municipality
About this study
Official title: A Randomized, Double Blinded, Placebo Controlled Multicenter Phase III Study of Apatinib Mesylate Tablets in the Treatment of Advanced or Metastatic Gastric Cancer
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
- Being tested
- apatinib, placebo
- Medical subject headings
- Stomach Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
apatinibDrug
apatinib 850 mg qd p.o. until disease progression or intolerable toxicity or patients withdrawal of consent
placeboDrug
placebo qd p.o. until disease progression or intolerable toxicity or patients withdrawal of consent
| Study group | Role | What they receive |
|---|---|---|
| apatinib | Experimental | Not described Receives: Drug: apatinib |
| placebo | Placebo comparator | Not described Receives: Drug: placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 30 months
Overall Survival(OS)
Overall Survival of the Participants
Measured: 30 months
Secondary outcomes (3)
Disease Control Rate(DCR)
Disease control is defined as the proportion of patients who had a best response rating of complete response, partial response, or stable disease, and lasted at least 4 weeks.
Measured: 30 months
Objective Response Rate(ORR)
Objective Response Rate is defined as the proportion of patients with complete response(CR) or partial response(PR)
Measured: 30 months
Percentage of Participants With Adverse Events
Measured: 30 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jan 2012 (estimated)
- Study startJan 2011
- Primary completionMay 2013
- Study completionMay 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Advanced or Metastatic Gastric CancerStudies of the same condition, open and under way.
- More trials run by Jiangsu HengRui Medicine Co., Ltd.The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 267 participants (actual)
Sponsor and investigators
- Lead sponsor
- Jiangsu HengRui Medicine Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Fudan University, The 81 Hospital of PLA
- Responsible party
- Sponsor
- Investigators
- Jin Li, MD, PHD, Principal investigator, Fudan UniversityShukui Qin, MD, Principal investigator, The 81 Hospital of PLA
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01512745
- Sponsor's protocol ID
- HENGRUI 20101208
- Status last verified
- Apr 2015
- First submitted
- 13 Jan 2012
- Last updated
- 17 Oct 2016
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes