NCI- and Investigator Sponsored Trials

Thirteen clinical studies are conducted with intravenous belinostat under sponsorship of the National Cancer Institute or other groups. These trials are complementary to the Topotarget A/S' clinical program, including single-agent treatment with IV belinostat in platinum resistant ovarian cancer, mesothelioma, hepatocellular carcinoma, thymic malignancies, B-cell lymphoma, AML, myelodysplastic syndrome (MDS) and lung cancer, both non-small cell and small cell. Combination studies are in progress with bortezomib, cis-retinoic acid, cisplatin, carboplatin, etoposide, and 5-azacytidine.

Three Investigator Sponsored Trials are conducted in NSCLC, acute leukemia or MDS.

	Indication	Combination	Phase I	Phase II	Phase III
Ongoing
NCI 7237 A Phase 1/2 Study of PXD101 in Patients with Unresectable Hepatocellular Carcinoma with Pharmacokinetic and Pharmacodynamic Evaluation Read more	Unresectable hepatocellular Carcinoma
NCI 7251 A Phase 1 Trial of PXD101 in Combination with 13-cis-Retinoic Acid in Advanced Solid Tumor Malignancies Read more	Solid tumor
NCI 7285 Phase 1 Study of PXD101 in Combination with Azacitidine (5-Aza) for Advanced Hematologic Malignancies Read more	Advanced hematologic malignancies
NCI 8174 A Multicenter Phase 2 Study of belinostat (PXD101) in Previously Chemotherapy Treated Thymoma and Thymic Carcinoma Read more	Thymoma and thymic carcinoma
NCI 8238 A Phase 1 Study of Belinostat in Combination with Cisplatin and Etoposide in Adults with Small Cell Lung Carcinoma and Other Advanced Cancers Read more	SCLC and other advanced cancers
GOG/NCI 0126T A Phase 2 Evaluation of Belinostat and Carboplatin in the Treatment of Recurrent or Persistent Platinum-Resistant Ovarian, Fallopian Tube, or Primary Peritoneal Cancer Read more	Ovarian cancer
Virginia Group/MCC-12517 Belinostat and Bortezomib in Treating Patients With Relapsed or Refractory Acute Leukemia or Myelodysplastic Syndrome Read more	Relapsed or refractory acute leukemia or myelodysplastic syndrome
Holy Cross Hospital, Florida/HCH003 A phase 1/2 Safety and Efficacy Study of Belinostat when used with Standard of Care Chemotherapy for untreated NSCLC Read more	NSCLC
NCI/8602 A Phase 1/2 Study of PXD101 (Belinostat) in Combination With Cisplatin, Doxorubicin and Cyclophosphamide in the First Line Treatment of Advanced or Recurrent Thymic, Malignancies Read more	Advanced or recurrent thymic malignancies
Herlev Hospital/NCT01188707 A Trial of Belinostat in Combination With Erlotinib in Patients With Non-small Cell Lung Cancer Read more	NSCLC
Completed
NCI 7255 Phase 2 Study of PXD101 (NSC 726630) as Second-Line Therapy for Treatment of Patients with Malignant Pleural Mesothelioma Read more	Malignant pleural mesothelioma
NCI 7267 A Phase 2 Study of PXD101 in Platinum Resistant Epithelial Ovarian Tumors and Micropapillary/Borderline (LMP) Ovarian Tumors Read more	Ovarian tumors
NCI 7281 A Phase 1 Study of PXD101 in Combination with Bortezomib (PS-341) in Patients with Advanced Solid Tumors and Lymphoma Read more	Solid tumors and lymphomas
NCI S0520 Phase 2 Study of PXD101 (NSC-726630) in Relapsed and Refractory Aggressive B-Cell Lymphomas Read more	B-cell lymphomas
NCI/7265 Phase 2 Study of PXD101 in Relapsed or refractory Acute Myeloid Leukemia Read more	AML
NCI/7258 Phase 2 Study of PXD101 in Patients with Myelodysplastic Syndromes Refractory to or is ineligible for azacitidine treatment Read more	MDS