The Jones Clinic

Our Clinical trials

The Jones Clinic Current Protocols
May 2012

BREAST CANCER| LUNG CANCER| PANCREATIC CANCER| PROSTATE CANCER| GASTROESOPHAGEAL CANCER| GYNECOLOGICAL CANCERS| HEAD AND NECK CANCERS| LEUKEMIA – CML| LYMPHOMA| MULTIPLE MYELOMA| Myelodysplastic Syndrome| PNH – PAROXYSMAL NOCTURNAL HEMOGLOBINURIA | SHINGLES Prevention | Clincial Access Program – Iressa | Clincial Access Program – ONTAK

Breast Cancer

Neo-Adjuvant or Adjuvant

A Pivotal Study in Breast Cancer patients Investigating efficacy and safety of LA-EP2006 and Neulasta.

Metastatic 1st Line

A Phase III, Randomized, Double –Blind, Placebo-Controlled, Mulitcenter Study to Evaluate the Efficacy and Safety of Bevacizumab and Associated Biomarkers in Combination with Paclitaxel in Comparison with Paclitaxel Plus Placebo as First Line Treatment of Pts with Her 2 Negative Breast Cancer.

A Phase II Multicenter, Single Arm Study of Eribulin Mesylate with Trastuzumab as First Line Therapy for Locally Recurrent or Metastatic Human Epidermal Growth Factor Receptor Two (HER2) Positive Breast Cancer.

Lung Cancers

Small Cell Lung Cancer

Extensive Stage Metastatic 1st line

A Randomized, Multicenter, Double –Blind, Phase III Trial Comparing the Efficacy of Ipilumumab Plus Etoposide/Platinum versus Placebo plus Etposide/Platinum in Subjects with Newly Diagnosed Extensive Stage Disease Small Cell Lung Cancer.

Non-small Cell Lung Cancer

Advanced or Metastatic 1st Line

A Randomized, Double – Blind, Multicenter, Phase II Trial Comparing Veliparib Plus Carboplatin and Paclitaxel versus Placebo Plus Carboplatin and Paclitaxel in Previously Untreated Metastatic or Advanced Non Small Cell Lung Cancer (NSCLC).

An Open-Label, Multicenter, Randomized, Phase II Study of Recombinant Human Anti-VEGFR-2 Monoclonal Antibody, Mab-V in Combination with Platinum Based Chemotherapy vs. Platinum Based Chemotherapy Alone as First Line Treatment of pts with recurrent or Advanced Non Small Cell Lung Cancer.

Prostate Cancer

A Phase II Indication Identification Study of LY2523355 in Patients with Ovarian, Non-Small Cell Lung, Prostate, Colorectal, Gastroesophageal, and Squamous Cell of Head and Neck Cancers.

A Multicenter, Single-Arm, Open-Label Treatment Protocol to provide Expaned Access to MDV3100 and to Monitor its Safety in Patients with Progressive Castration-Resistant Prostate Cancer Previously Treated with a Docetaxel Based Chemotherapy

Gastroesophageal Cancer

A Phase II Indication Identification Study of LY2523355 in Patients with Ovarian, Non-Small Cell Lung, Prostate, Colorectal, Gastroesophageal, and Squamous Cell of Head and Neck Cancers.

Gastrointestinal Cancers

Pancreatic Cancer

Advanced Disease 2nd Line

A Phase II Study of STA – 9090 as Second Line Therapy for Metastatic Pancreatic Cancer

Genitourinary Cancers

Renal Cell Cancer

A Phase I/II Study of BNC105P in Combination with Everolimus or Following Everolimus for Progressive Metastatic Clear Cell Renal Cell Carcinoma Following Prior Tyrosine Kinase Inhibitors

Gynecological Cancers

Ovarian Cancer

A Phase II Indication Identification Study of LY2523355 in Patients with Ovarian, Non-Small Cell Lung, Prostate, Colorectal, Gastroesophageal, and Squamous Cell of Head and Neck Cancers.

Head and Neck Cancers

A Phase II Indication Identification Study of LY2523355 in Patients with Ovarian, Non-Small Cell Lung, Prostate, Colorectal, Gastroesophageal, and Squamous Cell of Head and Neck Cancers.

Leukemia’s

Leukemia – CML

A Single Arm, Open Label, Multi-Center Study of Complete Molecular Response (CMR) in Adult Patients with NEWLY DIAGNOSED Philadelphia Chromosome Positive (Ph+) Chronic Myelogenous Leukemia in Chronic Phase

Lymphoma’s

Diffuse Large B-Cell Lymphoma

Relapsed or Refractory

A Randomized, Multicenter, Study Comparing Pixantrone + Rituximab or Gemcitabine + Rituximab, in Non Stem Cell Transplant Eligible Patients with Aggressive B-Cell Non-Hodgkins Lymphoma who have Relapsed after Therapy with CHOP-R or Equivalent Regimen.

Multiple Myeloma

Relapsed or Refractory, 2n, 3rd, or 4th Line txt

An Open Label, Dose Escalation, Multicenter, Phase 1 / 2 Study of KW-2478 in Combination with Bortezomib in Subjects with Relapsed or Refractory Multiple Myeloma

A Phase III, Randomized, Double Blind, Multicenter, Study Comparing Oral MLN9708 Plus Lenalidomide and Dexamethasone vs. Placebo Plus Lenalidomide and Dexamethasone in Adult Patients with Relapsed and/or refractory Multiple Myeloma

Myelodysplastic Syndrome

Micro RNA’s in Myelodysplastic Syndrome – to determine the contribution of hypermethylation in the dysregulation of miRNA expression in MDS; also to determine if treatment with DNMTI’s (DNA Methyltransferase Inhibitors) corrects the expression changes in miRNAs as associated with MDS

Myeloproliferative Neoplasms

A Phase II Study of LY2784544 in patients with Myeloproliferative Neoplasms – Polycythemia Vera, Essential Thrombocytopenia, or Myelofibrosis.

Thrombocytopenia – ITP

A Phase III, Multicenter, Randomized , Double-Blind, Active Controlled Parallel Group Trial with an Open-Label Extension Phase to Evaluste the Efficacy and Safety of Oral E5501 vs. Eltrombopag, in Adults with Chronic Immune Thrombocytopenia.  ( Idiopathic Thrombocytopenic Purpura )

PNH – Paroxysmal Nocturnal Hemoglobinuria

The PNH Registry is a prospective, multi-center, multi-national, observational registry compiling data on the natural history and management of subjects diagnosed with PNH ( Alexion # 1399 )

SHINGLES Prevention

A Phase II Randomized, Placebo-Controlled, Clinical trial to Study the Safety and Efficacy of V212 (Inactivated Varicella-Zoster Virus Vaccine) in Adult Patients with Solid Tumor or Hematologic Malignancy.   ( Merck Sharp & Dohme – # 011-00 )

Clincial Access Program – Iressa

An Open Label, Multicenter, IRESSA Clinical Access Program of Gefitinib 250 mg (IRESSA) for Continued Treatment of Patints in the United States who are currently Benefiting or have Benefitted from Gefitinib Treatment.  ( AstraZeneca – D7913N00017 )

Clincial Access Program – ONTAK

An Access Program with Denileukin Diftitox for the treatment of patients currently receiving  treatment with commercially available ONTAK