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A Phase Ib Study of the Safety and Pharmacokinetics of PRO95780 Administered in Combination With the FOLFOX Regimen and Bevacizumab in Patients With Previously Untreated, Locally Advanced, Recurrent, and Metastatic Colorectal Cancer


Phase 1
18 Years
N/A
Not Enrolling
Both
Metastatic Colorectal Cancer

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Trial Information

A Phase Ib Study of the Safety and Pharmacokinetics of PRO95780 Administered in Combination With the FOLFOX Regimen and Bevacizumab in Patients With Previously Untreated, Locally Advanced, Recurrent, and Metastatic Colorectal Cancer


Inclusion Criteria:



- Histologically confirmed CRC with evidence of locally advanced recurrent or
metastatic disease and measurable tumor lesions

- Life expectancy > 3 months

- For patients of reproductive potential (males and females), use of reliable means for
contraception throughout the trial and for 6 months following their final exposure to
study treatment

- Willingness and capability to be accessible for study follow-up

Exclusion Criteria:

- Prior 5-FU, capecitabine, and/or oxaliplatin treatment with the exception of: prior
oxaliplatin treatment≤ 6 weeks in the advanced or metastatic setting; prior treatment
with 5-FU, capecitabine, and/or oxaliplatin in the adjuvant setting if relapse
occurred > 6 months from concluding adjuvant therapy

- Peripheral neuropathy Grade ≥ 2

- Prior radiotherapy to a measurable metastatic lesion(s) to be used for response
assessment, unless the lesion has progressed subsequent to the radiotherapy

- Radiotherapy to a peripheral lesion within 14 days prior to Cycle 1, Day 1, or
radiotherapy to a thoracic, abdominal, or pelvic field within 28 days prior to Cycle
1, Day 1

- Chemotherapy, hormonal therapy, or immunotherapy within 4 weeks prior to Cycle 1, Day
1

- Evidence of clinically detectable ascites

- Other invasive malignancies within 5 years prior to Cycle 1, Day 1

- History or evidence upon physical examination of active central nervous system (CNS)
disease

- Current or recent participation in another experimental drug study

- Clinically significant cardiovascular disease, New York Heart Association (NYHA)
Grade II or greater congestive heart failure, serious cardiac arrhythmia within 1
year prior to Cycle 1, Day 1, or Grade II or greater peripheral vascular disease

- Active infection requiring parenteral antibiotics

- Major surgical procedure, open biopsy, or significant traumatic injury within 28 days
prior to Cycle 1, Day 1, fine needle aspirations within 7 days prior to Cycle 1, Day
1, or anticipation of need for major surgical procedure during the course of the
study

- Known or suspected to be positive for the human immunodeficiency virus (HIV)

- Known to be positive for hepatitis C or hepatitis B surface antigen

- Inadequately controlled hypertension

- Prior history of hypertensive crisis or hypertensive encephalopathy

- History of arterial thromboembolic event 6 months prior to Cycle 1, Day 1

- History of abdominal fistula or gastrointestinal perforation within 6 months prior to
Cycle 1, Day 1

- Bleeding diathesis or coagulopathy

- Pregnancy (positive pregnancy test) or breast feeding

- Serious, non-healing wound, ulcer, or bone fracture

Type of Study:

Interventional

Study Design:

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Incidence and nature of dose-limiting toxicities

Outcome Time Frame:

Length and study

Principal Investigator

Chia Portera, M.D.

Investigator Role:

Study Director

Investigator Affiliation:

Genentech

Authority:

United States: Food and Drug Administration

Study ID:

APM4566g

NCT ID:

NCT00851136

Start Date:

May 2009

Completion Date:

June 2010

Related Keywords:

  • Metastatic Colorectal Cancer
  • CRC
  • Colon cancer
  • Avastin
  • APM4566g
  • Colorectal Neoplasms

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