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Clinical Trials/EUCTR2011-003502-24-AT
EUCTR2011-003502-24-AT
Active, not recruiting
Not Applicable

A Phase 2, Open Label, Multicenter, Randomized Trial Comparing Tivozanib in Combination with mFOLFOX6 with Bevacizumab in Combination with mFOLFOX6 in Stage IV Metastatic Corectal Cancer (mCRC) Subjects - Not available

Astellas Pharma Global Development, Inc.0 sites252 target enrollmentJanuary 12, 2012
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ConditionsMetastatic colorectal cancer (CRC)MedDRA version: 16.1Level: PTClassification code 10010035Term: Colorectal cancer stage IVSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)Therapeutic area: Diseases [C] - Cancer [C04]
DrugsAvastin

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Metastatic colorectal cancer (CRC)
Sponsor
Astellas Pharma Global Development, Inc.
Enrollment
252
Status
Active, not recruiting
Last Updated
11 years ago
OverviewInvestigatorsEligibility CriteriaOutcomesSimilar Trials

Overview

Brief Summary

No summary available.

Registry
who.int
Start Date
January 12, 2012
End Date
TBD
Last Updated
11 years ago
Study Type
Interventional clinical trial of medicinal product
Sex
All

Investigators

Eligibility Criteria

Inclusion Criteria

  • •Subject is eligible for the study if all of the following apply:
  • •1\.) The subject, prior to any study\-related procedures, has provided
  • •IRB/IEC approved written Informed Consent and privacy language as
  • •per national regulations (e.g., HIPAA Authorization for US sites).
  • •2\.) The subject is male or female, aged 18 years or older.
  • •3\.) The subject has histologically or cytologically confirmed mCRC for
  • •which bevacizumab/ mFOLFOX6 chemotherapy regimen would be the
  • •appropriate treatment per the investigator.
  • •4\.) The subject has at least one measurable lesion by RECIST Version
  • •1\.1\. A lesion that has received prior radiotherapy may only be counted as

Exclusion Criteria

  • •The subject has;
  • •1\. had any prior VEGF\-directed therapy including VEGF antibody or any other agent or investigational agent targeting the VEGF pathway.
  • •2\. primary CNS malignancies or CNS metastases; subjects with previously treated brain metastases will be allowed if the brain metastasis have been stable without steroid treatment for at least 3 months following prior treatment (radiotherapy or surgery).
  • •3\. any of the following hematologic abnormalities:
  • •Hemoglobin \< 9\.0 g/dL (90 g/L, 5\.5854 mmol/L)
  • •ANC \< 2000 per mm3
  • •Platelet count \< 100,000 per mm3
  • •PT or PTT \> 1\.5 X ULN
  • •4\. any of the following serum chemistry abnormalities:
  • •Total bilirubin \> 1\.5 X ULN (or \> 2\.5 X ULN for subjects with Gilbert's syndrome)

Outcomes

Primary Outcomes

Not specified

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Study comparing Tivozanib in combination with mFOLFOX6 against Bevacizumab in combination with mFOLFOX6 in patients with bowel cancer.Metastatic colorectal cancer (CRC)MedDRA version: 16.1Level: PTClassification code 10010035Term: Colorectal cancer stage IVSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)Therapeutic area: Diseases [C] - Cancer [C04]
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Study comparing Tivozanib in combination with mFOLFOX6 against Bevacizumab in combination with mFOLFOX6 in patients with bowel cancer.Metastatic colorectal cancer (CRC)MedDRA version: 16.1Level: PTClassification code 10010035Term: Colorectal cancer stage IVSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)Therapeutic area: Diseases [C] - Cancer [C04]
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