Please select the arm or intervention descriptions that belong to the clinical trial below.
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
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. 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.


Options:
A: Arm Label: GSK1120212 plus Gemcitabine; Type: EXPERIMENTAL; Interventions: Drug: GSK1120212, Drug: Gemcitabine | Arm Label: Placebo plus Gemcitabine; Type: ACTIVE_COMPARATOR; Interventions: Drug: Gemcitabine, Drug: Placebo | Intervention Type: DRUG; Name: GSK1120212; Assigned to Arm(s): GSK1120212 plus Gemcitabine | Intervention Type: DRUG; Name: Gemcitabine; Assigned to Arm(s): GSK1120212 plus Gemcitabine, Placebo plus Gemcitabine | Intervention Type: DRUG; Name: Placebo; Assigned to Arm(s): Placebo plus Gemcitabine
B: Intervention Type: DRUG; Name: Gefitinib; Assigned to Arm(s): N/A
C: Arm Label: Control; Type: ACTIVE_COMPARATOR; Interventions: Drug: Gemcitabine+erlotinib | Arm Label: Experimental; Type: EXPERIMENTAL; Interventions: Drug: Gemcitabine+erlotinib+capecitabine | Intervention Type: DRUG; Name: Gemcitabine+erlotinib; Assigned to Arm(s): Control | Intervention Type: DRUG; Name: Gemcitabine+erlotinib+capecitabine; Assigned to Arm(s): Experimental
D: Arm Label: Simtuzumab (open-label); Type: EXPERIMENTAL; Interventions: Drug: Simtuzumab, Drug: Gemcitabine | Arm Label: Simtuzumab 200 mg (randomized); Type: EXPERIMENTAL; Interventions: Drug: Simtuzumab, Drug: Gemcitabine | Arm Label: Simtuzumab 700 mg (randomized); Type: EXPERIMENTAL; Interventions: Drug: Simtuzumab, Drug: Gemcitabine | Arm Label: Placebo (randomized); Type: PLACEBO_COMPARATOR; Interventions: Drug: Gemcitabine, Drug: Placebo to match simtuzumab | Intervention Type: DRUG; Name: Simtuzumab; Assigned to Arm(s): Simtuzumab (open-label), Simtuzumab 200 mg (randomized), Simtuzumab 700 mg (randomized) | Intervention Type: DRUG; Name: Gemcitabine; Assigned to Arm(s): Placebo (randomized), Simtuzumab (open-label), Simtuzumab 200 mg (randomized), Simtuzumab 700 mg (randomized) | Intervention Type: DRUG; Name: Placebo to match simtuzumab; Assigned to Arm(s): Placebo (randomized)

Answer: A