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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: 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

DISEASE(S): Metastatic Colorectal Cancer

PROVIDER: 2610037 | 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: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

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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

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

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

The Biological Activity of Cediranib (AZD2171) in Gastro-Intestinal Stromal Tumours(GIST).

Project description:To determine the anti-tumour activity and biological effects of cediranib (AZD2171) at a dose of 45mg, primarily in Gastrointestinal Stromal Tumour (GIST) patients who are resistant to imatinib mesylate (current standard therapy) and also in patients with metastatic Soft Tissue Sarcoma (STS) resistant to standard therapy.

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Second Line ColoRectal Cancer Therapy in Combination With Combination of FOL- Folinic Acid(Leucovorin), F - Fluorouracil and OX - Oxaliplatin (FOLFOX)

Project description:The primary purpose of this study is to compare the efficacy of AZD2171 in combination with FOLFOX to the efficacy of bevacizumab in combination with FOLFOX, in the second-line treatment of patients with metastatic colorectal cancer

| 2025397 | ecrin-mdr-crc

AZD2171 + Chemotherapy in Advanced NSCLC, Colorectal Cancer, or Other Cancer Suitable for Treatment With Capecitabine (Non-Small Lung Cancer Patients Closed to Enrollment as 8/9/07)

Project description:RATIONALE: AZD2171 may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth and by blocking blood flow to the tumor. Drugs used in chemotherapy, such as paclitaxel, carboplatin, or capecitabine, 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 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 chemotherapy in treating patients with advanced non-small cell lung cancer (closed to enrollment as of 8/9/07), colorectal cancer, or other cancer suitable to capecitabine treatment.

| 2012540 | ecrin-mdr-crc

Indicators to assess physiological heat strain - Part 2: Delphi exercise.

Project description:In a series of three companion papers published in this Journal, we identify and validate the available thermal stress indicators (TSIs). In this second paper of the series, we identified the criteria to consider when adopting a TSI to protect individuals who work in the heat, and we weighed their relative importance using a Delphi exercise with 20 experts. Two Delphi iterations were adequate to reach consensus within the expert panel (Cronbach's α = 0.86) for a set of 17 criteria with varying weights that should be considered when adopting a TSI to protect individuals who work in the heat. These criteria considered physiological parameters such as core/skin/mean body temperature, heart rate, and hydration status, as well as practicality, cost effectiveness, and health guidance issues. The 17 criteria were distributed across three occupational health-and-safety pillars: (i) contribution to improving occupational health (55% of total importance), (ii) mitigation of worker physiological strain (35.5% of total importance), and (iii) cost-effectiveness (9.5% of total importance). Three criteria [(i) relationship of a TSI with core temperature, (ii) having categories indicating the level of heat stress experienced by workers, and (iii) using its heat stress categories to provide recommendations for occupational safety and health] were considered significantly more important when selecting a TSI for protecting individuals who work in the heat, accumulating 37.2 percentage points. These 17 criteria allow the validation and comparison of TSIs that presently exist as well as those that may be developed in the coming years.

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