COMPREHENSIVE ACTIVE STUDY LIST
BOOTH * ORANGE PARK * ST. VINCENT'S
Updated 6-111
BRAIN
LINE SPONSOR STUDY Site PI Status Abbreviated Eligibility
RTOG 0913 - Phase I/II Trial of Concurrent RAD001 (Everolimus) with
RADIATION Temozolomide/Radiation Followed by Adjuvant RAD001/Temozolomide in All FROG Michael OPEN Confirmed GBM by resection or open biopsy; Supratentorial and not
1st line RTOG 0913 Newly Diagnosed Glioblastoma Locations Olson 5-16-11 recurrent or multifocal; Treatment starts 5 cm (T3) or locally
advance disease (T4); must be receiving or scheduled to receive SOC adjuvant or
V-10-004 Randomized, Double-Blind, Placebo-Controlled, Multi-Center Phase 3 neoadjuvant chemo and/or endocrine and/or HER-2 targeted therapy. Time
Amgen 20060359 Study of Denosumab as Adjuvant Treatment for Women with Early-Stage OP, SS & OPEN between definitive surgery & randomization must be ≤ 8 wks. Time between start of
Adjuvant D-CARE Breast Cancer at High Risk of Recurrence (D-CARE) Accrual: 6 SF: 3 STV only Sylvester 8-16-10 neoadjuvant & randomization must be ≤ 4 wks.
TORI A Phase III Clinical Trial Comparing the Combination od TC + Bevacizumab
NSABP B-46-I to TC Alone and to TAC for Women with Node Positive or High Risk Node OPEN Inclusion: Adenocarcinoma. – If FISH, CISH or other is equivocal, pt
Adjuvant TC TAC TOE Negative, HER2 Negative Breast Cancer Accrual: 11 SF: 6 All Sites Moezi 3-1-10 eligible as long as no plan to administer HER2-targeted therapy.
A Phase 2, Multicenter, Single-Arm, Study of Single-Agent Eribulin Female breast adenocarcinoma, locally recurrent or metastatic with 1
Mesylate as First-Line Therapy for Locally Recurrent or Metastatic Human measurable lesion ≥10mm longest diameter (non-LN) or ≥15mm short axis
Eisai Epidermal Growth Factor Receptor Two (HER2) Negative Breast Cancer OPEN diameter (LN), no prior chemo/biologic/invest tx for recurrent/metastatic
1st line (HER-) E7389-A001-206 Accrual: 1 All Sites Dees 02-15-11 disease (prior endocrine therapy is permitted), HER2 negative
Breast adenocarcinoma, locally recurrent or metastatic with 1 measurable
A Phase 2, Multicenter, Single-Arm, Open-Label Study of Eribulin Mesylate lesion ≥10mm longest diameter (non-LN) or ≥15mm short axis diameter
V-10-008 with Trastuzumab as First-Line Therapy for Locally Recurrent or Metastatic (LN), 12 months since (neo)adjuvant tx, prior endocrine therapy
Eisai Human Epidermal Growth Factor Receptor Two Positive (HER2+) Breast OPEN permitted, one prior treatment herceptin/lapatinib in metastatic setting
1st Line (HER+) E7389-A001-208 Cancer All Sites Dees 1-20-11 permissible if not given with chemotherapy, Males or Females eligible
Adenocarcinoma of the breast (locally recurret or metastatic), no
A Randomized Phase II Study of Imetelstat (GRN163L) in Combination with prior therapy or one prior non-taxane regimen, no restrictions on
1st or 2nd line V-10-012 Paclitaxel + Bevacizumab in Patients with Locally Recurrent or Metastatic OPEN prior hormonal therapy, pts are excluded for prior adjuvant or
(HER-) Geron CP14B014 Breast Cancer Accrual: 3 All Sites Bubis 11-24-2010 neoadjuvant taxane tx w/in 12 months of 1st relapse
Central confirmation HER2+, prior treatment in adjuvant, locally
advanced/metastatic must include both a taxane + trastuzumab,
A Randomized, Multicenter, Phase III Open-label Study of the Efficacy and progression for locally advanced/MBC following most recent
Genentech Safety of Trastuzumab-MCC-DM1 vs. Capecitabine + Lapatinib in Patients OP, SS, treatment or w/in 6 months after adjuvant tx, measurable or non-
1st, 2nd line TDM4370g with HER2-Positive Locally Advanced or Metastatic Breast Cancer who Baptist-all, OPEN measurable disease, CNS only pts excluded, prior treatment with
(HER+) EMILIA have Received Prior Trastuzumab-Based Therapy Accrual: 1 STV Moezi 3-28-11 lapatinib/capecitabine exclusionary
An open-label, expanded access protocol of BSI-201 in combination with Histologically documented TNBC: prior tx includes never receiving
2nd to 4th line BiPar Sciences gemcitabine/Carboplatin in patients with ER-, PR-, and HER2-negative OPEN chemo for metastatic breast ca or having rec’d 1-3 prior chemo
Expanded Access 2010EAP metastatic breast cancer Accrual: 23 SF:2 All Sites Naot 6-4-10 regimens in a metastatic setting.
