Lynn Cancer Institute Oncology Trials Clinical Trials – FEBRUARY 2014 Eugene M. and Christine E. Lynn Clinical Research Center 561.955.4800 Center for Hematology-Oncology 561.955.6400 Radiation Oncology 561.955.4111 BREAST Primary Site Sponsor/Study ID Breast Metastatic Triple negative Celgene ABI-007-MBC-001 TnAcity Protocol Description Eligibility A phase 2/3, multi-center, open-label, randomize3d study of weekly nab-paclitaxel in combination with gemcitabine or carboplatin, compared to gemcitabine/ carboplatin, as first-line treatment in subjects with ER,PR and HER2 negative (triple negative) metastatic breast cancer • 18 years of age or older • Metastatic Breast Cancer ER/PR & HER2 negative • NO prior cytotoxic chemo for metastatic breast cancer • > 30 days post neo adjuvant or adjuvant chemo • Radiation treatment at least 2 weeks prior ClinicalTrials.gov Identifier: NCT01881230 Breast Metastatic BRCA 1 or 2 ABBOTT M12-895 A Randomized, Phase II Study of the Efficacy and Tolerability of Veliparib in Combination with Temozolomide or Veliparib in Combination with Carboplatin and Paclitaxel versus Placebo plus Carboplatin and Paclitaxel in Subjects with BRCA 1 or BRCA 2 mutation and Metastatic Breast Cancer • • • • • 18 years of age or older Must have BRCA 1 or 2 mutation Metastatic Breast Cancer One measurable lesion If HER-2 positive, must have progressed on at least 1 prior standard HER2 directed therapy ClinicalTrials.gov Identifier: NCT01506609 GASTROINTESTINAL Primary Site Sponsor/Study ID Protocol Description MDS Nordion Treatment of Unresectable Hepatocellular Carcinoma with TheraSphere® (Yttrium-90 Glass Microspheres): An HDE Treatment Protocol Liver Humanitarian Device TX Contact Dr. Khoriaty Eligibility • • • • • Pancreatic Borderline/ unresectable New Link Genetics NLG-0505 PILLAR A Phase Iii Study Of Folfirinox With Or Without Hyperacute®-Pancreas (Algenpantucel-L) Immunotherapy In Subjects With Borderline Resectable Or Locally Advanced Unresectable Pancreatic Cancer ClinicalTrials.gov Identifier: NCT01836432 Updated 01/31/2014 • • • Hepatocellular carcinoma of the liver > 4 weeks since prior Radiation Therapy or surgery > 1 month post other chemotherapy. Excludes contraindications to angiography and selective visceral catheterization Excludes extra-hepatic disease representing an imminent life-threatening outcome or active infection Borderline resectable or locally advanced unresectable pancreatic cancer with no metastatic Exclusion –Prior chemo or Rad Tx for pancreas cancer Exclusion Peripheral neuropathy Page 1 of 5 Lynn Cancer Institute Oncology Trials Clinical Trials – FEBRUARY 2014 Eugene M. and Christine E. Lynn Clinical Research Center 561.955.4800 Center for Hematology-Oncology 561.955.6400 Radiation Oncology 561.955.4111 GENITOURINARY Primary Site Renal Cell Cancer with– Clear Cell component Sponsor/Study ID Exelixis XL184-308 METEOR Protocol Description XL184-308: A Phase 3, randomized, controlled study of cabozantinib (XL184) vs. everolimus in subjects with metastatic renal cell carcinoma that has progressed after prior VEGFR tyrosine kinase inhibitor therapy. ClinicalTrials.gov Identifier: NCT01865747 Prostate CRPC • Clear cell component • Prior Tx with at least 1 VEGFR targeting TKI • Progress on Tx or within 6 months of at least 4-wks of VEGFR • EXCLUSION: Prior tx w/everolimus • Castrate Tokai TOK-200-10 ARMOR2 A 2 Part, Phase 2 Trial of Galeterone in the Treatment of Castration Resistant Prostate Cancer ClinicalTrials.gov Identifier: NCT01709734 Prostate MCRPC 2nd line Eligibility OncoGenenX OGX 011-12: AFFINITY resistant--- progression—At least one of the following: • --Nodal spread with NO bone or visceral disease • --Bone disease w/ or w/o nodal disease w/o visceral disease • --visceral mets w/ or w/o nodal or bone disease • OR • --PSA rise x2 at least 1 week apart • Able to swallow multiple LARGE pills • Life expectancy >12 weeks OGX 011-12: A Randomized Phase 3 Study comparing Cabazitaxel/Prednisone in Combination with Custirsen (OGX-011) to Cabazitaxel/ Prednisone for Second-Line Chemotherapy in Men with Metastatic Castrate Resistant Prostate Cancer.