|
Home
Search
Study Topics
Glossary
|
![]() |
![]() |
|
![]() |
|
![]() |
|
![]() |
![]() |
![]() |
|
![]() |
![]() |
||||||||||||||||||||||||||||||||||||
| Sponsor: | Genentech |
|---|---|
| Collaborators: |
National Cancer Institute (NCI) Sidney Kimmel Comprehensive Cancer Center |
| Information provided by: | Genentech |
| ClinicalTrials.gov Identifier: | NCT00607724 |
Purpose
RATIONALE: Drugs used in chemotherapy, such as GDC-0449, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing.
PURPOSE: This phase I trial is studying the side effects and best dose of GDC-0449 in treating patients with locally advanced or metastatic solid tumors.
| Condition | Intervention | Phase |
|---|---|---|
|
Unspecified Adult Solid Tumor, Protocol Specific |
Drug: Hedgehog antagonist GDC-0449 Genetic: gene expression analysis Genetic: protein analysis Genetic: reverse transcriptase-polymerase chain reaction Other: liquid chromatography Other: mass spectrometry Other: pharmacological study |
Phase I |
| Study Type: | Interventional |
| Study Design: | Treatment, Open Label |
| Official Title: | An Open-Label, Phase I Study of Systemic Hedgehog Pathway Antagonist, GDC-0449, in Patients With Locally Advanced or Metastatic Solid Tumors That Are Refractory to Standard Therapy or For Whom No Standard Therapy Exists |
| Estimated Enrollment: | 60 |
| Study Start Date: | April 2007 |
| Estimated Primary Completion Date: | April 2009 (Final data collection date for primary outcome measure) |
OBJECTIVES:
Primary
Secondary
Tertiary
OUTLINE: This is a multicenter study.
Patients receive oral systemic Hedgehog antagonist GDC-0449 once on day 1 and then once or twice daily beginning on day 8 and continuing for up to 49 weeks in the absence of disease progression or unacceptable toxicity.
Patients undergo plasma, urine, and hair sample collection and skin punch biopsies periodically for pharmacokinetic and pharmacodynamic analyses. The plasma and urine samples are analyzed separately using liquid chromatography/tandem mass spectrometry-based methods. Ex vivo plasma protein binding of GDC-0449 is assayed using an equilibrium dialysis approach. Expression levels of Gli1 and other Hedgehog target genes in hair follicle samples and/or tumor tissue are measured at the RNA level using qRT-PCR.
After completion of study therapy, patients are followed at 21 days.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Histologically confirmed locally advanced or metastatic solid tumor that is refractory to standard therapy or for which no standard therapy exists
Progressed after first-line and second-line therapy (if there is a second-line therapy that has been shown to provide clinical benefit)
Evaluable disease by physical examination, imaging, and/or one of the following:
PATIENT CHARACTERISTICS:
No history of significant atherosclerotic disease, including the following:
PRIOR CONCURRENT THERAPY:
No concurrent medications known to prolong the QT interval, including any of the following:
Contacts and Locations| United States, Maryland | |
| Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins | |
| Baltimore, Maryland, United States, 21231-2410 | |
| Study Chair: | Charles M. Rudin, MD, PhD | Sidney Kimmel Comprehensive Cancer Center |
More Information
| Study ID Numbers: | CDR0000585468, JHOC-J06131, GENETECH-SHH3925g |
| Study First Received: | January 31, 2008 |
| Last Updated: | March 13, 2009 |
| ClinicalTrials.gov Identifier: | NCT00607724 History of Changes |
| Health Authority: | United States: Food and Drug Administration |
|
unspecified adult solid tumor, protocol specific |
|
Neoplasms |