AVN944 in Combination With Gemcitabine for the Treatment of Pancreatic Cancer

This study has been terminated.

(lack of efficacy)

Sponsor:

Information provided by (Responsible Party):

Vertex Pharmaceuticals Incorporated

ClinicalTrials.gov Identifier:

NCT00493441

First received: June 26, 2007

Last updated: September 21, 2011

Last verified: September 2011

History of Changes

Tracking Information
First Received Date ^ICMJE	June 26, 2007
Last Updated Date	September 21, 2011
Start Date ^ICMJE	June 2007
Primary Completion Date	December 2009 (final data collection date for primary outcome measure)
Current Primary Outcome Measures ^ICMJE (submitted: August 2, 2011)	Safety [ Time Frame: 4 weeks ] [ Designated as safety issue: Yes ] Pharmacokinetics [ Time Frame: Days 1, 8, 15, and 22 ] [ Designated as safety issue: No ]
Original Primary Outcome Measures ^ICMJE	Same as current
Change History	Complete list of historical versions of study NCT00493441 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ^ICMJE
Original Secondary Outcome Measures ^ICMJE
Current Other Outcome Measures ^ICMJE
Original Other Outcome Measures ^ICMJE

Descriptive Information
Brief Title ^ICMJE	AVN944 in Combination With Gemcitabine for the Treatment of Pancreatic Cancer
Official Title ^ICMJE	A Phase II Study of AVN944 in Combination With Gemcitabine for the Treatment of Pancreatic Cancer
Brief Summary	The study will find the optimum AVN944 dose to use in combination with gemcitabine in patients with pancreatic cancer and see if the combination of the 2 drugs is more effective for treating pancreatic cancer than using gemcitabine alone.
Detailed Description
Study Type ^ICMJE	Interventional
Study Phase	Phase 2
Study Design ^ICMJE	Allocation: Non-Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment
Condition ^ICMJE	Pancreatic Cancer
Intervention ^ICMJE	Drug: AVN944 150, 200, 250, 300, or 400 mg q12h
Study Arm (s)
Publications *
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information
Recruitment Status ^ICMJE	Terminated
Enrollment ^ICMJE	28
Completion Date	December 2009
Primary Completion Date	December 2009 (final data collection date for primary outcome measure)
Eligibility Criteria ^ICMJE	Inclusion Criteria: Patients with histologically or cytologically confirmed adenocarcinoma of the pancreas not eligible for curative intent resection with or without adjuvant radiation therapy Measurable disease as defined by RECIST criteria No prior chemotherapy for pancreatic cancer including no prior "radiosensitizing" chemotherapy Patients are candidates to receive gemcitabine as first line treatment for adenocarcinoma of the pancreas Age > 18 years Karnofsky Performance Score of less than or equal to 60 Patients must be recovered from the clinically significant effects of any prior surgery or prior radiotherapy Adequate bone marrow, hepatic and renal function as evidenced by: Serum total bilirubin < 2.0 mg/dL AST/ALT (SGOT/SGPT) < 4X the ULN forthe reference lab; Serum creatinine < 2.0 mg/dL; ANC > 1.5 x 109/L; Platelet count > 100 x 109/L, Hgb > 9.0 g/dL Female patients of childbearing potential as well as fertile men and their partners who agree to use an effective form of contraception during the study and for 90 days following the last dose of study medication (an effective form of contraception is an oral contraceptive or a double barrier method) Patients or their legal representatives must be able to read, understand and provide written informed consent to participate in the trial. Exclusion Criteria: Patients with a life expectancy < 3 months Patients with known CNS metastases Patients with an uncontrolled active infection Prior treatment with an IMPDH-inhibitor Patients with known hypersensitivity to any of the components of AVN944 or gemcitabine History of prior malignancy within the past 5 years except for curatively treated non-melanoma skin cancers; cervical intra-epithelial neoplasia, or localized prostate cancer with a current PSA of < 1.0 mg/dL Patients who are receiving concurrent investigational therapy or who have received investigational therapy within 14 days of the first scheduled day of dosing (investigational therapy is defined as treatment for which there is currently no regulatory authority approved indication). Clinically significant toxicities from this therapy must have resolved to < Grade 2. Patients who are pregnant or lactating Myocardial Infarction within the past 6 months Patients with clinically significant intra-ventricular conduction delays Any other intercurrent medical condition, including mental illness or substance abuse, deemed by the Investigator to be likely to interfere with a patient's ability to sign informed consent, cooperate and participate in the study, or interfere with the interpretation of the results. History of solid organ transplant Known HIV or Hepatitis B or C (active, previously treated or both) Previous treatment under this protocol
Gender	Both
Ages	18 Years and older
Accepts Healthy Volunteers	No
Contacts ^ICMJE	Contact information is only displayed when the study is recruiting subjects
Location Countries ^ICMJE	United States

Administrative Information
NCT Number ^ICMJE	NCT00493441
Other Study ID Numbers ^ICMJE	AVN944-006
Has Data Monitoring Committee	Yes
Responsible Party	Vertex Pharmaceuticals Incorporated
Study Sponsor ^ICMJE	Vertex Pharmaceuticals Incorporated
Collaborators ^ICMJE
Investigators ^ICMJE
Information Provided By	Vertex Pharmaceuticals Incorporated
Verification Date	September 2011
^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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