- http://www.clinicaltrials.gov/ct2/show/NCT01096732?term=GDC-0449
Purpose
This clinical trial is looking at the effect of a new drug called GDC-0449 in patients with cancer of the pancreas. Laboratory studies have shown that this drug blocks a process in pancreatic cells thought to be involved in cancer development and spread. This process is called the 'Hedgehog signalling pathway'. As yet, it is unclear whether blocking hedgehog signalling will directly affect the tumour cells themselves or the surrounding normal tissue. Understanding this distinction will help improve treatment strategies for pancreatic cancer. Patients will be offered to participate in this research study if they have localised pancreatic cancer that can be removed by surgery. In the period between diagnosis and surgery the investigators do not normally treat patients, however in this trial the investigators will ask patients to take GDC-0449 during the approximately two weeks until the day of surgery. All patients that enter this study will have undergone a diagnostic biopsy of the pancreatic tumour and the investigators will collect a second sample of the tumour at surgery. The main question of this study is whether the investigators can detect a change in hedgehog signalling in the normal tumour surrounding tissue. Furthermore the investigators will look very carefully whether this treatment is safe for patients. All problems before and after surgery will be carefully documented and the investigators have defined strict rules to stop the study if the investigators observe serious problems.
Estimated Enrollment: 20
Study Start Date: July 2010
Estimated Study Completion Date: January 2012
Estimated Primary Completion Date: January 2012 (Final data collection date for primary outcome measure)
Hedgehog Inhibitors for Metastatic Adenocarcinoma of the Pancreas
- http://clinicaltrials.gov/ct2/show/NCT01088815?term=gdc-0449
Purpose
This is an open-label, single arm, multi-center, Phase II trial to evaluate the progression free survival in patients with metastatic adenocarcinoma of the pancreas treated with a hedgehog inhibitor (GDC-0449) in combination with chemotherapy (gemcitabine and nab-Paclitaxel).
Estimated Enrollment: 80
Study Start Date: May 2010
Estimated Primary Completion Date: December 2012 (Final data collection date for primary outcome measure)
GDC-0449 and RO4929097 in Treating Women With Advanced Breast Cancer PI
- http://clinicaltrials.gov/ct2/show/NCT01071564 PII
PURPOSE: This phase I trial is studying the side effects and best dose of giving GDC-0449 together with RO4929097 in treating women with advanced breast cancer.
Estimated Enrollment: 36
Study Start Date: November 2009
Estimated Primary Completion Date: September 2010
Basal Cell Nevus Syndrome (BCNS) PII
- http://clinicaltrials.gov/ct2/show/NCT00957229?term=GDC-0449
The purpose of this study is to reduce the number of new surgically eligible BCCs by 50% appearing during month 3-18 of medication ingestion.
Study Start Date: August 2009
Estimated Study Completion Date: March 2013
Previous Genentech-Sponsored Phase I or II Cancer Study PII
- http://clinicaltrials.gov/ct2/show/NCT00959647?term=GDC-0449
This is a multicenter, open-label extension study. Patients receiving GDC-0449 in a Genentech-sponsored study who have completed the parent study or who continue to receive GDC-0449 at the time of the parent study closure are eligible for continued treatment on this protocol.
Study Start Date: August 2009
Estimated Primary Completion Date: August 2017
Metastatic Pancreatic Cancer PI
- http://clinicaltrials.gov/ct2/show/NCT00878163?term=GDC-0449
This phase I trial is studying the side effects and best dose of erlotinib hydrochloride when given together with GDC-0449 with or without gemcitabine hydrochloride in treating patients with metastatic pancreatic cancer or solid tumors that cannot be removed by surgery.
Study Start Date: March 2009
Estimated Primary Completion Date: November 2009
Gemcitabine Hydrochloride With or Without GDC-0449 in Treating Patients With Recurrent or Metastatic Pancreatic Cancer PII
- http://clinicaltrials.gov/ct2/show/NCT01064622?term=hedgehog
RATIONALE: Drugs used in chemotherapy, such as gemcitabine hydrochloride, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. GDC-0449 may slow the growth of tumor cells. It is not yet known whether giving gemcitabine hydrochloride together with GDC-0449 is more effective than gemcitabine hydrochloride alone in treating patients with pancreatic cancer.
PURPOSE: This randomized phase II trial is studying gemcitabine hydrochloride and GDC-0449 to see how well they work compared with gemcitabine hydrochloride alone in treating patients with recurrent or metastatic pancreatic cancer.