A Randomized Phase II Study of AFP464 +/- Faslodex in ER-positive ER+, progression on AI for MBC or recurrence within 1 yr on
Breast Cancer Patients who had progressed on Aromatase Inhibitor (AI) adjuvant AI, only one prior chemo regimen for metastatic disease
USO 09056 therapy allowed, confirmed AhR cytoplasm localization (central path), ECOG
Tigris **See USO 08118 (sub-study) 0-2, measurable or evaluable disease (CA27.29≥≥50), Dlco grade 0-
Pharmaceuticals OPEN 1, HER2+ pts are excluded unless they have progressed on both
Recurrent/ER+ TG-AFP-003 All Sites Moezi 4-26-11 trastuzumab and lapatinib, symptomatic brain mets are exclusionary
1
COMPREHENSIVE ACTIVE STUDY LIST
BOOTH * ORANGE PARK * ST. VINCENT'S
Updated 6-111
SUB-STUDY -Linked to USO 09056:
Collection of Patient's Tumor Tissue for Analysis of Molecular Markers that OPEN
Tissue Specimen USO 08118 Predict for Benefit from Cancer Therapies All Sites Moezi 4-26-11 Must be enrolled to USO 09056 Breast Protocol
COLON
Line SPONSOR STUDY Site PI Status Abbreviated Eligibility
Genentech A Randomized Phase 2 Study of Bevacizumab/mFOLFOX6 vs.
ML25710 Bevacizumab/FOLFIRI With Biomarker Stratification In Patients OPEN
1st line Metastatic MAVERICC With Previously Untreated Metastatic Colorectal Cancer All Sites Badarinath 7-7-11
A Randomized, Double-Blind, Multicenter Phase 3 Study of Irinotecan,
Folinic Acid, and 5-Fluorouracil (FOLFIRI) Plus Ramucirumab (IMC-1121B)
Drug Product of Placebo in Patients With Metastatic Colorectal Carcinoma Metastatic CRC, received FOLFOX+bev 1st line & progressed on tx or w/in
Lilly Progressive Following First-Line Combination Therapy With Bevacizumab, OPEN 6 mo last dose, measurable or non-measureable disease by RECIST, rec’d
st
2nd line Metastatic I4T-MC-JVBB Oxaliplatin, and a Fluoropyrimidine All Sites Badarinath 1-27-11 a minimum 2 doses of bevacizumab w/ 1 line tx
Phase 1/2 study of PX-866 and cetuximab – To determine the maximum
tolerated dose (MTD) or recommended Phase 2 dose (RD) of PX-866 to be
Oncothyreon administered orally once per day in combination with cetuximab in patients metastatic CRC or SCCHN pts with measurable disease per
PX-866-003 with incurable metastatic colorectal carcinoma (CRC) or incurable RECIST 1.1, progression after irinotecan and oxaliplatin for
progressive, recurrent or metastatic squamous cell carcinoma of the head OPEN metastatic disease (or intolerance)-CRC pts. Exclusionary: pts with
3rd line Metastatic and neck (SCCHN). [phase 2 portion @ ICON] All Sites Badarinath 6-16-11 prior cetuximab or KRAS mutant codon 12/13
ENDROMETRIAL
LINE SPONSOR STUDY Site PI Status Abbreviated Eligibility
Hysterectomy & BSO for uterine cancer ( 50% myometrial invasion, or Grade 2
A Phase II study of postoperative IMRT with concurrent cisplatin and or 3 w/cervical stromal invasion or Extra-uterine disease confined to
RADIATION bevacizumab followed by carboplatin and paclitaxel for patients with OPEN pelvis. No (+) common iliac or para-aortic disease or (+) peritoneal
Adjuvant RTOG 0921 endrometrial cancer All Sites Johnson 4-23-10 cytology. Performance 0-1.
