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Phase 2b, DB, Randomized Study Evaluating Efficacy & Safety of Sorafenib Compared With Placebo When Administered in Combination With Modified FOLFOX6 for the Treatment of Metastatic CRC Subjects Previously Untreated for Stage IV Disease


Phase 2
18 Years
N/A
Not Enrolling
Both
Metastatic Colorectal Cancer

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Trial Information

Phase 2b, DB, Randomized Study Evaluating Efficacy & Safety of Sorafenib Compared With Placebo When Administered in Combination With Modified FOLFOX6 for the Treatment of Metastatic CRC Subjects Previously Untreated for Stage IV Disease


Inclusion Criteria:



- Histological confirmation of adenocarcinoma of the colon or rectum

- Tumor tissue sample available for KRAS and BRAF assessment

- Measurable metastatic Stage IV disease including at least one measurable lesion that
has not previously been radiated

- No prior chemotherapy for metastatic CRC

- Eastern Cooperative Oncology Group (ECOG) performance status (PS) of 0 or 1

- Life expectancy of at least 12 weeks

- Adequate bone marrow, liver, and renal function; adequate clotting parameters

Exclusion Criteria:

- Prior treatment with sorafenib

- Clinical or radiographic evidence of brain metastasis

- Major surgery, surgical biopsy, or significant traumatic injury within 28 days of
randomization; evidence or history of bleeding diathesis or coagulopathy

- Red blood cell (RBC), white blood cell (WBC), or platelet transfusions and/or growth
factor use within 28 days before randomization

- Adjuvant therapy for CRC (Stage I, II, or III) completed within 12 months before
randomization

- Serious, non-healing wound, ulcer, or bone fracture; Grade 3 or 4 hemorrhage within
28 days before randomization

- Use of anticoagulation therapy (low dose anticoagulation therapy to mitigate risk of
thrombosis due to placement of a semi-permanent central venous port for
administration of chemotherapy is allowed. The use of coumadin and related compounds
is excluded.)

- Uncontrolled hypertension (systolic blood pressure > 150 mmHg or diastolic pressure >
100 mmHg on repeated measurement) despite optimal medical management

- Thrombolic, embolic, venous, or arterial events (eg, cerebrovascular accident,
including transient ischemic attacks) within 6 months before randomization

- Active cardiac disease including:

- Congestive heart failure

- Unstable angina or myocardial infarction within the 6 months before
randomization

- Cardiac ventricular arrhythmias requiring antiarrhythmic treatment

- Peripheral neuropathy > Grade 1 (CTCAE)

- Known HIV infection or chronic hepatitis B or C infection

- Any active infection >/= Grade 2 (CTCAE)

- Any medical, psychological, or social condition that may interfere with the subject's
participation in the study or evaluation of the study results

- Use of any investigational drug within 28 days or 5 half-lives of that drug,
whichever is longer, before randomization

- Subjects with metastatic CRC who are currently candidates for surgery with curative
intent

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Outcome Measure:

Progression-Free Survival (PFS)

Outcome Description:

Progression-free Survival (PFS) was defined as the time from date of randomization to disease progression or death due to any cause, whichever occurred first. Subjects without progression or death at the time of analysis were censored at their last date of tumor evaluation. Disease progression was defined as an increase of at least 20% in the sum of tumor lesions sizes.

Outcome Time Frame:

From randomization of the first subject until 23 months later, assessed every 8 weeks.

Safety Issue:

No

Principal Investigator

Bayer Study Director

Investigator Role:

Study Director

Investigator Affiliation:

Bayer

Authority:

Belgium: Federal Agency for Medicines and Health Products, FAMHP

Study ID:

13162

NCT ID:

NCT00865709

Start Date:

March 2009

Completion Date:

February 2012

Related Keywords:

  • Metastatic Colorectal Cancer
  • Colorectal Cancer
  • Metastasis
  • Stage IV
  • Liver Metastasis
  • Colorectal Neoplasms

Name

Location

Austin, Texas  78705
Kansas City, Kansas  66160
Metairie, Louisiana  70006
Boston, Massachusetts