Clinical Trials
EUGENE M. & CHRISTINE E. LYNN CANCER RESEARCH

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BREAST

Primary SiteSponsor/Study ID
NCT#
Protocol DescriptionEligibility
Breast

Metastatic
Triple negative
Celgene
ABI-007-MBC-001

TnAcity

NCT01881230

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

  • ECOG 0-1
  • Path confirmed metastatic breast ca
  • Path confirmed triple neg by central lab at screening
  • Measurable disease by RECIST1.1
  • NO prior cytotoxic chemo for metastatic breast cancer
  • ≥ 30 days post neo adjuvant or adjuvant chemo
  • Rad Tx at least 2 weeks prior w/measurable disease outside portal or evidence of progression post RadTx.
Breast

HER +
MBC third line
PUMA-
NER-1301
NALA

NCT01808573
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
    Exclusions: Prior treatment with capecitabine, neratinib, lapatinib, HER2 directed TKI
    Cumulative exposure to anthracyclines: see protocol
    Active CNS metastases; Active uncontrolled cardiac disease:
    QTc interval >0.450 sec or hx of QTc prolongation or TdP
Breast

HER 2+
Genentech
ML28257
SystHERs

NCT01615068
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
FUJIREBIO
DIAGNOSTICS

FDI - 69
A Prospective Longitudinal Study of CA 15-3 as an Aid in Monitoring Recurrence or Progressive Disease in Patients with Breast Cancer


HOLD as of 06-17-2015 at 50 patients
  • 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 CancerAbbVie2014.21
M12-914
NCT02163694
M12-914: 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 RegistryCity of Hope National Medical Center 96144 GENETICS STUDYMolecular Genetic Studies of Cancer Patients and Their Relatives
  • Hepatocellular carcinoma of the liver
  • ECOG PS score of ≤ 2 with a life expectancy of > 3 months
  • >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

GASTROINTESTINAL

Primary SiteSponsor/Study ID
NCT#
Protocol DescriptionEligibility
Liver

Humanitarian Device TX
MDS Nordion

Contact
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 score 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
Pancreatic

Surgically Resected
1st line adjuvant

Celgene
ABI-007-PANC-003

APACT

NCT01964430
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
Pancreatic

Borderline/ unresectable
New Link Genetics
NLG-0505

NCT01836432
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
Pancreatic

FUJIREBIO DIAGNOSTICS


PILLAR

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.
Pancreas

Incyte
18424-362

The 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 Faliled 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:
    a) mGPS of 1: CRP> 10mg/Land albumin > or35 g/L
    b) mGPS of 2: CRP >10mg/L and albumin<35 g/L
  • Life expectancy > 6 months
  • 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
Pancreas

AstraZenca
D081FC00001

POLO

NTC02184195
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

GENITOURINARY

LUNG

Primary SiteSponsor/Study ID
NCT#
Protocol DescriptionEligibility
NSCLC adv
Stage IIIB/IV
Synta 9090-14

GALAXY2

NCT01798485
A Randomized, Phase 3 Study Of Ganetespib In Combination With Docetaxel Versus Docetaxel Alone In Patients With Advanced Non-Small-Cell Lung Adenocarcinoma

  • Pre-dominate Adenocarcinoma.
  • Progression following 1st line tx for adv
  • Only 1 prior systemic tx for IIIB/IV w/ platinum regime progression on or following Adv tx
  • Prior tx for Stage I, II or IIIA allowed
  • Measurable disease; Archived tissue available
  • Dx Stage IIB/IV ≥ 6 months prior to ICF
NSCLC-SQM

CELGENE
ABI-007-NSCL-003

ABOUND.SQM


NCT02027428
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
SCLC 1st line

BAY 14615

NCT02161419
Bay 100-0394 in combination with cisplatin/etoposide or carboplatin/etoposide as first line therapy in patients with SCLC.
  • Extensive-stage disease SCLC
  • At least 1 solid tumor lesion measurable by CT or MRI
  • ECOG PS of 0 - 1
  • Exclusion Criteria: Prior systemic Tx for SCLC (including previous therapy with a CDK inhibitor)
SCLC 2nd line
LS or ES
Millennium

C14018

NCT02038647
C14018: A Randomized, Double-blind, Placebo-controlled, Phase 2 Clinical Trial of Alisertib (MLN8237) in Combination With Paclitaxel Versus Placebo in Combination With Paclitaxel as Second Line Therapy for Small Cell Lung Cancer (SCLC)

  • Progressed after 1st line platinum chemo SOC
  • No 2nd line chemo for relapsed or progression
  • Progressed within 180 days of 1st line tx
  • Tx to start no earlier than 21 days post 1st line.
Advanced Non Small Cell Lung Cancer-1st Line-Elderly SubjectsCelgene

ABI-007-NSCL-005

ABOUND.70+
ABI-007-NSCL-005: 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 performance status 0 or 1
NSCL IIIB with Pleural/Pericardial effusion, Stage IV or Recurrent-Initial TreatmentIncyte

18424-266

NCT02119650
INCB 18424-266: 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 performance status 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
NSCL IIIB with Pleural/Pericardial effusion, Stage IV or Recurrent-Initial TreatmentIncyte

18424-266

NCT02119650
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
Adv/Met NSCLC Who are T790M+AstraZeneca

D5160C00021

NCT02451852
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 refractoryCytRx Corp. ALDOXORUBICIN-P2-SCLC-01

NCT02200757
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 MutationEli Lilly I3Y-MC-JPBK JUNIPER

NCT02152631
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

MELANOMA

Primary SiteSponsor/Study ID
NCT #
Protocol DescriptionEligibility
Melanoma

Adjuvant
ECOG 1609

NCT01274338

Arms B & C – Closing 8/15/2014
A Phase III, Randomized Study of Adjuvant Ipilimumab Anti-CTLA4 Therapy Versus High-Dose Interferon a - 2b for Resected High-Risk Melanoma

*3rd Arm Added*

10-1-14
HOLD
pediatrics only
  • 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
  • Recurrence after adequate surgical excision of original primary cutaneous melanoma allowed

ANEMIA

Primary SiteSponsor/Study ID
NCT #
Protocol DescriptionEligibility
PNH - RenalAlexion M07-001
PNH Registry

NCT01374360
Paroxysmal Nocturnal Hemoglobinuria (PNH) Registry

  • Diagnosis of PNH
  • Prior treatment with Solaris acceptable

LEUKEMIA

MULTIPLE MYELOMA

Primary SiteSponsor/Study ID
NCT #
Protocol DescriptionEligibility
MM Relapsed or Refractory Celgene
CC-4047-MM-007
OPTIMISIMM

NCT01734928
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

  • Measureable disease by serum and urine protein electrophoresis
  • At least 1 but no more than 3 Prior tx
  • Prior tx with Lenalidomide (at least 2 cycles)
  • Documented disease progression after last anti-MM tx
  • EXCLUSION: Refractory to Bortezomib (1.3mg/m2 2x-wk); Non-secretory MM; Dialysis; Peripheral Neuropathy Grade 3 or 4 or 2 w/pain

GENERAL ONCOLOGY

Primary SiteSponsor/Study ID
NCT #
Protocol DescriptionEligibility
General OncologyH. 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 OncologyLCI 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

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