HEAD AND NECK
Line SPONSOR STUDY Site PI Status Abbreviated Eligibility
Squamous - oral cavity, oropharynx or larynx - Clinical T2-3, N0-2,
M0 or T1, N1-2, M0; Gross total resect w/at least 1 risk factor -
perineural or lymphovascular invasion; 1 LN > 3cm or > 2 LN (all 5 mm depth of invasion; Registered 10% in past month, FEV1> 1.2 L/sec. No prior chemo for
unresectable RTOG 0617 IIIA/IIIB Non Small Cell Lung Cancer Accrual: 13 Locations Johnson 3-4-08 study cancer. PS 0-1
Medically inoperable, T1 or T2 (12 months; previous RT is OK if recurrence outside
ECLIPSE SF: 1 All Sites Bubis 7-13-10 original radiation site; ECOG of 0 or 1.
A Randomized, Double-blind, Placebo-controlled Study to Evaluate the
Long-term Safety and Efficacy of Darbepoetin Alfa Administered at 500 mg Inclusion: Stage IV or stage IIIB malignant NSCLC; Receiving or
Once-Every-3-Weeks (Q3W) to a Hemoglobin Ceiling of 12.0 g/dL in about to receive 1st line cyclic chemo. Chemo-induced anemia
Amgen Anemic Subjects with Advanced Stage Non-small Cell Lung Cancer OPEN defined as Hgb level 2 mg/mL) and vitamin B12 (>200 pg/mL).
Inclusion: Stage IIIb or IV; squamous histology allowed (randomized
to imetelstat alone arm); not amenable to radiation or surgery with
curative intent; patients should have completed 4 cycles of platinum
based chemo doublet with no evidence of dx progression; adjuvant
A Randomized Phase II Study of Imetelstat as Maintenance Therapy after chemo greater than one yr prior to progression is allowed. Pts will be
Ist line V-10-006 Initial Induction Chemotherapy for Advanced Non-Small Cell Lung Cancer OPEN excluded from being randomized if: * last dose of induction chemo 42 days prior to randomization
pts w/ progression on 1 prior platinum regimen (adjuvant or
USO 10061 A Randomized, Double-Blind, Phase 3 Study of Docetaxel and neoadjuvant platinum based tx with progression w/in 6 mo.), prior
Ramucirumab versus Docetaxel and Placebo in the Treatment of Stage IV OPEN bev (1st line/maintenance) allowed, measurable disease by RECIST
2nd line Metastatic Eli Lilly
Non-Small Cell Lung Cancer Following Disease Progression after One Prior 04-12-11 1.1; exclusion for pts with more than 1 prior tx, pts with only prior
I4T-MC-JVBA
Platinum- erlotinib tx, pts on therapeutic anticoag (prophylactic low dose
Based Therapy Accrual: 1 SF: 1 All Sites Badarinath allowed w/ INR criteria)
LYMPHOMA
LINE SPONSOR STUDY Site PI Status Abbreviated Eligibility
DLBCL or DLBCL transformed from FL, bone core bx within 8wks
A Randomized, Single-Blind, Multicenter Study Comparing Pixantrone + randomization, received 1 but no more than 3 prior therapies,
Rituximab with an Investigator’s Choice of Single Agent Rituximab or OPEN received RCHOP or equivalent previously w/ confirmed PR or CR, at
V-10-027 Gemcitabine + Rituximab in Non-Stem Cell Transplant Eligible Patients with 04-28-11 least 1 measureable (≥1.5cm short axis) nodal site (not previously
