Mission Hope Cancer Center
IThrivePlan

Clinical Trials Newsletter

Clinical Trials at Mission Hope Cancer Center - As of 2.17.15

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. Our goal is to provide the most advanced cancer treatments and newest technologies for an array of cancer disease types—and to do this as a collabo-ra-tive extension of your practice. We understand that the growth and viability of your practice is built upon the patients you serve. By working with our Clinical Research program, your treating physician status is maintained and the continuity of service to your patient is preserved. 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 Stephen Vara, M.D. by phone at 349.9393. Additionally, our Clinical Research Coordinator is available by phone; please call Alison Fernandez, RN, MPH, OCN, at 346.346.

Breast


BREAST- HER 2 NEGATIVE

1st Line- A Randomized, Double –Blind, Placebo-Controlled, Phase 3 study of non-steroidal aromatase inhibitors ( Anastrozole or Letrozole) plus LY2835219, a CDK4/6 inhibitor, or placebo in women with hormone receptor positive, HER2 negative locally advanced or metastatic breast cancer who have not received prior systemic therapy for locally advanced or metastatic disease.

1st Line- A randomized open-label Phase 2 study of Letrozole plus Afatinib (BIBW2992) vs Letrozole alone in 1st line treatment of advanced ER+, HER2- post menopausal breast cancer with low ER expression.

1st Line-A Phase 2/3 Multi-Center, Open-Label, Randomized study of weekly Nab-Paclitaxel in combination with Gemcitabine or Carboplatin compared with Gemcitabine/Carboplatin as 1st line treatment in subjects with ER-, PR-, HER2 – (Triple Negative) metastatic breast cancer.

2nd /3rd Line- Phase 2 randomized trial of Mugard compared with best supportive care for prevention and treatment of stomatitis in women with hormone receptor positive breast cancer initiating treatment with Everolimus-based endocrine therapy.

BREAST – HER2 POSITIVE
NeoAdjuvant- A randomized, Multicenter, Open-Label, Two-Arm, Phase 3 NeoAdjuvant Study evaluating Trastuzumab Emtansine and Pertuzumab alone or in combination with chemotherapy for patients with HER2 positive breast cancer.

2nd/3rd Line- Phase 1b/2 single-arm trial evaluating the combination of Lapatinib, Everolimus and Capecitabine for the treatment of patients with HER2-positive metastatic breast cancer with CNS progression after Trastuzumab. BREAST – HER2 POSITIVE (continued)

3rd Line- A study of Neratinib + Capecitabine vs Lapatinib + Capecitabine in patients with HER2+ metastatic breast cancer who have received 2 or more prior HER2- directed regimens in the metastatic setting (NALA) 3rd Line- An observational cohort study of treatment patterns and outcomes in patients with HER2 Positive (HER2+) metastatic breast cancer.

BREAST ( Her 2 positive & negative)
2nd Line- A Phase 2, randomized, open-label, multicenter, safety and efficacy study of oral Lucatinib in patients with FGF aberrant metastatic breast cancer.

2nd/3rd Line- A Phase 3, Open-Label, Randomized, Parallel, 2-Arm study of BMN 673 vs physician’s choice in germline BRCA mutation subjects with locally advanced and/or metastatic breast cancer, who have received no more than 2 prior chemotherapy regimens for metastatic breast disease.

3rd Line- A Phase 2, Two-stage, 2-cohort study of BMN673 administered to germline BRCA mutation subjects with locally advanced and/or metastatic breast cancer.

Colorectal


2ND Line- Open-label, multi-center, randomized Phase1b/2 study to assess the efficacy, safety and tolerability of PF-05212384 + 5FU-Leucovorin-Irinotecan (FOLFIRI) compared to Bevacizumab + FOLFIRI.

Lung


1st Line- TIGER 1: A randomized, Open-Label, Phase 2 study of CO-1686 or Erlotinib as 1st line treatment of patients with EGFR-Mutant Advanced Non-Small Cell Lung Cancer(NSCLC).

1st Line- A randomized Open-Label Phase 3 trial of MK-3475 vs Platinum based chemotherapy in subjects with PD-L1 strong metastatic Non-Small Cell Lung Cancer

2nd Line- A Phase 3b/4 Safety trial of Nivolumab (BMS-936558) in subjects with advanced or metastatic Non-Small Cell Lung Cancer who have progressed during or after receiving at least 1 prior systemic regimen.

2nd/3rd Line-A Phase 3, open-label, multicenter, randomized study to investigate the efficacy and safety of MPDL3280A (anti-PD-11 antibody) compared with Docetaxel in patients with NSCLC after Platinum failure

2nd/3rd Line-A Phase 1B Dose-Escalation study of Pemetrexed and AUY922 in previously-treated patients with metastatic Non Squamous, Non-Small Lung Cancer.

3rd Line- A Randomized phase 3 study of LY2835219 + best supportive care vs Erlotinib + best supportive care in patients with stage 4 NSCLC with a detectable KRAS Mutation who have progressed after Platinum-based chemotherapy.

3rd Line-Lung cancer molecular profiling and clinical outcomes in U.S. community oncology practices.

Lymphoma


2ND/3RD Line- A Phase 3 , randomized, double-blind, placebo-controlled study evaluating the efficacy and safety of GS-1101 (CAL-101) in combination with Rituxumab for previously treated Indolent Non-Hodgkin Lymphoma

Multiple Myeloma


2nd/3rd Line- A Phase I/II study of Pomalidomide, Dexamethasone & Pegylated Liposomal Doxorubicin for patients with relapsed/refractory Multiple Myeloma. Must have failed Revlimid.

Ovarian


Maintenance- A multi-center, randomized, double-blind, placebo-controlled, phase 3 study of Rucaparib as switch maintenance therapy following Platinum-based chemotherapy.

Pancreatic


2ND Line- A Randomized, Double-Blind, Phase 3 study of the JAK1/2 Inhibitor, Ruxolitinib or placebo in combination with Capecitabine in subjects with advanced or metastatic adenocarcinoma of the pancreas who have failed or are intolerant to 1st line chemotherapy.

Polycytemia


Prospective Observational study of Patients with primary Polycythemia Vera in U.S. clinical practices.