Download Clinical Trials at Mission Hope Cancer Center, continued

AN AFFILIATE OF
January-February 2014
Clinical Trials at Mission Hope Cancer Center
n For Colleagues in the Community:
This publication is designed to inform our colleagues in the medical commu­
nity, and especially physicians who are considering treatment options for
their patients with cancer, about current clinical trials and research studies
available at the Mission Hope Cancer Center. We strive to provide the most
advanced cancer treatments and newest technologies for an array of cancer
disease types—and to do this as a collabo­ra­tive extension of your practice.
We understand that the growth and viability of your practice is built upon
the patients you serve. Our goal is to, not only have more treatment options
at Mission Hope, but also to allow you to have more options available for
your patients. We hope you find the newsletter to be a valuable resource
worthy of your regular attention.
For further information please contact Bob Dichmann, M.D., April
Kennedy, M.D., Todd Erickson, M.D., or Steve Vara, M.D., by phone at
349.9393. Additionally, our Clinical Research Coordinators are available
by phone; please call Alison Fernandez, RN, MPH, OCN, at 346.3461, or
Suzanne VerWest, RN, at 346.3466.
Breast:
Breast: HER2 Negative
A Phase II/III Multi-Center, Open
Label, Randomized Study of weekly
Nab-Pacli-taxel in combination with
Gemcitabine or Carboplatin, compared
to Gemcitabine/Carbo-platin as First
Line Treatment in subjects with ER(-),
PR (-) and Her2 (-) (Triple Negative)
metastatic breast cancer
1st Line Breast. A randomized,
Multicenter, Double-Blind Phase III
Study of PD-0332991 (Oral CDK 4/6
inhibitor) plus letrozole versus placebo
plus letrozole for the treatment of
postmenopausal women with ER (+),
HER2 (-) breast cancer who have not
received any prior systemic anti-cancer
treatment for advanced disease
A Randomized, Phase II Study to
estimate the effect of prophylactic
intervention with Naproxen or
Loratidine on bone pain in breast
cancer subjects receiving chemotherapy and Pegfilgrastim (Neulasta)
1st Line/2nd Line Breast. A Phase
III randomized, Double Blind Placebo
Controlled Study of fulvestrant in
combination with oral BKM120
versus fulvestrant plus placebo, in the
treatment of postmenopausal women
with hormone receptor-positive
HER2-negative locally advanced or
metastatic breast cancer whose disease
has progressed on or after aromatase
inhibitor treatment
2nd Line/3rd Line Breast. A DoubleBlind, Randomized Phase II Trial of
active immunotherapy with Globo
H-KLH (OPT-822) in subjects with
metastatic breast cancer who have
achieved SD, PR, or CR after at least
1 regimen of chemo or hormonal or
targeted therapy. HER2neu positive
patients are eligible if anti-Her2
therapy is not available or
contraindicated
2nd Line/3rd Line HerNeg Breast.