Cell Therapeutics Aggressive B-cell Non-Hodgkins Lymphoma Who Have Relapsed after irradiated), ECOG 0-2, LVEF≥45%; pts are excluded wtih CNS or
Relapsed PIX 306 Therapy with CHOP-R or an Equivalent Regimen Accrual: 0 SF: 1 All Sites Moezi leptomeningeal lymphoma involvement
small lymphocytic, lymphoplasmacytic, marginal zone and follicular
lymphomas (GR 1,2,3a), CD20+ pathology, + response to rituximab
OPEN (PR/CR) lasting 6 mo from completion of tx, measurable disease [2
Phase II Open-Label Study of Ofatumumab and Bendamustine Followed by 6-6-11 lesions ≥1.5cm LD or 1 lesion ≥ 2.0cm], ECOG 0-2 Exclusionary:
GSK Maintenance Ofatumumab for Indolent B-cell Non-Hodgkin’s Lymphoma (B- previous bendamustine, RIT w/in 6 months, previous allogeneic SC
Relapsed OFB114612 NHL) Which Has Relapsed after Rituximab Therapy All Sites Moezi transplant, CNS involvement
Treatment naïve DLBCL pts subclassified as non-GCB
An Open-Label, Randomized, Phase 2 Study to Assess the Effectiveness
OPEN (central path testing req'd), at least 1 measurable mass >
of RCHOP With or Without VELCADE in Previously Untreated Patients with
DAVA Millenium Non Germinal Center B-Cell-like Diffuse Large B-Cell Lymphoma 05-10-11 1.5cm long axis and >1.0cm short axis, ECOG 45%, pts excluded for : CNS lymphoma, > grade 2
3
COMPREHENSIVE ACTIVE STUDY LIST
BOOTH * ORANGE PARK * ST. VINCENT'S
Updated 6-111
MELANOMA
LINE SPONSOR STUDY Site PI Status Abbreviated Eligibility
measurable disease (RECIST), no more than 1 prior systemic
ECOG Trial of GM-CSF Protein Plus Ipilimumab in Patients with Advanced OPEN regimen for Stage III, IV melanoma (does not include adjuvant tx),
st nd
1 or 2 line E1608 Melanoma Accrual: 3 All Sites Sylvester 2-2-11 patients with CNS metastases are excluded, ECOG 0-1
MDS
Line Sponsor / CRO STUDY Site PI Status Abbreviated Eligibility
MDS confirmed w/in 6 weeks prior to entry (WHO/FAB
A Phase III, Multi-Center, Randomized, Controlled Study to Assess the classification), one cytopenia, progression OR failure to achieve
Relapsed/
Efficacy and Safety of ON01910.Na Administered as a 72-hour Continuous OPEN CR/PR OR relapse OR intolerance to azacitidine/decitabine w/in
refractory/ Onconova 04-21
Intravenous Infusion Every Other Week in Myelodysplastic Syndrome 6-6-11 past 2 yrs, ECOG 0-2 Exclusionary: hyponatremia ( 0.1 - 6 mos pre or any post prostatectomy. No
RTOG 0534 Patients With a Rising PSA After Radical Prostatectomy Locations Johnson 4-3-08 prior pelvic RT.
A Phase II Trial of Samarium 153 Followed by Salvage Prostatic Fossa 3D-
RADIATION CRT or IMRT Irradiation in High-Risk, Clinically Non-Metastatic Prostate All FROG OPEN T2-4, NO-1, MO - Post-op PSA within 4 weeks of registration: PSA
RTOG 0622 Cancer After Radical Prostatectomy Locations Johnson 12-11-08 > 2.0 ng/ml; or - PSA > 0.2 if GS 9 or 10.
