A Study of Dulanermin Administered in Combination With Camptosar®/Erbitux® Chemotherapy or FOLFIRI (With or Without Bevacizumab) in Subjects With Previously Treated Metastatic Colorectal Cancer

NCT00671372 | Completed Phase 1

• 2 other identifiers: APO3583gGO00933
• Study Type: interventional
• Target: 42
• Locations: 1 country
• Sites: 10

Brief Summary

This study will assess the safety and pharmacokinetics of adding dulanermin to Camptosar®/Erbitux® or the FOLFIRI regimen (Camptosar®, 5-FU, and leucovorin) plus bevacizumab (only for Cohort 6 subjects who have not received prior bevacizumab therapy).

Conditions

Colorectal Cancer

Keywords

CRC; Metastatic CRC; APO2L/TRAIL

Outcome Measures

Primary Outcomes (2)

• The safety and tolerability of dulanermin administered in combination with Camptosar and Erbitux

  Length of study

• The safety and tolerability of dulanermin administered in combination with FOLFIRI (with or without Bevacizumab)

  Length of study

Study Arms (2)

Cohorts 1-5

EXPERIMENTAL

Drug: cetuximab; Drug: dulanermin; Drug: irinotecan

Cohorts 6, 6A, 7, 7A

EXPERIMENTAL

Drug: FOLFIRI regimen; Drug: bevacizumab; Drug: dulanermin

Interventions

FOLFIRI regimen DRUG

Intravenous repeating dose

Cohorts 6, 6A, 7, 7A

bevacizumab DRUG

Intravenous repeating dose (for Cohort 6 subjects not previously treated with bevacizumab)

Cohorts 6, 6A, 7, 7A

cetuximab DRUG

Intravenous repeating dose

Cohorts 1-5

dulanermin DRUG

Intravenous repeating dose

Cohorts 1-5; Cohorts 6, 6A, 7, 7A

irinotecan DRUG

Intravenous repeating dose

Cohorts 1-5

Eligibility Criteria

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

You may qualify if:

• Signed Informed Consent Form
• Age \>= 18 years
• Histologically confirmed CRC with evidence of metastases and measurable tumor lesion(s)
• Progression of disease following, or intolerance to, treatment with 5-fluorouracil-based therapy
• Progression of disease during or within =\< 6 months following the last dose of a prior first-line treatment with a fluoropyrimidine and oxaliplatin-based chemotherapy plus bevacizumab for metastatic disease
• Use of an effective means of contraception for women of childbearing potential and men with partners of childbearing potential (use per institutional standard)
• Life expectancy of \> 3 months
• Willingness and capability to be accessible for study follow-up

You may not qualify if:

• Prior radiotherapy to a measurable, metastatic lesion(s) to be used to measure response
• Radiation therapy to a peripheral lesion within 14 days prior to Day 1; Radiation therapy to a thoracic, abdominal or pelvic field within 28 days prior to Day 1
• Chemotherapy, hormonal therapy, or immunology within 4 weeks prior to Day 1
• Previous exposure to DR4-targeted therapy or DR5-targeted therapy
• Evidence of clinically detectable ascites on Day
• Other invasive malignancies within 5 years prior to Day 1 (other than basal cell carcinoma of the skin or in situ carcinoma of the cervix)
• History or evidence upon physical examination of CNS disease
• Active infection requiring parenteral antibiotics on Day 1
• Major surgical procedure, open biopsy, or significant traumatic injury within 28 days prior to Day 1 or anticipation of need for major surgical procedure during the course of the study and fine needle aspirations within 7 days prior to Day 1
• Pregnancy or lactation
• Serious nonhealing wound, ulcer, or bone fracture
• Current or recent participation in another experimental drug study
• Clinically significant cardiovascular disease
• 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 that might affect interpretation of the results of the study or render the subject at high risk from treatment complications
• Cohort 5 only: Subjects who have a Kras mutation will be excluded from enrollment

Sponsors & Collaborators

• Genentech, Inc.: lead

Study Sites (10)

Unknown Facility

Los Angeles, California, 90095, United States

Location

Unknown Facility

Redlands, California, 92374, United States

Location

Unknown Facility

San Francisco, California, 94115, United States

Location

Unknown Facility

Fort Myers, Florida, 33916, United States

Location

Unknown Facility

Harvey, Illinois, 60426, United States

Location

Unknown Facility

Buffalo, New York, 14263, United States

Location

Unknown Facility

Durham, North Carolina, 27710, United States

Location

Unknown Facility

Hershey, Pennsylvania, 17033, United States

Location

Unknown Facility

Nashville, Tennessee, 37203, United States

Location

Unknown Facility

Tacoma, Washington, 98405, United States

Location

MeSH Terms

Conditions

Colorectal Neoplasms

Interventions

Bevacizumab; Cetuximab; TNFSF10 protein, human; Irinotecan

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; Camptothecin; Alkaloids; Heterocyclic Compounds

Study Officials

• Chia Portera, M.D.

  Genentech, Inc.

  STUDY DIRECTOR

Study Design

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

Study Record Dates

• First Submitted: April 18, 2008
• First Posted: May 5, 2008
• Study Start: July 1, 2006
• Primary Completion: March 1, 2012
• Study Completion: March 1, 2012
• Last Updated: November 2, 2016

Record last verified: 2016-11

Locations

US (10)