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A Phase I, Open-label, Non-randomized Study, to Assess the Safety and Tolerability of Cediranib (AZD2171) in Combination With Cisplatin Plus a Fluoropyrimidine (Capecitabine or S-1) in Japanese Patients With Previously Untreated Locally Advanced or Metastatic Unresectable Gastric Cancer


Phase 1
20 Years
N/A
Not Enrolling
Both
Gastric Cancer

Thank you

Trial Information

A Phase I, Open-label, Non-randomized Study, to Assess the Safety and Tolerability of Cediranib (AZD2171) in Combination With Cisplatin Plus a Fluoropyrimidine (Capecitabine or S-1) in Japanese Patients With Previously Untreated Locally Advanced or Metastatic Unresectable Gastric Cancer


Inclusion Criteria:



- Histological or cytological confirmation of gastric adenocarcinoma (including the
gastric cardia and esophagogastric junction)

- Having locally advanced or metastatic gastric cancer for which they must have
received no prior systemic therapy for locally advanced disease. Previous
gastrectomy, neoadjuvant and adjuvant therapy received > 6 months ago are acceptable

- Having a mild symptom in ordinal daily lives including walking and simple labour or
works in the sitting position

Exclusion Criteria:

- A history of poorly controlled hypertension or resting BP > 150/100 mmHg in the
presence or absence of a stable regimen of anti-hypertensive therapy or patients who
are requiring maximal doses of calcium channel blockers to stabilize BP

- Significant Haemorrhage (> 30 ml bleeding/episode in previous 3 months) or
haemoptysis (> 5 ml fresh blood in previous 4 weeks)

- Arterial thromboembolic event (including ischemic attack) in the previous 12 months

Type of Study:

Interventional

Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Safety of each treatment arm will be measured in terms of adverse events, vital signs, clinical chemistry, haematology, urinalysis, electrocardiogram, and physical examinations.

Outcome Time Frame:

Cycle 1 of each treatment arm

Safety Issue:

Yes

Principal Investigator

Narikazu Boku, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Shizuoka Cancer Center, Japan

Authority:

Japan: Pharmaceuticals and Medical Devices Agency

Study ID:

D8480C00066

NCT ID:

NCT00960349

Start Date:

August 2009

Completion Date:

March 2011

Related Keywords:

  • Gastric Cancer
  • Gastric cancer
  • Japanese
  • PhI
  • Safety and tolerability
  • Cediranib in combination with cisplatin plus a fluoropyrimidine
  • Cediranib
  • Capecitabine
  • S-1
  • Cisplatin
  • Untreated locally advanced or metastatic unresectable gastric cancer (GC)
  • Stomach Neoplasms

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