Select Clinical Trials Currently Enrolling Patients with Pancreatic Cancer

January 2017, Vol 7, No 1 - Clinical Trials Tracker


The following clinical trials represent a selection of key studies that are currently recruiting patients with pancreatic cancer for inclusion in investigations of new therapies or new regimens of existing treatments for patients with pancreatic cancer. Each description includes the NLM Identifier to be used as a reference with ClinicalTrials.gov. This information can help oncology practice managers and providers direct eligible patients to an appropriate clinical trial.

1 Olaparib in gBRCA Mutation–Positive Pancreatic Cancer: The POLO Clinical Trial

The purpose of this randomized, parallel-assignment, double-blind, phase 3 clinical trial is to evaluate the safety and efficacy of maintenance olaparib (Lynparza) monotherapy in patients with gBRCA mutation–positive metastatic pancreatic cancer that did not progress during first-line platinum-based chemotherapy. Men and women aged ≥18 years with histologically or cytologically confirmed pancreatic adenocarcinoma receiving initial chemotherapy for metastatic disease who have no evidence of disease progression during treatment and have gBRCA1 or gBRCA2 mutations that are predicted to be deleterious may be eligible for enrollment if other criteria are met. Eligible patients will receive olaparib or placebo.

The primary outcome measure is progression-free survival (PFS). The secondary outcome measures include overall survival (OS), time from randomization to second progression or death, time from randomization to first subsequent therapy or death, time from randomization to second subsequent therapy or death, time from randomization to study treatment discontinuation or death, objective response rate, disease control rate, adjusted mean change from baseline in global quality of life, safety and tolerability, and improvement rate of global quality of life. This study plans to enroll 145 patients at multiple locations across the United States and abroad. For more information, contact the AstraZeneca Clinical Study Information Center at 877-240-9479 or information.center@astrazeneca.com, or the AstraZeneca Cancer Study Locator Service at 877-400-4656 or astrazeneca@emergingmed.com. The NLM Identifier is NCT02184195.

2 Nimotuzumab plus Gemci­tabine in KRAS Wild-Type Locally Advanced/Metastatic Pancreatic Cancer

This randomized, parallel-assignment, double-blind, phase 3 clinical trial is designed to assess OS of the combination of nimotuzumab plus gemcitabine in patients with KRAS Wild-Type locally advanced or metastatic pancreatic cancer. Men and women aged 18 to 75 years with a life expectancy of at least 12 weeks and with a Karnofsky performance status score of ≥60 may be eligible for enrollment if other criteria are met. Participants will receive nimotuzu­mab plus gemcitabine or placebo plus gemcitabine.

The primary outcome measure is OS. The secondary outcome measures include time to disease progression, PFS, objective response rate, disease control rate, clinical benefit response, and safety. This study expects to enroll 276 patients in China. For more information, contact Shukui Qin, MD, PhD, at qinsk@csco.org.cn. The NLM Identifier is NCT02395016.

3 Glufosfamide versus Fluorouracil in Second-Line Metastatic Pancreatic Cancer

This phase 3, randomized, open-label, parallel-assignment clinical trial assesses whether glufosfamide provides additional survival benefit compared with bolus fluorouracil in patients with metastatic pancreatic cancer that has progressed with or did not respond to a gemcitabine-based first-line regimen. Men and women aged ≥18 years with an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 and with disease progression during or after treatment with gemcitabine may be eligible for enrollment if other criteria are met. Eligible patients will receive glufosfamide or fluorouracil.

The primary outcome measure is OS. This study expects to enroll 480 patients at multiple locations across the United States. For more information, contact Matthew Parris, BS, at 609-721-1227 or matthew.parris@eleison-pharma.com. The NLM Identifier is NCT01954992.

4 Addition of Pioglitazone to Standard Chemotherapy in Pancreatic Cancer

The purpose of this open-label, single-group assignment, phase 2 clinical trial is to determine whether the addition of pioglitazone (Actos) to standard chemotherapy results in improvement of blood tests that measure the body’s ability to utilize sugar (glucose and insulin metabolism). Men and women aged ≥18 years with histologically confirmed pancreatic cancer and with an ECOG functional status of 0 to 2 may be eligible for enrollment if other criteria are met. Patients will receive pioglitazone.

The primary outcome measure is improvement in insulin resistance markers. The secondary outcome measures are change in weight and ECOG performance status. This study plans to enroll 15 patients at the University of Texas Southwestern Medical Center. For more information, contact Muhammad S. Beg, MD, at 214-648-4673 or Muhammad.Beg@utsouthwestern.edu, or Tyson D. Dudley, MBA, MPH, at 214-648-7031 or tyson.Dudley@utsouthwestern.edu. The NLM Identifier is NCT01838317.

