A Study of PRO95780 Administered in Combination With the FOLFOX Regimen and Bevacizumab in Patients With Previously Untreated, Locally Advanced, Recurrent, and Metastatic Colorectal Cancer (APM4566g)

NCT ID: NCT00851136

Last Updated: 2022-12-13

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 9 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2009-05-31
• Study Completion Date: 2010-06-30

Brief Summary

This will be a multicenter, open-label study enrolling a total of up to 23 patients.

Conditions

Metastatic Colorectal Cancer

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

1

Group Type: EXPERIMENTAL

bevacizumab

Intervention Type: DRUG

Intravenous repeating dose

FOLFOX

Intervention Type: DRUG

Intravenous repeating dose

PRO95780

Intervention Type: DRUG

Intravenous repeating dose

Interventions

bevacizumab

Intravenous repeating dose

Intervention Type: DRUG

FOLFOX

Intravenous repeating dose

Intervention Type: DRUG

PRO95780

Intravenous repeating dose

Intervention Type: DRUG

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Genentech, Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Chia Portera, M.D.

Role: STUDY_DIRECTOR

Genentech, Inc.

Other Identifiers

APM4566g

Identifier Type: -

Identifier Source: org_study_id