The Clinical Research E-News

Transcription

1 The Clinical Research E-News Volume 7: ISSUE 1: January 16, 2015 Jefferson Kimmel Cancer Center Network: For urgent clinical trial questions or assistance please page: New Featured Trials Actively Recruiting at the Sidney Kimmel Cancer Center at Jefferson University: 1. Title: A Randomized, Double-Blind, Phase 3 Study of the Janus Kinase (JAK) 1/2 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 First-Line Chemotherapy (The JANUS 1 Study) a. Principal Investigator: Ashwin Sama, MD b. Primary Objective: To determine the efficacy, based upon overall survival, of ruxolitinib added to capecitabine for the treatment of metastatic pancreatic cancer. c. Eligibility: Histologically or cytologically confirmed adenocarcinoma of the pancreas. Advanced adenocarcinoma of the pancreas that is inoperable or metastatic. Received no more than 1 prior chemotherapy regimen for advanced or metastatic disease (not including neoadjuvant and/or adjuvant therapy). Radiographically measurable or evaluable disease. d. Treatment: This is a randomized, double-blinded, placebo-controlled, Phase 3 study, in which approximately 310 subjects with advanced or metastatic adenocarcinoma of the pancreas who have failed, or were intolerant to first-line chemotherapy, will be randomized (1:1) to one of the following treatment groups: Arm A: (N = 155): Capecitabine 2000 mg/m^2 daily (1000 mg/m^2 twice daily [BID]) + ruxolitinib 15 mg BID and Arm B (N = 155): Capecitabine 2000 mg/m^2 daily (1000 mg/m^2 BID) + placebo (administered BID) e. Contact: Saira Malik at Pager or Saira.malik@jefferson.edu Open to Accrual E2511, 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

2 Pending Studies for Network Participation: A011202, A Randomized Phase III Trial Evaluating the Role of Axillary Lymph Node Dissection in Breast Cancer Patients (ct1-3 N1) Who Have Positive Sentinel Lymph Node Disease After Neoadjuvant Chemotherapy EA2212, A Randomized, Double-Blinded, Placebo-Controlled Phase II Study of Adjuvant Everolimus Following the Resection of Metastatic Pancreatic Neuroendocrine Tumors to the Liver 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 Co-deleted Anaplastic Glioma NRG-BR001, Phase I Study of Stereotactic Body Radiotherapy (SBRT) for the Treatment of Multiple Metastases NRG-LU001, Randomized Phase II Trial of Concurrent Chemoradiotherapy +/- Metformin HCL in Locally Advanced NSCLC S1406, Randomized Phase II Study of Irinotecan and Cetuximab with or without Vemurafenib in BRAF Mutant Metastatic Colorectal Cancer Please contact Rashada Dawson at or Rashada.dawson@jefferson.edu if your site is interested in participating in any of these trials. Regulatory Update: C Update #7 E2511- New Approval PACCT-1- Update #10 E1412- Increasing accrual for SKCN E5508- Update #1 R1012- Final Report Please contact Rashada Dawson for any regulatory update inquiries. Regulatory Update Guidance for Staffing of Personnel on Research Studies - Personnel that are conducting activities considered research fall under IRB oversight and thus must be listed as research personnel on the OHR-1 and must complete appropriate CITI training and submit conflict of interest disclosure to the Office of University Counsel prior to involvement in the research. The following table has been provided to help to define who should be considered key personnel on research studies conducted under the TJU IRB.

3 Activities considered research 1. Administering non-fda approved study drugs not provided by the Investigational Drug Service (IDS) (does not pertain to standard of care drugs) 2. Performing study-mandated, researchspecific assessments 3. Collecting PHI for research purposes and that is not otherwise routinely collected for clinical care 4. Reporting SAEs &UAPs 5. Making independent, protocol-related decisions 6. Consenting subjects 7. Independently interacting with subjects to collect research data Activities not considered research 1. Administering study drugs provided by the IDS, and as per order of the principal or coinvestigator. 2. Performing study-related procedures that are within standard scope of clinical practice, e.g., blood draws 3. Preparing & submitting IRB paperwork 4. Handling de-identified patient data 5. Interacting with a patient on a clinical basis 6. Informing patients about a study or providing them with recruitment materials 7. Following direct orders of principal investigator or co-investigator CITI Training Requirement No Longer Halts Protocol Review: Also effective immediately, lack or lapse of CITI training for research personnel named on the OHR-1 will no longer halt new studies from being accepted and scheduled for IRB review. However studies will not be approved until all personnel met the appropriate training requirements. CIRB Update: The NIC CIRB has established a new Cancer Prevention and Control CIRB (CPC), effective January 14, The CPC CIRB will review studies developed by NCTN Sponsored programs beginning February Institutions already enrolled in the CIRB Initiative are not required to make any changes to their FWA or Authorization Agreement.

