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A Two Part Study in Japanese Patients With mCRC, Consisting of an Open-Label Phase I Part to Assess the Safety and Tolerability of AZD2171 in Combination With FOLFOX Followed by a Phase II, Randomised, Double-Blind, Parallel Group Study to Assess the Efficacy of AZD2171 in Combination With FOLFOX

ABSTRACT: Interventions: investigational material(s) Generic name etc : AZD2171 INN of investigational material : Therapeutic category code : 429 Other antitumor agents Dosage and Administration for Investigational material : Oral Primary outcome(s): Efficacy Primary Outcome Measures:- Progression of Metastatic Colorectal Cancer (mCRC) - PFS Secondary Outcome Measures: - Safety and tolerability [Time Frame: assessed at each visit] Study Design: Randomized, Double-Blind, Placebo Control, Parallel Assignment Study

DISEASE(S): Metastatic Colorectal Cancer

PROVIDER: 99530 | ecrin-mdr-crc |

REPOSITORIES: ECRIN MDR

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A Two Part Study in Japanese Patients With mCRC, Consisting of an Open-Label Phase I Part to Assess the Safety and Tolerability of AZD2171 in Combination With FOLFOX Followed by a Phase II, Randomised, Double-Blind, Parallel Group Study to Assess the Efficacy of AZD2171 in Combination With FOLFOX

Project description:Intervention name : AZD2171 Dosage And administration of the intervention : Oral Primary outcome(s): Efficacy Primary Outcome Measures:- Progression of Metastatic Colorectal Cancer (mCRC) - PFS Secondary Outcome Measures: - Safety and tolerability [Time Frame: assessed at each visit] Study Design: Randomized, Double-Blind, Placebo Control, Parallel Assignment Study

| 2610037 | ecrin-mdr-crc

A Phase I/II Study of Cediranib (AZD2171) in Japanese Metastatic Colorectal Cancer Patients in Combination With FOLFOX

Project description:This Study is in two parts, the first part is to make sure that combining a potential new treatment, cediranib (AZD2171), with a standard treatment (FOLFOX) for metastatic colorectal cancer is safe. Once this part is complete and it is decided that it is safe to continue the Study will the go on to look at the efficacy of the two drugs together. This will be done by studying two treatment options. One will be the standard treatment alone (FOLFOX) + dummy cediranib (AZD2171) tablets and the other will be the standard treatment (FOLFOX) + real cediranib (AZD2171) tablets. Using dummy tablets means the study is ‘blinded’ and that non-one can tell the difference between the two treatment groups. This kind of study design is done to try to avoid the chance that the results might be biased in some way. The overall aim of the second part of the study is to see if adding cediranib (AZD2171) to a standard treatment for Metastatic Colorectal Cancer (mCRC), in this case FOLFOX, gives better results. That is, it’s better than giving standard treatment alone in helping to prevent progression of mCRC.

| 2041551 | ecrin-mdr-crc

AZD2171 and Standard Combination Chemotherapy in Advanced Non-Small Cell Lung Cancer or Colorectal Cancer

Project description:RATIONALE: AZD2171 may stop the growth of tumor cells by blocking blood flow to the tumor and by blocking some of the enzymes needed for cell growth. Drugs used in chemotherapy work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving AZD2171 together with standard combination chemotherapy may kill more tumor cells. PURPOSE: This phase I trial is studying the side effects and best dose of AZD2171 when given together with standard combination chemotherapy in treating patients with advanced non-small cell lung cancer (NSCLC) or colorectal cancer.

| 2030216 | ecrin-mdr-crc

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

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

Combination testing of cediranib (AZD2171) against childhood cancer models by the pediatric preclinical testing program.

