NK012 phase II clinical study
Ontology highlight
ABSTRACT:
DISEASE(S): Colorectal Cancer
PROVIDER: 2610152 | ecrin-mdr-crc |
REPOSITORIES: ECRIN MDR
Similar Datasets
Project description:Interventions: investigational material(s)
Generic name etc : NK012(other antitumor agents)
INN of investigational material :
Therapeutic category code : 429 Other antitumor agents
Dosage and Administration for Investigational material : Intravenous
| 98783 | ecrin-mdr-crc
Project description:Interventions: investigational material(s)
Generic name etc : ONO-4538/BMS-936558
INN of investigational material : Nivolumab
Therapeutic category code : 429 Other antitumor agents
Dosage and Administration for Investigational material : Intravenous administration
control material(s)
Generic name etc : Fluorouracil, Leucovorin Calcium Folinate, Oxaliplatin, Bevacizumab
INN of investigational material : Fluorouracil, Leucovorin Calcium Folinate, Oxaliplatin, Bevacizumab
Therapeutic category code : 42- Antineoplastic agents
Dosage and Administration for Investigational material : Intravenous administration
Primary outcome(s): efficacy
PFS
Study Design: Randomized, open-label
| 102159 | ecrin-mdr-crc
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
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
| 2658327 | ecrin-mdr-crc
Project description:Interventions: investigational material(s)
Generic name etc : S-1 (tegafur + gimeracil + oteracil potassium)
INN of investigational material : S-1: tegafur, gimeracil, oteracil potassium
Therapeutic category code : 422 Antimetabolic agents
Dosage and Administration for Investigational material : 40-60 mg bid day 1 (evening) - day 15 (morning). Repeat cycles every 3 weeks
Generic name etc : L-OHP (Oxaliplatin)
INN of investigational material : oxaliplatin
Therapeutic category code : 429 Other antitumor agents
Dosage and Administration for Investigational material : 130 mg/m2 IV on day 1. Repeat cycles every 3 weeks
Generic name etc : BV (Bevacizumab)
INN of investigational material : bevacizumab
Therapeutic category code : 429 Other antitumor agents
Dosage and Administration for Investigational material : 7.5 mg/kg IV on day 1. Repeat cycles every 3 weeks
control material(s)
Generic name etc : 5-FU (Fluorouracil)
INN of investigational material : fluorouracil
Therapeutic category code : 422 Antimetabolic agents
Dosage and Administration for Investigational material : 400 mg/m2 IV bolus on day 1, followed by 2400 mg/m2 over 46 hours. Repeat cycles every 2 weeks.
Generic name etc : l-LV (Levofolinate calcium)
INN of investigational material : folic acid
Therapeutic category code : 392 Antidotes
Dosage and Administration for Investigational material : 200 mg IV on day 1. Repeat cycles every 2 weeks.
Generic name etc : L-OHP (Oxaliplatin)
INN of investigational material : oxaliplatin
Therapeutic category code : 429 Other antitumor agents
Dosage and Administration for Investigational material : 85 mg/m2 IV on day 1. Repeat cycles every 2 weeks.
Generic name etc : BV (Bevacizumab)
INN of investigational material : bevacizumab
Therapeutic category code : 429 Other antitumor agents
Dosage
Primary outcome(s): Progression free survival(PFS)
Study Design: Randomized, open-label, comparative study
| 97778 | ecrin-mdr-crc
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
| 99192 | ecrin-mdr-crc
Project description:Interventions: investigational material(s)
Generic name etc : Oxaliplatin|Fluorouracil|Levofolinate calcium
INN of investigational material :
Therapeutic category code : 429 Other antitumor agents
Dosage and Administration for Investigational material : Intravenous infusion
Primary outcome(s): Safety
Study Design: Open-label, multicenter trial
| 99274 | ecrin-mdr-crc
Project description:Interventions: investigational material(s)
Generic name etc : TSU-68, S-1, Oxaliplatin
INN of investigational material : TSU-68:orantinib, S-1: tegafur, gimeracil, oteracil potassium, oxaliplatin
Therapeutic category code : 429 Other antitumor agents
Dosage and Administration for Investigational material : 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. Additionally for the patients of group A, TSU-68 is orally administered at 200 mg twice a day after meals on day 1 to 21.
control material(s)
Generic name etc : S-1, Oxaliplatin
INN of investigational material : S-1: tegafur, gimeracil, oteracil potassium oxaliplatin
Therapeutic category code : 429 Other antitumor agents
Dosage and Administration for Investigational material : 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.
Primary outcome(s): Progression free survival
RECIST (ver. 1.1)
Study Design: Open-label, multicenter, randomized phase II study
| 100336 | ecrin-mdr-crc
Project description:Interventions: investigational material(s)
Generic name etc : trifluridine/tipiracil
INN of investigational material : trifluridine/tipiracil
Therapeutic category code : 429 Other antitumor agents
Dosage and Administration for Investigational material : 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.
Generic name etc : bevacizumab
INN of investigational material : bevacizumab
Therapeutic category code : 429 Other antitumor agents
Dosage and Administration for Investigational material : Bevacizumab 5 mg/kg was given as a 30-min continuous intravenous infusion on Day 1 and Day 15.
control material(s)
Generic name etc : fluorouracil
INN of investigational material : fluorouracil
Therapeutic category code : 422 Antimetabolic agents
Dosage and Administration for Investigational material : [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.
Generic name etc : TS-1(tegafur + gimeracil + oteracil potassium)
INN of investigational material : TS-1(tegafur + gimeracil + oteracil potassium)
Therapeutic category code : 422 Antimetabolic agents
Dosage and Administration for Investigational material : [Treatment with TS-1+ irinotecan +bevacizumab (3-
Primary outcome(s): efficacy
Overall survival
Study Design: Randomized, open-label, comparative study
| 98099 | ecrin-mdr-crc
Project description: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
| 2610657 | ecrin-mdr-crc