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A Randomised, Open Label, Parallel Group Phase II Study Comparing the Efficacy and Tolerability of BIBF 1120 Versus Sunitinib in Previously Untreated Patients With Renal Cell Cancer


Phase 2
18 Years
N/A
Open (Enrolling)
Both
Carcinoma, Renal Cell

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Trial Information

A Randomised, Open Label, Parallel Group Phase II Study Comparing the Efficacy and Tolerability of BIBF 1120 Versus Sunitinib in Previously Untreated Patients With Renal Cell Cancer

Inclusion Criteria


Inclusion criteria:

1. Patients with unresectable or metastatic Renal Cell Cancer, who have received no
previous systemic anti-cancer treatment.

2. Histological-confirmed diagnosis of renal cell cancer with clear cell component.

3. Acceptable renal,liver,cardiovascular,bone marrow and other functions to allow
sunitinib/BIBF 1120 treatment.

Exclusion criteria:

1. Patients unable to tolerate Sunitinib/BIBF 1120 treatment

2. Treatment with other investigational drugs or participation in another clinical study
within the past 4 weeks before start of therapy or concomitantly with this study.

3. Patients unable to comply with the 1199.26 protocol.

4. Pregnancy or breast feeding.

5. Active alcohol or drug abuse.

6. Women of child bearing potential, or men who are able to father a child, unwilling to
use a medically acceptable form of contraception during the study period.

Type of Study:

Interventional

Study Design:

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

Outcome Measure:

Progression Free Survival at 9 months.

Outcome Time Frame:

9 months of treatment

Safety Issue:

No

Principal Investigator

Boehringer Ingelheim

Investigator Role:

Study Chair

Investigator Affiliation:

Boehringer Ingelheim Pharmaceuticals

Authority:

Hungary: National Institute of Pharmacy

Study ID:

1199.26

NCT ID:

NCT01024920

Start Date:

December 2009

Completion Date:

January 2014

Related Keywords:

  • Carcinoma, Renal Cell
  • Carcinoma
  • Carcinoma, Renal Cell

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