NCT00536770

Brief 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.

Trial Health

40
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial recruitment is currently suspended
Enrollment
132

participants targeted

Target at P75+ for phase_2 pancreatic-cancer

Geographic Reach
1 country

1 active site

Status
suspended

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2007

Completed
25 days until next milestone

First Submitted

Initial submission to the registry

September 26, 2007

Completed
2 days until next milestone

First Posted

Study publicly available on registry

September 28, 2007

Completed
Last Updated

November 6, 2007

Status Verified

November 1, 2007

First QC Date

September 26, 2007

Last Update Submit

November 2, 2007

Conditions

Pancreatic Cancer

Outcome Measures

Primary Outcomes (1)

  • Overall survival rate at 6 months

Secondary Outcomes (3)

  • Objective response rate

  • Duration of progression free survival

  • Duration of overall survival

Study Arms (4)

A

PLACEBO COMPARATOR

Placebo + gemcitabine

Drug: Placebo + gemcitabine

B

PLACEBO COMPARATOR

Placebo + gemcitabine + erlotinib

Drug: placebo + gemcitabine + erlotinib

C

ACTIVE COMPARATOR

DN-101 + gemcitabine

Drug: calcitriol + gemcitabine

D

ACTIVE COMPARATOR

DN-101 + gemcitabine + erlotinib

Drug: calcitriol + gemcitabine + erlotinib

Interventions

placebo + gemcitabine + erlotinibDRUG
B
Placebo + gemcitabineDRUG
A
calcitriol + gemcitabineDRUG
C
calcitriol + gemcitabine + erlotinibDRUG
D

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Novacea Investigational Site

Nashville, Tennessee, United States

Location

MeSH Terms

Conditions

Pancreatic Neoplasms

Interventions

GemcitabineErlotinib HydrochlorideCalcitriol

Condition Hierarchy (Ancestors)

Digestive System NeoplasmsNeoplasms by SiteNeoplasmsEndocrine Gland NeoplasmsDigestive System DiseasesPancreatic DiseasesEndocrine System Diseases

Intervention Hierarchy (Ancestors)

Heterocyclic CompoundsDeoxycytidineCytidinePyrimidine NucleosidesPyrimidinesHeterocyclic Compounds, 1-RingQuinazolinesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingDihydroxycholecalciferolsHydroxycholecalciferolsCholecalciferolCholestenesCholestanesSteroidsFused-Ring CompoundsPolycyclic CompoundsSterolsVitamin DSecosteroidsMembrane LipidsLipids

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

September 26, 2007

First Posted

September 28, 2007

Study Start

September 1, 2007

Last Updated

November 6, 2007

Record last verified: 2007-11

Locations

US(1)