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

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BREAST

Primary SiteSponsor/Study ID
NCT#
Protocol DescriptionEligibility
Breast

HER2 +
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 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 CancerAbbVie
M12-914
NCT02163694
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
HER2-negative Progressed on or after AI treatmentNovartis
CBYL719C2301
SOLAR-1)

NCT02437318
A phase III randomized double-blind, placebo controlled study of alpelisib in combination with fulvestrant for men and postmenopausal women with hormone receptor positive, HER2-negative advanced breast cancer which progressed on or after aromatase inhibitor treatment
  • ECOG 0 or 1
  • Her2 negative
  • ER + and/or PgR+ by local laboratory
  • Recurrence or PD during or after AI therapy. AI therapy does not need to be latest treatment regimen.
  • No prior treatment with chemotherapy, fulvestrant, any PI3K, mTOR or AKT inhibitor for metastatic disease

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

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

GENITOURINARY

Primary SiteSponsor/Study ID
NTC#
Protocol DescriptionEligibility
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
  • 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

LUNG

Primary SiteSponsor/Study ID
NCT#
Protocol DescriptionEligibility
NSCLC-SQMCELGENE
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
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 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
IIIA, II or IB Resected
Non-Squamous NSCLC
NCI
A151216
ALCHEMIST

NCT02194738
Adjuvant Lung Cancer Enrichment Marker Identification and Sequencing Trial (ALCHEMIST)

This is the pre-registration study which randomizes to either A081105 or E4512
  • ECOG PS: 0 or 1
  • No neoadjuvant (chemo or radio-therapy) for this lung cancer
  • No prior treatment with agents targeting EGFR mutation or ALK rearrangement
  • No pure squamous carcinoma
  • Pre-surgical: Suspected clinical stage of IIIA, II or large IB (defined as size ≥4cm)
  • Post-surgical: Pathologic stage IIIA, II or IB (defined as size ≥4 cm)
  • Patients may be receiving adjuvant chemotherapy at the time of registration.
  • Adequate FFPE tissue for central EGRF and ALK genotyping for all patients, include those already locally tested
  • Complete resection.
IIIA, II or IB Resected
Non-Squamous
NSCLC
NCI
A081105
ALCHEMIST

NCT029193282
Randomized double blind placebo controlled study of erlotinib or placebo in patients with completely resected epidermal growth factor receptor (EGFR) mutant non-small cell lung center (NSCLC)
  • ECOG PS: 0 or 1
  • Registered to A151216 with result of EGFR exon 19 deletion or L858R mutation
  • Completely resected stage IB (≥ 4cm), II, or IIIA non-squamous NSCLC with negative margins
  • Patients with known resistant mutations in the EGFR TK domain (T790M) are not eligible.
  • Patients that are both EGFR mutant and ALK rearrangements will be registered to A081105
IIIA, II or IB Resected
Non-Squamous
NSCLC
Mirati 265-109

NCT02544633
Phase 2, Parallel-Arm Study of MGCD265 in Patients with Locally Advanced or Metastatic Non-Small Cell Lung Cancer with Activating Genetic Alterations in Mesenchymal-Epithelial Transition Factor
  • ECOG PS 0-2
  • Tumor tissue and/or ctDNA
  • No prior positive test for EGFR mutation or ALK gene rearrangement
  • No prior treatment with small molecule or antibody inhibitor of MET or HGF
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
Met. Squamous
NSCLC
1st line
Merck & Co.
MK3475-407

NCT02775435
A Randomized, Double-Blind, Phase III Study of Carboplatin-Paclitaxel/Nab-Paclitaxel Chemotherapy with or without Pembrolizumab (MK-3475) in First Line Metastatic Squamous Non-small Cell Lung Cancer Subjects (KEYNOTE-407)
  • ECOG PS: 0–1
  • Stage IV Squamous NSCLC
  • Creatinine or calculated CrCl (≤1.5 X upper limit of normal (ULN) OR ≥60 mL/min for subjects with creatinine levels > 1.5 X institutional ULN
  • No radiation therapy to lung > 30 Gy w/in 6 mths of 1st dose of trial treatment
  • Completed palliative radiotherapy < 7 days of 1st dose of trial treatment
NSCLC Metastatic
EGFR muatated
Prev. Untreated
Aveo Pharmaceuticals
AV299-14-206

NCT02318368
A Phase 2, multicenter, randomized, double-blind study of Ficlatuzumab plus Erlotinib versus placebo plus Erlotinib in subjects who have previously untreated metastatiC, EGFR-mutAted non-small cell lung cancer (NSCLC) and BDX004 Positive Label
  • ECOG PS: 0–1
  • An EGFR exon 19 deletion &/or an exon 21 (L858R) substitution mutation
  • BDX004 Positive label
  • No Hx of prior malignancy within 2 years
NSCLC
Metastatic
1st line
Merck & Co.
MK3475-189

NCT02578680
A Randomized, Double-Blind, Phase III Study of Platinum+ Pemetrexed Chemotherapy with or without Pembrolizumab (MK-3475) in First Line Metastatic Non-squamous Non-small Cell Lung Cancer Subjects (KEYNOTE-189)
  • No FNA or Cell Block
  • ECOG PS: 0 or 1
  • EGFR and ALK Negative
  • No prior systemic treatment for advanced/metastatic NSCLC
  • Creatinine Clearance greater than 50 mL/min
  • Previously treated CNS metastases okay if clinically stable for 2 weeks minimum

