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Sunitinib as Second-line Treatment in Advanced Biliary Tract Carcinoma

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Samsung Medical Center

Status and phase

Completed
Phase 2

Conditions

Advanced Biliary Tract Adenocarcinoma

Treatments

Drug: Sunitinib

Study type

Interventional

Funder types

Other

Identifiers

NCT01082809
2009-02-025

Details and patient eligibility

About

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

Full description

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

Enrollment

59 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Single Group Assignment

Masking

None (Open label)

59 participants in 1 patient group

Sunitinib
No Intervention group
Description:
Sunitinib, 37.5 mg orally once daily continuously, comprising a 4-week cycle
Treatment:
Drug: Sunitinib

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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