NCT00969033

Brief Summary

The purpose of this study is to determine the effect of CS-1008 in combination with irinotecan compared to irinotecan alone on Progression-Free Survival (PFS) in subjects with metastatic or advanced colorectal cancer (CRC) who have failed oxaliplatin-based first-line treatment.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
8

participants targeted

Target at below P25 for phase_2

Timeline
Completed

Started Jul 2009

Geographic Reach
1 country

9 active sites

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2009

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

August 28, 2009

Completed
3 days until next milestone

First Posted

Study publicly available on registry

August 31, 2009

Completed
2.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2011

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2011

Completed
Last Updated

January 31, 2012

Status Verified

January 1, 2012

Enrollment Period

2.4 years

First QC Date

August 28, 2009

Last Update Submit

January 30, 2012

Conditions

Metastatic Colorectal Cancer

Outcome Measures

Primary Outcomes (1)

  • Determine the difference in progression-free survival (PFS) for CS-1008 administered in combination with irinotecan and irinotecan alone.

    1 year

Secondary Outcomes (4)

  • Determine the difference in overall survival for CS-1008 administered in combination with irinotecan and irinotecan alone.

    1 year

  • Determine the difference in median survival for CS-1008 administered in combination with irinotecan and irinotecan alone.

    1 year

  • Determine the difference in objective response rate (ORR) for CS-1008 administered in combination with irinotecan and irinotecan alone.

    1 year

  • To determine the Incidence of anti- CS-1008 antibody formation.

    1 year

Study Arms (2)

CS-1008 with irinotecan

EXPERIMENTAL

CS-1008 and irinotecan

Drug: CS-1008Drug: irinotecan

irintoecan

ACTIVE COMPARATOR

irinotecan alone

Drug: irinotecan

Interventions

CS-1008DRUG

CS-1008

CS-1008 with irinotecan
irinotecanDRUG

irinotecan

Also known as: Camptosar
CS-1008 with irinotecanirintoecan

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Histologically confirmed CRC which is now metastatic and after failure of oxaliplatin-based first-line treatment.
  • At least 18 years of age.
  • ECOG performance status =\< 1.
  • Measurable disease based on RECIST criteria.
  • Adequate organ and bone marrow function as evidenced by:
  • Hemoglobin \>= 9.0 g/dL (may be transfused to this level)
  • Absolute neutrophil count (ANC) \>= 1.5 x 109/L
  • Platelet count \>= 100 x 109/L
  • Serum creatinine =\< upper limit of normal (ULN) or creatinine clearance \> 50 mL/min
  • AST \<= 2.5 x ULN in subjects with no liver metastasis and \<= 5.0 x ULN in subjects with liver metastasis
  • Total bilirubin \< 1.5 x ULN
  • Men and women of childbearing potential must be willing to consent to using effective contraception (e.g., hormonal contraceptives, bilateral tubal ligation, barrier with spermicide, intrauterine device) while on treatment and for 3 months thereafter.
  • All female subjects of childbearing potential must have a negative pregnancy test (serum or urine) result within 7 days before initiating study treatment.
  • Subjects must be fully informed about their illness and the investigational nature of the study protocol (including foreseeable risks and possible side effects) and must sign and date an IEC/IRB approved ICF before performance of any study specific procedures or tests.
  • Subjects must be willing and able to comply with scheduled visits, treatment plan, laboratory tests, and other study procedures.

You may not qualify if:

  • Anticipation of need for a major surgical procedure or radiotherapy (RT) during the study.
  • Treatment with chemotherapy hormonal therapy, RT, minor surgery, or any investigational agent within 4 weeks before study enrollment. Treatment with nitrosoureas, mitomycin C, immunotherapy, biological therapy, or major surgery within six weeks prior to study enrollment. St John's Wort within 2 weeks prior to study enrollment or during the study.
  • History of any of the following conditions within 6 months before study enrollment:
  • Clinically significant myocardial infarction or severe/unstable angina pectoris
  • New York Heart Association (NYHA) class III or IV congestive heart failure (Section 17.2)
  • Clinically significant cerebrovascular accident, transient ischemic attack or pulmonary embolism- Clinically significant pulmonary disease (e.g., severe chronic obstructive pulmonary disease or asthma)
  • Presence of any of the following: Symptomatic brain metastasis; an uncontrolled seizure disorder; spinal cord compression; or carcinomatous meningitis.
  • Clinically significant active infection that requires antibiotic therapy or Human Immunodeficiency Virus (HIV) positive subjects receiving antiretroviral therapy.
  • History of malignancy other than CRC, unless there is the expectation that the malignancy has been cured, and tumor specific treatment for the malignancy has not been administered within the previous 5 years. Exceptions to this are non melanotic cancer of the skin and adequately treated carcinoma of the cervix-in-situ.
  • Previous treatment with CS 1008, other agonistic DR5 antibody agents, or TRAIL agents.
  • History of active chronic inflammatory bowel disease and/or bowel obstruction within the last 3 months.
  • Pregnant or breast feeding.
  • Known history of hypersensitivity reactions to irinotecan or to one of the excipients.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (9)

Broomfield Hospital

Chelmsford, Essex, CM1 7ET, United Kingdom

Location

Mount Vernon Hospital

Northwood, Middlesex, HA6 2RN, United Kingdom

Location

Nottingham City Hospital

Nottingham, Notts, NG5 1PB, United Kingdom

Location

Chrichill Hospital

Oxford, Oxon, OX37LJ, United Kingdom

Location

Royal Marsden Hospital

Sutton, Surrey, SM2 5PT, United Kingdom

Location

Clatterbridge Hospital

Bebington, Wirral, CH634JY, United Kingdom

Location

Royal United Hospital Bath

Bath, BA1 3NG, United Kingdom

Location

Russels Hall Hospital

Dudley, DY1 2HQ, United Kingdom

Location

Leicester Royal Infirmary

Leicester, LE1 5WW, United Kingdom

Location

MeSH Terms

Conditions

Colorectal Neoplasms

Interventions

tigatuzumabIrinotecan

Condition Hierarchy (Ancestors)

Intestinal NeoplasmsGastrointestinal NeoplasmsDigestive System NeoplasmsNeoplasms by SiteNeoplasmsDigestive System DiseasesGastrointestinal DiseasesColonic DiseasesIntestinal DiseasesRectal Diseases

Intervention Hierarchy (Ancestors)

CamptothecinAlkaloidsHeterocyclic Compounds

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 28, 2009

First Posted

August 31, 2009

Study Start

July 1, 2009

Primary Completion

December 1, 2011

Study Completion

December 1, 2011

Last Updated

January 31, 2012

Record last verified: 2012-01

Locations

GB(9)