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

Metastatic Colorectal Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00873756
• Other study ID #: APO4565g
• Secondary ID: GO00934
• Status: Completed
• Phase: Phase 1
• First received: March 5, 2009
• Last updated: November 1, 2016
• Start date: May 2009
• Est. completion date: April 2014

Study information

• Verified date: November 2016
• Source: Genentech, Inc.
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 23
• Est. completion date: April 2014
• Est. primary completion date: March 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

• Major surgical procedure, open biopsy, or significant traumatic injury within 28 days prior to Cycle 1, Day 1, fine needle aspirations or minor surgery (such as port placement) 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

• History of other disease, metabolic dysfunction, physical examination finding, or clinical laboratory finding giving reasonable suspicion of a disease or condition that contraindicates use of an investigational drug or specified study treatment, or that might affect interpretation of the results of the study or render the patient at high risk from treatment complications

• 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 Design

Allocation: Non-Randomized, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Colorectal Neoplasms
• Metastatic Colorectal Cancer

Intervention

Drug:
• FOLFOX regimen
Intravenous repeating dose
• bevacizumab
Intravenous repeating dose
• dulanermin
Intravenous repeating dose

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Genentech, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Incidence and nature of dose-limiting toxicities		Until study discontinuation or the end of Cycle 26	No
Secondary	Incidence, nature, and severity of adverse events		Until study discontinuation or the end of Cycle 26	No
Secondary	Change in vital signs		Until study discontinuation or the end of Cycle 26	No
Secondary	Change in clinical laboratory results		Until study discontinuation or the end of Cycle 26	No
Secondary	Incidence of anti-dulanermin antibodies		Until study discontinuation or the end of Cycle 26	No