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A Study of Dulanermin Administered in Combination With the FOLFOX Regimen and Bevacizumab in Patients With Previously Untreated, Locally Advanced, Recurrent, or Metastatic Colorectal Cancer | Clinical Trials | Clareo Health

COMPLETEDPHASE1

A Study of Dulanermin Administered in Combination With the FOLFOX Regimen and Bevacizumab in Patients With Previously Untreated, Locally Advanced, Recurrent, or Metastatic Colorectal Cancer

A Phase Ib Study of the Safety and Pharmacokinetics of Dulanermin Administered in Combination With the FOLFOX Regimen and Bevacizumab in Patients With Previously Untreated, Locally Advanced, Recurrent, or Metastatic Colorectal Cancer

NCT00873756•Genentech, Inc.

View on ClinicalTrials.gov

Summary

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

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•Histologically confirmed CRC with evidence of locally advanced recurrent or metastatic disease (i.e., by radiographic imaging or biopsy) 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
•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
•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 on Cycle 1, Day 1
•Active infection requiring parenteral antibiotics
+11 more criteria

Locations (7)

Los Angeles, California, United States

San Francisco, California, United States

Aurora, Colorado, United States

Fort Collins, Colorado, United States

Harvey, Illinois, United States

Albuquerque, New Mexico, United States

Chapel Hill, North Carolina, United States

Key Dates

Start Date

May 1, 2009

Primary Completion Date

March 1, 2014

Completion Date

April 1, 2014

Last Updated

November 2, 2016

Enrollment

ACTUAL participants

Conditions

Metastatic Colorectal Cancer

Interventions

FOLFOX regimen

DRUG

bevacizumab

DRUG

dulanermin

DRUG

A Study of ART0380 for the Treatment of Advanced or Metastatic Solid Tumors

NCT04657068

Advanced CancerMetastatic Cancer+7 more

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RECRUITINGPHASE1

Open-Label Study of BBO-10203 in Subjects With Advanced Solid Tumors

NCT06625775

Solid Tumor, AdultMetastatic Breast Cancer+9 more

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: November 2, 2016Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

A Study of Dulanermin Administered in Combination With the FOLFOX Regimen and Bevacizumab in Patients With Previously Untreated, Locally Advanced, Recurrent, or Metastatic Colorectal Cancer

Inclusion Criteria

Exclusion Criteria

A Study of ART0380 for the Treatment of Advanced or Metastatic Solid Tumors

Open-Label Study of BBO-10203 in Subjects With Advanced Solid Tumors

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A Phase Ib/III Study of Suvemcitug Plus FTD/TPI in Participants With Refractory Metastatic Colorectal Cancer

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