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Phase I/II study of R435 (Bevacizumab) in patients with metastatic colorectal cancer

ABSTRACT: Intervention name : Bevacizumab Dosage And administration of the intervention : Injection Primary outcome(s): Initial safety, PK parameter of bevacizumab Study Design: Open, Single Arm study

DISEASE(S): Metastatic Colorectal Cancer

PROVIDER: 2609866 | ecrin-mdr-crc |

REPOSITORIES: ECRIN MDR

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Phase I/II study of R435 (Bevacizumab) in patients with metastatic colorectal cancer

Project description:Interventions: investigational material(s) Generic name etc : Bevacizumab INN of investigational material : Therapeutic category code : 429 Other antitumor agents Dosage and Administration for Investigational material : Injection Primary outcome(s): Initial safety, PK parameter of bevacizumab Study Design: Open, Single Arm study

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Safety comformation study of R435 (Bevacizumab) in patients with metastatic colorectal cancer

Project description:Intervention name : Bevacizumab Dosage And administration of the intervention : Injection Primary outcome(s): Safety Study Design: Open, Single Arm study

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Phase I/II study of R340 (Capecitabine), L-OHP (Oxaliplatin) and R435 (Bevacizumab) in advanced and/or metastatic colorectal cancer

Project description:Intervention name : Capecitabine|Oxaliplatin|Bevacizumab Dosage And administration of the intervention : Capecitabine: oral administration Oxaliplatin and Bevacizumab: injection Primary outcome(s): Response Rate, Safety Study Design: Open, Single Arm study

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Phase I/II study of R340 (Capecitabine), L-OHP (Oxaliplatin) and R435 (Bevacizumab) in advanced and/or metastatic colorectal cancer

Project description:Interventions: investigational material(s) Generic name etc : Capecitabine|Oxaliplatin|Bevacizumab INN of investigational material : Therapeutic category code : 42- Antineoplastic agents Dosage and Administration for Investigational material : Capecitabine: oral administration Oxaliplatin and Bevacizumab: injection Primary outcome(s): Response Rate, Safety Study Design: Open, Single Arm study

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ONO-4538/CA2099X8 Phase 2/3 Study(ONO-4538-72/CA2099X8)

Project description:Intervention name : ONO-4538/BMS-936558 INN of the intervention : Nivolumab Dosage And administration of the intervention : Intravenous administration Control intervention name : Fluorouracil, Leucovorin Calcium Folinate, Oxaliplatin, Bevacizumab INN of the control intervention : Fluorouracil, Leucovorin Calcium Folinate, Oxaliplatin, Bevacizumab Dosage And administration of the control intervention : Intravenous administration Primary outcome(s): efficacy PFS Study Design: Randomized, open-label

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A Randomized Phase III Trial of SOX/Bevacizumab versus FOLFOX/Bevacizmab in Treating Patients with Metastatic Colorectal Cancer (SOFT).

Project description:Intervention name : S-1 (tegafur + gimeracil + oteracil potassium) INN of the intervention : S-1: tegafur, gimeracil, oteracil potassium Dosage And administration of the intervention : 40-60 mg bid day 1 (evening) - day 15 (morning). Repeat cycles every 3 weeks Intervention name : L-OHP (Oxaliplatin) INN of the intervention : oxaliplatin Dosage And administration of the intervention : 130 mg/m2 IV on day 1. Repeat cycles every 3 weeks Intervention name : BV (Bevacizumab) INN of the intervention : bevacizumab Dosage And administration of the intervention : 7.5 mg/kg IV on day 1. Repeat cycles every 3 weeks Control intervention name : 5-FU (Fluorouracil) INN of the control intervention : fluorouracil Dosage And administration of the control intervention : 400 mg/m2 IV bolus on day 1, followed by 2400 mg/m2 over 46 hours. Repeat cycles every 2 weeks. Control intervention name : l-LV (Levofolinate calcium) INN of the control intervention : folic acid Dosage And administration of the control intervention : 200 mg IV on day 1. Repeat cycles every 2 weeks. Control intervention name : L-OHP (Oxaliplatin) INN of the control intervention : oxaliplatin Dosage And administration of the control intervention : 85 mg/m2 IV on day 1. Repeat cycles every 2 weeks. Control intervention name : BV (Bevacizumab) INN of the control intervention : bevacizumab Dosage And administration of the control intervention : 5 mg/kg IV on day 1. Repeat cycles every 2 weeks. Primary outcome(s): Progression free survival(PFS) Study Design: Randomized, open-label, comparative study

