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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT02013830




Registration number
NCT02013830
Ethics application status
Date submitted
3/12/2013
Date registered
17/12/2013
Date last updated
6/06/2014

Titles & IDs
Public title
A Study of Avastin (Bevacizumab) and Xeloda (Capecitabine) in Patients With Advanced or Metastatic Liver Cancer
Scientific title
A Single-arm, Open-label Study of Avastin Plus Xeloda on Objective Treatment Response in Patients With Advanced or Metastatic Liver Cancer Who Have Had no Previous Cytotoxic Chemotherapy
Secondary ID [1] 0 0
ML18469
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Liver Cancer 0 0
Condition category
Condition code
Cancer 0 0 0 0
Liver
Oral and Gastrointestinal 0 0 0 0
Other diseases of the mouth, teeth, oesophagus, digestive system including liver and colon

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - bevacizumab [Avastin]
Treatment: Drugs - capecitabine [Xeloda]

Experimental: Avastin + Xeloda -


Treatment: Drugs: bevacizumab [Avastin]
7.5mg/kg iv on day 1 of each 3 week cycle.

Treatment: Drugs: capecitabine [Xeloda]
1600mg/m2/day po in 2 divided doses, on days 1 to 14 of each 3 week cycle.
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Percentage of Participants With Objective Response (OR)
Timepoint [1] 0 0
Screening; Weeks 6, 12, 18, 24, and 30; Every 3 months through follow-up
Secondary outcome [1] 0 0
Percentage of Participants With Disease Control
Timepoint [1] 0 0
Screening; Weeks 6, 12, 18, 24, and 30; Every 3 months through follow-up
Secondary outcome [2] 0 0
Time to Disease Progression - Percentage of Participants With an Event
Timepoint [2] 0 0
Screening; Weeks 6, 12, 18, 24, and 30; Every 3 months through follow-up
Secondary outcome [3] 0 0
Time to Disease Progression
Timepoint [3] 0 0
Screening; Weeks 6, 12, 18, 24, and 30; Every 3 months through follow-up
Secondary outcome [4] 0 0
Time to Disease Progression - Percentage of Participants Progression-free at 12 Months
Timepoint [4] 0 0
Day 1, Weeks 1-18, Weeks 24 and 30, then every 3 months until death.
Secondary outcome [5] 0 0
Overall Survival - Percentage of Participants With an Event
Timepoint [5] 0 0
Day 1, Weeks 1-18, Weeks 24 and 30, then every 3 months until death.
Secondary outcome [6] 0 0
Overall Survival
Timepoint [6] 0 0
Day 1, Weeks 1-18, Weeks 24 and 30, then every 3 months until death.
Secondary outcome [7] 0 0
Overall Survival - Percentage of Participants Event Free at 12 Months
Timepoint [7] 0 0
Day 1, Weeks 1-18, Weeks 24 and 30, then every 3 months until death.

Eligibility
Key inclusion criteria
* adult patients >=18 years of age;
* advanced or metastatic liver cancer;
* >=1 measurable lesion.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
* current radiotherapy, chemotherapy, or other experimental therapies;
* prior cytotoxic chemotherapy;
* major surgery, open biopsy, or traumatic injury within 28 days of study entry;
* history of a malignancy during the last 5 years, other than cutaneous basal cell cancer or in situ cervical cancer.

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Phase 2
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/05/2005
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/03/2008
Sample size
Target
Accrual to date
Final
45
Recruitment in Australia
Recruitment state(s)
Recruitment hospital [1] 0 0
- Melbourne
Recruitment postcode(s) [1] 0 0
3181 - Melbourne
Recruitment outside Australia
Country [1] 0 0
Hong Kong
State/province [1] 0 0
Hong Kong
Country [2] 0 0
Singapore
State/province [2] 0 0
Singapore
Country [3] 0 0
Taiwan
State/province [3] 0 0
Kueishan
Country [4] 0 0
Taiwan
State/province [4] 0 0
Taipei

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Hoffmann-La Roche
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
This study will evaluate the efficacy and safety of oral Xeloda (capecitabine) plus intravenous Avastin (bevacizumab) in patients with advanced or metastatic liver cancer. The anticipated time on study treatment is 3-12 months.
Trial website
https://clinicaltrials.gov/study/NCT02013830
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Clinical Trials
Address 0 0
Hoffmann-La Roche
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/study/NCT02013830