A Randomized, Double-Blinded, Placebo-Controlled Phase III Trial to T1b-T2b adenocarcinoma; (-) LN by imaging, nodal sampling or
Evaluate the Effectiveness of a Phosphodiesterase 5 Inhibitor, Tadalafil, in OPEN dissection; No bone mets; PSA - GS
RADIATION Prevention of Erectile Dysfunction in Patients Treated with Radiotherapy for All FROG 1-8-10 7 & PSA 100 on C1, D1. Exclusion: CV hx (CHF
Administered to Patients with Solid Tumors Receiving Gemcitabine grade III/IV, A Fib, unstable angina. FVL, APS, Protein C/S
GSK monotherapy or Gemcitabine Plus Carboplatin or Cisplatin Chemotherapy OPEN deficiemcies. DVT, PE or MI within 6 months. RT requires 4 wk
PHASE I TRC112765 Accrual: 0 SF: 1 OP only Moezi 8-16-10 washout
SUPPORTIVE CARE
Line Sponsor / CRO STUDY Site PI Status Abbreviated Eligibility
Colorectal, NSCLC or SCLC pts, metastatic or locally advanced,
V-11-005 starting new chemotherapy (new line of therapy included), pts on
DIREG_C_04823 non blinded clinical trials are eligible; Exclusionary: anticoagulant use
CANTARISK A prospective, non-interventional, cohort survey on VTE risk in patients OPEN (exception is central venous catheter patency), life expectancy<4
Supportive Care receiving new chemotherapy for cancer All Sites Bubis 06-29-11 months
UNKNOWN PRIMARY
LINE SPONSOR STUDY Site PI Status Abbreviated Eligibility
Must have biopsy material available from a surgical biopsy or a core
needle biopsy; must have adequate path specimen for molecular
A Phase II Study of Chemotherapy Treatment Based on Molecular Profiling profiling; measurable or evaluable disease; patients with brain
SCRI Diagnosis for Patients with Carcinoma of Unknown Primary Site Accrual: 9 OPEN metastases ok if all lesions have been controlled by resection or
UNKPRI 20 SF: 4 All Sites Sylvester 11-12-08 radiation therapy (RT) not steriod-dependent.
5
COMPREHENSIVE PENDING NEW STUDY LIST
Updated 5-10-11
BREAST
Line Sponsor / CRO STUDY Site PI Status
USO 10167 A Randomized, Phase 2 Trial of Preoperative MM-121 with Paclitaxel in HER2- on hold due to
MerriMack negative Breast Cancer sponsor training
Neoadjuvant Pharmaceuticals Bubis requirements
A randomized multicenter, double-blind, placebo-controlled comparison of
Roche BIG-04-11 / chemotherapy plus trastuzumab plus placebo versus chemotherapy plus
BO25126 Genentech trastuzumab plus pertuzumab as adjuvant therapy in patients with operable HER2-
Adjuvant TOC4939G positive primary breast cancer Bubis SQV 6/7/2011
A Phase III Randomized, Multicenter, Two-Arm, Open-Label Trial to Evaluate the
Efficacy of T-DM1 Compared with Treatment of Physician's Choice in Patients with
2nd or 3rd line Genentech HER2-Positive Metastatic Breast Cancer Who Have Received At 3 main waiting
metastatic TDM4997g Least Two Prior Regimens of HER2-Directed Therapy sites Moezi contract/budget
LUNG
Line Sponsor / CRO STUDY Site PI Status
Approved Nov 2010;
A randomized, phase III, multi-center, double blind, placebo-controlled study
FPI estimated Fall
2nd & 3rd line Genentech evaluating the safety and efficacy of MetMAb, a monovalent antibody antagonist to
2011; site selection
Metastatic OAM4971g the Met receptor, in combination with Tarceva® (erlotinib) in patients with Met high
