Lynn Cancer Institute Oncology Trials

lynn cancer institute
  • November 13, 2015

Clinical Trials – November 2015

Eugene M. and Christine E. Lynn Office of Research Administration 561.955.4800

Center for Hematology-Oncology 561.955.6400 Radiation Oncology 561.955.4111


Primary Site

Sponsor/Study ID


Protocol Description Eligibility


HER2 +

MBC third line





A Study of Neratinib Plus Capecitabine Versus

Lapatinib Plus Capecitabine in Patients with

Her2+ Metastatic Breast Cancer Who Have Received

Two or More Prior Her2-Directed Regimens in the Metastatic Setting (NALA)

  • Histologically confirmed MBC; stage IV
  • HER2+ (IHC3+ or FISH+), by central lab
  • Prior tx w/> two (2) HER2-directed regimens for MBC
  • >1 measurable metastatic lesion by RECIST v1.1
  • LVEF >50% by MUGA or ECHO;   
  • ECOG status of 0 or 1
  • No prior treatment w/ capecitabine, neratinib, lapatinib,
  • No prior HER2 directed TKI
  • No cumulative exposer to anthracyclines
  • No active CNS metastases
  • No active uncontrolled cardiac disease


HER2 +





An Observational Cohort Study Of Treatment

Patterns And Outcomes In Patients

With Her2 Positive (Her2+) Metastatic

Breast Cancer

  • Her2+ MBC within 6 months of enrollment
  • Excludes—prior systemic therapy started > 6 month of enrollment

Breast Cancer

All staged



FDI – 69

A Prospective Longitudinal Study of CA

15-3 as an Aid in Monitoring Recurrence

or Progressive Disease in Patients with Breast Cancer

  • Histologic/pathologic confirmation of breast ca
  • Any stage of disease; Any treatment time point:
  • Life expectancy > 6 months
  • If HX other cancers must be >5 years in remission

HER2 – Metastatic or Locally

Advanced Unresetable BRCA

Associated Breast Cancer




A Phase 3 Randomized, Placebo-Controlled Trial of
Carboplatin and Paclitaxel With or Without the PARP
Inhibitor Veliparib (ABT-888) in HER2-Negative
Metastatic or Locally Advanced Unresectable
BRCA-Associated Breast Cancer

  • Histologicallyor cytologically confirmed breast cancer advanced or metastatic
  • Suspected deleterious or deleterious BRCA1 or BRCA2 germline mutation
  • HER2 negative
  • Measurable or non-measurable disease
  • ECOG 0-2
  • 1st, 2nd or 3rd line

Genetic Registry

City of Hope National Medical Center



Molecular Genetic Studies of Cancer Patients and Their Relatives

  • Personal History of family history of cancer suggestive of presence of an inherited predisposition
  • In a group known or suspected to have increased risk of carrying genetic alteration  or of sustaining exposure that would place them at risk of cancer
  • Willing historian to provide information or access


Primary Site

Sponsor/Study ID


Protocol Description Eligibility



Device TX

MDS Nordion


Dr. George Khoriaty

Treatment of Unresectable Hepatocellular

Carcinoma with TheraSphere® (Yttrium-90 Glass Microspheres): An HDE Treatment Protocol

  • Hepatocellular carcinoma of the liver
  • ECOG PS of 2 with a life expectancy of > 3 months
  • > 4 weeks since prior RT 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


1st Line Metastatic

OncoMed Pharmaceuticals, Inc.




A3-Arm Phase 2 Double-Blind Randomized StudY of Gemcitabine Abraxane Plus PlacebO VersuS GEMcitabIne Abraxane plus 1 or 2 TruncatEd Courses of Demcizumab in Subjects with 1st Line Metastatic Pancreatic Ductal Adenocarcinoma

  • Cytologically or histologically confirmed metastatic pancreatic ductal adenocarcinoma
  • No prior chemotherapy and/or radiotherapy in adjuvant or neoadjuvant setting or for metastatic disease
  • ECOG PS 0 or 1
  • No therapeutic doses of heparin, warfarin, factor Xa inhibitors or other similar anticoagulants
  • Certain cardiac-related criteria is excluded – ask study coordinator


Surgically Resected

1st line adjuvant





Phase 3, Multicenter, Open-Label, Randomized Study Of nab®-Paclitaxel Plus Gemcitabine Versus Gemcitabine Alone As Adjuvant Therapy In Subjects With Surgically Resected Pancreatic Adenocarcinoma

  • Resected ductal pancreatic adenoca w/ macroscopic resection (R0 and R1).
  • T 1-3, N0-1, M0. 3.
  • start treatment < 12 weeks postsurgery.
  • (ECOG) PS 0 -1.
  • excluded neuroendocrine (and mixed type) tumors


