A Pharmacogenomics Study of TAS-102
Ontology highlight
ABSTRACT:
DISEASE(S): Metastatic Colorectal Cancer
PROVIDER: 2610782 | ecrin-mdr-crc |
REPOSITORIES: ECRIN MDR
Similar Datasets
Project description:Interventions: investigational material(s)
Generic name etc : TAS-102
INN of investigational material :
Therapeutic category code : 422 Antimetabolic agents
Dosage and Administration for Investigational material : 35 mg/m2/dose, orally, twice daily on days 1-5 and 8-12 of each 28-day cycle. Number of cycles: until at least one of the discontinuation criteria are met.
control material(s)
Generic name etc : Placebo
INN of investigational material :
Therapeutic category code : --- Other
Dosage and Administration for Investigational material : Placebo tablets, orally, twice daily on days 1-5 and 8-12 of each 28-day cycle. Number of cycles: until at least one of the discontinuation criteria are met.
Primary outcome(s): Correlation between the relative factor and disease control rate, overall survival, or progression-free survival
RECIST (ver.1.1)
Study Design: Multinational, double-blind, two-arm, parallel, randomized Phase 3 comparison study
| 100784 | ecrin-mdr-crc
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
| 2611617 | ecrin-mdr-crc
Project description:Intervention name : TAS-102
Dosage And administration of the intervention : TAS-102 as a starting dose of 25 mg/m2/dose BID (50 mg/m2/day) is administered orally in a 28-day cycle (2-week cycle of 5 days of treatment followed by a 2-day rest period, and then a 14-day rest period).
Control intervention name : irinotecan
INN of the control intervention : irinotecan
Dosage And administration of the control intervention : Irinotecan is administered by intravenous infusion at a dose of 150 mg/m2 over 90 minutes on day 1 and 15.
Primary outcome(s): Safety
CTCAE (ver.3.0)
Study Design: Open-label, multi-center, phase I study
| 2610898 | ecrin-mdr-crc
Project description:Intervention name : Lonsurf combination tablet T15/T20
INN of the intervention : trifluridine + tipiracil hydrochloride
Dosage And administration of the intervention : In 1 course consisting of 28 days, FTD/TPI or placebo will be orally administered twice daily after breakfast and after dinner for 5 consecutive days (Days 1 to 5 and Days 8 to 12), followed by withdrawal for 2 days. After repeating this cycle twice, the subject is withdrawn from study treatment for 14 days.
Control intervention name : Placebo
INN of the control intervention : -
Dosage And administration of the control intervention : In 1 course consisting of 28 days, FTD/TPI or placebo will be orally administered twice daily after breakfast and after dinner for 5 consecutive days (Days 1 to 5 and Days 8 to 12), followed by withdrawal for 2 days. After repeating this cycle twice, the subject is withdrawn from study treatment for 14 days.
Primary outcome(s): efficacy
Disease-Free Survival 1 (DFS1)
The time from the date of enrollment to any of the following events, whichever occurs first: a relapse, the first development of a secondary large intestine carcinoma lesion other than a relapse (an intramucosal cancer lesion will not be treated as an event) that is confirmed after the date of enrollment, and death from any cause. In principle, events will be assessed by the investigator.
Study Design: This trial is a randomized, double-blind, multinational Phase III study to evaluate the efficacy and safety of preemptive treatment with FTD/TPI compared with administration of placebo as follow-up, which is the standard of care, in patients who underwent curative resection of colorectal cancer and then tested positive for ctDNA.
| 2658591 | ecrin-mdr-crc
Project description:Intervention name : TAS-102
Dosage And administration of the intervention : TAS-102 70 mg/m2 was administered orally twice a day for 5 days followed by 2 day rest and repeated two times this procedure.
Control intervention name : Placebo
Dosage And administration of the control intervention : Placebo was administered orally twice a day for 5 days followed by 2 day rest and repeated two times this procedure.
Primary outcome(s): Overall survival
To evaluate the overall survivals of TAS-102 versus placebo in patients with chemotherapy-refractory metastatic colorectal cancer
Study Design: Randomized, double-blind, placebo-controlled, parallel-group comparative study
| 2610203 | ecrin-mdr-crc
Project description:Intervention type:DRUG
Name of intervention:Lenvatinib
Dose form / Japanese Medical Device Nomenclature:CAPSULE
Route of administration / Site of application:ORAL
Dose per administration:24mg
24mg
24mg
Dosing frequency / Frequency of use:QD
Planned duration of intervention:Treatment will continue until the discontinuation criteria are met.
Intended dose regimen:24mg of lenvatinib is orally taken once daily for 28 days each course
detailes of teratment arms:Treatment will continue with lenvatinib 24mg qd until the criteria of interruption, resuming, reduction and discontinuation of treatment are met.
Dose of lenvatinib will be reduced to 20mg, 14mg, 10mg, 8mg, and 4mg qd according to the reduction criteria, and treatment will be discontinued if unable to tolerate at 4mg qd.
Comparative intervention name:
Dose form / Japanese Medical Device Nomenclature:
Route of administration / Site of application:
Dose per administration:
Dosing frequency / Frequency of use:
Planned duration of intervention:
Intended dose regimen:
Primary outcome(s): Disease control rate
Study Design: Open-label, single-arm and single-center trial, no treatment control standard of care control, No, open(masking not used),
| 98667 | 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 : 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
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
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