Please select the arm or intervention descriptions that belong to the clinical trial below.
Title: Phase II Trial in Platinum-refractory Ovarian Cancer: A Randomized Multicenter Trial With SU11248 to Evaluate Dosage, Tolerability, Toxicity and Effectiveness of a Multitargeted Receptor Tyrosine Kinase Inhibitor Monotherapy
Brief Summary: Ovarian cancer is most often recognized in advanced clinical state, the initial therapeutic strategies consist of a platinum containing chemotherapy subsequent to primary surgery. Although initially responsive to platinum-paclitaxel containing chemotherapy, a significant number of patients will show tumor progression during first line chemotherapy or relapse within six months after completion of first line chemotherapy, therefore being characterized as chemotherapy resistant. Any second line chemotherapy will result in approximately 10% of overall response, underlining the poor prognosis for these patients with an estimated median overall survival of 20 weeks.

In addition to conventional chemotherapeutics, so called small molecules are of high interest to establish new strategies in chemotherapy-refractory ovarian cancer (and in the long run first line chemotherapy). SU11248 is a polytargeting tyrosine kinase inhibitor.

SU11248 has demonstrated clinical efficacy in kidney cancer and GIST, further clinical trials have been initiated in other tumor entities. Growth pattern and biological targets present in ovarian cancer indicate that SU11248 might be a promising compound for the treatment of ovarian cancer. Especially, VEGFR, PDGFR and c-kit are specific targets for SU11248, which are expressed in ovarian cancer. The different targets of SU11248 provide a potential advantage of this compound compared to single-target molecules in chemotherapy-refractory ovarian cancer.


Options:
A: Arm Label: BIBF 1120; Type: EXPERIMENTAL; Interventions: Drug: BIBF 1120, Drug: Paclitaxel, Drug: Carboplatin | Arm Label: Placebo; Type: PLACEBO_COMPARATOR; Interventions: Drug: Placebo, Drug: Paclitaxel, Drug: Carboplatin | Intervention Type: DRUG; Name: Placebo; Assigned to Arm(s): Placebo | Intervention Type: DRUG; Name: Paclitaxel; Assigned to Arm(s): Placebo | Intervention Type: DRUG; Name: BIBF 1120; Assigned to Arm(s): BIBF 1120 | Intervention Type: DRUG; Name: Carboplatin; Assigned to Arm(s): Placebo | Intervention Type: DRUG; Name: Paclitaxel; Assigned to Arm(s): BIBF 1120 | Intervention Type: DRUG; Name: Carboplatin; Assigned to Arm(s): BIBF 1120
B: Arm Label: Aflibercept 2.0 mg/kg; Type: EXPERIMENTAL; Interventions: Drug: Aflibercept (ziv-aflibercept, AVE0005, VEGF trap, ZALTRAP®) | Arm Label: Aflibercept 4.0 mg/kg; Type: EXPERIMENTAL; Interventions: Drug: Aflibercept (ziv-aflibercept, AVE0005, VEGF trap, ZALTRAP®) | Intervention Type: DRUG; Name: Aflibercept (ziv-aflibercept, AVE0005, VEGF trap, ZALTRAP®); Assigned to Arm(s): Aflibercept 4.0 mg/kg | Intervention Type: DRUG; Name: Aflibercept (ziv-aflibercept, AVE0005, VEGF trap, ZALTRAP®); Assigned to Arm(s): Aflibercept 2.0 mg/kg
C: Arm Label: Arm I (paclitaxel, docetaxel, carboplatin); Type: ACTIVE_COMPARATOR; Interventions: Drug: Carboplatin, Drug: Docetaxel, Other: Laboratory Biomarker Analysis, Drug: Paclitaxel, Other: Quality-of-Life Assessment | Arm Label: Arm II (paclitaxel, docetaxel, carboplatin, bevacizumab); Type: EXPERIMENTAL; Interventions: Biological: Bevacizumab, Drug: Carboplatin, Drug: Docetaxel, Other: Laboratory Biomarker Analysis, Drug: Paclitaxel, Other: Quality-of-Life Assessment | Arm Label: Arm III (gemcitabine hydrochloride, carboplatin); Type: EXPERIMENTAL; Interventions: Drug: Carboplatin, Drug: Gemcitabine Hydrochloride, Other: Laboratory Biomarker Analysis, Other: Quality-of-Life Assessment | Arm Label: Arm IV (gemcitabine hydrochloride, bevacizumab, carboplatin); Type: EXPERIMENTAL; Interventions: Biological: Bevacizumab, Drug: Carboplatin, Drug: Gemcitabine Hydrochloride, Other: Laboratory Biomarker Analysis, Other: Quality-of-Life Assessment | Intervention Type: BIOLOGICAL; Name: Bevacizumab; Assigned to Arm(s): Arm II (paclitaxel, docetaxel, carboplatin, bevacizumab), Arm IV (gemcitabine hydrochloride, bevacizumab, carboplatin) | Intervention Type: DRUG; Name: Carboplatin; Assigned to Arm(s): Arm I (paclitaxel, docetaxel, carboplatin), Arm II (paclitaxel, docetaxel, carboplatin, bevacizumab), Arm III (gemcitabine hydrochloride, carboplatin), Arm IV (gemcitabine hydrochloride, bevacizumab, carboplatin) | Intervention Type: DRUG; Name: Docetaxel; Assigned to Arm(s): Arm I (paclitaxel, docetaxel, carboplatin), Arm II (paclitaxel, docetaxel, carboplatin, bevacizumab) | Intervention Type: DRUG; Name: Gemcitabine Hydrochloride; Assigned to Arm(s): Arm III (gemcitabine hydrochloride, carboplatin), Arm IV (gemcitabine hydrochloride, bevacizumab, carboplatin) | Intervention Type: OTHER; Name: Laboratory Biomarker Analysis; Assigned to Arm(s): Arm I (paclitaxel, docetaxel, carboplatin), Arm II (paclitaxel, docetaxel, carboplatin, bevacizumab), Arm III (gemcitabine hydrochloride, carboplatin), Arm IV (gemcitabine hydrochloride, bevacizumab, carboplatin) | Intervention Type: DRUG; Name: Paclitaxel; Assigned to Arm(s): Arm I (paclitaxel, docetaxel, carboplatin), Arm II (paclitaxel, docetaxel, carboplatin, bevacizumab) | Intervention Type: OTHER; Name: Quality-of-Life Assessment; Assigned to Arm(s): Arm I (paclitaxel, docetaxel, carboplatin), Arm II (paclitaxel, docetaxel, carboplatin, bevacizumab), Arm III (gemcitabine hydrochloride, carboplatin), Arm IV (gemcitabine hydrochloride, bevacizumab, carboplatin)
D: Arm Label: 1 non-continuous; Type: OTHER; Interventions: Drug: Sunitinib | Arm Label: 2 continuous; Type: OTHER; Interventions: Drug: SUNITINIB | Intervention Type: DRUG; Name: Sunitinib; Assigned to Arm(s): 1 non-continuous | Intervention Type: DRUG; Name: SUNITINIB; Assigned to Arm(s): 2 continuous

Answer: D