A Study of Gemcitabine ± Erlotinib and DN-101 Versus Gemcitabine ± Erlotinib and Placebo in Patients With Advanced Pancreatic Cancer

A Randomized Phase 2 Study of Gemcitabine ± Erlotinib and DN-101 Versus Gemcitabine ± Erlotinib and Placebo in Subjects With Advanced Pancreatic Adenocarcinoma

Status

Suspended

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00536770

Enrollment

132

Registered

2007-09-28

Start date

2007-09-30

Completion date

Unknown

Last updated

2007-11-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Pancreatic Cancer

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.

Interventions

DRUGplacebo + gemcitabine + erlotinib

DRUGPlacebo + gemcitabine

DRUGcalcitriol + gemcitabine

DRUGcalcitriol + gemcitabine + erlotinib

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame
Overall survival rate at 6 months	—

Secondary

Measure	Time frame
Objective response rate	—
Duration of progression free survival	—
Duration of overall survival	—

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026