The Clinical Research E-News

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1 The Clinical Research E-News Volume 6: ISSUE 5: June 12, 2014 Jefferson Kimmel Cancer Center Network: For urgent clinical trial questions or assistance please page: New Featured Trials Actively Recruiting at the Kimmel Cancer Center at Jefferson: 1. Title: A Phase III, Double-Blind, Randomised, Placebo-Controlled Study to Assess the Efficacy and Safety of Selumetinib (AZD6244; ARRY ) (Hyd- Sulfate) in Combination With Docetaxel, in Patients Receiving Second Line Treatment for KRAS Mutation-Positive Locally Advanced or Metastatic Non Small Cell Lung Cancer (Stage IIIB - IV) (SELECT 1) a. Objective: To assess the efficacy of selumetinib in combination with docetaxel, compared with placebo in combination with docetaxel in terms of: Overall Survival (OS), Objective Response Rate (ORR), Duration of Response (DoR), to assess the efficacy of selumetinib in combination with docetaxel compared to placebo in combination with docetaxel on NSCLC symptoms, to assess the safety and tolerability profile of selumetinib in combination with docetaxel compared with placebo in combination with docetaxel and to investigate the pharmacokinetics (PK) of selumetinib and N-desmethyl selumetinib when administered in combination with docetaxel. b. Treatment: Patients will be selected on the basis of the KRAS mutation status of their tumour sample; patients whose tumour sample is positive for KRAS mutation and fulfil all eligibility criteriawill be randomised in a ratio of 1:1 to receive: Selumetinib 75 mg bd in combination with docetaxel 75 mg/m2 or Placebo in combination with docetaxel 75 mg/m2. c. Contact: Deborah Kilpatrick, RN at or Deborah.kilpatrick@jefferson.edu Pending Studies for Network Participation: ALLIANCE , A Randomized Phase III Study of Bendamustine Plus Rituximab Versus Ibrutinib Plus Rituximab Versus Ibrutinib Alone in

2 Untreated Older Patients (>/= 65 Years of Age) with Chronic Lymphocytic Leukemia (CLL) ECOG 1910, A Phase III Randomized Trial of Blinatumomab for Newly Diagnosed BCR-ABL-negative B lineage Acute Lymphoblastic Leukemia in Adults ECOG 2212, A Randomized, Double-Blinded, Placebo-Controlled Phase II Study of Adjuvant Everolimus Following the Resection of Metastatic Pancreatic Neuroendocrine Tumors to the Liver ECOG 2511, Phase I and Randomized Phase II Double Blind Clinical Trial of Cisplatin and Etoposide in Combination with Veliparib (ABT-888) or Placebo as Frontline Therapy for Extensive Stage Small Cell Lung Cancer- ECOG Members only ECOG 3612, A Randomized Phase II Trial of Ipilimumab with or without Bevacizumab in Patients with Unresectable Stage III or Stage IV Melanoma- ECOG Members only N0577, Phase III Intergroup Study of Temozolomide Alone Versus Radiotherapy with Concomitant and Adjuvant Temozolomide Versus Radiotherapy with Adjuvant PCV Chemotherapy in Patients with 1p/19q Codeleted Anaplastic Glioma RTOG1306, A Randomized Phase II Study of Individualized Combined Modality Therapy for Stage III Non-Small Cell Lung Cancer (NSCLC) RTOG1308, Phase III Randomized Trial Comparing Overall Survival after Photon Versus Proton Chemoradiotherapy for Inoperable Stage II-IIIB NSCLC

3 Please contact Rashada Dawson at or if your site is interested in participating in any of these trials. Regulatory Update: E1208- Amend close to accrual E2408- Amend close to accrual R0848- Amend #5 R0839-Amend # 7 R0912- Amend R1216- Amend #2 B-44-I- Final Report Please contact Rashada Dawson for any regulatory update inquiries. NCTN Update: OPEN Funding Dates: For trials with funding that require completion dates in OPEN; completion dates may be entered in the OPEN funding screen for any funding that was completed after March 1st, regardless of when the patient was enrolled to the trial. The NCI Central IRB (CIRB) and the CTSU are integrating systems in order to streamline the regulatory submission process and alleviate the burden of submitting IRB approval documentation for institutions utilizing the CIRB. Educational material will soon be available on the CTSU members homepage in the Transition News section by clicking the link CIRB-CTSU Integration and within the Regulatory and Education & Resources tabs. Please contact Joshua Schoppe at or at Joshua.schoppe@jefferson.edu with any NCTN related issues.