4 Please contact Joshua Schoppe at or for any Regulatory inquiries. ECOG-ACRIN Update ECOG-ACRIN Operations Office - Martin Luther King Jr. Day Closure on Monday, January 19, 2015: The ECOG-ACRIN Operations Office-Boston will be closed on Monday, January 19, 2015 in observance of Martin Luther King Jr. Day. E1305, A Phase III Randomized Trial of Chemotherapy with or without Bevacizumab in Patients with Recurrent or Metastatic Head and Neck Cancer, will close to accrual effective February 11, The study is approaching its accrual goal. Patients currently on study may continue on treatment. Patients enrolled on the study should continue to be followed per protocol. ECOG-ACRIN Operations Office: The American College of Radiology (ACR) is in the process of moving their data center. This move will necessitate an outage. The outage is scheduled to occur between 5pm on Friday January 16th and 8am on Tuesday January 20th. Participation on studies is only affected by the TRIAD downtime as RAVE, OPEN, and legacy ECOG systems will remain operational. Please contact or , extension 4150 or your study team for additional clarification. Please contact Joshua Schoppe for any ECOG-ACRIN update inquiries. NRG Update NSABP-B47 : NSABP B-47, A Randomized Phase III Trial of Adjuvant Therapy Comparing Chemotherapy Alone (Six Cycles of Docetaxel Plus Cyclophosphamide or Four Cycles of Doxorubicin Plus Cyclophosphamide Followed by Weekly Paclitaxel) to Chemotherapy Plus Trastuzumab in Women with Node-Positive or High-Risk Node-Negative HER2-Low Invasive Breast Cancer, Accrual Update and Important Information: NRG Oncology is still projecting that the accrual goal for NSABP B-47 will be met in late January or early February 2015, but the closure date will depend on the accrual rate and accrual may close sooner if necessary. NRG Oncology will update sites again in mid-january with a definite accrual closure date. Please continue to monitor upcoming correspondence for further updates regarding accrual closure of NSABP B-47. RTOG 1010 A Phase III Trial Evaluating the Addition of Trastuzumab to Trimodality Treatment of Her2-Overexpressing Esophageal Adenocarcinoma: Amendment #4 dated 1/13/2015 has been released. Changes to the Risk section of the consent form have been approved the Adult CIRB and no patient notification or reconsent is required.

5 NRG Oncology Semiannual Meeting in San Diego: February 5-8, 2015 Online Registration is now CLOSED! Registration is available onsite at the meeting Meeting information can be found on Oncology-February-2015-Meeting Please contact Cynthia Perez at or with any related NRG issues. Upcoming Events: NRG Meeting: San Diego, CA, February 5-8 Lung Cancer Symposium: Jefferson Campus, March 6th CRA Meeting: Virtual Meeting, March 26 th SKCN Social Workers Meeting: Jefferson Campus, March 13 th SKCC Annual Symposium, Upper GI Malignancies: Hyatt Penn s Landing, April 17 th SKCN Administrators Meeting: Jefferson Campus, April 24 th ECOG-ACRIN Meeting: Chicago, IL, April 30 th to May 2 nd SKCN Navigators Meeting: Jefferson Campus, May 5 th CRA Meeting: Jefferson Campus, June 17th CRA Meeting: Virtual Meeting, September 30th CRA Meeting: Jefferson Campus, December 16th The Clinical Research E-News Archive is now located on the Sidney Kimmel Cancer Center webpage under the JKCCN Member Area: Please provide feedback and any suggestions to Joshua Schoppe. Sidney Kimmel Cancer Network Homepage: This page contains links to the Remote Access Portal as well as the clinical trial document repository.