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| Sponsor: | Exelixis |
|---|---|
| Information provided by: | Exelixis |
| ClinicalTrials.gov Identifier: | NCT00486135 |
Purpose
The purpose of this study is to evaluate the safety and tolerability of XL147 in subjects with solid tumors or lymphoma. XL147 is a new chemical entity that inhibits PI3 Kinase. Inactivation of PI3K has been shown to inhibit growth and induce apoptosis (programmed cell death) in tumor cells.
| Condition | Intervention | Phase |
|---|---|---|
|
Cancer Lymphoma |
Drug: XL147 |
Phase I |
| 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 XL147 Administered Orally Daily to Subjects With Solid Tumors or Lymphoma |
| Estimated Enrollment: | 149 |
| Study Start Date: | June 2007 |
| Estimated Study Completion Date: | September 2010 |
| Estimated Primary Completion Date: | September 2010 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
1: Experimental
Daily dosing for 21 days/7 days off
|
Drug: XL147
Gelatin capsules supplied in 25-mg and 100-mg dosage strengths
|
|
2: Experimental
Continuous daily dosing
|
Drug: XL147
Gelatin capsules supplied in 25-mg and 100-mg dosage strengths
Drug: XL147
Tablets supplied as 100-mg, 150-mg, and 200-mg dosage strengths
|
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
For the subjects with solid tumors who are to be enrolled into the expanded MTD cohort and tumor genetic alteration subjects:
Exclusion Criteria:
Contacts and Locations| Contact: Exelixis Contact Line | 1-866-939-4041 |
| United States, Massachusetts | |
| Dana-Farber / Harvard Cancer Center | Recruiting |
| Boston, Massachusetts, United States, 02115 | |
| Contact: Linda Pointon 617-632-4391 | |
| Principal Investigator: Geoffrey Shapiro, MD | |
| United States, Texas | |
| Mary Crowley Medical Research Center | Recruiting |
| Dallas, Texas, United States, 75246 | |
| Contact: Kay Easterwood-Sanchez 214-658-1943 | |
| Principal Investigator: Gerald Edelman, MD, PhD | |
| Spain | |
| Hospital Universitario Vall d'Hebron | Recruiting |
| Barcelona, Spain, 08035 | |
| Contact: Gemma Sala +34 93 489 4158 gsala@vhebron.net | |
| Principal Investigator: Jose Baselga, MD, PhD | |
More Information
| Responsible Party: | Exelixis, Inc. ( Christian Scheffold, MD/Director, Clinical Research ) |
| Study ID Numbers: | XL147-001 |
| Study First Received: | June 11, 2007 |
| Last Updated: | December 2, 2009 |
| ClinicalTrials.gov Identifier: | NCT00486135 History of Changes |
| Health Authority: | United States: Food and Drug Administration; Spain: Spanish Agency of Medicines |
|
Cancer Solid tumors Lymphoma |
|
Lymphatic Diseases Neoplasms Immunoproliferative Disorders Neoplasms by Histologic Type |
Immune System Diseases Lymphoproliferative Disorders Lymphoma |