[AFFINITY] • Metastatic Castrate Resistant st • Previously TX w/docetaxel as 1 line (3-cycles) st • No chemo TX beyond 1 line • Progression : measurable dx or bone scan or rising ClinicalTrials.gov Identifier: NCT01578655 • 21 days post RT or major surgery • Willing to continue androgen suppression Updated 01/31/2014 PSA (x2) Page 2 of 5 Lynn Cancer Institute Oncology Trials Clinical Trials – FEBRUARY 2014 Eugene M. and Christine E. Lynn Clinical Research Center 561.955.4800 Center for Hematology-Oncology 561.955.6400 Radiation Oncology 561.955.4111 HEMATOLOGY ANEMIA Primary Site Sponsor/Study ID Protocol Description Paroxysmal Nocturnal Hemoglobinuria (PNH) Registry PNH - Renal Alexion M07-001 PNH Registry ClinicalTrials.gov Identifier: NCT01374360 Eligibility • Diagnosis of PNH • Prior treatment with Solaris acceptable LEUKEMIA Primary Site Sponsor/Study ID CLL Maintenance/ Placebo Post-2nd line Celgene CC-5013-CLL-002 CONTINUUM Protocol Description Eligibility Phase III Randomized, Double-blind, Placebo-controlled, Parallel-group Study of Lenalidomide as Maintenance Therapy in B-cell CLL Following Second-line Therapy • Two prior treatments • Partial response minimum required after completion ClinicalTrials.gov Identifier: NCT00774345 of 2nd line induction therapy prior to randomization of 2nd line treatment >8 weeks and ≤16 weeks prior to randomization • Excludes CNS involvement • Last cycle MULTIPLE MYELOMA Primary Site MM 1ST line untreated Sponsor/Study ID BMS CA204006 ELOQUENT – 1 Protocol Description A Phase 3, Randomized, Open Label Trial of Lenalidomide/Dexamethasone With or Without Elotuzumab in Subjects with Previously Untreated Multiple Myeloma. Eligibility • No prior anti-MM therapy • Measureable disease • Not eligible for High-dose + stem-cell transplant ClinicalTrials.gov Identifier: NCT01335399 MM Relapsed or Refractory Celgene CC-4047-MM-007 OPTIMISIMM A Phase 3, Multicenter, Randomized, Open label Study To Compare The Efficacy And Safety Of Pomalidomide, Bortezomib And Low-Dose Dexamethasone Versus Bortezomib And Low-Dose Dexamethasone In Subjects With Relapsed Or Refractory Multiple Myeloma • At least 1 but no more than 3 Prior tx • Prior tx with Lenalidomide (at least 2 • EXCLUSION: Refractory to Bortezomib; Nonsecretory MM; Dialysis ClinicalTrials.gov Identifier: NCT01734928 Updated 01/31/2014 cycles) Page 3 of 5 Lynn Cancer Institute Oncology Trials Clinical Trials – FEBRUARY 2014 Eugene M. and Christine E. Lynn Clinical Research Center 561.955.4800 Center for Hematology-Oncology 561.955.6400 Radiation Oncology 561.955.4111 LUNG Primary Site NSCLC adv Stage IIIB/IV Sponsor/Study ID Synta 9090-14 GALAXY2 Protocol Description A Randomized, Phase 3 Study Of Ganetespib In Combination With Docetaxel Versus Docetaxel Alone In Patients With Advanced Non-Small-Cell Lung Adenocarcinoma ClinicalTrials.gov Identifier: NCT01798485 NSCLC SWOG S0819 Stage IV 1st Line A Randomized, Phase III Study Comparing Carboplatin/Paclitaxel or Carboplatin/Paclitaxel/ Bevacizumab with or without Concurrent Cetuximab in Patients with Advanced Non-Small Cell Lung Cancer (NSCLC) Eligibility • Pre-dominate Adenocarcinoma. st • Progression following 1 line treatment for advanced Lung Cancer • Prior tx for Stage I, II or IIIA allowed • Archived tissue available • Dx of Advanced Stage > 6 months prior to ICF • Newly diagnosed stage IV, advanced or recurrent disease after surgery and/or irradiation • Controlled brain metastasis acceptable • No prior chemotherapy, monoclonal antibody, EGFR, or VEGF targeted agents ClinicalTrials.gov Identifier: NCT00946712 NSCLC – Non-Squamous Recurrent or Metastatic 2nd Line PrECOG-0502 MO22097 NSCLC M1a or M1b or SCLC any stage BRRH ALCMI An open-label, randomized, Phase IIIb trial evaluating the efficacy and safety of standard of care +/- continuous bevacizumab treatment beyond progression of disease (PD) in patient with advanced non-squamous non-small cell lung cancer (NSCLC) after first (1st)-line treatment with bevacizumab plus a platinum doublet-containing chemotherapy ClinicalTrials.gov Identifier: NCT01351415 Addario Lung Cancer Medical Institute (ALCMI) Collaborative Advanced Stage Tissue Lung Cancer (CASTLE) Network Study ClinicalTrials.gov Identifier: NCT01574300 Updated 01/31/2014 • Locally recurrent or metastatic lung cancer • Progressed beyond 1st line treatment chemotherapy • Bev (monotherapy) maintenance treatment • Lung Cancer • Plan for chemotherapy treatment • Willing to biopsy collection or paraffin available w/in last 12 months. Page 4 of 5 block Lynn Cancer Institute Oncology Trials Clinical Trials – FEBRUARY 2014 Eugene M. and Christine E. Lynn Clinical Research Center 561.955.4800 Center for Hematology-Oncology 561.955.6400 Radiation Oncology 561.955.4111 MELANOMA Primary Site Sponsor/Study ID Protocol Description ECOG 1609 A Phase III, Randomized Study of Adjuvant Ipilimumab Anti-CTLA4 Therapy Versus High-Dose Interferon a - 2b for Resected High-Risk Melanoma Melanoma Adjuvant *3rd Arm Added* Eligibility • Diagnosis of melanoma of a cutaneous origin or unknown primary • Stage IIIB, IIIC, or IV (M1a or M1b) disease • Complete resection with negative margins on resected specimens within past 12 weeks ClinicalTrials.gov Identifier: NCT01274338 Updated 01/31/2014 Page 5 of 5
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