GoldBamboo.com - Knowledge is strong medicine
  

Safety and Pharmacokinetics of XL647 Administered Orally to Subjects with Solid Tumors - Article


  Not Signed In - Sign In / Register


Get Your Free Credit Report Right Now!

Zip Code:






Clonazepam Orally Disintegrating Tablets

Klonopin Wafer 




Clinical Trial: Safety and Pharmacokinetics of XL647 Administered Orally to Subjects with Solid Tumors

This study is currently recruiting patients.

Sponsored by: Exelixis
Information provided by: Exelixis

Purpose

The primary objective of this study is as follows:

  • To evaluate the safety and tolerability of XL647 administered orally as a single dose and as repeat doses (up to 11 different dose levels) in subjects with solid tumors.

The secondary objectives of this study are as follows:

  • To evaluate the plasma pharmacokinetics of XL647 administered orally as a single dose and as repeat doses (up to 11 different dose levels) in subjects with solid tumors,
  • To estimate renal elimination of XL647 administered orally as a single dose (up to 11 different dose levels) in subjects with solid tumors.

The exploratory objective of this study is as follows:

In addition, subjects may be eligible to enter a Treatment Extension Period. The following information will be obtained from this part of the study:

  • Long-term safety and tolerability of XL647 after repeat administration,
  • Tumor response after repeat administration of XL647.

Condition Treatment or Intervention Phase
Cancer
 Drug: XL647
Phase I

MedlinePlus related topics:  Cancer;   Cancer Alternative Therapy

Study Type: Interventional
Study Design: Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety Study

Official Title: A Phase 1 Dose-Escalation Study of the Safety and Pharmacokinetics of XL647 Administered Orally to Subjects with Solid Tumors

Further Study Details: 

Expected Total Enrollment:  66

Study start: June 2004

Eligibility

Ages Eligible for Study:  18 Years and above,  Genders Eligible for Study:  Both

Criteria

Inclusion Criteria:

  • The subject has a histologically confirmed malignancy that is metastatic or unresectable, and for which standard curative or palliative measures do not exist or are no longer effective,
  • The subject has disease that is assessable by tumor marker, physical, or radiologic means,
  • The subject is ≥18 years old,
  • There have been at least 4 weeks since prior chemotherapy or radiation therapy (6 weeks if the last treatment regimen included BCNU or mitomycin C),
  • The subject has an ECOG performance status ≤2 (Karnofsky >60%),
  • The subject has a life expectancy of ≥3 months,
  • The subject has normal organ and marrow function (hemoglobin >10g/dL, leukocytes >3,000/mL, absolute neutrophil count >1,500/µL, platelets >100,000/µL, total bilirubin within normal institutional limits), AST (SGOT)/ALT(SGPT) <2.5 times the upper limit of normal, and creatinine within normal limits],
  • The subject is capable of understanding and complying with the protocol and has signed the informed consent document,
  • Sexually active subjects (both male and female) must use an accepted method of contraception during the course of the study,
  • Female subjects of childbearing potential (pre-menopausal) must have a negative pregnancy test.

Exclusion Criteria:

  • The subject has had chemotherapy or radiotherapy within 4 weeks (6 weeks for nitrosoureas or mitomycin C) prior to entering the study or has not recovered from AEs due to agents administered more than 4 weeks earlier,
  • The subject has received another investigational agent within 30 days (or 5.5 half-lives) of the first dose of study drug,
  • The subject has known brain metastases,
  • The subject has a corrected QT interval (QTc) of >0.44 seconds,
  • The subject has a history of allergic reactions attributed to aspartame or to any other component in the formulation vehicle,
  • The subject has an uncontrolled intercurrent illness including,but not limited to ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements,
  • The subject is pregnant or nursing,
  • The subject is known to be positive for the human immunodeficiency virus (HIV).

