Sunitinib as Second-line Treatment in Advanced Biliary Tract Carcinoma

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

59 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-03-31

Study Completion Date

2012-02-29

Brief Summary

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The purpose of this study is to determine whether sunitinib as second-line treatment in advanced biliary tract carcinoma

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Detailed Description

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Phase II study of sunitinib as second-line treatment in advanced biliary tract carcinoma: multicenter, multinational study

Conditions

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Advanced Biliary Tract Adenocarcinoma

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Sunitinib

Sunitinib, 37.5 mg orally once daily continuously, comprising a 4-week cycle

Group Type NO_INTERVENTION

Sunitinib

Intervention Type DRUG

Sunitinib 37.5 mg orally once daily continuously, comprising a 4-week cycle

Interventions

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Sunitinib

Sunitinib 37.5 mg orally once daily continuously, comprising a 4-week cycle

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

1. age ≥ 18
2. histologically or cytologically confirmed adenocarcinoma of biliary tract
3. unresectable or metastatic
4. ECOG performance status of 0\~2
5. measurable or evaluable lesion per RECIST criteria
6. adequate marrow, hepatic, renal and cardiac functions
7. One prior treatment of cytotoxic chemotherapy (including adjuvant treatment within 12 months)
8. provision of a signed written informed consent

Exclusion Criteria

1. severe co-morbid illness and/or active infections
2. pregnant or lactating women
3. active CNS metastases not controllable with radiotherapy or corticosteroids
4. known history of hypersensitivity to study drugs

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No