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

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BREAST

Primary SiteSponsor/Study ID
NCT#
Protocol DescriptionEligibility
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
  • 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
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


  • 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 STUDY
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

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

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

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
Pancreatic

1st Line Metastatic


OncoMed Pharmaceuticals, Inc.
M18-006 YOSEMITE

NCT02289898

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

Enrollment on Hold
  • 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

GENITOURINARY

Primary SiteSponsor/Study ID
NTC#
Protocol DescriptionEligibility
mCRPCSanofi
LPS 14022
(PRIMCAB)

NCT02379390
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

Non-metastatic CRPCBayer HealthCare Pharmaceuticals Inc.

ARAMIS 17712

NCT02200614

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

Not yet Site Activated, anticipated to start enrolling 9/21/15
  • 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

mCRPBayer HealthCare Pharmaceuticals Inc.

NCT02141438

RADIATION STUDY

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

M1 CRPCTokai Pharmaceuticals TOK200-15

NCT02438007

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

LUNG

Primary SiteSponsor/Study ID
NCT#
Protocol DescriptionEligibility
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
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
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
Stage IV Squamous NSCLCRoche GO29432

NCT02409355
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
Stage IV Non-Squamous NSCLCRoche
GO29431

NCT02409342
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
NSCLC ALK + Met to brain or leptomeningesNovartis
CLDK378A2205

NCT02336451
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
Resected Stage IB-IIIA NSCLCRoche
GO29527

NCTO2486718
A Phase III, open label, randomized study to investigate the efficacy and safety of MPDL3280A (Anti-PD-L1 Antibody) compared with best supportive care following adjuvant cisplatin based chemotherapy in PD-L1 selected patients with completely resected stage IB-IIIA non-small-cell lung cancer.
  • ECOG PS: 0 or 1
  • Histological or cytological diagnosis of Stage IB (tumors greater than or equal 4cm)- IIIA (T2-3, NO, T1-3, N1, T1-3, N2)
  • Tumor PD-L1 expression of TC3 or IC3 performed by central lab
  • No prior treatment with systemic chemotherapy
  • No segmentectomy or wedge resection

MELANOMA

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 OncologyLCI Senior Exercise Project/ SPP-2014-38-LCI

No NCT #
Senior Adult Cancer Treatment Optimization of Performance Project (Pilot study)

  • 70 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

LYMPHOMA

Primary SiteSponsor/Study ID
NCT #
Protocol DescriptionEligibility
Relapsed or Refactory large B-Cell LymphomaProNai
PNT2258-03-DLBCL
NCT02226965
WOLVERINE: A Phase II study of PNT2258 in patients with relapsed or refractory diffuse large B-Cell Lymphoma

  • ECOG PS 0-2
  • Histologically confirmed diffuse large B-cell lymphoma refractory prior to therapy or has relapsed after prior therapy
  • Willing to undergo pre-treatment bx or archived tumor for analysis
  • Previously received at least 2 prior systemic regimens
  • FDG-PET-CT disease positive baseline scan

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