Project description:BackgroundCediranib (AZD2171) is a potent small molecule inhibitor of vascular endothelial growth factor (VEGF) receptors. Cediranib has demonstrated single agent activity in several adult cancers and is being studied in combination with standard cytotoxic agents in multiple disease settings.ProceduresCediranib was tested in vivo against six childhood tumor xenograft models (four sarcomas, one glioblastoma, one neuroblastoma) alone or combined with cyclophosphamide (two models), vincristine (three models) or cisplatin (one model), each administered at its maximum tolerated dose, or rapamycin (six models).ResultsThe combination of cediranib with standard cytotoxic agents was superior to the cytotoxic agent used alone for a single xenograft (one of the three xenografts evaluated for the vincristine-cediranib combination). The cediranib-cyclophosphamide combination was inferior to single agent cyclophosphamide in time to event for both models studied and was significantly inferior for one of the models. Cediranib combined with rapamycin was superior to each of the agents used alone in two of the six models and was determined to be additive or supra-additive with rapamycin in four models, although the effects were not large.ConclusionsCediranib combined with cytotoxic chemotherapy agents demonstrated little or no benefit (and in one case was significantly inferior) compared to chemotherapy alone for the six pediatric cancer xenografts studied. By contrast, the combination of cediranib with rapamycin was additive or supra-additive in four of the six models in terms of prolongation of time to event, though tumor regressions were not observed for this combination.

| S-EPMC3253323 | biostudies-literature

A feasibility study of Oxaliplatin(L-OHP)in combination with infusional 5-FU/l-LV(FOLFOX4 regimen)for advanced colorectal cancer

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

Phase 1 study of CS-7017 in combination with FOLFIRI

Project description:Interventions: investigational material(s) Generic name etc : CS-7017 INN of investigational material : efatutazone Therapeutic category code : 429 Other antitumor agents Dosage and Administration for Investigational material : CS-7017(0.25-0.50 mg) administered orally twice a day 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

| 100185 | ecrin-mdr-crc

Part two: an unblinded, parallel, randomized study to assess nicotine pharmacokinetics of four Vuse Solo ENDS flavors in smokers.

Project description:We report the findings from a randomized, parallel study designed to evaluate nicotine pharmacokinetics (PK) following 10 min of ad libitum use of electronic nicotine delivery system (ENDS) in four flavor variants. Subjects were randomized an investigational product (IP) and blood samples were collected for PK assessments during a test session. Primary endpoints were baseline-adjusted values of maximum plasma nicotine concentration (Cmax) and area under the nicotine concentration-vs-time curve up to 60 min (AUCnic0-60). Baseline-adjusted mean Cmax ranged from 6.53 to 8.21 ng/mL, and mean AUCnic0-60 ranged from 206.87 to 263.52 ng min/mL for all ENDS IPs. Results of geometric mean Cmax and AUCnic0-60 values were within 95% confidence intervals (CI) among the ENDS IP flavor variants tested.

| S-EPMC10235118 | biostudies-literature

Use-results survey for Lonsurf combination tablet T15 & Lonsurf combination tablet T20

Project description:Interventions: investigational material(s) Generic name etc : Lonsurf combination tablet T15/T20 INN of investigational material : trifluridine + tipiracil hydrochloride Therapeutic category code : 429 Other antitumor agents Dosage and Administration for Investigational material : Usually, the standard doses below are defined as the initial dose (single dose) for adults according to body surface area (approximately 35 mg of Trifluridine/m2/dose). Lonsurf is administered twice daily, after breakfast and after the evening meal, for 5 consecutive days, followed by a 2-day rest. After repeating this twice, follows a 14-day rest. This is one cycle of the regimen and it shall be repeated. Study Design: Postmarketing surveillance

| 97953 | ecrin-mdr-crc

DS-Screen

Project description:Interventions: investigational material(s) Generic name etc : - INN of investigational material : - Therapeutic category code : --- Other Dosage and Administration for Investigational material : - control material(s) Generic name etc : - INN of investigational material : - Therapeutic category code : Dosage and Administration for Investigational material : - Primary outcome(s): exploratory FGFR2 and HER2 protein expression IHC Study Design: Observational study

| 98039 | ecrin-mdr-crc

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