Expired Study
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Philadelphia, Pennsylvania 19104


Purpose:

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. This study is a Phase II, randomized placebo-controlled trial of the MEK inhibitor GSK1120212 plus gemcitabine vs. placebo plus gemcitabine in subjects with metastatic pancreatic cancer. Eligible subjects will receive intravenous gemcitabine with oral GSK1120212 or placebo. Therapy will continue until treatment discontinuation criteria are met. The primary objective will be to compare the overall survival of subjects in the GSK1120212 plus gemcitabine arm vs. subjects in the placebo plus gemcitabine arm. Secondary objectives include comparison of progression free survival, overall response rate, and duration of response between the two arms. Exploratory research objectives include the evaluation of population pharmacokinetics as well as blood and tissue based biomarkers. Safety will also be monitored throughout dosing. Once the determined number of survival events has occurred, if subjects are eligible, they will have the option to enter MEK114375, an open-label, Phase Ib rollover study of GSK1120212 monotherapy or GSK1120212 in combination with other anti-cancer treatments.


Criteria:

Inclusion Criteria: - 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 Criteria: - 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


Study is Available At:


Original ID:

113487


NCT ID:

NCT01231581


Secondary ID:


Study Acronym:


Brief Title:

Study of GSK1120212 Plus Gemcitabine vs Placebo Plus Gemcitabine in Metastatic Pancreatic Cancer


Official Title:

A Randomized, Double-Blind Placebo-Controlled Phase II Study of the MEK Inhibitor GSK1120212 Plus Gemcitabine vs Placebo Plus Gemcitabine in Subjects With Metastatic Pancreatic Cancer


Overall Status:

Completed


Study Phase:

Phase 2


Genders:

Both


Minimum Age:

18 Years


Maximum Age:

N/A


Quick Facts

Healthy Volunteers
Oversight Has DMC
Study Is FDA Regulated
Study Is Section 801
Has Expanded Access

Study Source:

GlaxoSmithKline


Oversight Authority:

United States: Food and Drug Administration


Reasons Why Stopped:


Study Type:

Interventional


Study Design:

Allocation: Randomized, Endpoint Classification:


Number of Arms:

2


Number of Groups:

0


Total Enrollment:

160


Enrollment Type:

Actual


Overall Contact Information

Official Name:GSK Clinical Trials
Study Director
GlaxoSmithKline

Study Dates

Start Date:June 2001
Completion Date:February 2013
Completion Type:Actual
Primary Completion Date:April 2012
Primary Completion Type:Actual
Verification Date:May 2013
Last Changed Date:May 16, 2013
First Received Date:August 30, 2010

Study Outcomes

Outcome Type:Secondary Outcome
Measure:Overall Response Rate
Time Frame:Approximately 18 months
Safety Issues:False
Outcome Type:Secondary Outcome
Measure:Safety profile as assessed through standard clinical and laboratory tests and through collection of AEs and SAEs
Time Frame:Approximately 18 months
Safety Issues:False
Outcome Type:Secondary Outcome
Measure:Duration of Response
Time Frame:Approximately 18 months
Safety Issues:False
Outcome Type:Secondary Outcome
Measure:Progression Free Survival
Time Frame:Approximately 18 months
Safety Issues:False
Outcome Type:Primary Outcome
Measure:Overall Survival
Time Frame:Approximately 18 months
Safety Issues:False

Study Interventions

Intervention Type:Drug
Name:Placebo
Description:administered orally starting on day 1 followed by a continuous daily dosing of 2.0 mg
Arm Name:Placebo plus Gemcitabine
Intervention Type:Drug
Name:Gemcitabine
Description:Intravenous gemcitabine infused over 30 minutes weekly for 7 weeks followed by one week of rest from treatment. Subsequent cycles will consist of 1000 mg/m2 intravenous infusion over 30 minutes on days 1, 8, and 15 followed by 1 week of rest from treatment for each 28-day treatment period.
Arm Name:GSK1120212 plus Gemcitabine
Intervention Type:Drug
Name:GSK1120212
Description:administered orally starting on day 1 followed by a continuous daily dosing of 2.0 mg
Arm Name:GSK1120212 plus Gemcitabine

Study Arms

Study Arm Type:Experimental
Arm Name:GSK1120212 plus Gemcitabine
Description:GSK1120212 administered orally plus gemcitabine IV
Study Arm Type:Active Comparator
Arm Name:Placebo plus Gemcitabine
Description:Placebo administered orally plus gemcitabine IV

Study Agencies

Agency Class:Industry
Agency Type:Lead Sponsor
Agency Name:GlaxoSmithKline

Sample and Retention Information

There are no available Sample and Retention Information

Study References

There are no available Study References

Data Source: ClinicalTrials.gov

Date Processed: October 09, 2019

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