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A Phase I, Open Label, Study of the Safety and Tolerability of KU-0059436 in Combination With Gemcitabine in the Treatment of Patients With Advanced Solid Tumours


Phase 1
18 Years
N/A
Not Enrolling
Both
Pancreatic Neoplasms

Thank you

Trial Information

A Phase I, Open Label, Study of the Safety and Tolerability of KU-0059436 in Combination With Gemcitabine in the Treatment of Patients With Advanced Solid Tumours


Inclusion Criteria:



- Histologically or cytologically confirmed adenocarcinoma of pancreas

- Locally advanced or metastatic unresectable disease

Exclusion Criteria:

- No prior anti cancer chemotherapy, radiotherapy (except palliative >4 weeks prior to
entry, endocrine or immunotherapy or use of other investigational agents;

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

To establish the maximum tolerated dose (MTD) or a tolerable and effective dose of KU 0059436 in combination with gemcitabine

Outcome Time Frame:

assessed at each visit

Safety Issue:

No

Principal Investigator

Howard A Burris III, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

The Sarah Cannon Cancer Center

Authority:

United States: Food and Drug Administration

Study ID:

D0810C00005

NCT ID:

NCT00515866

Start Date:

August 2007

Completion Date:

July 2012

Related Keywords:

  • Pancreatic Neoplasms
  • Advanced pancreatic cancer
  • Poly (ADP ribose) polymerases
  • Advanced Solid Tumours
  • Neoplasms
  • Pancreatic Neoplasms

Name

Location
Research Site Albany, New York  
Research Site Chattanooga, Tennessee