NCT00595985

Brief Summary

The purpose of this study is to evaluate the efficacy and tolerability of sorafenib as second line treatment in patients with Advanced or Metastatic Gastric Cancer (A/MGC).

Trial Health

57
Monitor

Trial Health Score

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

Enrollment
5

participants targeted

Target at below P25 for phase_2 gastric-cancer

Timeline
Completed

Started Jul 2007

Shorter than P25 for phase_2 gastric-cancer

Geographic Reach
1 country

1 active site

Status
terminated

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

July 1, 2007

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

January 7, 2008

Completed
9 days until next milestone

First Posted

Study publicly available on registry

January 16, 2008

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2009

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2009

Completed
Last Updated

July 7, 2009

Status Verified

July 1, 2009

Enrollment Period

1.5 years

First QC Date

January 7, 2008

Last Update Submit

July 6, 2009

Conditions

Gastric Cancer

Keywords

Time to ProgressionToxicityOverall survivalResponse rateQuality of liveToxicities

Outcome Measures

Primary Outcomes (1)

  • time to progression

    every six weeks

Secondary Outcomes (1)

  • toxicity

    6 weeks

Study Arms (1)

A

EXPERIMENTAL

administer sorafenib 400mg bid until disease progression or intolerable toxicity or patients withdrawal of consent

Drug: sorafenib

Interventions

sorafenibDRUG

sorafenib 400mg bid, and it should be continued until disease progression or intolerable toxicity or patients withdrawal of consent

Also known as: treatment group
A

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Histologically confirmed advanced or metastatic adenocarcinoma of the stomach
  • ECOG performance scale ≤ 2
  • At least one measurable lesion (larger than 10 mm in diameter by spiral CT scan)
  • 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)
  • serum transaminase ≤ 2.5 × the ULN

You may not qualify if:

  • Pregnant or lactating women
  • Concurrent cancer
  • History of other malignancies except cured basal cell carcinoma of skin and carcinoma in-situ of uterine cervix
  • Neuropathy, brain, or leptomeningeal involvement
  • Uncontrolled significant comorbid conditions and previous radiotherapy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Fudan University Cancer Hospital

Shanghai, Shanghai Municipality, 200032, China

Location

MeSH Terms

Conditions

Stomach Neoplasms

Interventions

Sorafenib

Condition Hierarchy (Ancestors)

Gastrointestinal NeoplasmsDigestive System NeoplasmsNeoplasms by SiteNeoplasmsDigestive System DiseasesGastrointestinal DiseasesStomach Diseases

Intervention Hierarchy (Ancestors)

Phenylurea CompoundsUreaAmidesOrganic ChemicalsBenzene DerivativesHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbonsNiacinamideNicotinic AcidsAcids, HeterocyclicHeterocyclic CompoundsPyridinesHeterocyclic Compounds, 1-Ring

Study Officials

  • Jin Li, PhD, M.D.

    Fudan University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER

Study Record Dates

First Submitted

January 7, 2008

First Posted

January 16, 2008

Study Start

July 1, 2007

Primary Completion

January 1, 2009

Study Completion

January 1, 2009

Last Updated

July 7, 2009

Record last verified: 2009-07

Locations

CN(1)