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Trial: NCT00998322 [RDF]

Label NCT00998322
Slug nct00998322
Trialid NCT00998322
Lookup name NCT00998322
Lastchanged date April 8, 2015
Firstreceived results date
Firstreceived date October 15, 2009
Id info nct id NCT00998322
Overall status Completed
Id info secondary id
Biospec retention
Required header link text Link to the current record.
Enrollment 34
Number of arms 1
Is section 801 Yes
Is fda regulated Yes
Brief title A Study of REOLYSIN® in Combination With Gemcitabine in Patients With Advanced Pancreatic Adenocarcinoma
Official title A Phase 2 Study of REOLYSIN in Combination With Gemcitabine for Patients With Advanced Pancreatic Adenocarcinoma
Study type Interventional
Id info nct alias
Completion date February 2015
Verification date April 2015
Why stopped
Id info org study id REO 017
Required header url
Study design Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Source Oncolytics Biotech
Primary completion date December 2013
Brief summary
Number of groups
Required header download date processed this data on September 07, 2016
Phase Phase 2
Start date October 2009
Has expanded access No
Biospec descr
Detailed description Pancreatic cancer remains one of the most lethal cancers, ranking as the fourth leading cause of cancer death for both men and women. The American Cancer Society estimates that 37,170 men and women (18,830 men and 18,340 women) will be diagnosed with pancreatic cancer and 33,370 men and women will die of pancreatic cancer in 2008. Activating KRAS mutations are the most frequent genetic abnormalities in pancreatic cancer (occurring in 75% to 95% of patients). REOLYSIN has been demonstrated to kill a wide variety of cells with mutations along the RAS pathway, including pancreatic cancer cells. The Phase 2 study is designed to characterize the efficacy and safety of REOLYSIN given intravenously in combination with gemcitabine every 3 weeks in patients with advanced pancreatic cancer. Response is a primary endpoint of this trial. Tumors will be evaluated by CT scan within 14 days of starting treatment, then at 6 weeks, and then every 6 weeks thereafter. The safety of the gemcitabine and REOLYSIN combination will be assessed by the evaluation of the type, frequency and severity of adverse events, changes in clinical laboratory tests, immunogenicity and physical examination. Patients may continue to receive therapy under this protocol, provided he/she has not experienced either progressive disease or unacceptable drug-related toxicity that does not respond to either supportive care or dose reduction.
Condition browse b91999db46298372253bcdbbebcefc0c
Intervention browse 8a1d1efc3cd2a7882f28bd242f2f82f1
Responsible party 015b495dfd0be1a85fcb46d41f363abd
Overall contact None
Overall contact backup None
Sponsor group e54a69e780a19d8cdfb5c949ecaaa9c6
Oversight info United States: Food and Drug Administration (Oversight_info)
Eligibility 4d6f00830fe5f364ec9559fc902c4737
Keywords adenocarcinoma, chemotherapy, gemcitabine, metastatic, pancreatic, REOLYSIN
Conditions Metastatic Pancreatic Adenocarcinoma
Locations 4d3dcadb50815fc2a388e4e856b05b89, ecc5963ca5c2c8e66a6b492ac7b0a0d9
Links None
Results references None
Arm groups None
Location countries United States
Interventions Gemcitabine (Intervention), REOLYSIN (Intervention)
Secondary outcomes 3caba57c17c33900ca042bc17dc82528, 799093418699f308316f5a4cc487e136
References None
Primary outcomes a884be4aaa25e7999ca8c83e4bd7b44b
Removed countries None
Overall officials None