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)
Primary Purpose
Metastatic Colorectal Cancer
Status
Completed
Phase
Phase 1
Locations
Study Type
Interventional
Intervention
bevacizumab
FOLFOX
PRO95780
Sponsored by
About this trial
This is an interventional treatment trial for Metastatic Colorectal Cancer focused on measuring CRC, Colon cancer, Avastin, APM4566g
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
Sites / Locations
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
1
Arm Description
Outcomes
Primary Outcome Measures
Incidence and nature of dose-limiting toxicities
Secondary Outcome Measures
Incidence, nature, and severity of adverse events
Change in vital signs
Incidence and severity of infusion reactions
Change in clinical laboratory results
Incidence of anti-PRO95780 antibodies
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00851136
Brief Title
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)
Official Title
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
Study Type
Interventional
2. Study Status
Record Verification Date
December 2022
Overall Recruitment Status
Completed
Study Start Date
May 2009 (Actual)
Primary Completion Date
June 2010 (Actual)
Study Completion Date
June 2010 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Genentech, Inc.
4. Oversight
5. Study Description
Brief Summary
This will be a multicenter, open-label study enrolling a total of up to 23 patients.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Metastatic Colorectal Cancer
Keywords
CRC, Colon cancer, Avastin, APM4566g
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
9 (Actual)
8. Arms, Groups, and Interventions
Arm Title
1
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
bevacizumab
Intervention Description
Intravenous repeating dose
Intervention Type
Drug
Intervention Name(s)
FOLFOX
Intervention Description
Intravenous repeating dose
Intervention Type
Drug
Intervention Name(s)
PRO95780
Intervention Description
Intravenous repeating dose
Primary Outcome Measure Information:
Title
Incidence and nature of dose-limiting toxicities
Time Frame
Length and study
Secondary Outcome Measure Information:
Title
Incidence, nature, and severity of adverse events
Time Frame
Length of study
Title
Change in vital signs
Time Frame
Length of study
Title
Incidence and severity of infusion reactions
Time Frame
Length of study
Title
Change in clinical laboratory results
Time Frame
Length of study
Title
Incidence of anti-PRO95780 antibodies
Time Frame
Length of study
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Chia Portera, M.D.
Organizational Affiliation
Genentech, Inc.
Official's Role
Study Director
12. IPD Sharing Statement
Learn more about this trial
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)
We'll reach out to this number within 24 hrs