Dasatinib in Treating Patients With Metastatic Pancreatic Cancer

NCT00474812 | Completed Phase 2 Results DMC

• 5 other identifiers: NCI-2009-00228CDR0000546554CASE 52067828U01CA062502
• Study Type: interventional
• Target: 51
• Locations: 1 country
• Sites: 1

Brief Summary

Dasatinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. This phase II trial is studying how well dasatinib works in treating patients with metastatic pancreatic cancer.

Conditions

Adenocarcinoma of the Pancreas; Recurrent Pancreatic Cancer; Stage IV Pancreatic Cancer

Outcome Measures

Primary Outcomes (1)

• Median Overall Survival

  From the date of onset of treatment to the date of death and to the date of last follow-up for those still alive, assessed up to 24 months

  assessed up to 24 months

Secondary Outcomes (4)

• Objective Response Rate (Complete Response, Partial Response, or Stable Disease), Evaluated Using the New International Criteria Proposed by the RECIST Committee

  Up to 5 years

• Median Progression Free Survival (PFS)

  Up to 5 years

• Gait Speed

  baseline

• Gait Speed

  at 8 weeks

Study Arms (1)

Dasatinib Treatment

EXPERIMENTAL

Patients receive oral dasatinib twice daily on days 1-28.

Drug: dasatinib; Procedure: laboratory biomarker analysis; Procedure: physiologic testing

Interventions

dasatinib DRUG

Also known as: BMS-354825, Sprycel

Dasatinib Treatment

laboratory biomarker analysis PROCEDURE

Correlative study

Dasatinib Treatment

physiologic testing PROCEDURE

Correlative study

Also known as: study of physiologic variables

Dasatinib Treatment

Eligibility Criteria

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

You may qualify if:

• Histologically or cytologically confirmed adenocarcinoma of the pancreas
• Metastatic disease
• Measurable or evaluable/nonmeasurable disease
• No known brain metastases
• ECOG performance status (PS) 0-2 OR Karnofsky PS 60-100%
• Life expectancy \> 12 weeks
• Absolute granulocyte count \>= 1,500/mm\^3
• Platelet count \>= 100,000/mm\^3
• Hemoglobin \> 8.5 g/dL
• Bilirubin =\< 1.5 times upper limit of normal (ULN)
• AST and ALT =\< 2.5 times ULN
• Creatinine =\< 2.0 mg/dL
• Not pregnant or nursing
• No history of allergic reactions attributed to compounds of similar chemical or biological composition to dasatinib
• No QTc prolongation (i.e., QTc interval \>= 480 msecs \[Fridericia correction\]) or other significant ECG abnormalities

Sponsors & Collaborators

• National Cancer Institute (NCI): lead

Study Sites (1)

Case Western Reserve University

Cleveland, Ohio, 44106, United States

Location

MeSH Terms

Conditions

Pancreatic Neoplasms

Interventions

Dasatinib

Condition Hierarchy (Ancestors)

Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Endocrine Gland Neoplasms; Digestive System Diseases; Pancreatic Diseases; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Thiazoles; Sulfur Compounds; Organic Chemicals; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Pyrimidines

Results Point of Contact

• Title: Charles Nock MD
• Organization: Case Medical Center, University Hospitals Seidman Cancer Center, Case Comprehensive Cancer Center

charles.nock@uhhospitals.org

216-844-3862

Study Officials

• Charles Nock

  Case Western Reserve University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: LTE60
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: NIH
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 16, 2007
• First Posted: May 17, 2007
• Study Start: May 1, 2007
• Primary Completion: January 1, 2013
• Study Completion: February 1, 2014
• Last Updated: May 5, 2015
• Results First Posted: December 23, 2013

Record last verified: 2013-11

Locations

US (1)