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Clinical Trial Details — Status: Suspended

Administrative data

NCT number NCT00536770
Other study ID # 011-017
Secondary ID
Status Suspended
Phase Phase 2
First received September 26, 2007
Last updated November 2, 2007
Start date September 2007

Study information

Verified date November 2007
Source Novacea
Contact n/a
Is FDA regulated No
Health authority United States: Food and Drug Administration
Study type Interventional

Clinical Trial Summary

The purpose of this study is to determine the safety and efficacy of an investigational study drug DN-101 (calcitriol) when given in combination with gemcitabine ± erlotinib in the treatment of pancreatic cancer.


Recruitment information / eligibility

Status Suspended
Enrollment 132
Est. completion date
Est. primary completion date
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility Inclusion Criteria:

- Histologically or cytologically confirmed diagnosis of locally advanced and unresectable, or metastatic pancreatic cancer

- Performance status 0, 1,or 2

- Adequate bone marrow, renal and hepatic function

Exclusion Criteria:

- Prior chemotherapy or radiation therapy for pancreatic cancer

- Prior treatment for other cancers in last 6 months

- Cancer of the brain or spine

- Active uncontrolled infection

- Hypercalcemia

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment


Related Conditions & MeSH terms


Intervention

Drug:
placebo + gemcitabine + erlotinib

Placebo + gemcitabine

calcitriol + gemcitabine

calcitriol + gemcitabine + erlotinib


Locations

Country Name City State
United States Novacea Investigational Site Nashville Tennessee

Sponsors (2)

Lead Sponsor Collaborator
Novacea Schering-Plough

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Overall survival rate at 6 months
Secondary Objective response rate
Secondary Duration of progression free survival
Secondary Duration of overall survival
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