Multicenter, Randomized, DoubleBlind, Placebo-Controlled, Phase III
Trial of Fulvestrant (Faslodex®) with
or without PD-0332991 (Palbociclib)
± Goserelin in women with hormone
receptor-positive, HER2-Negative
metastatic breast cancer whose disease
progressed after prior Endocrine
Therapy. No prior Faslodex
Information continues
Clinical Trials at Mission Hope Cancer Center, continued
Colorectal:
Lung:
2nd Line Colorectal-KRAS
Mutation. A Phase II Randomized,
Double-Blinded, Placebo-Controlled
Study to evaluate the efficacy and
safety of GS-6624 or placebo combined
with FOLFIRI as second line treatment
for metastatic RAS or RAF mutant
colorectal Adenocarcinoma that has
progressed following a First Line
Oxaliplatin- and Fluoropyrimidinecontaining regimen
2nd Line or more NSCLC. ARCHER
1042: A Phase II, Multi-Cohort Study
to evaluate the impact of prophylactic
intervention on dermatologic and
gastrointestinal adverse events and
patient reported outcomes in patients
treated with dacomitinib
(PF-00299804)
2nd Line Colorectal-KRAS Wild
Type. A Phase II, Multi-Center, OpenLabel, Randomized Study evaluating
the efficacy and safety of FOLFIRI
+ MEHD7945A versus FOLFIRI +
Cetuximab in second line patients with
KRAS Wild-Type metastatic colorectal
cancer
Gastrointestinal–Gastric:
2nd Line Gastric. Randomized, Open
Label, Phase II Study of MM-111 and
Paclitaxel with or without Trastuzumab in patients with ‘Traditional’ and
‘Non-Traditional’ HER2 Expressing
Carcinomas of the distal esophagus,
Gastroesophageal (GE) junction and
stomach who have failed front line
metastatic or locally advanced
therapy. FISH 2+ or 3+
Head and Neck:
A Phase II, Multi-Centre, Randomized Double Blind Placebo-Controlled
Study comparing the efficacy and safety of Clonidine Lauriad 50ug & 100ug
Mucoadhesive Buccal Tablet (MBT)
applied once daily to those of placebo
in the prevention and treatment of
Chemoradiation Therapy induced oral
mucositis in patients with head and
neck cancer
1st Line NSCLC. A Randomized,
Phase III, Multi-Center, Double-Blind,
Placebo-Controlled Study evaluating
the efficacy and safety of onartuzumab
(MetMAB)in combination with erloti–
nib as first-line treatment for patients
with met-positive unresectable Stage
IIIb or IV non-small-cell lung cancer
(NSCLC) carrying an activating EGFR
mutation. EGFR tested Centrally
Includes EGFR negative
NHL. A Phase III, Double Blind Randomized Study to compare the efficacy
and safety of Rituximab plus Lenalidomide (CC-5013) versus Rituximab
plus -placebo in subjects with relapsed/
refractory Indolent Lymphoma
Multiple Myeloma:
A Phase I/II Study of weekly Carfilzomib in combination with Dexamethasone for progressive Multiple Myeloma
A Phase I/II Study of Pomalidomide,
Dexamethasone and Pegylated
Liposomal Doxorubicin for patients
with Relapsed/Refractory Multiple
Myeloma
Pancreas:
2nd Line/3rd Line NSCLC. A Phase
IB Dose-Escalation Study of Pemetrexed and AUY922 in previouslytreated patients with metastatic
Non-Squamous, Non-Small Cell Lung
Cancer
A Randomized, Double Blind, Phase
III Study of the efficacy and safety
of Gemcitabine in combination with
TH-302 compared with Gemcitabine
with placebo in previously untreated
subjects with metastatic or locally
advanced unresectable Pancreatic
Adenocarcinoma
Lymphoma:
Prostate:
2nd Line (Follicular, Marginal Zone,
SLL, Waldenstroms). A Phase III,
Randomized, Double-Blind, PlaceboControlled Study evaluating the
efficacy and safety of Idelalisib
(GS-1101) in combination with
Bendmustine and Rituximab for
previously treated Indolent NonHodgkin’s Lymphoma (No prior
chemotherapy)
2nd Line (Follicular, Marginal Zone,
SLL, Waldenstroms). A Phase III
Randomized, Double-Blind, PlaceboControlled Study evaluating the
efficacy and safety of Idelalisib (GS1101) in combination with Rituximab
for previously treated Indolent
Non-Hodgkin’s Lymphoma (Prior
chemotherapy mandatory)
3rd Line Prostate. A Phase II Trial
of NRX 194204 in castration and
Taxane-resistant Prostate Cancer
Women’s Cancers:
2nd Line Endometrial. A Phase II,
Open-Label, Non-Randomized, MultiCenter Study to evaluate the efficacy
of oral TKI258 as second-line therapy
in patients with either FGFR2 mutated
or wild-type advanced endometrial
cancer
Mission Hope Cancer Center
1325 East Church Street
Santa Maria, California
www.missionhopecancercenter.com
Clinical Research Coordinators:
805.346.3461 • 805.346.3466