Borderline/ Unresectable

New Link Genetics NLG-0505


A Phase III Study Of Chemotherapy With Or Without Hyperacute®-Pancreas (Algenpantucel-L) Immunotherapy In Subjects With Borderline Resectable Or Locally Advanced Unresectable Pancreatic Cancer


  • Borderline resectable or locally advanced unresectable pancreatic cancer with no metastatic
  • ECOG < 1
  • Exclusion –Prior chemo or Rad Tx for pancreas CA
  • Exclusion Peripheral neuropathy > grade 2




FDI – 68

A Prospective Longitudinal Study of CA 19-9 as an Aid in Monitoring Disease in Patients with Pancreatic Cancer

  • Histologic/pathologic confirmation of exocrine pancreatic ca
  • Any stage of disease; Any treatment time point:
  • Life expectancy > 6 months
  • If HX other cancers must be >5 years in remission.




JANUS 1 Study


A Randomized, Double-Blind, Phase 3 Study of the JAK 1/2 Inhibitor, Ruxolitinub or Placebo in Combination With Capecitabine in Subjects With Advanced or Metastatic Adenocarcinoma of the Pancreas Who Have Failed or Are Intolerant to First-Line Chemotherapy 

  • Advanced adenocarcinoma of the pancreas that is inoperable or metastatic
  • Modified Glasgow Prognostic Score (mGPS) of 1 or 2 as defined below:
  1. mGPS of 1:  CRP> 10mg/Land albumin > or35 g/L
  2. mGPS of 2:  CRP >10mg/L and albumin<35 g/L
  • Received 1 prior chemotherapy regimen for advanced or metastatic disease (not including neoadjuvant and/or adjuvant therapy)
  • ECOG performance status 0 to 2
  • EXCLUSION: Known brain or central nervous system metastases or history of uncontrolled seizures    






A Phase III, Randomized, Double Blind, Placebo Controlled, Multicentre Study of Maintenance Olaparib Monotherapy in Patients with gBRCA Mutated Metastatic Pancreatic Cancer whose Disease Has Not Progressed on First Line Platinum Based Chemotherapy

  • Histologic/pathologic confirmation pancreatic adenocarcinoma
  • Receiving initial chemotherapy for metastatic disease and without evidence of disease progression on treatment
  • 1st Line with platinum-based regimen received a minimum of 16 weeks of continuous platinum treatment with no evidence of progression
  • Documented mutation in gBRACA1 or gBRACA2 that is predicted to be deleterious or suspected deleterious
  • ECOG performance status 0-1


Primary Site

Sponsor/Study ID


Protocol Description


General Oncology H. Lee Moffitt Cancer Center/ MCC 18059

No NCT #

Pilot testing of a real-time oncogeriatric teleconsultation system using the Total Cancer CareTM database
  • 70+ years old
  • Documented malignancy initially seen at LCI
  • Treatment decision has to be made within 1st month
  • LCI oncologist wants to review outside established treatment appropriateness
General Oncology LCI Senior Exercise Project/ SPP-2014-38-LCI

No NCT #

Senior Adult Cancer Treatment Optimization of Performance Project (Pilot study)
  • 75 years or older at time of cancer diagnosis
  • Understand and adhere to study related assessments/procedures
  • No prior cancer treatment
  • Scheduled to start cytotoxic chemotherapy and/or radiation therapy
  • No restriction on tumor stage


Primary Site

Sponsor/Study ID


Protocol Description






A Phase III, Randomized, Open-Label, Crossover, Multi-Center, Safety And Efficacy Study To Evaluate Nab-Paclitaxel (Abraxane®) As Maintenance Treatment After Induction With Nab-Paclitaxel Plus Carboplatin In Subjects With Squamous Cell Non-Small Cell Lung Cancer
  • Stage IIIB or IV SQ NSCLC
  • No Prior chemo for metastatic (prior adjuvant >12 months allowed)
  • Measureable disease w/target lesion in non-radiated area.
  • Exclusion: Active brain mets; peripheral neuropathy > grade 2


Met to brain or leptomeninges




A Phase II, multi-center, open-label, five-arm study to evaluate the efficacy and safety of oral ceritinib treatment for patients with ALK-positive non-small cell lung cancer (NSCLC) metastatic to the brain and/or to leptomeninges
  • WHO PS: 0-2
  • Tumor tissue sample available as an archival sample or as a new biopsy to send to Novartis designated central laboratory
  • At least 1 extracranial measurable lesion
  • Be neurologically stable within at least 1 week prior to first dose of study drug
  • Discontinued treatment 2 weeks prior to starting study drug. Includes chemo, biological therapy or investigational agents. ALK inhibitors are 1 week prior to first dose of study drug.
  • Life expectancy > 6 weeks
Advanced Non Small Cell  Lung Cancer-1st Line-Elderly ubjects Celgene



