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A Phase II Uncontrolled Study of BAY73-4506 in Previously Untreated Patients With Metastatic or Unresectable Renal Cell Cancer (RCC)

Phase 2
18 Years
Open (Enrolling)
Carcinoma, Renal Cell

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Trial Information

A Phase II Uncontrolled Study of BAY73-4506 in Previously Untreated Patients With Metastatic or Unresectable Renal Cell Cancer (RCC)

The final analysis of efficacy will be performed after last patient has been treated for at
least 6 months. Additional periodic safety and efficacy data reviews will be performed for
any patients continuing to receive study drug afterwards.

Inclusion Criteria:

- Male or female patients >/= 18 years of age.

- Patients, who suffer from unresectable and/or metastatic, measurable predominantly
clear cell RCC histologically or cytologically documented.

- Patients must be previously untreated for advanced disease. Prior palliative
radiation therapy is allowed if the target lesion(s) are not included within the
radiation field and no more than 30% of the bone marrow is irradiated.

- Patients who have at least one uni-dimensional measurable lesion by CT-scan or MRI
according to Response Evaluation Criteria in Solid Tumors (RECIST).

- Patients with "Intermediate" or "Low" risk per the Motzer score.

- Patients who have an Eastern Co-operative Oncology Group (ECOG) performance status of
0 or 1.

- Adequate bone marrow, renal and hepatic function as assessed by the following
laboratory requirements to be conducted within 7 days prior to study drug treatment

Exclusion Criteria:

- Patients who have received prior systemic treatment regimens for RCC.

- Uncontrolled/unstable cardiac disease

- Uncontrolled hypertension

- Active clinically serious infections (> CTCAE grade 2 )

- History of HIV infection or chronic hepatitis B or C.

- Known history or symptomatic metastatic brain or meningeal tumours

- Patients with seizure disorder requiring medication

- Patients with evidence or history of bleeding diathesis. Any hemorrhage or bleeding
event >/= CTCAE Grade 3 within 4 weeks of first dose of study.

- Pregnant or breast-feeding patients

Type of Study:


Study Design:

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

Outcome Measure:

Objective Tumor Response

Outcome Description:

Objective tumor response of a participant was defined as the best tumor response (confirmed Complete Response [CR, tumor disappears] or Partial Response [PR, sum of lesion sizes decreased at least 30% from baseline]) observed during trial period assessed according to the Response Evaluation Criteria in Solid Tumors (RECIST) committee.

Outcome Time Frame:

From start of treatment of the first participant until database cut-off approximately 13 months later (13May2008 - 31May2009). Assessed every 8 weeks for 6 months, then every 12 weeks

Safety Issue:


Principal Investigator

Bayer Study Director

Investigator Role:

Study Director

Investigator Affiliation:



United States: Food and Drug Administration

Study ID:




Start Date:

April 2008

Completion Date:

May 2014

Related Keywords:

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



Fountain Valley, California  92708
Austin, Texas  78705