process underway;
incurable stage IIIB/IV non-small cell lung cancer (NSCLC) who have failed
SQV 6-20-11
standard therapy for advanced or metastatic disease Bubis
SCLC - Randomized, Multicenter, Double-Blind, Phase 3 Trial Comparing the Efficacy of
Treatment BristolMyerSquibb Ipilimumab Plus Etoposide/Platinum versus Placebo plus Etoposide/Platinum in Approved June 2011
Naïve; Extensive CA184-156 Subjects with Newly Diagnosed Extensive-Stage Disease Small Cell Lung Cancer
stage (ED SCLC)
MDS
Line Sponsor / CRO STUDY Site PI Status
Thrombo- GSK A three-part Study of Eltrombopag in Thrombocytopenic Subjects with Pending contract &
cytopenia TRC114968 Myelodysplastic Syndromes or Acute Myeloid Leukemia (Part 1: open-label, Part 2: budget
randomized, double-blind, placebo-controlled, Part 3: open-label extension). Moezi
MELANOMA
Line Sponsor / CRO STUDY Site PI Status
Morphotek A Study of the Efficacy and PK/PD Relationship of Monotherapy MORAb-004 in
2nd or 3rd line Approved Mar 2011
004-201-Mel Subjects with Metastatic Melanoma
MULTIPLE MYELOMA
6
COMPREHENSIVE PENDING NEW STUDY LIST
Updated 5-10-11
Line Sponsor / CRO STUDY Site PI Status
BristolMyers Squibb A Phase 3, Randomized, Open Label Trial of Lenalidomide/dexamethasone With
CA204006 or Without Elotuzumab in Ist Line Multiple Myeloma
1st line Moezi SIV 7/18
PANCREATIC
Line Sponsor / CRO STUDY Site PI Status
Pharmacyclics Phase II Study of Coagulation Factor VIIa Inhibitor PCI-27483 in Pancreatic Cancer Need potential patient
1st line PCYC-1001 Patients Receiving Treatment with Gemcitabine to complete
Metastatic Moezi Regulatory
A Randomized Phase 3 Study of the Efficacy and Safety of Glufosfamide
V-10-025
Compared with Fluorouracil (5-FU) in Patients with Metastatic Pancreatic
2nd line Elieson EP-GF-301 Per veeda pushed
Adenocarcinoma Previously Treated with Gemcitabine
Metastatic Moezi back to June/July
US Oncology A Randomized Phase III Study of Weekly ABI-007 plus Gemcitabine versus
Approved May 2011
1st line 05129 Gemcitabine Alone in Patients with Metastatic Adenocarcinoma of the Pancreas.
Metastatic
PROSTATE
Line Sponsor / CRO STUDY Site PI Status
Randomized, Open Label Multi-Center Study comparing cabazitaxel at 25 mg/m2 Contract/Budget:
SanofiAventis and at 20 mg/m² in Combination with Prednisone Every 3 Weeks to Docetaxel in pending, Bubis;
EFC11784 Combination with Prednisone in Patients with Hormone Refractory Metastatic Dees Dees/IRB approved SIV
1st line Prostate Cancer not Pretreated with Chemotherapy Bubis 6-28
Randomized, Open Label Multi-Center Study comparing cabazitaxel at 20 mg/m2 Contract/Budget:
SanofiAventis and at 25 mg/m² in Combination with Prednisone Every 3 Weeks to the Treatment pending, Bubis;
EFC11785 of Hormone Refractory Metastatic Prostate Cancer Treated with a Docetaxel- Dees Dees/IRB approved SIV
2nd line Containing Regimen Bubis 6-28
SUPPORTIVE CARE
Line Sponsor / CRO STUDY Site PI Status
SQV completed 4/11/11;
Merck-V212-011 A Phase III Randomized, Placebo-Controlled, Clinical Trial to Study the Safety and Site selected; regulatory
Supportive Care Efficacy of V212 in Adult Patients with Solid Tumor or Hematologic Malignancy Badarinath started
7