Location and Contact Information

Barbara Skinn, PhD, RN, OCN      215.282.5459    Barbara.Skinn@premier-research.com

California
      Stanford University Medical Center, Stanford,  California,  94305,  United States; Recruiting
Joanne Halsey  650-723-7688 
Branimir I Sikic, M.D.,  Principal Investigator

Minnesota
      Mayo Clinic, Rochester,  Minnesota,  55905,  United States; Recruiting
Debra Kaul  507-538-6646    kaul.debra@mayo.edu 
Alex A Adjei, M.D., Ph.D.,  Principal Investigator

Study chairs or principal investigators

Harold Keer, M.D., Ph.D.,  Study Director,  Exelixis, Inc. (Study Sponsor)   

More Information

Study ID Numbers:  XL647-001
Record last reviewed:  March 2005
Last Updated:  March 22, 2005
Record first received:  July 2, 2004
ClinicalTrials.gov Identifier:  NCT00086528
Health Authority: United States: Food and Drug Administration
ClinicalTrials.gov processed this record on 2005-04-08


Source: ClinicalTrials.gov
Cache Date: April 9, 2005

Resources



[ Disclaimer: The information on GoldBamboo for any particular treatment, medicine, drug, or herbal product might be missing or incomplete, and should never be used as a single source of knowledge. GoldBamboo generally has links to authoritative sites displayed toward the bottom of each topic page under the heading "Resources". ]

Take control over your directory listings...INSTANTLY

Every day, thousands of users find businesses like yours in the GoldBamboo directory.

Limited Time Offer!!!

For only $30 a year, a savings of 70% off our standard rate:

  • Edit your listing (whenever you want!)
  • Link to your website
  • Choose which categories you are listed in
  • Describe your services

The process will take only a few minutes and consists of 3 easy steps:

1. Register     >     2. Edit Listings     >     3. Publish

Your Company
your street
yourtown, YS 12345
888-888-8888



No Thanks

Popular Treatments

Acne Treatment ADHD Treatment Allergy Treatment Alzheimer's Treatment
Anemia Treatment Arthritis Treatment Asthma Treatment Bipolar Disorder Treatment
Bird Flu Treatment Bladder Cancer Treatment Bladder Control Treatment Blood Pressure Treatment
Brain Tumor Treatment Breast Cancer Treatment Bronchitis Treatment Cancer Treatment
Cancer Alternative Treatment Cataract Treatment Cirrhosis Treatment Colitis Treatment
Colon Cancer Treatment Common Cold Treatment Conjunctivitis Treatment Constipation Treatment
Crohn's Disease Treatment Cystic Fibrosis Treatment Depression Treatment Dermatitis Treatment
Diabetes Treatment Edema Treatment Epilepsy Treatment Erectile Dysfunction Treatment
Fibromyalgia Treatment GERD Treatment Glaucoma Treatment Gout Treatment
Hay Fever Treatment Headache Treatment Heart Disease Treatment Hepatitis Treatment
High Blood Pressure Treatment High Cholesterol Treatment Hives Treatment Hypertension Treatment
Hypoglycemia Treatment IBS Treatment Impotence Treatment Indigestion Treatment
Infertility Treatment Influenza Treatment Insomnia Treatment Lactose Intolerance Treatment
Leukemia Treatment Lung Cancer Treatment Lyme Disease Treatment Macular Degeneration Treatment
Menopause Treatment Migraine Treatment Osteoarthritis Treatment Osteoporosis Treatment
Pancreatic Cancer Treatment PMS Treatment Pneumonia Treatment Prostate Diseases Treatment
Restless Leg Treatment Rheumatoid Arthritis Treatment Sepsis Treatment Sinusitis Treatment
Skin Cancer Treatment Sleep Apnea Treatment Snoring Treatment Stroke Treatment
Testicular Cancer Treatment
GoldBambooTM

Your Integrative Health and Wellness Resource for Clonazepam Orally Disintegrating Tablets.

November 27, 2009



Page Updated: June 1, 2005
============== Advertisement ==============
Disclaimer: All material displayed on the GoldBamboo.com website is provided for educational purposes only. Consult a physician regarding the applicability of any information found on GoldBamboo.com to your symptoms or medical condition.

Home | About Us | Link To Us | Feedback | Disclaimer | Privacy Policy | Terms of Use | Health Forums

Copyright © 2004-2009 - Anaconda Partners LLC - All rights reserved.

HONcode accreditation seal.

We comply with the HONcode standard for health trust worthy information:
verify here.