Apatinib Versus Placebo as a Third Line Treatment in Patients With Advanced or Metastatic Gastric Cancer
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ClinicalTrials.gov Identifier: NCT00970138 |
Recruitment Status :
Completed
First Posted : September 2, 2009
Last Update Posted : July 12, 2011
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Gastric Carcinoma | Drug: apatinib tablet | Phase 2 Phase 3 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 141 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor) |
Primary Purpose: | Treatment |
Official Title: | A Randomized Phase 2/3 Study of Apatinib as Third Line Treatment in Patients With Metastatic Gastric Carcinoma |
Study Start Date : | June 2009 |
Actual Primary Completion Date : | October 2010 |
Actual Study Completion Date : | December 2010 |

Arm | Intervention/treatment |
---|---|
Experimental: A 850
apatinib 850 mg qd, and it should be continued until disease progression or intolerable toxicity or patients withdrawal of consent
|
Drug: apatinib tablet
A850: apatinib 850 mg qd p.o. plus placebo qd p.o. until disease progression or intolerable toxicity or patients withdrawal of consent B425: apatinib 425 mg bid p.o. until disease progression or intolerable toxicity or patients withdrawal of consent Cpla: placebo bid p.o. until disease progression or intolerable toxicity or patients withdrawal of consent |
Experimental: B 425
apatinib 425 mg bid, and it should be continued until disease progression or intolerable toxicity or patients withdrawal of consent
|
Drug: apatinib tablet
A850: apatinib 850 mg qd p.o. plus placebo qd p.o. until disease progression or intolerable toxicity or patients withdrawal of consent B425: apatinib 425 mg bid p.o. until disease progression or intolerable toxicity or patients withdrawal of consent Cpla: placebo bid p.o. until disease progression or intolerable toxicity or patients withdrawal of consent |
Placebo Comparator: C pla
placebo bid, and it should be continued until disease progression or intolerable toxicity or patients withdrawal of consent
|
Drug: apatinib tablet
A850: apatinib 850 mg qd p.o. plus placebo qd p.o. until disease progression or intolerable toxicity or patients withdrawal of consent B425: apatinib 425 mg bid p.o. until disease progression or intolerable toxicity or patients withdrawal of consent Cpla: placebo bid p.o. until disease progression or intolerable toxicity or patients withdrawal of consent |
- Progression free survival [ Time Frame: 8 weeks ]
- Overall survival safety [ Time Frame: 8 weeks ]
- DCR (Disease control rate) [ Time Frame: 8 weeks ]
- ORR (Objective response rate) [ Time Frame: 8 weeks ]
- QoL (Quality of life) [ Time Frame: 8 weeks ]
- Toxicity [ Time Frame: 8 weeks ]

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Ages Eligible for Study: | 18 Years to 70 Years (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- ≥ 18 and ≤ 70 years of age
- Histologically confirmed advanced or metastatic adenocarcinoma of the stomach
- Have failed for 2 lines of chemotherapy
- Life expectancy of more than 3 months
- ECOG performance scale ≤ 2
- At least one measurable lesion (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 (platelets > 80 × 109/L, neutrophil > 2.0 × 109/L, serum creatinine ≤ 1.5mg/dl, total bilirubin within upper limit of normal(ULN), and serum transaminase≤2.5×the ULN).
Exclusion Criteria:
- Pregnant or lactating women
- History of other malignancies except cured basal cell carcinoma of skin and carcinoma in-situ of uterine cervix
- Any factors that influence the usage of oral administration; Evidence of CNS metastasis
- History of another malignancy within the last five years except cured basal cell carcinoma of skin and carcinoma in-situ of uterine cervix
- Intercurrence with one of the following: hypertension, coronary artery disease, arrhythmia and heart failure
- Receiving the therapy of thrombolysis or anticoagulation
- Abuse of alcohol or drugs
- Allergy to the ingredient of the agent or more than two kinds of food and drug
- Less than 4 weeks from the last clinical trial
- Disability of serious uncontrolled intercurrence infection.

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00970138
China, Shanghai | |
Fudan University Cancer Hospital | |
ShangHai, Shanghai, China, 200032 |
Principal Investigator: | Jin Li, MD, PHD | Fudan University |
Responsible Party: | Jin Li/Dr, Fudan University cancer hospital |
ClinicalTrials.gov Identifier: | NCT00970138 |
Other Study ID Numbers: |
2009APA-MGC |
First Posted: | September 2, 2009 Key Record Dates |
Last Update Posted: | July 12, 2011 |
Last Verified: | September 2010 |
Progress free survival Toxicity Response rate Overall survival Quality of live |
Carcinoma Stomach Neoplasms Neoplasms, Glandular and Epithelial Neoplasms by Histologic Type Neoplasms Gastrointestinal Neoplasms Digestive System Neoplasms Neoplasms by Site |
Digestive System Diseases Gastrointestinal Diseases Stomach Diseases Apatinib Antineoplastic Agents Protein Kinase Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action |