Safety and Efficacy Of Continuous Weekly nab-Paclitaxel Vs. With 1 Week Break, In Combination With Carboplatin As First Line Treatment In Elderly Subjects With Advanced Non-Small Cell Lung Cancer (NSCLC):  a Phase IV Randomized, Open-Label, Multi-Center Study
  • Age > 70 years at the time of signing the ICF
  • Histologically or cytologically confirmed locally advanced or metastatic NSCLC who are not candidates for curative surgery or radiation
  • Radiographically documented measurable disease (defined by the presence of > radiographically documented measurable lesion)
  • No prior chemotherapy for the treatment of metastatic disease.  Adjuvant chemotherapy is permitted providing cytotoxic chemotherapy was completed 12 months prior to signing the ICF and without disease recurrence.
  • ECOG  PS:  0 or 1
NSCL IIIB with Pleural/Pericardial effusion, Stage IV or Recurrent-Initial Treatment Incyte



A Randomized, Double-Blind Phase 2 Study of Ruxolitinib or Placebo in Combination With Pemetrexed/Cisplatin and PemetrexedMaintenance for Initial Treatment of Subjects With Nonsquamous Non-Small cell Lung Cancer That is Stage IIIB with Pleural/Pericardial Effusion, Stage IV or Recurrent
  • ECOG PS:  0 or 1
  • Subjects must not have received prior chemotherapy for advanced or metatstatic disease
  • Life expectancy of at least 12 weeks
  • Radiographically measurable or evaluable disease
  • mGPS of 1 or 2

Who are T790M+




A Multi-center, AZD9291 expanded access program for the treatment of patients with advanced/metastatic EGFR T790M mutation-positive NSCLC who have received prior EGFR TKI therapy
  • EGFR T790M + NSCLC locally advanced or metastatic
  • Two lines of prior therapy including at least one EGFR TKI
  • WHO Performance Status 0-2
  • No prior treatment with AZD9291
  • No past medical history nor current ILD
  • No neurologically unstable w/ symptomatic CNS metastases
Met SCLC relapsed or were refractory CytRx Corp.



A Multicenter, Randomized, Open-Label Phase 2b Study to Investigate the Efficacy and Safety of Aldoxorubicin Compared to Topotecan in Subjects with Metastatic Small Cell Lung Cancer Who Either Relapsed or Were Refractory to Prior Chemotherapy
  • Life expectancy >8 weeks
  • ECOG PS: 0 -2
  • Histological confirmation of SCLC
  • Relapsed or refractory to no more than 1 course of systemic therapy regimen and is incurable by either surgery or radiation
  • No prior treatment with topotecan
  • Radiographically measurable or evaluable disease
NSCLC Stage IV, detectable KRAS Mutation Eli Lilly




A Randomized Phase 3 Study of LY2835219 plus Best
Supportive Care versus Erlotinib plus Best Supportive
Care in Patients with Stage IV NSCLC with a Detectable
KRAS Mutation Who Have Progressed After
Platinum-Based Chemotherapy
  • Adequate FFPE tumor-derived material for analysis of KRAS mutation status as has to be confirmed by Sponsor lab
  • Progressed after platinum-based chemotherapy and received 1 additional chemotherapy for advanced and/or metastatic disease or judged by physician as ineligible for further standard second-line chemotherapy
  • No prior EGFR – target therapy, including any multi-target TKIs
  • Prior Bevacizumab is allowed
  • ECOG PS:  0 or 1
NSCLC Stage IIIb/IV or recurrent EMD Serono

EMR 100070-004


A Phase III open-label, multicenter trial of Avelumab (MSB0010718C) versus docetaxel in subjects with ALK Negative NSCLC that have progressed after a platinum-containing doublet
  • ECOG PS: 0 or 1
  • ALK Negative
  • Estimated life expectancy > 12 weeks
  • Tumor tissue block or 7 unstained tumor slides suitable for PD-L1 expression assessment by central laboratory
  • Confirmed stage IIIb/IV or recurrent NSCLC experience disease progression
Stage IV






A Phase III, open-label, randomized study of MPDL3280A (Anti−PDL1 Antibody) compared with Cisplatin or Carboplatin + Pemetrexed for PD-L1−selected chemotherapy naïve patients with stage IV non-squamous-non-small cell lung cancer
  • ECOG PS: 0 or 1
  • Histologically or cytologically confirmed stage IV non-squamous NSCLC
  • No prior chemo treatment for Stage IV unless patient had previously detected EGFR or ALK. Previous targeted therapy for those is allowed.
  • Treated stable brain mets is allowed
  • Tumor PD-L1 expression (TC3 or IC3) determined by an IHC assay performed by central laboratory on previous archival tumor tissue or tissue obtained from biopsy at screening
Stage IV






