Please select the arm or intervention descriptions that belong to the clinical trial below.
Title: Study PMA112509, a Phase I/II Study of Eltrombopag in Thrombocytopenic Subjects With Advanced Myelodysplastic Syndrome (MDS) or Secondary Acute Myeloid Leukemia After MDS (sAML/MDS)
Brief Summary: This study will evaluate the safety and tolerability of eltrombopag in the treatment of low platelet counts in adult subjects with advanced myelodysplastic syndrome (MDS), secondary acute myeloid leukemia after MDS (sAML/MDS), or de novo AML that are relapsed, refractory or ineligible to receive azacitidine, decitabine, intensive chemotherapy or autologous/allogeneic stem cell transplantation. This is a placebo-controlled study in which patients will receive study medication daily for 6 months, during which time the dose of study medication may be adjusted based upon individual platelet counts and bone marrow blast counts. All subjects will receive best standard of care (platelet transfusions, mild chemotherapy, cytokines, valproic acid, all-trans retinoic acid, ESAs or G-CSF) in addition to study medication. Subjects taking placebo may be allowed to crossover to eltrombopag treatment if a clinically and statistically significant improvement in bone marrow blast counts is seen in subjects treated with eltrombopag.


Options:
A: Arm Label: Dose level 1 500 AMG 531 (Part A - azacitidine); Type: ACTIVE_COMPARATOR; Interventions: Biological: AMG 531 (Romiplostim), Drug: Azacitidine | Arm Label: Dose level 1 750 AMG 531 (Part B - decitabine); Type: ACTIVE_COMPARATOR; Interventions: Biological: AMG 531 (Romiplostim), Drug: Decitabine | Arm Label: Dose level 2 750 AMG 531 (Part A - azacitidine); Type: ACTIVE_COMPARATOR; Interventions: Biological: AMG 531 (Romiplostim), Drug: Azacitidine | Arm Label: Placebo (Part A - azacitidine); Type: PLACEBO_COMPARATOR; Interventions: Drug: Placebo, Drug: Azacitidine | Arm Label: Placebo (Part B - decitabine); Type: PLACEBO_COMPARATOR; Interventions: Drug: Placebo, Drug: Decitabine | Intervention Type: DRUG; Name: Placebo; Assigned to Arm(s): Placebo (Part A - azacitidine), Placebo (Part B - decitabine) | Intervention Type: BIOLOGICAL; Name: AMG 531 (Romiplostim); Assigned to Arm(s): Dose level 1 500 AMG 531 (Part A - azacitidine), Dose level 1 750 AMG 531 (Part B - decitabine), Dose level 2 750 AMG 531 (Part A - azacitidine) | Intervention Type: DRUG; Name: Azacitidine; Assigned to Arm(s): Dose level 1 500 AMG 531 (Part A - azacitidine), Dose level 2 750 AMG 531 (Part A - azacitidine), Placebo (Part A - azacitidine) | Intervention Type: DRUG; Name: Decitabine; Assigned to Arm(s): Dose level 1 750 AMG 531 (Part B - decitabine), Placebo (Part B - decitabine)
B: Intervention Type: PROCEDURE; Name: low dose of 2.25 x 10^11 platelets/transfusion (range 1.5 to 2.9); Assigned to Arm(s): N/A
C: Arm Label: Eltrombopag; Type: ACTIVE_COMPARATOR; Interventions: Drug: eltrombopag olamine | Arm Label: Placebo; Type: PLACEBO_COMPARATOR; Interventions: Other: Placebo | Intervention Type: DRUG; Name: eltrombopag olamine; Assigned to Arm(s): Eltrombopag | Intervention Type: OTHER; Name: Placebo; Assigned to Arm(s): Placebo
D: Arm Label: Arm 1; Type: ACTIVE_COMPARATOR; Interventions: Drug: SB497115 | Arm Label: Arm 2; Type: ACTIVE_COMPARATOR; Interventions: Drug: SB497115 | Arm Label: Arm 3; Type: ACTIVE_COMPARATOR; Interventions: Drug: SB497115 | Arm Label: Placebo Arm; Type: PLACEBO_COMPARATOR; Interventions: Other: Placebo | Intervention Type: DRUG; Name: SB497115; Assigned to Arm(s): Arm 1, Arm 2, Arm 3 | Intervention Type: OTHER; Name: Placebo; Assigned to Arm(s): Placebo Arm

Answer: C