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Inlyta (Axitinib) - Summary

 
 



INLYTA SUMMARY

INLYTA (axitinib) is a kinase inhibitor.

INLYTA is indicated for the treatment of advanced renal cell carcinoma (RCC) after failure of one prior systemic therapy.


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NEWS HIGHLIGHTS

Published Studies Related to Inlyta (Axitinib)

Randomized, placebo-controlled, double-blind, phase II study of axitinib plus docetaxel versus docetaxel plus placebo in patients with metastatic breast cancer. [2011]
safety and efficacy of axitinib plus docetaxel in metastatic breast cancer (MBC)... CONCLUSION: The addition of axitinib to docetaxel did not improve TTP in

Efficacy and safety of axitinib in combination with gemcitabine in advanced pancreatic cancer: subgroup analyses by region, including Japan, from the global randomized Phase III trial. [2015]
North America and the European Union, enrolled in a randomized Phase III study... CONCLUSIONS: Axitinib/gemcitabine, while tolerated, did not provide survival

Intermittent dosing of axitinib combined with chemotherapy is supported by (18)FLT-PET in gastrointestinal tumours. [2014]
((18)FLT-PET)... CONCLUSION: Axitinib administered in a week-on/week-off schedule combined with

Randomised phase II study of axitinib or bevacizumab combined with paclitaxel/carboplatin as first-line therapy for patients with advanced non-small-cell lung cancer. [2014]
lung cancer (NSCLC) was evaluated... CONCLUSIONS: In patients with advanced non-squamous NSCLC,

Treatment rationale and study design for a randomized, double-blind, placebo-controlled phase II study evaluating onartuzumab (MetMAb) in combination with bevacizumab plus mFOLFOX-6 in patients with previously untreated metastatic colorectal cancer. [2013]
BACKGROUND: Dysregulation of the hepatocyte growth factor (HGF)/MET pathway is associated with poor prognosis, more aggressive biological characteristics of the tumor, and shortened survival in patients with metastatic colorectal cancer (mCRC)... Correlative studies will be performed on tissue- and blood-derived biomarkers related to both HGF/MET signaling and other associated pathway markers.

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Clinical Trials Related to Inlyta (Axitinib)

A Study Of Effectiveness Of Axitinib (CT), In Comparison With Axitinib - Pfizer (INLYTA) Confirmed Objective Response (ORR) In Patients With Solid Tumors [Active, not recruiting]

A Randomized Phase II Clinical Trial on the Efficacy of Axitinib as a Monotherapy or in Combination With Lomustine for the Treatment of Patients With Recurrent Glioblastoma [Active, not recruiting]
This clinical trial will recruit patients diagnosed with glioblastoma at the time of recurrence or progression following prior treatment with surgery, radiation therapy and alkylating chemotherapy. Patients will be screened and if found eligible will be randomized to one of two treatment arms (1: 1 randomization). Patients randomized to the Axitinib treatment-arm will be treated with Axitinib until progression (they can be treated after progression in the Axitinib plus lomustine arm), unacceptable treatment related toxicity, or patients refusal to continue study treatment. Patients randomized to the Axitinib plus Lomustine-arm will receive treatment until progression, unacceptable treatment related toxicity, or patients refusal to continue study treatment.

Pharmacodynamic Study of Axitinib in Patients With Advanced Solid Malignancies [Completed]
The main purpose of this study is to see what changes happen to the tumors while taking the axitinib and after it is stopped (during the scheduled breaks), and what changes in the tumor may be responsible for this growth. This will be done by using a special kind of scan called an 18F-FLT PET/CT. In addition, the investigators want to find out how the drugs are processed and distributed in the human body. The investigators will also look at how different types of cancer are affected by axitinib. The investigators will also correlate vasculature kinetics extracted from the dynamic FLT PET/CT imaging with the vasculature kinetics extracted from DCE-CT.

Investigational Agent AG-013736 In Combinations With Standard Of Care Treatments For Patient's With Advanced Solid Tumor [Completed]
To determine the best dose of this investigational agent AG-013736 in combination with various standard of care treatments for advanced solid tumors.

VEGF Receptor Tyrosine Kinase Inhibitor Axitinib in Children With Recurrent or Refractory Solid Tumors [Recruiting]
This trial will be the first study of axitinib in children and adolescents. The primary objective of this Phase 1 trial is to determine a maximum tolerated dose (MTD) or recommended Phase 2 dose (RP2D) of axitinib in pediatric patients with refractory solid tumors. Additional objectives include measurement of pharmacokinetic and pharmacodynamic parameters, description of the toxicity profile of this agent in children and adolescents, and assessment of response within the confines of a Phase 1 trial. A standard rolling 6 design will be used for dose escalation. Further development of axitinib will focus on development of a joint cooperative group (COG/ECOG) Phase 2 study of axitinib in pediatric, adolescent and young adult translocation renal cell carcinoma.

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Reports of Suspected Inlyta (Axitinib) Side Effects

Death (37)Fatigue (37)Disease Progression (34)Diarrhoea (22)Decreased Appetite (21)Dysphonia (19)Headache (16)Weight Decreased (14)Constipation (14)Renal Cancer (14)more >>


Page last updated: 2015-08-10

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