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A Phase II, Multi-centre, Open-label Study to Assess the Efficacy, Safety, Tolerability and Pharmacokinetics of Intrapatient Dose Escalation of Sorafenib as First Line Treatment for Metastatic Renal Cell Carcinoma.


Phase 2
18 Years
N/A
Not Enrolling
Both
Carcinoma, Renal Cell

Thank you

Trial Information

A Phase II, Multi-centre, Open-label Study to Assess the Efficacy, Safety, Tolerability and Pharmacokinetics of Intrapatient Dose Escalation of Sorafenib as First Line Treatment for Metastatic Renal Cell Carcinoma.


Issues on Outcome Measure "Safety and tolerability" will be addressed in the Adverse Events
section.

The following abbreviations were used in the Adverse Events section:

- Gastrointestinal (GI)

- Alanine aminotransferase (ALT)

- Aspartate aminotransferase (AST)

- Gammaglutamyltransferase (GGT)


Inclusion Criteria:



- Age > 18 years.

- Metastatic clear cell RCC

- Subjects with at least one uni-dimensional measurable lesion.

- ECOG Performance Status of 0 or 1

- MSKCC good or intermediate category

- Life expectancy of at least 12 weeks.

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

- Signed informed consent must be obtained prior to any study specific procedures.

- Subjects must have received no prior systemic anticancer therapy for the treatment of
their renal cell carcinoma

- Prior total nephrectomy

Exclusion Criteria:

- History of cardiac disease

- History of HIV infection or chronic hepatitis B or C

- Active clinically serious infections (> grade 2 NCI-CTCAE version 3.0)

- Symptomatic metastatic brain or meningeal tumors unless the subject is > 6 months
from definitive therapy, has a negative imaging study within 4 weeks of study entry
and is clinically stable with respect to the tumor at the time of study entry.

- Subjects with evidence or history of bleeding diathesis

- Deep vein thrombosis and/or pulmonary embolus within 12 months of the start of
treatment.

- Delayed healing of wounds, ulcers or bone fractures

- Subjects with pre-existing thyroid abnormality whose thyroid function cannot be
maintained within the normal range by medication

- Subjects undergoing renal dialysis

- Pregnant or breast-feeding subjects. Women of childbearing potential must have a
negative serum pregnancy test performed within 7 days prior to the start of
treatment. Both men and women enrolled in this trial must use adequate barrier birth
control measures during the course of the trial and three months after the completion
of trial.

- Prior adjuvant sorafenib is excluded.

- Radiotherapy during study or within 3 weeks of start of study drug

- Major surgery within 4 weeks of start of study

- Investigational drug therapy outside of this trial during or within 4 weeks of study
entry

Type of Study:

Interventional

Study Design:

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

Outcome Measure:

Tumor Response

Outcome Description:

Tumor Response of a subject was defined as the best tumor response observed during trial period assessed according to the Response Evaluation Criteria in Solid Tumors (RECIST) criteria. Confirmed Complete Response (CR) was defined as disappearance of tumor, Partial Response (PR) was defined as a decrease of at least 30% in the sum of tumor lesion sizes, Stable Disease (SD) was defined as steady state of disease, or Progressive Disease (PD) was defined as an increase in the sum of tumor lesions sizes.

Outcome Time Frame:

From start of treatment assessed every 2 cycles up to 6 cycles

Safety Issue:

No

Principal Investigator

Bayer Study Director

Investigator Role:

Study Director

Investigator Affiliation:

Bayer

Authority:

France: Direction Générale de la Santé

Study ID:

12913

NCT ID:

NCT00618982

Start Date:

February 2008

Completion Date:

January 2011

Related Keywords:

  • Carcinoma, Renal Cell
  • Kidney cancer,
  • Sorafenib,
  • Dose escalation,
  • No previous treatment
  • Carcinoma
  • Carcinoma, Renal Cell

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