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A Randomized Phase 2/3 Study of Apatinib as Third Line Treatment in Patients With Metastatic Gastric Carcinoma


Phase 2/Phase 3
18 Years
70 Years
Not Enrolling
Both
Gastric Carcinoma

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Trial Information

A Randomized Phase 2/3 Study of Apatinib as Third Line Treatment in Patients With Metastatic Gastric Carcinoma


Up to now, although FU based, cisplatin based and taxane based regimen, and ECF regimen have
been suggested as the first line therapy for A/MGC by FDA, the efficacy of these treatment
is still unsatisfied for their toxicity and limitation in prolonging survival. Based on the
promising results of apatinib in the phase I study, this clinical trial has been designed to
evaluate whether apatinib can improve progression free survival in patients with metastatic
gastric carcinoma who failed two lines of chemotherapy compared with placebo. Patients will
be randomized to 3 groups, one group patients will receive the treatment of apatinib 850mg
qd, one group patients will receive apatinib 425mg bid, and the other group will receive
placebo.


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.

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Outcome Measure:

Progression free survival

Outcome Time Frame:

8 weeks

Safety Issue:

Yes

Principal Investigator

Jin Li, MD, PHD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Fudan University

Authority:

China: Ethics Committee

Study ID:

2009APA-MGC

NCT ID:

NCT00970138

Start Date:

June 2009

Completion Date:

December 2010

Related Keywords:

  • Gastric Carcinoma
  • Progress free survival
  • Toxicity
  • Response rate
  • Overall survival
  • Quality of live
  • Carcinoma
  • Stomach Neoplasms

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