Lynn Cancer Institute Oncology Trials

Sponsor/Study ID

NCT #

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

HER2 +

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 Cancer

AbbVie

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
• 1^st, 2^nd or 3^rd line

Genetic Registry

City 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

Sponsor/Study ID

NCT #

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 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

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

• 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

Pancreatic

Surgically Resected

1^st 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

ENROLLMENT CLOSING SOON ~ 10/2/2015

• 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

JANUS 1 Study

NCT02117479

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 Failed 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:

1. mGPS of 1:  CRP> 10mg/Land albumin > or35 g/L
2. mGPS of 2:  CRP >10mg/L and albumin<35 g/L

• 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
• 1^st 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

Primary Site

Sponsor/Study ID

NCT #

Protocol Description

Eligibility

No NCT #

• 70+ years old
• Documented malignancy initially seen at LCI
• Treatment decision has to be made within 1^st month
• LCI oncologist wants to review outside established treatment appropriateness

No NCT #

• 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

Primary Site

Sponsor/Study ID

NCT #

Protocol Description

Eligibility

ABI-007-NSCL-003

ABOUND.SQM

NCT02027428

• 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

ALK +

Met to brain or leptomeninges

CLDK378A2205

NCT02336451

• 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

ABI-007-NSCL-005

ABOUND.70+

• 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  PS:  0 or 1

18424-266

NCT02119650

• 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

Who are T790M+

D5160C00021

NCT02451852

• 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

ALDOXORUBICIN-P2-SCLC-01

NCT02200757

• 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

I3Y-MC-JPBK

JUNIPER

NCT02152631

• 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

EMR 100070-004

NCT02395172

• ECOG PS: 0 or 1
• ALK Negative
• Estimated life expectancy > 12 weeks
• Tumor tissue block or 7 unstained tumor slides suitable for PD-L1 expression assessment by central laboratory
• Confirmed stage IIIb/IV or recurrent NSCLC experience disease progression

Non-Squamous

NSCLC

GO29431

NCT02409342

• 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

Squamous

NSCLC

GO29432

NCT02409355

• 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

Primary Site

Sponsor/Study ID

NCT #

Protocol Description

Eligibility

LPS 14022

(PRIMCAB)

NCT02379390

• 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

WO29637

NCT02420821

ONLY 30 MORE SUBJECTS FROM US SITES ALLOWED

• Unresectable advanced or metastatic RCC with clear histology and/or sarcomatoid carcinoma
• Formalin-fixed, paraffin-embedded tumor specimen accompanied by associated pathology report collected within 24 months prior to C1D1 at study site that allows determination of PD-L1 expression status
• KPS > 70
• Cannot have radiotherapy for RCC within 14 days prior to C1D1
• No prior treatment with active or experimental systemic agents, including treatment in neoadjuvant or adjuvant setting. (Prior placebo treatment in adjuvant setting is allowed)

ARAMIS 17712

NCT02200614

• 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

TOK200-15

NCT02438007

• 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

NCT02141438

RADIATION STUDY

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