4 ECOG-ACRIN Update: The latest issue of the e-newsletter is now posted on the ECOG-ACRIN website. Follow this link to view the June 2014 issue of News from ECOG-ACRIN. The next Performance Monitoring data cut-off date of June 30, 2014 is approaching. Any data received on or before June 30, 2014 will be included in the upcoming Performance Monitoring. Data received after June 30, 2014 will be considered late. It is important to remember that data timeliness will be evaluated by assessing two components: The rate of CRF submitted and the rate of survival follow-up. To avoid penalties, each evaluable ECOG-ACRIN institution must have a score of 90% or better on each component. Please contact Joshua Schoppe with any ECOG-ACRIN related issues. NRG Update: The NRG Oncology Semi Annual Meeting will be held July 10 13, 2014, in Chicago, Illinois. The link to the meeting registration is here: ng/registration.aspx RTOG 0848, A Phase II-R and a Phase III Trial Evaluating Both Erlotinib (Ph II-R) and Chemoradiation (Ph III) as Adjuvant Treatment for Patients with Resected Head of Pancreas Adenocarcinoma: Dear Investigator and Dear Patient letters have been posted for RTOG RTOG 1005, Phase III Trial of Accelerated Whole Breast Irradiation With Hypofractionation Plus Concurrent Boost Versus Standard Whole Breast Irradiation Plus Sequential Boost for Early Stage Breast Cancer, will soon meet its accrual objective. New benchmark plans will no longer be accepted for credentialing as of close of business Tuesday, May 20, Benchmark plans already in the credentialing process will be reviewed.

5 Study Pre-Activation: NSABP B-55/BIG 6-13, A Randomized, Double-Blind, Parallel Group, Placebo-Controlled Multi-Centre Phase III Study to Assess the Efficacy and Safety of Olaparib Versus Placebo as Adjuvant Treatment in Patients with Germline BRCA1/2 Mutations and High Risk HER2 Negative Primary Breast Cancer Who Have Completed Definitive Local Treatment and Neoadjuvant or Adjuvant Chemotherapy: Biospecimen Kits Shipment Information must be provided to NRG at the time you submit documents to your IRB. Online viewing of the Site Initiation Visit (SIV) is a requirement for the site Principal Investigator (PI) (the PI on the IRB approval) and at least one research associate. Tumor blocks and blood sample submissions are required for all patients for participation in the study. The investigational drug in this trial is olaparib. Olaparib and placebo will be provided by the NCI Pharmaceutical Management Branch (PMB). The trial is being conducted under IND , which is sponsored by NRG Oncology, Inc. This study uses Medidata Rave for remote capture of data. Patient-reported outcomes and quality of life will be evaluated through the Behavioral and Health Outcomes (BAHO) component of the NSABP B-55/BIG 6-13 trial. Please contact Christine Bonaccorso at or Christine.Bonaccorso@jefferson.edu with any related NRG issues. Jefferson Kimmel Cancer Center Network Homepage: This page contains links to the Remote Access Portal as well as the clinical trial document repository.

6 Upcoming Events: NRG Meeting: Chicago, IL, July CRA Quarterly Meeting: September 19 ECOG Meeting: Orlando, FL, November 13-5 CRA Quarterly Meeting: December 12 The Clinical Research E-News Archive is now located on the Kimmel Cancer Center webpage under the JKCCN Member Area: Please provide feedback and any suggestions to Joshua Schoppe at or