5 Immune Checkpoint Inhibition plus Radiation Therapy for Pancreatic Cancer: The CheckPAC Clinical Trial

This randomized, open-label, parallel-assignment, phase 2 clinical trial assesses the efficacy and safety of nivolumab (Opdivo) or nivolumab plus ipilimumab (Yervoy) administered concurrently with high-dose radiation therapy in patients with metastatic pancreatic cancer that is refractory or intolerant to at least 1 line of systemic chemotherapy with gemcitabine or platinum-containing regimens. Men and women aged ≥18 years with a life expectancy of more than 3 months and with an ECOG performance status of 0 or 1 may be eligible for enrollment if other criteria are met. Eligible patients will receive nivolumab plus radiotherapy or nivolumab plus ipilimumab and radiotherapy.

The primary outcome measure is the clinical benefit rate. The secondary outcome measure is the incidence of treatment-emergent adverse events, clinical benefit rate, overall response rate, PFS, OS, and quality of life. This study plans to enroll 80 patients in Denmark. For more information, contact Inna Chen, MD, at Inna.Chen@regionh.dk, or Dorte Nielsen, MD, DMSc, at Dorte.Nielsen.01@regionh.dk. The NLM Identifier is NCT02866383.

6 Sulfatinib for Advanced Pancreatic Neuroendocrine Tumors

This randomized, parallel-assignment, double-blind, phase 3 clinical trial will assess the efficacy of sulfatinib 300 mg once daily in advanced pancreatic neuroendocrine tumors. Men and women aged ≥18 years with a confirmed pathology diagnosis of low- or intermediate-grade advanced pancreatic neuroendocrine tumors may be eligible for enrollment if other criteria are met. Patients will be randomized to receive sulfatinib or placebo.

The primary outcome measure is PFS. The secondary outcome measures include objective response rate, disease control rate, duration of response, time to response, OS, and adverse events. This study expects to enroll 195 patients at multiple locations in China. For more information, contact Neo Li at Jingli@hmplglobal.com. The NLM Identifier is NCT02589821.

7 FOLFIRI or Modified FOLFIRI plus Veliparib as Second-Line Therapy for Metastatic Pancreatic Cancer

This randomized, open-label, parallel-assignment, phase 2 clinical trial assesses the efficacy and safety of modified irinotecan hydrochloride, leucovorin calcium, fluorouracil (FOLFIRI) plus veliparib compared with FOLFIRI alone as second-line therapy in patients with relapsed pancreatic cancer. Men and women aged ≥18 years with a Zubrod performance status of 0 or 1 and without a history of brain metastases may be eligible for enrollment if other criteria are met. Eligible patients will be randomized to receive veliparib plus modified FOLFIRI or FOLFIRI alone.

The primary outcome measure is OS. The secondary outcome measures include disease control rate, duration of response, incidence of treatment-related adverse events, overall response rate, and PFS. This study expects to enroll 143 patients at multiple locations across the United States. For more information, contact Elena G. Chiorean at 206-288-6248 or gchiorea@uw.edu. The NLM Identifier is NCT02890355.

8 Preoperative FOLFIRINOX versus Gemcitabine/Nab-Paclitaxel in Resectable Pancreatic Cancer

The purpose of this phase 2, randomized, parallel-assignment, open-label clinical trial is to evaluate the efficacy of folinic acid, fluorouracil, irinotecan (Camptosar), and oxaliplatin (Eloxatin; FOLFIRINOX) versus gemcitabine (Gemzar)/nab-paclitaxel (Abraxane) in patients with resectable pancreatic cancer before surgery. Men and women aged ≥18 years with a life expectancy of more than 3 months and with an ECOG status of 0 or 1 may be eligible for enrollment if other criteria are met. Eligible patients will receive FOLFIRINOX or gemcitabine/nab-paclitaxel.

The primary outcome measure is the survival rate at 18 months. The secondary outcome measures include the pathologic complete response rate, OS rate, number of participants with serious or nonserious adverse events, surgical morbidity rate, 30-day postoperative mortality rate, correlation of biomarkers with PFS, rate of pathologic downstaging, and local control rate. This study plans to enroll 112 patients at the Massachusetts General Hospital. For more information, contact David Ryan, MD, at 617-724-4000 or dpryan@partners.org. The NLM Identifier is NCT02243007.

9 FOLFIRINOX plus Ramucirumab versus FOLFIRINOX plus Placebo in Advanced Pancreatic Cancer

This randomized, double-blind, parallel-assignment, phase 2 study is evaluating the efficacy and safety of FOLFIRINOX plus ramucirumab (Cyramza) versus FOLFIRINOX plus placebo in patients with advanced pancreatic cancer that is not amenable to curative treatment. Men and women aged ≥18 years with an ECOG performance status of 0 or 1 and who have not received first-line systemic treatment may be eligible for enrollment if other criteria are met. Eligible patients will receive modified FOL­FIRINOX plus ramucirumab or modified FOLFIRINOX plus placebo.

The primary outcome measure is PFS. The secondary outcome measures include median OS, response rate, and adverse events. This study plans to enroll 95 patients at the Emory University Winship Cancer Institute in Atlanta, GA. For more information, contact Walid Shaib, MD, at 404-686-4411 or walid.shaib@emory.edu, or Donna Sullivan at 317-634-5842 ext 40 or dsullivan@hoosiercancer.org. The NLM Identifier is NCT02581215.

