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
  • Histologically or cytologically confirmed breast cancer with evidence of metastatic disease
  • ≥18 years of age
  • 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

GASTROINTESTINAL

Primary SiteSponsor/Study ID
NCT#
Protocol DescriptionEligibility
Liver

Humanitarian Device TX
MDS Nordion

Contact
Dr. 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

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

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
Prostate CRPC Tokai
TOK-200-10
ARMOR2

NCT01709734
A 2 Part, Phase 2 Trial of Galeterone in the Treatment of Castration Resistant Prostate Cancer
  • CRPC---progression—either tx naive or abiraterone failure.
  • At least one of the following:
    • --Nodal spread with NO bone or visceral disease
    • --Bone disease w/ or w/o nodal disease w/o visceral disease
    • --visceral mets w/ or w/o nodal or bone disease
    • OR
    • --PSA rise x2 at least 1 week apart
  • Able to swallow multiple LARGE pills
  • Life expectancy >12 weeks
Prostate
MCRPC
2nd line
OncoGenenX
OGX 011-12:
AFFINITY

NCT01578655
OGX 011-12: A Randomized Phase 3 Study comparing Cabazitaxel/Prednisone in Combination with Custirsen (OGX-011) to Cabazitaxel/ Prednisone for Second-Line Chemotherapy in Men with Metastatic Castrate Resistant Prostate Cancer.[AFFINITY]

  • Metastatic Castrate Resistant
  • Previously TX w/docetaxel as 1st line (3-cycles)
  • No chemo TX beyond 1st line
  • Progression : measurable dx or bone scan or rising PSA (x2)
  • 21 days post RT or major surgery
  • Willing to continue androgen suppression

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)
  • 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

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 IIB or
Stage IV
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 Measureable ECOG PS ≤ 2
    4 wk washout post cytotoxic chemo
  • 1 wk washout post Crizotinib
  • No other Alk inhibitor
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

  • 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
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*
SUSPENDED PENDING AMENDMENT
  • 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
CLL

Maintenance/ Placebo
Post-2nd line
Celgene
CC-5013-CLL-002
CONTINUUM

NCT00774345
Phase III Randomized, Double-blind, Placebo-controlled, Parallel-group Study of Lenalidomide as Maintenance Therapy in B-cell CLL Following Second-line Therapy

  • Prior treatment with purine analog in the 1st or 2nd regimen required
  • Partial response minimum required after completion of 2nd line induction therapy prior to randomization
  • Last cycle of 2nd line treatment >8 weeks and ≤16 weeks prior to randomization
  • Excludes CNS involvement

MULTIPLE MYELOMA

Primary SiteSponsor/Study ID
NCT #
Protocol DescriptionEligibility
MM
1st line untreated
BMS
CA204006
ELOQUENT – 1

NCT01335399
A Phase 3, Randomized, Open Label Trial of Lenalidomide/Dexamethasone With or Without Elotuzumab in Subjects with Previously Untreated Multiple Myeloma

  • New diagnosis with symptomatic
  • No prior anti-MM therapy
  • Measureable disease
  • Not eligible for High-dose + stem-cell
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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