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

NCT01600807 | Withdrawn Phase 1 DMC

• 1 other identifier: 11-148
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 2

Brief Summary

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.

Conditions

Pancreatic Cancer, Metastatic

Keywords

Metastatic; Pancreas; Cancer; Adenocarcinoma

Outcome Measures

Primary Outcomes (2)

• Number of patients with adverse events as a measure of safety and tolerability

  Phase I study to assess the safety, tolerability and maximally tolerated dose (MTD) of OSI-906 administered in combination with gemcitabine and erlotinib is patients with metastatic pancreatic ductal adenocarcinoma

  1 years

• Survival among patients receiving gemcitabine + erlotinib versus gemcitabine + erlotinib + OSI-906

  Phase II trial to assess overall survival associated with OSI-906, gemcitabine and erlotinib compared with gemcitabine and erlotinib alone in patients with previous untreated metastatic pancreatic ductal adenocarcinoma

  2 years

Secondary Outcomes (2)

• Progression-free survival among patients receiving gemcitabine + erlotinib vs. gemcitabine + erlotinib + OSI-906

  2 years

• Tumor response rate among patients receiving gemcitabine + erlotinib versus gemcitabine + erlotinib + OSI-906

  2 years

Study Arms (2)

Gemcitabine, Erlotinib, OSI-906

EXPERIMENTAL

Experimental treatment arm

Drug: Gemcitabine, Erlotinib, OSI-906

Gemcitabine, Erlotinib

ACTIVE COMPARATOR

Standard treatment arm

Drug: Gemcitabine, Erlotinib

Interventions

Gemcitabine, Erlotinib, OSI-906 DRUG

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

Also known as: Gemzaar, Tarceva

Gemcitabine, Erlotinib, OSI-906

Gemcitabine, Erlotinib DRUG

Gemcitabine 1000 mg/m2 d1,8,15; Erlotinib 100 mg QD

Also known as: Gemzaar, Tarceva

Gemcitabine, Erlotinib

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Metastatic pancreatic ductal adenocarcinoma
• Measurable disease
• Life expectancy \> 12 weeks
• Normal organ and marrow function
• Fasting blood glucose \</= 150 mg/dL
• Able to swallow pills

You may not qualify if:

• Prior chemotherapy or radiotherapy for treatment of pancreatic cancer
• Receiving any other experimental agent
• Known brain metastases
• History of allergic reaction attributed to compounds of similar chemical or biologic composition to gemcitabine, erlotinib, or OSI-906
• Impairment of gastrointestinal function or gastrointestinal disease (e.g., ulcerative disease, uncontrolled nausea, vomiting, or diarrhea)
• Use of enzyme-inducing anti-epileptic drugs
• Diabetes mellitus which requires the use of exogenous insulin for glucose control
• Major surgery within 4 weeks of the start of study treatment
• Uncontrolled intercurrent illness including, but not limited to ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements
• Use of strong or moderate CYP1A2 inhibitors/inducers
• Pregnant or breast feeding
• History of a different malignancy unless disease-free for at least 3 years
• HIV positive

Sponsors & Collaborators

• Dana-Farber Cancer Institute: lead

Study Sites (2)

Massachusetts General Hospital

Boston, Massachusetts, 02114, United States

Location

Dana-Farber Cancer Institute

Boston, Massachusetts, 02214, United States

Location

MeSH Terms

Conditions

Pancreatic Neoplasms; Neoplasm Metastasis; Neoplasms; Adenocarcinoma

Interventions

Gemcitabine; Erlotinib Hydrochloride; 3-(8-amino-1-(2-phenylquinolin-7-yl)imidazo(1,5-a)pyrazin-3-yl)-1-methylcyclobutanol

Condition Hierarchy (Ancestors)

Digestive System Neoplasms; Neoplasms by Site; Endocrine Gland Neoplasms; Digestive System Diseases; Pancreatic Diseases; Endocrine System Diseases; Neoplastic Processes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type

Intervention Hierarchy (Ancestors)

Heterocyclic Compounds; Deoxycytidine; Cytidine; Pyrimidine Nucleosides; Pyrimidines; Heterocyclic Compounds, 1-Ring; Quinazolines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring

Study Officials

• Brian Wolpin, MD, MPH

  Dana-Farber Cancer Institute

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Overall PI

Study Record Dates

• First Submitted: August 8, 2011
• First Posted: May 17, 2012
• Last Updated: June 26, 2013

Record last verified: 2013-06

Locations

US (2)