Select Ongoing Trials Currently Enrolling Patients with Pancreatic Cancer

The following descriptions represent a selection of key clinical trials that are currently recruiting patients with pancreatic cancer for inclusion in investigations of new therapies or new combinations of available therapies for patients with pancreatic cancer. Each clinical trial description includes the NLM Identifier to be used as a reference with ClinicalTrials.gov. The information below can help oncology practice managers and providers direct their eligible patients to one of these clinical trials.
1. 90Y-Clivatuzumab Tetraxetan and Gemcitabine versus Placebo and Gemcitabine in Metastatic Pancreatic Cancer This randomized, double-blind, multicenter phase 3 study examines the efficacy of 90Y-clivatuzumab tetraxetan with low-dose gemcitabine versus placebo plus low-dose gemcitabine in patients with metastatic pancreatic cancer that has progressed with at least 2 previous therapies for metastatic cancer, one of which was a gemcitabine-containing regimen. Men and women aged ≥18 years with histologically documented pancreatic cancer and who have completed at least 1 cycle of the treatment may be eligible for enrollment if other criteria are met. Eligible patients will be randomized to receive 90Y-clivatuzumab tetraxetan plus low-dose gemcitabine or to receive placebo plus low-dose gemcitabine. The primary outcome measure is overall survival. The secondary outcome measures include overall survival at 3, 6, and 12 months; objective tumor response; progression-free survival; and clinical benefit. This study plans to enroll 440 patients at multiple locations across the United States and abroad. For more information, contact Dion Yeldell at 973-605-8200. The NLM Identifier is NCT01956812. 2. Glufosfamide versus Fluorouracil in Second-Line Metastatic Pancreatic Cancer This randomized, parallel-assignment, open-label, randomized, phase 3 study is designed to assess whether glufosfamide provides additional survival benefit compared with bolus 5-fluorouracil in patients with metastatic pancreatic cancer that has already progressed or failed therapy on a gemcitabine-based first-line regimen. Men and women aged ≥18 years with metastatic pancreatic cancer and disease progression during or after treatment with gemcitabine may be eligible for enrollment if other criteria are met. Eligible patients will be randomized to receive glufosfamide or fluorouracil. The primary outcome measure is overall survival. This study plans to enroll 480 patients at multiple locations across the United States. For more information, contact Forrest Anthony, MD, PhD, at 215-554-3530 or This email address is being protected from spambots. You need JavaScript enabled to view it.. 3. Study of Nanoliposomal Irinotecan-Containing Regimens in Patients with Previously Untreated, Metastatic Pancreatic Cancer This randomized, open-label, parallel-assignment, phase 2 study examines the safety, tolerability, and efficacy of nanoliposomal irinotecan in combination with other anticancer therapies compared with nab-paclitaxel plus gemcitabine, in patients with advanced pancreatic cancer who have not received previous chemotherapy. Men and women aged ≥18 years with pathologically confirmed adenocarcinoma of the pancreas who have not been previously treated in the metastatic setting and who have an Eastern Cooperative Oncology Group (ECOG) performance of 0 or 1 may be eligible for enrollment if other criteria are met. Eligible patients will be randomized to receive nanoliposomal irinotecan, the combination of 5-fluorouracil and leucovorin, and oxaliplatin; nanoliposomal irinotecan plus 5-fluorouracil and leucovorin; or nab-paclitaxel plus gemcitabine. The primary outcome measure is progression-free survival at 24 weeks. The secondary outcome measures include overall survival, cancer antigen 19-9 response, health-related quality of life, and safety and adverse event. This study plans to enroll 168 patients in the United States and Australia. For more information, contact Brooke Belota at 617-441-1000 or This email address is being protected from spambots. You need JavaScript enabled to view it.. The NLM Identifier is NCT02551991. 4. Nab-Paclitaxel and Gemcitabine versus Gemcitabine Alone as Adjuvant Therapy for Patients with Resected Pancreatic Cancer This phase 3, randomized, parallel-assignment, open-label study compares whether there is a delay in or prevention of disease recurrence or death in patients with surgically removed pancreatic cancer who then take nab-paclitaxel in combination with gemcitabine versus those who receive gemcitabine alone. Men and women aged ≥18 years with resected ductal pancreatic adenocarcinoma with macroscopic complete resection and an ECOG performance status of 0 or 1 may be eligible for enrollment if other criteria are met. Eligible patients will be randomized to receive nab-paclitaxel plus gemcitabine or gemcitabine alone. The primary outcome measure is disease-free survival. The secondary outcome measures include overall survival and the number of participants with adverse events. This study expects to enroll 800 patients at multiple locations across the United States and abroad. For more information, contact the Associate Director of Clinical Trial Disclosure at 888-260-1599 or This email address is being protected from spambots. You need JavaScript enabled to view it.. The NLM Identifier is NCT01964430. 