Zalutumumab With or Without Irinotecan Chemotherapy in Cetuximab-Refractory Colorectal Cancer

NCT00677924 | Terminated Phase 1 Results DMC

• 1 other identifier: GEN206
• Study Type: interventional
• Target: 9
• Locations: 1 country
• Sites: 3

Brief Summary

The purpose of this trial is to determine the safety and efficacy of Zalutumumab alone or in combination with Irinotecan for the treatment of patients with Colorectal Cancer

Conditions

Colorectal Cancer

Keywords

Colorectal Neoplasms; Colorectal Tumors; Colorectal Carcinoma

Outcome Measures

Primary Outcomes (1)

• Number of Participants With Adverse Events (AEs)

  An AE is any untoward medical occurrence in a participant or clinical investigation participant administered a pharmaceutical product and that does not necessarily have a causal relationship with this treatment. An AE can therefore be any unfavourable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not related to the medicinal (investigational) product.

  From first dose up to follow-up (up to approximately 1 year)

Secondary Outcomes (1)

• Number of Participants With Best Overall Tumour Response (BOR)

  Up to 1 year

Study Arms (2)

Zalutumumab 8 mg/kg

EXPERIMENTAL

Zalutumumab in combination with Irinotecan

Drug: Zalutumumab

Zalutumumab 16 mg/kg

EXPERIMENTAL

Zalutumumab in combination with Irinotecan

Drug: Zalutumumab

Interventions

Zalutumumab DRUG

Solution for infusion

Also known as: HuMax-EGFr

Zalutumumab 16 mg/kg; Zalutumumab 8 mg/kg

Eligibility Criteria

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

You may qualify if:

• Males and Females age ≥ 18 years
• Confirmed diagnosis of CRC
• Documented disease progression
• Failure and/or intolerance to standard chemotherapy

You may not qualify if:

• Prior treatment with anti-EGFR antibodies other than cetuximab
• Expected survival \< 3 months
• Clinical significant cardiac disease and/or uncontrolled medical conditions

Sponsors & Collaborators

• Genmab: lead

Study Sites (3)

Institut Jules Bordet

Brussels, 1000, Belgium

Location

Hospital Erasme

Brussels, 1070, Belgium

Location

St-Luc University Hospital

Brussels, 1200, Belgium

Location

Related Publications (1)

• Mano M, Hendlisz A, Machiels JP, Ehrnrooth E, Aladdin H, Van Laethem JL. Phase I trial of zalutumumab and irinotecan in metastatic colorectal cancer patients who have failed irinotecan and cetuximab based therapy. J Clin Oncol 27 2009 (suppl;abstr e15028)

  RESULT

MeSH Terms

Conditions

Colorectal Neoplasms

Interventions

zalutumumab

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

Limitations and Caveats

The trial was prematurely closed when 9 out of 97 patients were enrolled. The trial design was originally divided in two parts. Patient allocation was terminated before Part 2 was started.

Results Point of Contact

• Title: Eva Järlid Westerberg, VP Clinical Operations
• Organization: Genmab A/S

E.Westerberg@genmab.com

+45 7020 2728

Study Officials

• Hassan Aladdin, ICTM

  Genmab

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

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

Study Record Dates

• First Submitted: May 13, 2008
• First Posted: May 15, 2008
• Study Start: April 1, 2008
• Primary Completion: April 1, 2009
• Study Completion: April 1, 2009
• Last Updated: July 18, 2023
• Results First Posted: December 23, 2011

Record last verified: 2023-07

Locations

BE (3)