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)

NCT00851136 | Completed Phase 1

• 1 other identifier: APM4566g
• Study Type: interventional
• Target: 9
• Locations: 0 countries
• Sites: N/A

Brief Summary

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

Conditions

Metastatic Colorectal Cancer

Keywords

CRC; Colon cancer; Avastin; APM4566g

Outcome Measures

Primary Outcomes (1)

• Incidence and nature of dose-limiting toxicities

  Length and study

Secondary Outcomes (5)

• 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

Study Arms (1)

1

EXPERIMENTAL

Drug: bevacizumab; Drug: FOLFOX; Drug: PRO95780

Interventions

bevacizumab DRUG

Intravenous repeating dose

1

FOLFOX DRUG

Intravenous repeating dose

1

PRO95780 DRUG

Intravenous repeating dose

1

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Genentech, Inc.: lead

MeSH Terms

Conditions

Colorectal Neoplasms; Colonic Neoplasms

Interventions

Bevacizumab; Folfox protocol; drozitumab

Condition Hierarchy (Ancestors)

Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Rectal Diseases

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins

Study Officials

• Chia Portera, M.D.

  Genentech, Inc.

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 23, 2009
• First Posted: February 25, 2009
• Study Start: May 1, 2009
• Primary Completion: June 1, 2010
• Study Completion: June 1, 2010
• Last Updated: December 13, 2022

Record last verified: 2022-12