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

Metastatic BRCA 1 or 2
ABBOTT
M12-895

BROCADE

NCT01506609
A Randomized, Phase II Study of the Efficacy and Tolerability of Veliparib in Combination with Temozolomide or Veliparib in Combination with Carboplatin and Paclitaxel versus Placebo plus Carboplatin and Paclitaxel in Subjects with BRCA 1 or BRCA 2 mutation and Metastatic Breast Cancer
  • Histological or cytological confirmed breast cancer w/ evidence of metastatic disease
  • Must have BRCA 1 or 2 mutation
  • One measurable lesion
  • ECOG PS 0-2
  • If HER-2 positive, must have progressed on at least 1 prior standard HER2 directed therapy
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 Stages
FUJIREBIO
DIAGNOSTICS

FDI - 68
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

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

PILLAR

NCT01836432
A Phase Iii Study Of Folfirinox 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


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.

GENITOURINARY

Primary SiteSponsor/Study ID
NCT#
Protocol DescriptionEligibility
Renal Cell Cancer with– Clear Cell componentExelixis
XL184-308

METEOR

NCT01865747
XL184-308: A Phase 3, randomized, controlled study of cabozantinib (XL184) vs. everolimus in subjects with metastatic renal cell carcinoma that has progressed after prior VEGFR tyrosine kinase inhibitor therapy.

  • Clear cell component
  • Prior Tx with at least 1 VEGFR targeting TKI
  • Progress on Tx or within 6 months of at least 4-wks of VEGFR
  • KPS ≥ 70
  • EXCLUSION: Prior tx w/everolimus or selective TORC1/PISK/AKT

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

Stage IV
1st Line
SWOG S0819

NCT00946712
A Randomized, Phase III Study Comparing Carboplatin/Paclitaxel or Carboplatin/Paclitaxel/ Bevacizumab with or without Concurrent Cetuximab in Patients with Advanced Non-Small Cell Lung Cancer (NSCLC)

ON HOLD per SWOG
  • Newly diagnosed stage IV, advanced or recurrent disease after surgery and/or irradiation
  • Controlled brain metastasis acceptable
  • No prior chemotherapy, monoclonal antibody, EGFR, or VEGF targeted agents
NSCLC — Non-Squamous Recurrent or Metastatic 2nd Line PrECOG-0502
MO22097

AVA ALL

NCT01351415
An open-label, randomized, Phase IIIb trial evaluating the efficacy and safety of standard of care +/- continuous bevacizumab treatment beyond progression of disease (PD) in patient with advanced non-squamous non-small cell lung cancer (NSCLC) after first (1st)-line treatment with bevacizumab plus a platinum doublet-containing chemotherapy

  • Locally recurrent or metastatic non-SQ NSCLC
  • ECOG Performance Status 0-2
  • Progressed beyond 1st line treatment with bev + a platinum doublet-containing chemotherapy
  • Bev (monotherapy) maintenance treatment
  • At least 1 un-dimensionally measurable lesion meeting RECIST criteria
NSCLC Stage IIIB or
StageIV

Roche

NP28761 AF-002JG

NCT01871805
A Phase I/II Study of the ALK Inhibitor CH5424802/ RO5424802 in Patients With ALK-Rearranged Non-Small Cell Lung Cancer Previously Treated With Chemotherapy and Crizotinib
  • Locally adv- not amenable to curative tx or metastatic ALK rearranged Measurable ECOG PS ≤ 2
    4 wk washout post cytotoxic chemo
  • 1 wk washout post Crizotinib
  • No other Alk inhibitor
NSCLC Unresected Locally advanced Stage III

Merck-Serano

START2

NCT0204915
EMD 63325-021: Phase III trial of tecemotide (also known as L-BLP25 or formerly Stimuvax®) in unresectable, locally advanced Stage III non-small cell lung cancer (NSCLC).
  • Stage per CT/MRI or PET
  • Prior CRT –Minimum 2-cycle w/platinum an CRT ≥ 60Gy
  • With stable or objective response
  • ECOG 0-1
  • Excludes-- radio sensitizing chemo; mets; pleural effusion
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.
NSCLC M1a or
M1b or SCLC
any stage
BRRH ALCMI
CASTLE

NCT01574300
Addario Lung Cancer Medical Institute (ALCMI) Collaborative Advanced Stage Tissue Lung Cancer (CASTLE) Network Study

HOLD
  • NSCL -M1a or M1b w/any # prior tx
  • SCLC any stage w/any # prior tx
  • Plan systemic tx
  • Measureable or evaluable disease
  • ECOG PS 0-2 w/expected survival > 3 mo
  • Willing to biopsy collection or paraffin block available w/in last 12 months.

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*

HOLD
  • 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

Primary SiteSponsor/Study ID
NCT#
Protocol DescriptionEligibility

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

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