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)

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

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

Study Overview

• Status: Completed
• Conditions: Metastatic Colorectal Cancer
• Intervention / Treatment: Drug: bevacizumab; Drug: PRO95780; Drug: FOLFOX

• Study Type: Interventional
• Enrollment (Actual): 9
• Phase: Phase 1

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 1	Drug: bevacizumab; Intravenous repeating dose; Drug: PRO95780; Intravenous repeating dose; Drug: FOLFOX; Intravenous repeating dose

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Incidence and nature of dose-limiting toxicities	Length and study

Secondary Outcome Measures

Outcome Measure	Time Frame
Incidence, nature, and severity of adverse events	Length of study
Change in vital signs	Length of study
Incidence and severity of infusion reactions	Length of study
Change in clinical laboratory results	Length of study
Incidence of anti-PRO95780 antibodies	Length of study

Collaborators and Investigators

• Sponsor: Genentech, Inc.

Study record dates

Study Major Dates

• Study Start (Actual): May 1, 2009
• Primary Completion (Actual): June 1, 2010
• Study Completion (Actual): June 1, 2010

Study Registration Dates

• First Submitted: February 23, 2009
• First Submitted That Met QC Criteria: February 23, 2009
• First Posted (Estimate): February 25, 2009

Study Record Updates

• Last Update Posted (Estimate): December 13, 2022
• Last Update Submitted That Met QC Criteria: December 9, 2022
• Last Verified: December 1, 2022

More Information

Terms related to this study

• Keywords: Avastin; CRC; Colon cancer; APM4566g
• Additional Relevant MeSH Terms: Digestive System Diseases; Neoplasms; Neoplasms by Site; Gastrointestinal Neoplasms; Digestive System Neoplasms; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Intestinal Neoplasms; Rectal Diseases; Colorectal Neoplasms; Physiological Effects of Drugs; Antineoplastic Agents; Antineoplastic Agents, Immunological; Angiogenesis Inhibitors; Angiogenesis Modulating Agents; Growth Substances; Growth Inhibitors; Bevacizumab
• Other Study ID Numbers: APM4566g