OSI-906 With Gemcitabine and Erlotinib for Metastatic Ductal Adenocarcinoma of the Pancreas

Conditions

• Pancreatic Cancer, Metastatic

Eligibility Criteria

Sex

ALL

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• Gemcitabine, Erlotinib, OSI-906 — DRUG
  Gemcitabine 1000 mg/m2 d1,8,15; Erlotinib 100 mg QD, OSI-906 dose to be determined BID
• Gemcitabine, Erlotinib — DRUG
  Gemcitabine 1000 mg/m2 d1,8,15; Erlotinib 100 mg QD

Study Details

OSI-906 is a new drug that may stop cancer cells from growing abnormally. This drug has been used in other research studies and information from those suggests that OSI-906 may help block cell receptors involved in tumor growth. Gemcitabine and erlotinib are used as standard treatment for pancreatic cancer. In this research study, the investigators are looking for the highest dose of OSI-906 that can be given safely in combination with gemcitabine and erlotinib. This dose will then be given together with gemcitabine and erlotinib to a further group of patients with pancreatic cancer.

Key Dates

First listed

May 17, 2012

Status verified

Jun 2013

Study Design

Enrollment

0 participants (actual)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• Experimental: Gemcitabine, Erlotinib, OSI-906
  Experimental treatment arm
• Active Comparator: Gemcitabine, Erlotinib
  Standard treatment arm

Primary Outcome Measure

Number of patients with adverse events as a measure of safety and tolerability [ Time Frame: 1 years ]

Locations (2)

Find similar trials in Boston, MA

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