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An Open Label, Dose Escalation Phase I Study to Evaluate the Safety and Tolerability of Continuous Twice-daily Oral Treatment of Nintedanib in Japanese Patients With Hepatocellular Carcinoma.


Phase 1
20 Years
N/A
Open (Enrolling)
Both
Carcinoma, Hepatocellular

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Trial Information

An Open Label, Dose Escalation Phase I Study to Evaluate the Safety and Tolerability of Continuous Twice-daily Oral Treatment of Nintedanib in Japanese Patients With Hepatocellular Carcinoma.

Inclusion Criteria


Inclusion criteria:

1. Histologically/cytologically confirmed hepatocellular carcinoma not amenable to
curative surgery or loco-regional therapy

2. Age 20 years or older

3. Eastern Cooperative Oncology Group (ECOG) performance status (PS) score of 0 or 1

4. Child-Pugh score of 7 or less

5. Life expectancy more than 3 months

6. Time interval from last loco-regional therapy more than 4 weeks

7. Written informed consent in accordance with good clinical practice (GCP)

Exclusion criteria:

1. More than one line of prior systemic therapy for metastatic/unresectable
hepatocellular carcinoma (HCC)

2. Fibrolamellar HCC

3. Uncontrolled or refractory ascites

4. Inadequate organ function

5. Variceal bleeding within 6 months or the presence of inappropriate varices

6. History of major thrombotic (except portal vein thrombosis) or clinically relevant
major bleeding event in the past 6 months

7. Major surgery within 4 weeks

8. Known inherited predisposition to bleeding or thrombosis

9. Significant cardiovascular diseases

Type of Study:

Interventional

Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Determination of maximum tolerated dose (MTD) of nintedanib

Outcome Time Frame:

up to 1 month

Safety Issue:

Yes

Principal Investigator

Boehringer Ingelheim

Investigator Role:

Study Chair

Investigator Affiliation:

Boehringer Ingelheim Pharmaceuticals

Authority:

Japan: Ministry of Health, Labor and Welfare

Study ID:

1199.120

NCT ID:

NCT01594125

Start Date:

May 2012

Completion Date:

August 2014

Related Keywords:

  • Carcinoma, Hepatocellular
  • Carcinoma
  • Carcinoma, Hepatocellular

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