Metastatic colorectal cancer (mCRC) MedDRA version: 9.1 Level: LLT Classification code 10052362 Term: Metastatic colorectal cancer
Conditions
Interventions
Trade Name: Vectibix® 20 mg/ml concentrate for solution for infusion
Product Name: Panitumumab
Product Code: -
Pharmaceutical Form: Intravenous infusion
INN or Proposed INN: Panitumumab
CAS Number: 33
Sponsors
AIO-Studien-gGmbH
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Male or female patients aged 18 years or more, with histologically or cytologically-confirmed and radiologically-measurable metastatic colorectal cancer. One prior chemotherapy regimen for mCRC consisting of first-line fluoropyrimidine and irinotecan based chemotherapy. Subjects must have disease progression (as assessed by the investigator) and must be no candidates for primary metastectomy. Measurable disease according to RECIST 1.1 guidelines. All sites of disease must have been evaluated within 28 days prior to registration / randomization, and diagnosed by the investigator. Liver and kidney function within defined ranges and sufficient bone marrow reserve. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: Central nervous system metastases, or significant cardiovascular disease. Prior anti-EGFR antibody therapy (e.g. cetuximab) or treatment with small molecule EGFR tyrosine kinase inhibitors (e.g. erlotinib). Prior treatment with oxaliplatin for metastatic disease. Adjuvant therapy with oxaliplatin based combination for non-metastatic disease is allowed if terminated > 6 months prior to initiation of screening and without progression during the treatment with oxaliplatin. Any condition interfering with study drug therapy as defined in the exclusion criteria.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To assess the differences in progression-free survival at 6 months in subjects with KRAS wild-type metastatic colorectal cancer receiving second line treatment (after failure of a previous irinotecan and 5FU based regimen) with panitumumab plus XELOX compared to the treatment with XELOX alone, without major safety problems;Secondary Objective: To assess that, for subjects with KRAS wild-type metastatic colorectal cancer, objective response rate (ORR), disease control rate (DCR), duration of response (DOR), time to progression (TTP), duration of stable disease (DOSD), time to treatment failure and overall survival time (OS) are greater and time to response (TTR) is shorter for subjects receiving second line treatment with panitumumab plus XELOX than for subjects treated with XELOX alone. To assess the differences in overall progression-free and overall survival between subjects with KRAS wild-type and KRAS mutant colorectal cancer who receive XELOX as second-line treatment.;Primary end point(s): Progression-free survival (PFS) rate at 6 months The primary efficacy analysis will be based on the progression-free survival rate at 6 months, calculated as a “crude” rate by dividing the number of patients alive free from progression at this time. | — |
Countries
Germany
Outcome results
None listed