Please select the arm or intervention descriptions that belong to the clinical trial below.
Title: A Randomized, Double-blind, Placebo Controlled, Multicenter Phase II Study to Assess the Efficacy and Safety of Sorafenib Added to Standard Treatment With Topotecan in Patients With Platinum-resistant Recurrent Ovarian Cancer
Brief Summary: It is assumed, that the patients of the standard arm show a median progression-free survival time of 4.4 months those of the experimental arm of at least 6.9 months. Assuming a recruitment period of 18 months and follow-up for at least 12 months a total sample size of 174 patients is required (two-sided, α=0.05, 80% power). To account for 5% drop-outs 184 patients will be randomized.

A Data Monitoring and Safety Board (DMSB) will be established. This board will evaluate the safety profile of the drug combination after 6 patients and after 12 patients have received 1 cycle of treatment.


Options:
A: Arm Label: Phase 3 -Active Treatment Arm; Type: EXPERIMENTAL; Interventions: Drug: AL3818, Drug: Paclitaxel, Drug: Pegylated Liposomal Doxorubicin (PLD), Drug: Topotecan | Arm Label: Phase 3-Control Treatment Arm; Type: OTHER; Interventions: Drug: Paclitaxel, Drug: Pegylated Liposomal Doxorubicin (PLD), Drug: Topotecan | Arm Label: Phase 1b: AL3818 plus carboplatin and paclitaxel; Type: EXPERIMENTAL; Interventions: Drug: Carboplatin, Drug: Paclitaxel, Drug: AL3818 | Arm Label: Phase 2a: AL3818 plus carboplatin and paclitaxel; Type: EXPERIMENTAL; Interventions: Drug: Carboplatin, Drug: Paclitaxel, Drug: AL3818 | Intervention Type: DRUG; Name: AL3818; Assigned to Arm(s): Phase 3 -Active Treatment Arm | Intervention Type: DRUG; Name: Paclitaxel; Assigned to Arm(s): Phase 3 -Active Treatment Arm, Phase 3-Control Treatment Arm | Intervention Type: DRUG; Name: Pegylated Liposomal Doxorubicin (PLD); Assigned to Arm(s): Phase 3 -Active Treatment Arm, Phase 3-Control Treatment Arm | Intervention Type: DRUG; Name: Topotecan; Assigned to Arm(s): Phase 3 -Active Treatment Arm, Phase 3-Control Treatment Arm | Intervention Type: DRUG; Name: Topotecan; Assigned to Arm(s): Phase 3 -Active Treatment Arm, Phase 3-Control Treatment Arm | Intervention Type: DRUG; Name: Carboplatin; Assigned to Arm(s): Phase 1b: AL3818 plus carboplatin and paclitaxel, Phase 2a: AL3818 plus carboplatin and paclitaxel | Intervention Type: DRUG; Name: Paclitaxel; Assigned to Arm(s): Phase 1b: AL3818 plus carboplatin and paclitaxel, Phase 2a: AL3818 plus carboplatin and paclitaxel | Intervention Type: DRUG; Name: AL3818; Assigned to Arm(s): Phase 1b: AL3818 plus carboplatin and paclitaxel, Phase 2a: AL3818 plus carboplatin and paclitaxel
B: Arm Label: vargatef/Nintedanib; Type: EXPERIMENTAL; Interventions: Drug: vargatef | Arm Label: placebo; Type: PLACEBO_COMPARATOR; Interventions: Drug: placebo | Intervention Type: DRUG; Name: vargatef; Assigned to Arm(s): vargatef/Nintedanib | Intervention Type: DRUG; Name: placebo; Assigned to Arm(s): placebo
C: Arm Label: Carboplatin plus PLD; Type: ACTIVE_COMPARATOR; Interventions: Drug: Carboplatin, Drug: Pegylated Lipoxomal Doxorubicin (PLD) | Arm Label: Trabectedin plus PLD; Type: EXPERIMENTAL; Interventions: Drug: Pegylated Lipoxomal Doxorubicin (PLD), Drug: Trabectedin | Intervention Type: DRUG; Name: Carboplatin; Assigned to Arm(s): Carboplatin plus PLD | Intervention Type: DRUG; Name: Pegylated Lipoxomal Doxorubicin (PLD); Assigned to Arm(s): Carboplatin plus PLD, Trabectedin plus PLD | Intervention Type: DRUG; Name: Trabectedin; Assigned to Arm(s): Trabectedin plus PLD
D: Arm Label: Experimental; Type: EXPERIMENTAL; Interventions: Drug: Sorafenib | Intervention Type: DRUG; Name: Sorafenib; Assigned to Arm(s): Experimental

Answer: D