10 Hypofractionated Radiochemotherapy with Gemcitabine plus Oxaliplatin for Unresectable, Nonmetastatic, Advanced Pancreatic Cancer

The purpose of this open-label, single-group assignment, phase 2 clinical trial is to assess the efficacy of hypofractionated radiochemotherapy with gemcitabine plus oxaliplatin for unresectable, nonmetastatic, locally advanced pancreatic cancer. Men and women aged 18 to 75 years with stage III pancreatic cancer with an ECOG performance status of 0 to 2 may be eligible for enrollment if other criteria are met. Eligible patients will receive hypo­fractionated radiotherapy plus gemcitabine and oxaliplatin.

The primary outcome measures are toxicity and the proportion of patients with resectable disease. The secondary outcome measures are the objective tumor response, objective tumor response rate, OS, and PFS. This study plans to enroll 40 patients in Italy. For more information, contact Oriana Nanni, PhD, at oriana.nanni@irst.emr.it. The NLM Identifier is NCT02035072.

11 SGT-53 plus Gemcitabine/Nab-Paclitaxel for Metastatic Pancreatic Cancer

This open-label, single-group assignment, phase 2 clinical trial will assess the safety and efficacy of the combination of intravenously administered SGT-53 and gemci­tabine/nab-paclitaxel in patients with metastatic pancreatic cancer as a first-line treatment. Men and women aged ≥18 years with a histologic or cytologic diagnosis of stage IV metastatic pancreatic cancer and with an ECOG performance status of ≤1 may be eligible for enrollment if other criteria are met. Patients will receive SGT-53 with gemcitabine/nab-paclitaxel.

The primary outcome measure is PFS. The secondary outcome measures include safety, antitumor activity, response rate, PFS, time to disease progression, disease control rate, and duration of disease control. This study expects to enroll 28 patients at the Mary Crowley Cancer Research Center in Dallas, TX. For more information, contact Alyssa Roth at 972-566-3061 or aroth@marycrowley.org. The NLM Identifier is NCT02340117.

12 Efficacy and Safety of GV1001 plus Gemcitabine and Capecitabine versus Gemcitabine plus Capecitabine Alone in Pancreatic Cancer

The purpose of this randomized, parallel-assignment, open-label study is to assess the efficacy and safety of GV1001 plus gemcitabine and capecitabine versus gemcitabine plus capecitabine alone in patients with locally advanced or metastatic pancreatic cancer. Men and women aged ≥19 years with an ECOG performance status of 0 to 2 and with a life expectancy of at least 90 days may be eligible for enrollment if other criteria are met. Eligible patients will receive GV1001 plus gemcitabine and capecitabine or gemci­tabine plus capecitabine alone.

The primary outcome measure is OS. The secondary outcome measures are the time to tumor progression, objective response rate, clinical benefit response, clinical response with eotaxin level, quality of life, change in serum cancer antigen levels, and toxicity. This study plans to enroll 148 patients in Korea. For more information, contact Hanna Park at hpark@kaelgemvax.com, or Yoon Jin Lee at yjlee@kaelgemvax.com. The NLM Identifier is NCT02854072.

13 BPM31510 plus Gemci­tabine versus BPM31510 Alone in Advanced Pancreatic Cancer

The purpose of this nonrandomized, open-label, parallel-assignment, phase 2 clinical trial is to examine the safety and efficacy of BPM31510 administered as a 144-hour continuous intravenous infusion alone or in combination with gemcitabine for advanced pancreatic cancer as second- or third-line therapy. Men and women aged ≥18 years with a life expectancy of more than 3 months and with measurable tumor lesions may be eligible for enrollment if other criteria are met. Eligible patients will receive BPM31510 plus gemcitabine or BPM31510 alone.

The primary outcome measure is the overall response rate. The secondary outcome measures include OS, time to progression, toxicity profile, change in cancer antigen levels, and PFS. This study expects to enroll 50 patients at multiple locations across the United States. For more information, contact David Lucius at 508-588-0774 or david.lucius@berghealth.com. The NLM Identifier is NCT02650804.

14 Cyclophosphamide, Pembrolizumab, GVAX, and Stereotactic Body Radiation Therapy in Advanced Pancreatic Cancer

The purpose of this single-group assignment, open-label, phase 2 clinical trial is to assess whether combining cyclophosphamide, pembrolizumab (Keytruda), GVAX (pancreatic cancer vaccine), and stereotactic body radiation therapy is effective and safe in patients with locally advanced pancreatic cancer. Men and women aged ≥18 years with adequate organ function and with an ECOG performance status of 0 or 1 may be eligible for enrollment if other criteria are met. Eligible patients will receive cyclophosphamide, pembrolizumab, GVAX, and stereotactic body radiation therapy.

The primary outcome measure is distant metastasis-free survival. The secondary outcome measures include OS, local PFS, and the number of participants with immune-related toxicities. This study expects to enroll 54 patients at the Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins in Baltimore, MD. For more information, contact Ella-Mae Shupe, RN, BSN, at 410-502-9243 or eburke4@jhmi.edu. The NLM Identifier is NCT02648282.