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Spots Global Cancer Trial Database for Study of Oral Clofarabine Administered Daily for 5 Days in Adult Patients With Refractory Solid Tumors

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Trial Identification

Brief Title: Study of Oral Clofarabine Administered Daily for 5 Days in Adult Patients With Refractory Solid Tumors

Official Title: A Phase I Dose Escalation and Pharmacokinetic Study of Oral Clofarabine Administered Daily for 5 Days in Adult Patients With Refractory Solid Tumors

Study ID: NCT00125827

Conditions

Solid Tumors

Study Description

Brief Summary: Clofarabine (injection) is approved by the Food and Drug Administration (FDA) for the treatment of pediatric patients 1 to 21 years old with relapsed acute lymphoblastic leukemia (ALL) who have had at least 2 prior treatment regimens. This is a research study of clofarabine that will be given to patients (orally) with advanced cancerous tumors or cancerous tumors that have spread in which standard drugs are no longer effective or no reliable effective treatment is available. The purpose of this study is to find the answers to the following research questions: 1. What is the largest dose of oral clofarabine that can be safely given daily for 5 days followed by 23 days of rest and repeated every 28 days? 2. What are the side effects of clofarabine when given on this schedule? 3. How much oral clofarabine is in the blood at specific times after administration and how does the body get rid of the drug? 4. Will oral clofarabine help treat solid tumor cancer?

Detailed Description:

Keywords

Eligibility

Minimum Age: 18 Years

Eligible Ages: ADULT, OLDER_ADULT

Sex: ALL

Healthy Volunteers: No

Locations

Mary Crowley Medical Research Center, Dallas, Texas, United States

Tyler Cancer Institute, Tyler, Texas, United States

Cancer Care Northwest, Spokane, Washington, United States

Contact Details

Name: Medical Monitor

Affiliation: Genzyme, a Sanofi Company

Role: STUDY_DIRECTOR

Useful links and downloads for this trial

Clinicaltrials.gov

Google Search Results

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