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A Phase 1 Study of OCV-C02 in Patients With Advanced or Relapsed Colorectal Cancer

Project description:Intervention name : OCV-C02 INN of the intervention : - Dosage And administration of the intervention : Once-weekly subcutaneous injection (0.3, 1 3 and 6 mg/body) Control intervention name : - INN of the control intervention : - Dosage And administration of the control intervention : - Primary outcome(s): safety Dose Limiting Toxicity (DLT) Common Terminology Criteria for Adverse Events (CTCAE), ver. 4.0 Study Design: multicenter, open, non-comparative study

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Phase II/III Trial of CPT-11/5-FU/l-LV (FOLFIRI) Versus CPT-11/TS-1 (IRIS) as Second Line Chemotherapy of Unresectable Colorectal Cancer

Project description:Intervention name : Irinotecan hydrochloride | Tegafur/Gimeracil/ Oteracil Potassium | Fluorouracil | Levofolinate Calcium Dosage And administration of the intervention : Irinotecan hydrochloride : injection, Fluorouracil : injection, Levofolinate Calcium : injection, Tegafur/Gimeracil/ Oteracil Potassium capsule : oral Primary outcome(s): Progression free survival Study Design: Open label, multicenter phase 2 / 3 study

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Phase 2/3 study of fluoropyrimidine and irinotecan plus bevacizumab versus trifluridine/tipiracil plus bevacizumab as second-line for metastatic colorectal cancer (TRUSTY)

Project description:Intervention name : trifluridine/tipiracil INN of the intervention : trifluridine/tipiracil Dosage And administration of the intervention : Trifluridine/tipiracil was given in a dose of 35-75 mg twice daily (after breakfast and dinner) (70-150 mg/day) from after dinner on Day 1 to after breakfast on Day 6 and from after dinner on Day 8 to after breakfast on Day 13. Treatment was given orally for 5 consecutive days followed by a 2-day rest. This treatment was repeated twice, followed by a 14-day rest. This 28-day cycle was repeated until the criteria for withdrawal of the study treatment were met. Intervention name : bevacizumab INN of the intervention : bevacizumab Dosage And administration of the intervention : Bevacizumab 5 mg/kg was given as a 30-min continuous intravenous infusion on Day 1 and Day 15. Control intervention name : fluorouracil INN of the control intervention : fluorouracil Dosage And administration of the control intervention : [Treatment with FOLFIRI + bevacizumab] Fluorouracil 400 mg/m2 was given by rapid intravenous injection on Day 1, followed by a 46-h continuous intravenous infusion of 2400 mg/m2. Each cycle was 14 days, and treatment was repeated until the criteria for withdrawal of the study treatment were met. Control intervention name : TS-1(tegafur + gimeracil + oteracil potassium) INN of the control intervention : TS-1(tegafur + gimeracil + oteracil potassium) Dosage And administration of the control intervention : [Treatment with TS-1+ irinotecan +bevacizumab (3-week cycles) ] TS-1 is given orally in a dose of 40-60 mg twice daily (after breakfast and dinner) in accordance with body-surface area (80-120 mg/day), starting from after dinner on Day 1 to after breakfast on Day 15, followed by a 7-day rest. Each cycle was 21 days, and treatmen Primary outcome(s): efficacy Overall survival Study Design: Randomized, open-label, comparative study

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