Phase 2
Completed N=49
A Phase II Uncontrolled Study of BAY73-4506 in Previously Untreated Patients With Metastatic or Unresectable RCC
Carcinoma, Renal Cell
Source: ClinicalTrials.gov NCT00664326 ↗
Enrolled (actual)
49
Serious AEs
65.3%
Results posted
Nov 2012
Primary outcomePrimary: Objective Tumor Response — 31.3 Percentage of participants
Summary
This is a uncontrolled, open-label, non-randomized Phase II study of oral BAY73-4506 to evaluate the response rate of BAY73-4506 in previously untreated patients with metastatic or unresectable renal cell cancer (RCC).
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Objective Tumor Response |
31.3 | — |
| PRIMARY Tumor Response |
0.0; 31.3; 50.0; 10.4; 8.3 | — |
| SECONDARY Disease Control |
62.5 | — |
| SECONDARY Overall Survival |
NA | — |
| SECONDARY Progression-free Survival (PFS) |
251 | — |
| SECONDARY Time to Progression (TTP) |
251 | — |
| SECONDARY Duration of Response |
NA | — |
| SECONDARY Duration of Stable Disease (SD) |
172 | — |
Eligibility Criteria
Inclusion Criteria
- Male or female patients >/= 18 years of age.
- Patients, who suffer from unresectable and/or metastatic, measurable predominantly clear cell RCC (renal cell carcinoma 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 computed tomography (CT-scan) or magnetic resonance imaging (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 (> Common Terminology Criteria for Adverse Events [CTCAE] grade 2 )
- History of human immunodeficiency virus (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
Data sourced from ClinicalTrials.gov (NCT00664326). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.