NCT00960349

Brief Summary

The primary objective of the study is to assess the safety and tolerability of cediranib in combination with Cisplatin plus a Fluoropyrimidine (Capecitabine or S-1) in Japanese patients with previously untreated locally advanced or metastatic unresectable gastric cancer (GC).

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
14

participants targeted

Target at below P25 for phase_1 gastric-cancer

Timeline
Completed

Started Aug 2009

Shorter than P25 for phase_1 gastric-cancer

Geographic Reach
1 country

4 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2009

Completed
10 days until next milestone

First Submitted

Initial submission to the registry

August 11, 2009

Completed
6 days until next milestone

First Posted

Study publicly available on registry

August 17, 2009

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2010

Completed
1.2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2011

Completed
Last Updated

June 14, 2011

Status Verified

June 1, 2011

Enrollment Period

5 months

First QC Date

August 11, 2009

Last Update Submit

June 13, 2011

Conditions

Gastric Cancer

Keywords

Gastric cancerJapanesePhISafety and tolerabilityCediranib in combination with cisplatin plus a fluoropyrimidineCediranibCapecitabineS-1CisplatinUntreated locally advanced or metastatic unresectable gastric cancer (GC)

Outcome Measures

Primary Outcomes (1)

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

    Cycle 1 of each treatment arm

Secondary Outcomes (1)

  • Pharmacokinetics will be assessed in terms of Css,max, Css,min, tmax, AUCss and AUC0-8 for cediranib, and Cmax, tmax, AUC, AUC(0-t), CL or CL/F, t½λz for capecitabine, cisplatin and TS-1. Additional PK parameters may be determined.

    Cycle 1 and 2 of each treatment arm

Study Arms (2)

Treatment A

OTHER

Cediranib 20mg + Cisplatin + S-1

Drug: CediranibDrug: CisplatinDrug: S-1

Treatment B

OTHER

Cediranib 20mg + Cisplatin + Capecitabine

Drug: CediranibDrug: CisplatinDrug: Capecitabine

Interventions

CediranibDRUG

Given orally at a dose of 20mg/day everyday until the patient meets any discontinuation criterion.

Treatment ATreatment B
CisplatinDRUG

Given as a intravenous infusion at a dose of 80mg/m2 over 2hours on Day 1 of each cycle followed by a 5-week rest period. A maximum of 8 cycles of cisplatin will be given.

Also known as: Randa, Briplatin,
Treatment A
S-1DRUG

Given orally at a dose of 80 - 120mg/day according to BSA for 3 weeks followed by a 2-week rest period in each cycle. Will be continued indefinitely until the patient meets any discontinuation criterion.

Also known as: TS-1
Treatment A
CapecitabineDRUG

Given orally at a dose of 1000mg/m2 twice daily for 2 weeks followed by a 1-week rest period in each cycle. Will be continued indefinitely until the patient meets any discontinuation criterion.

Also known as: Xeloda
Treatment B

Eligibility Criteria

Age20 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (4)

Research Site

Nagoya, Aichi-ken, Japan

Location

Research Site

Sayama, Osaka, Japan

Location

Research Site

Sunto-gun, Shizuoka, Japan

Location

Research Site

Chūō, Tokyo, Japan

Location

MeSH Terms

Conditions

Stomach Neoplasms

Interventions

cediranibCisplatinS 1 (combination)titanium silicideCapecitabine

Condition Hierarchy (Ancestors)

Gastrointestinal NeoplasmsDigestive System NeoplasmsNeoplasms by SiteNeoplasmsDigestive System DiseasesGastrointestinal DiseasesStomach Diseases

Intervention Hierarchy (Ancestors)

Chlorine CompoundsInorganic ChemicalsNitrogen CompoundsPlatinum CompoundsDeoxycytidineCytidinePyrimidine NucleosidesPyrimidinesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsFluorouracilUracilPyrimidinonesDeoxyribonucleosidesNucleosidesNucleic Acids, Nucleotides, and Nucleosides

Study Officials

  • Narikazu Boku, MD

    Shizuoka Cancer Center, Japan

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

August 11, 2009

First Posted

August 17, 2009

Study Start

August 1, 2009

Primary Completion

January 1, 2010

Study Completion

March 1, 2011

Last Updated

June 14, 2011

Record last verified: 2011-06

Locations

JP(4)