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Phase I/II trial of YHI-1003 plus Capecitabine

ABSTRACT: Intervention name : YHI-1003 INN of the intervention : Perifosine Dosage And administration of the intervention : oral Control intervention name : null Primary outcome(s): safety CTCAE v4.0 Study Design: open-label, multicenter trial

DISEASE(S): Refractory Advanced Colorectal Cancer

PROVIDER: 2610657 | ecrin-mdr-crc |

REPOSITORIES: ECRIN MDR

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Phase I/II trial of YHI-1003 plus Capecitabine

Project description:Interventions: investigational material(s) Generic name etc : YHI-1003 INN of investigational material : Perifosine Therapeutic category code : 429 Other antitumor agents Dosage and Administration for Investigational material : oral Primary outcome(s): safety CTCAE v4.0 Study Design: open-label, multicenter trial

| 100604 | ecrin-mdr-crc

Phase 1 study of CS-7017 in combination with FOLFIRI

Project description:Intervention name : CS-7017 INN of the intervention : efatutazone Dosage And administration of the intervention : CS-7017(0.25-0.50 mg) administered orally twice a day Control intervention name : null Primary outcome(s): Safety and Pharmacokinetics -To evaluate the safety profile according to CTCAE -To evaluate the pharmacokinetics according to the protocol Study Design: Open Label Phase 1 Study

| 2610363 | ecrin-mdr-crc

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

| 2657927 | ecrin-mdr-crc

METBEIGE Study

Project description:Intervention name : Cabozantinib Malate INN of the intervention : Cabozantinib Dosage And administration of the intervention : Cabozantinib: 40 mg or 60 mg, once daily at bedtime, oral, in a 28 day-course. Control intervention name : - INN of the control intervention : - Dosage And administration of the control intervention : - Primary outcome(s): safety, efficacy - Proportion of subjects with DLT (phase 1 part) - Confirmed ORR by investigators’ assessment in patients who received study treatment as 3rd line or later (phase 2 part) Study Design: An open-label, single arm phase I study and an open-label, randomized controlled multicenter phase II study

| 2611903 | ecrin-mdr-crc

ONO-7702 and ONO-7703 Expansion Study(ONO-7702/7703-02E)

Project description:Intervention name : Encorafenib, Binimetinib INN of the intervention : encorafenib, binimetinib Dosage And administration of the intervention : Encorafenib will be administered on a QD schedule and binimetinib will be administered on a BID schedule Control intervention name : - INN of the control intervention : - Dosage And administration of the control intervention : - Primary outcome(s): safety, efficacy - Study Design: A Multicenter, Single arm, Open-label Study

| 2612052 | ecrin-mdr-crc

A phase I study of TSU-68 in patient with metastatic colorectal cancer

Project description:Intervention name : TSU-68, S-1, Oxaliplatin INN of the intervention : TSU-68:orantinib, S-1: tegafur, gimeracil, oteracil potassium oxaliplatin Dosage And administration of the intervention : Treatment is repeated every 21 days as follows: S-1 is orally administered at 35 mg/m2 twice a day after meals on day 1-14 followed by 7 days rest. Oxaliplatin is given as an intravenous infusion of 130 mg/m2 on day 1. TSU-68 is orally administered at 200 mg or 400 mg twice a day after meals on day 1 to 21. Control intervention name : null Primary outcome(s): Safety (dose limiting toxicity) CTCAE (ver. 3.0) Study Design: Open-label, phase I study

| 2610478 | ecrin-mdr-crc

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

Project description:Interventions: investigational material(s) Generic name etc : OCV-C02 INN of investigational material : - Therapeutic category code : 42- Antineoplastic agents Dosage and Administration for Investigational material : Once-weekly subcutaneous injection (0.3, 1 3 and 6 mg/body) control material(s) Generic name etc : - INN of investigational material : - Therapeutic category code : Dosage and Administration for Investigational material : - 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

| 100907 | ecrin-mdr-crc

DS-Screen

Project description:Intervention name : - INN of the intervention : - Dosage And administration of the intervention : - Control intervention name : - INN of the control intervention : - Dosage And administration of the control intervention : - Primary outcome(s): exploratory FGFR2 and HER2 protein expression IHC Study Design: Observational study

| 2611525 | ecrin-mdr-crc

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

| 2610116 | ecrin-mdr-crc

A Randomized Controlled Study of Postoperative Adjuvant Chemotherapy of Uracil- Tegafur (UFT) Compared With Surgery Alone (NSAS-CC).

Project description:Intervention name : UFT(tegafur + uracil) INN of the intervention : UFT:tegafur, uracil Dosage And administration of the intervention : oral uracil-tegafur 400 mg square meter for one year Primary outcome(s): Efficacy and safety Study Design: Randomized, comparative study

| 2609887 | ecrin-mdr-crc

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