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

Chronic Lymphocytic Leukemia
Primary SiteSponsor/Study ID
NCT #
Protocol DescriptionEligibility
CLLTG Therapeutics TGTX-LAB-001
No NCT #
Screening Protocol to Determine High-risk Cytogenetic Features in Patients with previously-treated CLL that may be eligible for trial UTX-IB-301

  • ECOG PS ≤2
  • Diagnosis of B-cell CLL, with diagnosis established according to IWCLL criteria
  • Received at least 2 cycles of one prior standard treatment regimen
Previously Treated High Risk CLLTG Therapeutics

UTX-IB-301

NCT02301156
A Phase 3, Randomized, Study to Assess the Efficacy and Safety of Ublituximab in Combination with Ibrutinib Compared to Ibrutinib Alone, in Patients with Previously Treated High-Risk Chronic Lymphocytic Leukemia (CLL)

  • ECOG PS ≤2
  • High-risk cytogenetics confirmed by FISH analysis presence of at least one of the following: 17p deletion, 11q deletion and/or P53 gene mutation
  • B-cell CLL that warrants treatment consistent with accepted IWCLL criteria for initiation of therapy
  • Massive, progressive, or symptomatic splenomegaly or lymphadenopathy
  • No previous therapy with ibrutinib, CC-292, or any drug that specifically inhibits Bruton’s tyrosine kinase (BTK)
Newly Dx or Relapsed or Refractory CLLTG Therapeutics

UTX-TGR-304

NCT02656303
A Phase 3, Randomized Study to Assess the Efficacy and Safety of Ublituximab in Combination with TGR-1202 Compared to Obinutuzumab in Combination with Chlorambucil in Patients with Chronic Lymphocytic Lymphoma

  • ECOG PS ≤2
  • B-cell CLL that warrants treatment consistent with accepted IWCLL criteria for initiation of therapy
  • Massive, progressive, or symptomatic splenomegaly or lymphadenopathy
  • No prior therapy with obinutuzumab and/or chlorambucil
CLL, PD while on UTX-TGR-304TG Therapeutics

UTX-TGR-204

NCT02612311
A multi-center, open-label, study to evaluate the safety and efficacy of Ublituximab (TG-1101) in combination with TGR-1202 for patients previously enrolled in protocol UTX-TGR-304

  • ECOG PS ≤2
  • After confirmed progression receiving treatment and randomized onto Arms B, C, or D while on UTX-TGR-304

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
Untreated MMJansen
54767414MMY3308

MAIA

NCT02252172
Phase 3 study comparing Daratumumab, Lenalidomide, and Dexamethasone (DRd) vs. Lenalidomide and Dexamethasone (Rd) in Subjects with Previously Untreated Multiple Myeloma who are Ineligible for High Dose Therapy
  • ECOG PS 0-2
  • Documented multiple myeloma satisfying the CRAB
  • Measurable disease, assessed by central laboratory, by serum or urine
  • Newly diagnosed not considered for high-dose chemo with SCT
  • No dx of primary amyloidosis, MGUS, or smoldering multiple myeloma

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

NEURO - ONCOLOGY

Primary SiteSponsor/Study ID
NTC#
Protocol DescriptionEligibility
Recurrent GBMNativis, Inc.
NAT-101

NCT02296580
A Feasibility Study of the Nativis Voyager System in Patients With Recurrent Glioblastoma Multiforme (GBM)
  • KPS ≥ 60
  • Histologically confirmed dx of GBM
  • Failed or intolerant to: radiotherapy and temozolomide therapy
  • Progressive disease with at least 1 measurable lesion on MRI or CT
  • No surgery within last 4 weeks
  • No active implantable or electromagnetic device or metal implant that are incompatible with MRI
Newly Dx GlioblastomaImmunoCellular
Therapeutics Ltd.
ICT-107-301

NCT02546102
A Phase III randomized double-blind, controlled study of ICT-107 with maintenance temozolomide (TMZ) in newly diagnosed glioblastoma following resection and concomitant TMZ chemoradiotherapy
  • Should have < 1 cm3 disease by MRI within the previous 4 weeks.
  • At least one positive DTH skin response (more than 5 mm) to tetanus diphtheria vaccine prior to randomization
  • No investigational study drug for any indication or immunological-based treatment for any reason
  • No glioblastoma mutated IDH by Immunohistochemistry
Newly Dx Glioblastoma w/ MGMT promoter HypermethylationNational Cancer Institute/Alliance

A071102

NCT02152982
Phase II/III randomized trial of Veliparib or Placebo in combination with adjuvant Temozolomide in newly diagnosed Glioblastoma with MGMT promoter Hypermethylation
  • ECOG performance status of ≤ 2
  • Confirmation by central pathology review of WHO grade IV glioblastoma or gliosarcoma
  • Completed concomitant radiation prescribed dose of 59.4 Gy in 33 fractions or 60 Gy in 30 fractions and
  • Completed concomitant TMZ 75 mg/m2 daily for the 6 to 6.5 weeks of radiation therapy

HEAD AND NECK

Primary SiteSponsor/Study ID
NTC#
Protocol DescriptionEligibility
1st line Recurrent or Met HNSCCMerck

MK3475-048

NCT02358031
A Phase 3 Clinical Trial of Pembrolizumab (MK-3475) in First Line Treatment of Recurrent/Metastatic Head and Neck Squamous Cell Carcinoma
  • ECOG PS: 0 to 1
  • Histologically or Cytologically confirmed R/M HNSCC considered incurable by local therapies
  • HPV status for oropharyngeal cancer defined as p16IHC using CINtec® p16 Histology assay and a 70% cutoff point
  • No prior therapy with an anti-PD-1, anti-PD-L1, or anti-PD-L2 agent

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