AZD6244 vs. Capecitabine (Xeloda®) in Patients With Advanced or Metastatic Pancreatic Cancer, Who Have Failed First Line Gemcitabine Therapy
This study has been completed.
Sponsor:
AstraZeneca
Information provided by (Responsible Party):
AstraZeneca
ClinicalTrials.gov Identifier:
NCT00372944
First received: September 5, 2006
Last updated: August 12, 2014
Last verified: August 2014
- Full Text View
- Tabular View
- No Study Results Posted
- Disclaimer
- How to Read a Study Record
Purpose
The purpose of this study is to assess the efficacy and safety of AZD6244 (ARRY-142886)versus capecitabine in patients with advanced or metastatic pancreatic cancer who have failed first-line therapy with gemcitabine. Following baseline assessments, a minimum of 64 patients in approximately 5-6 centers from the US will be treated with either AZD6244 or capecitabine. Treatment will be continued for as long as the patients receive clinical benefit. The status of all patients will be checked (whether they are still taking treatment or not) approximately 3 months after the last patient has entered the study.
| Condition | Intervention | Phase |
|---|---|---|
|
Pancreatic Cancer |
Drug: AZD6244 Drug: capecitabine |
Phase 2 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | A Phase II, Open, Randomised Study to Assess the Efficacy and Safety of AZD6244 vs. Capecitabine (Xeloda®) in Patients With Advanced or Metastatic Pancreatic Cancer, Who Have Failed First Line Gemcitabine Therapy |
Resource links provided by NLM:
Further study details as provided by AstraZeneca:
Primary Outcome Measures:
- Median time to death (TTD) [ Time Frame: Data cut off for this analysis was 5th April 2008. ] [ Designated as safety issue: No ]The TTD (days) was calculated as the interval from date of randomisation to date of patient death (from any cause). Patients who had not died at the time of the final analysis were censored at the last date the patient was known to be alive. Median TTD in days is presented here.
Secondary Outcome Measures:
- Progression event count [ Time Frame: The mandatory tumour assessment visit (MTAV) occurred on 27th February 2008 (+/-3days) ] [ Designated as safety issue: No ]The number of patients with a progression event occurring on or before MTAV where an event is defined as Objective and/or clinical disease progression as measured using RECIST criteria, or death from any cause
- To assess the safety and tolerability of AZD6244 in the treatment of advanced or metastatic pancreatic cancer by review of adverse events (AEs) and laboratory parameters. [ Time Frame: Review of AEs for duration of study, from First Subject in August 2006 to Last Subject Last visit October 2008 ] [ Designated as safety issue: Yes ]
| Enrollment: | 70 |
| Study Start Date: | August 2006 |
| Study Completion Date: | October 2008 |
| Primary Completion Date: | April 2008 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Active Comparator: 1
Xeloda
|
Drug: capecitabine
oral tablet
Other Name: Xeloda®
|
|
Experimental: 2
AZD6244
|
Drug: AZD6244
oral capsule
Other Name: ARRY-142886
|
Eligibility| Ages Eligible for Study: | 18 Years and older (Adult, Senior) |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- Confirmed with pancreatic cancer
- Have failed first line gemcitabine therapy
Exclusion Criteria:
- Previous therapy with EGFR inhibitor, MEK inhibitor or capecitabine.
- Any recent surgery, unhealed surgical incision or severe condition such as uncontrolled cardiac disease or chronic gastrointestinal diseases.
Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study.
To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.
For general information, see Learn About Clinical Studies.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00372944
Please refer to this study by its ClinicalTrials.gov identifier: NCT00372944
Locations
| United States, California | |
| Research Site | |
| Alhambra, California, United States | |
| Research Site | |
| Bakersfield, California, United States | |
| Research Site | |
| Palm Springs, California, United States | |
| Research Site | |
| Santa Maria, California, United States | |
| United States, Florida | |
| Research Site | |
| Orlando, Florida, United States | |
| United States, Maryland | |
| Research Site | |
| Chevy Chase, Maryland, United States | |
| United States, Michigan | |
| Research Site | |
| Ann Arbor, Michigan, United States | |
| United States, New York | |
| Research Site | |
| New York, New York, United States | |
| United States, Tennessee | |
| Research Site | |
| Nashville, Tennessee, United States | |
| United States, Texas | |
| Research Site | |
| Temple, Texas, United States | |
| United States, Washington | |
| Research Site | |
| Seattle, Washington, United States | |
| Australia | |
| Research Site | |
| Heidelburg, Australia | |
| Bulgaria | |
| Research Site | |
| Plovdiv, Bulgaria | |
| Research Site | |
| Sofia, Bulgaria | |
| Research Site | |
| Varna, Bulgaria | |
| Hungary | |
| Research Site | |
| Budapest, Hungary | |
| Romania | |
| Research Site | |
| Cluj-Napoca, Romania | |
Sponsors and Collaborators
AstraZeneca
Investigators
| Study Director: | Emerging Oncology Medical Science Director, MD | AstraZeneca |
More Information
Additional Information:
| Responsible Party: | AstraZeneca |
| ClinicalTrials.gov Identifier: | NCT00372944 History of Changes |
| Other Study ID Numbers: | D1532C00008 |
| Study First Received: | September 5, 2006 |
| Last Updated: | August 12, 2014 |
| Health Authority: | United States: Food and Drug Administration |
Keywords provided by AstraZeneca:
|
advanced pancreatic cancer metastatic pancreatic cancer AZD6244 |
Additional relevant MeSH terms:
|
Pancreatic Neoplasms Digestive System Neoplasms Neoplasms by Site Neoplasms Endocrine Gland Neoplasms Digestive System Diseases Pancreatic Diseases Endocrine System Diseases Gemcitabine Capecitabine |
Antimetabolites, Antineoplastic Antimetabolites Molecular Mechanisms of Pharmacological Action Antineoplastic Agents Antiviral Agents Anti-Infective Agents Enzyme Inhibitors Immunosuppressive Agents Immunologic Factors Physiological Effects of Drugs |
ClinicalTrials.gov processed this record on September 23, 2016