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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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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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

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

Detailed Description

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Conditions

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Metastatic Colorectal Cancer

Keywords

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CRC Colon cancer Avastin APM4566g

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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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

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bevacizumab

Intravenous repeating dose

Intervention Type DRUG

FOLFOX

Intravenous repeating dose

Intervention Type DRUG

PRO95780

Intravenous repeating dose

Intervention Type DRUG

Eligibility Criteria

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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

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Genentech, Inc.

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Chia Portera, M.D.

Role: STUDY_DIRECTOR

Genentech, Inc.

Countries

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United States

Other Identifiers

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APM4566g

Identifier Type: -

Identifier Source: org_study_id