Status:
COMPLETED
Study of GSK1120212 Plus Gemcitabine vs Placebo Plus Gemcitabine in Metastatic Pancreatic Cancer
Lead Sponsor:
GlaxoSmithKline
Conditions:
Cancer
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
GSK1120212 is a potent and highly selective inhibitor of MEK phosphorylation and kinase activity and has demonstrated potent anti-proliferative activity against human pancreatic cancer cell lines. Thi...
Eligibility Criteria
Inclusion
- 18 years old or older
- Histologically or cytologically confirmed diagnosis of metastatic (Stage IV) adenocarcinoma of the pancreas with measurable or non-measurable disease per Response Evaluation Criteria in Solid Tumors (RECIST) 1.1
- Performance status score of 0 or 1 according to the Eastern Cooperative Oncology Group (ECOG) scale
- All prior treatment related toxicities must be Common Terminology Criteria for Adverse Events (CTCAE) (Version 4.0) ≤ Grade 1 (except alopecia) at the time of randomization
- Adequate baseline organ function
- Able to swallow and retain orally administered medication and does not have any clinically significant gastrointestinal abnormalities that may alter absorption such as malabsorption syndrome or major resection of the stomach or bowels
Exclusion
- Prior systemic therapy (i.e., chemotherapy, immunotherapy, hormone therapy, , targeted therapy or any investigational anti-cancer drug) for metastatic pancreatic adenocarcinoma.
- (Prior treatment with 5-FU based or gemcitabine administered as a radiation sensitizer during and up to 4 weeks after radiation therapy is allowed. Prior systemic chemotherapy in the adjuvant setting is allowed ; however, prior therapy with gemcitabine is allowed only if tumor recurrence occurred at least 6 months after completing the last dose of gemcitabine)
- History of another malignancy. Exception: Subjects who have been disease-free for 5 years, or subjects with a history of completely resected non-melanoma skin cancer or successfully treated in situ carcinoma are eligible. Subjects with second malignancies that are indolent or definitively treated may be enrolled. Consult GSK Medical Monitor if unsure whether second malignancies meet requirements specified above
- Any serious and/or unstable pre-existing medical (aside from malignancy exception above), psychiatric disorder, or other conditions that could interfere with subject's safety, obtaining informed consent or compliance to the study procedures, in the opinion of the Investigator or GSK Medical Monitor
- History of interstitial lung disease or pneumonitis
- History or current evidence / risk of retinal vein occlusion (RVO) or central serous retinopathy (CSR)
- Symptomatic or untreated leptomeningeal or brain metastases or spinal cord compression
- History of acute coronary syndromes (including unstable angina), coronary angioplasty, or stenting within the past 6 months
Key Trial Info
Start Date :
August 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 1 2013
Estimated Enrollment :
160 Patients enrolled
Trial Details
Trial ID
NCT01231581
Start Date
August 1 2010
End Date
February 1 2013
Last Update
September 26 2013
Active Locations (7)
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1
GSK Investigational Site
Seoul, South Korea, 110-744
2
GSK Investigational Site
Seoul, South Korea, 120-752
3
GSK Investigational Site
Seoul, South Korea, 135-710
4
GSK Investigational Site
Seoul, South Korea, 138-736