Study Start Date: September 2009
Estimated Primary Completion Date: November 2011 (Final data collection date for primary outcome measure)
Advanced Stomach Cancer or Gastroesophageal Junction Cancer PII
- http://clinicaltrials.gov/ct2/show/NCT00982592?term=GDC-0449
This randomized phase II trial is studying giving combination chemotherapy together with GDC-0449 to see how well it works compared with giving combination chemotherapy without GDC-0449 in treating patients with advanced stomach cancer or gastroesophageal junction cancer.
Study Start Date: September 2009
Estimated Primary Completion Date: April 2011
Locally Advanced or Metastatic Solid Tumors That Are Refractory to Standard Therapy or for Whom No Standard Therapy Exists P1
- http://clinicaltrials.gov/ct2/show/NCT00968981?term=GDC-0449
This is a two stage, Phase Ib study designed to describe the pharmacokinetics of GDC-0449 in patients with advanced solid tumors that are refractory to treatment or for whom no standard therapy exists.
Estimated Enrollment: 60
Study Start Date: September 2009
Advanced Basal Cell Carcinoma PII
- http://clinicaltrials.gov/ct2/show/NCT00833417?term=GDC-0449
This is a Phase II, single-arm, two-cohort multicenter clinical trial evaluating the efficacy and safety of GDC-0449 in patients with advanced BCC. All patients will receive GDC-0449 until evidence of progression, intolerable toxicities most probably attributable to GDC-0449, or withdrawal from the study.
Study Start Date: January 2009
Estimated Primary Completion Date: July 2012
Extensive-Stage Small Cell Lung Cancer PII
- http://clinicaltrials.gov/ct2/show/NCT00887159?term=GDC-0449
Drugs used in chemotherapy, such as cisplatin and etoposide phosphate, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. GDC-0449 may slow the growth of tumor cells. Monoclonal antibodies, such as cixutumumab, can block tumor growth in different ways. Some block the ability of tumor cells to grow and spread. Others find tumor cells and help kill them or carry tumor-killing substances to them. It is not yet known whether giving cisplatin and etoposide are more effective when given together with GDC-0449 or cixutumumab in treating small cell lung cancer
http://clinicaltrials.gov/ct2/show/NCT0 ... m=GDC-0449
Study Start Date: July 2009
Estimated Primary Completion Date: December 2010
Young Patients With Medulloblastoma PI
- http://clinicaltrials.gov/ct2/show/NCT00822458?term=GDC-0449
This phase I trial is studying the side effects and best dose of GDC-0449 in treating young patients with medulloblastoma that is recurrent or did not respond to previous treatment.
Study Start Date: January 2009
Estimated Primary Completion Date: August 2010
Adult Patients With Recurrent or Refractory Medulloblastoma PII
- http://clinicaltrials.gov/ct2/show/NCT00939484?term=GDC-0449
This phase II trial is studying how well GDC-0449 works in treating adult patients with recurrent or refractory medulloblastoma
Study Start Date: June 2009
Estimated Primary Completion Date: September 2010
Recurrent Glioblastoma Multiforme PII
- http://clinicaltrials.gov/ct2/show/NCT00980343?term=GDC-0449
This randomized phase II trial is studying how well GDC-0449 works in treating patients with recurrent glioblastoma multiforme that can be removed by surgery.
Study Start Date: October 2009
Estimated Primary Completion Date: April 2010
First-Line Therapy for Metastatic Colorectal Cancer PII
- http://clinicaltrials.gov/ct2/show/NCT00636610?term=GDC-0449
This is a randomized, placebo-controlled, double-blind study of GDC-0449 added to biochemotherapy standard-of-care regimens for metastatic CRC, with treatment until disease progression. Patients will receive either FOLFOX or FOLFIRI chemotherapy with bevacizumab. The decision of which regimen (FOLFOX or FOLFIRI) to use will be made by the treating physician and patient. Patients will be randomized to receive GDC-0449 or placebo and will be stratified based on the chemotherapy regimen chosen and whether or not Response Evaluation Criteria in Solid Tumors (RECIST) measurable disease is present at baseline.
Study Start Date: March 2008
Estimated Primary Completion Date: March 2011
Maintenance Therapy in Patients With Ovarian Cancer PII
- http://clinicaltrials.gov/ct2/show/NCT00739661?term=GDC-0449
The proposed study is a Phase II, randomized, placebo-controlled, double-blind, multicenter clinical trial of GDC-0449 in patients with ovarian cancer in a second or third complete remission. Patients will be randomized in a 1:1 ratio to either GDC-0449 or placebo. Randomization will be stratified based on whether their cancer is in a second or third complete remission.
Study Start Date: September 2008
Estimated Primary Completion Date: January 201
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