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A clinical trial to study to compare Safety, Efficacy and PK Study of DRL Bevacizumab (DRL_BZ), as compared to Reference Product AvastinÂ, in Patients with Metastatic Colorectal Cancer and Non-squamous Non-small Cell Lung Cancer


ABSTRACT: Intervention1: DRL_BZ (Bevacizumab): Part A: DRL_BZ, 5 mg/kg administered intravenously (i.v.) on day 1 as a 90 min infusion with the needed adjustments every two weeks in conjunction with mFOLFOX6. Patients will continue to be treated with their assigned treatment until documented progressive disease, death, unacceptable toxicity, withdrawal of consent or Investigator decision to discontinue in the best interest of patient or for 9 months, whichever occurs earlier. Part B: DRL_BZ; 15 mg/kg administered intravenously (i.v.) on day 1 every three weeks plus pemetrexed+carboplatin chemotherapy for 4 cycles. After 4 cycles, treatment will be continued with bevacizumab and pemetrexed only. Patients need to be premedicated with folic acid, vitamin B12 and dexamethasone as per institutional practice. Patients will be treated until documented progressive disease, death, unacceptable toxicity, patient withdrawal or Investigator decision to discontinue in the best interest of patient or up to 6 months Control Intervention1: Avastin (Bevacizumab): AvastinÂ, 5 mg/kg administered intravenously (i.v.) on day 1 as a 90 min infusion with the needed adjustments every two weeks in conjunction with mFOLFOX6. Patients will continue to be treated with their assigned treatment until documented progressive disease, death, unacceptable toxicity, withdrawal of consent or Investigator decision to discontinue in the best interest of patient or for 9 months, whichever occurs earlier. Part B: AvastinÂ; 15 mg/kg administered intravenously (i.v.) on day 1 every three weeks plus pemetrexed+carboplatin chemotherapy for 4 cycles. After 4 cycles, treatment will be continued with bevacizumab and pemetrexed only. Patients need to be premedicated with folic acid, vitamin B12 and dexamethasone as per in Primary outcome(s): PART A: To compare the efficacy measured in terms of progression free survival at 9 months (PFS9) of two anti-VEGF antibodies administered in combination with chemotherapy for mCRC (stage IV) as first-line treatment for metastatic disease. PART B: To compare the efficacy measured in terms of progression free survival at 6 months (PFS6) of two anti-VEGF antibodies administered in combination with chemotherapy for recurrent or advanced non-squamous NSCLC not previously treated with chemotherapy.Timepoint: 9 months Study Design: Randomized, Parallel Group, Multiple Arm Trial Method of generating randomization sequence:Stratified block randomization Method of allocation concealment:Centralized Blinding and masking:Participant, Investigator, Outcome Assessor and Date-entry Operator Blinded

DISEASE(S): Non-resectable Metastatic Colorectal Cancer (mcrc) And Recurrent Or Advanced Non-squamous Non-small Cell Lung Cancer (nsclc)

PROVIDER: 2577283 | ecrin-mdr-crc |

REPOSITORIES: ECRIN MDR

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