A Phase III, open-label, randomized study of MPDL3280A (Anti−PDL1 Antibody) compared with Gemcitabine + Cisplatin or Carboplatin for PD-L1−Selected, chemotherapy naïve patients with stage IV squamous non-small cell lung cancer
  • ECOG PS: 0 or 1
  • Histologically or cytologically confirmed stage IV squamous NSCLC
  • No prior chemo treatment for Stage IV unless patient had previously detected EGFR or ALK. Previous targeted therapy for those is allowed.
  • Treated stable brain mets is allowed
  • Tumor PD-L1 expression (TC3 or IC3) determined by an IHC assay performed by central laboratory on previous archival tumor tissue or tissue obtained from biopsy at screening


Primary Site

Sponsor/Study ID


Protocol Description


mCRPC Sanofi

LPS 14022



Phase II, randomized, open label, multicenter study in chemotherapy-naïve metastatic Castration-Resistant Prostate Cancer (mCRPC) patients who have PRIMary resistance to Abiraterone acetate or Enzalutamide treatment comparing the anti-tumor effect of CABazitazel to alternative Androgen Receptors (AR) targeted therapy
  • Histologically or cytologically confirmed prostate adenocarcinoma
  • ECOG PS: 0 or 1
  • Prior AR targeted therapy (abiraterone acetate or enzalutamide) stopped at least 2 weeks before study treatment
  • PD while receiving AR targeted therapy with abiraterone acetate or enzalutamide within 6 months of treatment initiation by at least one of the following:
  • Minimum of 1 measurable lesion per RECIST 1.1
  • 2 or more new bone lesions (CT; MRI)
  • At least 2 consecutive rises in PSA taken at least one week apart
  • Serum testosterone levels <0.5 ng/mL
  • Cannot have history of brain metastases, uncontrolled spinal cord compression, carcinomatous meningitis or new evidence of brain or leptomeningeal disease
Advanced or Metastatic Renal Roche



A Phase III, OPEN-LABEL, Randomized study of mpdl3280a (Anti-PD-L1 ANTIBODY) in combination with bevacizumab versus sunitinib in patients with untreated advanced renal cell carcinoma


  • Unresectable advanced or metastatic RCC with clear histology and/or sarcomatoid carcinoma
  • Formalin-fixed, paraffin-embedded tumor specimen accompanied by associated pathology report collected within 24 months prior to C1D1 at study site that allows determination of PD-L1 expression status
  • KPS > 70
  • Cannot have radiotherapy for RCC within 14 days prior to C1D1
  • No prior treatment with active or experimental systemic agents, including treatment in neoadjuvant or adjuvant setting. (Prior placebo treatment in adjuvant setting is allowed)
Non-metastatic CRPC Bayer HealthCare Pharmaceuticals Inc.

ARAMIS 17712


A Phase III multination randomized, double-blind, placebo-controlled efficacy and safety study of ODM-201 in men with high-risk non-metastatic castration-resistant prostate cancer
  • Histologically or cytologically confirmed adenocarcinoma of prostate without neuroendocrine differentiation or small cell features
  • CRPC with 3 rising PSA levels at least 1 week apart during ADT. History of antiandrogen use, most recent PSA must be at least 4 weeks after antiandrogen withdrawal
  • ECOG PS: 0 to 1
  • Castrate level of serum testosterone (< 1.7 nmol/l [50 ng/dl]) on GnRH agonist or antagonist therapy or after bilateral orchiectomy. Patients who have not undergone bilateral orchiectomy must continue GnRH therapy during the study
M1 CRPC Tokai Pharmaceuticals



ARMOR3-SV: A Phase 3, randomized, open label, Multicenter, controlled study of Galeterone compared to Enzalutamide in men expressing androgen receptor splice variant-7mRNA (AR-V7) Metastatic (M1) castrate resistant prostate cancer (CRPC)
  • ECOG PS: 0 to 1
  • Positive AR-V7 mRNA transcript in CTCs performed at central laboratory
  • Progression on castrate serum testosterone defined by one or more of following: 2 rising PSA, or new Bone mets, or Soft Tissue Mets
  • Prior use of docetaxel to be reviewed w/ sponsor
  • Prior treatment involving experimentally therapy completed  within 4 weeks of randomization
mCRP Bayer HealthCare Pharmaceuticals Inc.



REASSURE – Radium-223 alpha Emitter Agent in Safety

Study in mCRPC popUlation for long-teRm Evaluation

  • Patients cannot have previously been treated with Radium-223 for any reason
  • Histologically or cytologically confirmed castration resistant adenocarcinoma of the prostate with bone metastases

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