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Clinical Research Trials

BREAST


ADJUVANT BREAST

Genentech/ Roche B025126  (Aphinity)  A Randomized, Multicenter, Double-Blind, Placebo-Controlled Comparison of Chemotherapy plus Trastuzumab plus Placebo versus Chemotherapy plus Trastuzumab plus Pertuzumab as Adjuvant Therapy in Patients with Operable HER-2 Positive Primary Breast Cancer. (APHINITY)


METASTATIC BREAST

  HER-2 POSITIVE

Genentech ML28257-An Observational Cohort Study of Treatment Patterns and Outcomes in Patients With HER2 Positive Metastatic Breast Cancer


  HER 2 NEGATIVE

Novartis CBKM120F2302:.  A phase III randomized, double blind placebo controlled study of fulvestrant in combination with oral BKM120 versus fulvestrant plus placebo, in the treatment of postmenopausal women with hormone receptor-positive HER2-negative locally advanced or metastatic breast cancer whose disease has progressed on or after aromatase inhibitor treatment

   



COLON

METASTATIC – 2nd line

Gilead GS-US-295-203 - A Phase 2 Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of GS-6624Combined with FOLFIRI as Second Line Treatment for Metastatic KRAS Mutant Colorectal Adenocarcinoma that Has Progressed Following a First Line Oxaliplatin- and Fluoropyrimidine-Containing Regimen.



CLL


FIRST THROUGH SIXTH +  LINE

Connect CLL: The Chronic Lymphocytic Leukemia Disease Registry-Disease Registry for treatment patterns-Treatment started or changed within 2 months prior to enrollment. Patients who are not going to receive or receiving treatment are not eligible.

SECOND LINE   (CLL cont’d)

Gilead GS-US-312-0115 -A phase 3, Randomized, Double-Blind, Placebo-Controlled Study Evaluating The Efficacy and Safety of GS-1101 (CAL-101) in Combination with Bendamustine and Rituximab For Previously Treated Chronic Lymphocytic Leukemia.    



MULTIPLE MYELOMA

FIRST LINE    


BMS 006: A Phase 3, Randomized, Open Label Trial Of Lenalidomide/ Dexamethasone With Or Without Elotuzumab In Subjects With Previously Untreated multiple myeloma.  Must be ineligible for transplant

Amgen 20090482- A Randomized, Double-Blind, Multicenter Study of Denosumab Compared With Zoledronic Acid (Zometa®) in the Treatment of Bone Disease in Subjects with Newly Diagnosed Multiple Myeloma


RELAPSED OR REFRACTORY


PREAMBLE--PROSPECTIVE RESEARCH ASSESSMENT IN MULTIPLEMYELOMA: AN OBSERVATIONAL EVALUATION






NON-HODGKINS LYMPHOMA


INDOLENT NHL

RELAPSED

GSK OFB:  PREVIOUS Phase II Open-Label Study of Ofatumumab  (Arzerra) and Bendamustine Followed by Maintenance Ofatumumab for Indolent B-cell Non-Hodgkin’s Lymphoma (B-NHL) Which  Has Relapsed after Rituximab Therapy.

      




NSCLC-  (LUNG)


SQUAMOUS


LILLY: Protocol I4X-MC-JFCL A Randomized, Multicenter, Open-Label, Phase 2 Study of Paclitaxel-Carboplatin Chemotherapy Plus Necitumumab (IMC-11F8) Versus Paclitaxel-Carboplatin Chemotherapy Alone in the First-Line Treatment of Patients With

Stage IV Squamous Non-Small Cell Lung Cancer (NSCLC)


SQUAMOUS AND NON-SQUAMOUS - NSCLC


FIRST LINE

Amgen 782:  A Randomized, Double-Blind, Placebo-Controlled Study To Evaluate The Long-Term Safety And Efficacy Of Darbepoetin Alfa Administered At 500 Μg once-Every-3-Weeks In Anemic Subjects With Advanced Stage Non-Small Cell Lung Cancer Receiving Multi-Cycle Chemotherapy.  


REFRACTORY TO STANDARD THERAPIES                                     

Pfizer A7471042: Failed previous therapies- Could not have received Tarceva or Erbitux-  A Phase 2, Multi-cohort study to evaluate the impact of prophylactic intervention on dermatologic and gastrointestinal adverse  events and patient reported outcomes in patients treated with Dacomitinib.


SUPPORTIVE CARE -NSCLC

HELSINN 302:    Anamorelin HCL in the Treatment of Non-Small Cell Lung Cancer - Cachexia (NSCLC-C): A Randomized, Double-Blind, Placebo-Controlled, Mutlicenter, Phase III Study to Evaluate the Safety and Efficacy of Anamorelin HCL in Patients with NSCLC-

 



PANCREATIC

GILEAD GS-US-324-0101: A Phase 2 Randomized, Double-Blinded, Placebo-Controlled Study to Evaluate the Efficacy and Safety of GS-6624 Combined with Gemcitabine as First Line Treatment for Metastatic Pancreatic Adenocarcinoma




PROSTATE

DENDREON- Den P10-3- A Registry of Sipuleucel-T (Provenge)  in Men with Advanced Prostate Cancer-**Must be enrolled prior to the first leukapheresis procedure.


MEDIVATION- STRIVE  A Multicenter Phase 2, Randomized, Double-Blind, Efficacy and Safety Study of Enzalutamide vs. Bicalutamide in Men with Prostate Cancer who have Failed Primary Androgen Deprivation Therapy


SANOFI-TAXYNERGY-  Phase II Trial to Evaluate Benefit of Early Switch from first-Line Docetaxel/Prednisone to Cabazitaxel /Prednisone and the opposite sequence ,exploring molecular markers and mechanisms of taxane resistance in men with Metastatic Castration-Resistant Prostate Cancer (mCRPC) who have not received prior chemotherapy-