5. Olaparib in gBRCA-Mutated Pancreatic Cancer Whose Disease Has Not Progressed with First-Line Platinum-Based Chemotherapy This randomized, double-blind, placebo-controlled, multicenter phase 3 study assessed the efficacy of olaparib as first-line treatment in patients with gBRCA-mutated metastatic pancreatic cancer whose disease has not progressed with first-line platinum-based chemotherapy. Men and women aged ≥18 years with histologically or cytologically confirmed pancreas adenocarcinoma receiving initial chemotherapy for metastatic disease and without evidence of disease progression with treatment may be eligible for enrollment if other criteria are met. Eligible patients will be randomized to receive olaparib or placebo. The primary outcome measure is progression-free survival. Some of the secondary outcome measures include overall survival, time from randomization to second progression or death, and time from randomization to study treatment discontinuation or death. 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. The NLM Identifier is NCT02184195. 6. Ruxolitinib in Patients with Pancreatic Cancer This randomized, parallel-assignment, double-blind, open-label, phase 3 clinical trial is evaluating the efficacy of ruxolitinib added to capecitabine for the treatment of patients with metastatic pancreatic cancer. Men and women aged ≥18 years with advanced adenocarcinoma of the pancreas that is inoperable or metastatic and with an ECOG performance status of 0 to 2 may be eligible for enrollment if other criteria are met. Eligible patients will be given a combination of ruxolitinib plus capecitabine or placebo plus capecitabine. The primary outcome measure is overall survival. The secondary outcome measures include progression-free survival, objective response rate, duration of response, and safety and tolerability. This study expects to enroll 270 patients at multiple locations across the United States and abroad. For more information, contact the Incyte Call Center at 844-235-2687. The NLM Identifier is NCT02119663. 7. Chemoradiation versus Chemotherapy Alone After Induction Chemotherapy in Patients with Pancreatic Cancer The purpose of this phase 3, randomized, open-label study is to examine the effectiveness of chemoradiotherapy compared with chemotherapy alone after induction chemotherapy with 3 cycles of gemcitabine or 6 cycles of the combination of leucovorin calcium, fluorouracil, irinotecan hydrochloride, and oxaliplatin (FOLFIRINOX) in patients with locally advanced, nonresectable and nonmetastatic pancreatic cancer. Men and women aged >18 years with no evidence of distant metastasis based on computed tomography of the thorax and abdomen and with an ECOG performance status of ≤2 may be eligible for enrollment if other criteria are met. Eligible patients will be randomized to receive induction chemotherapy with gemcitabine or FOLFIRINOX followed by chemoradiotherapy or induction chemotherapy and chemotherapy alone. The primary outcome measure is overall survival. The secondary outcome measures include tumor-free survival, rate of distant metastasis, rate of local recurrence or local progression, quality of life, acute and late toxicity of the chemoradiotherapy, rate of curative resections, and rate of remission. This study expects to enroll 830 patients at multiple locations in Germany. For more information contact Rainer Fietkau, MD, at This email address is being protected from spambots. You need JavaScript enabled to view it.. The NLM Identifier is NCT01827553. 8. Second-Line Adjuvant Therapy with Nab-Paclitaxel plus Gemcitabine versus Oxaliplatin plus Folinic Acid and Fluorouracil for Gemcitabine-Refractory Pancreatic Cancer After Curative Resection This phase 3, prospective, multicenter, randomized, controlled study assessed the activity and safety of second-line adjuvant therapy with nab-paclitaxel plus gemcitabine versus oxaliplatin plus folinic acid and fluorouracil for gemcitabine-refractory pancreatic cancer after curative resection. Men and women aged 18 to 75 years with ECOG performance status of 0 to 2 and with no severe defects in their hematologic system, immune system, cardiac function, and pulmonary function may be eligible for enrollment if other criteria are met. Eligible patients will be randomized to receive nab-paclitaxel plus gemcitabine or oxaliplatin plus folinic acid and fluorouracil. The primary outcome measure is overall survival from the date of enrollment until the date of death from any cause. The secondary outcome measures include objective response rate, time to remission, progression-free survival, the levels of tumor biomarkers in the serum, the number of grade 3 or 4 adverse reactions, and quality of life. This study plans to enroll 300 patients at multiple locations in China. For more information, contact Xian-Jun Yu, MD, PhD, at This email address is being protected from spambots. You need JavaScript enabled to view it.. The NLM Identifier is NCT02506842. 9. Gemcitabine, Cisplatin, Epirubicin, and Capecitabine in Patients with Stage I/II Resectable Pancreatic Cancer The purpose of this randomized phase 2/3 clinical trial is to evaluate how well gemcitabine hydrochloride, with or without cisplatin, epirubicin hydrochloride, and capecitabine, works when given before and/or after surgery in patients with stage I or stage II resectable pancreatic cancer. Men and women aged 18 to 75 years with a Karnofsky performance status of 70% to 100% and no symptomatic duodenal stenosis may be eligible for enrollment if other criteria are met. Eligible patients will be randomized to receive adjuvant treatment with cisplatin, epirubicin, gemcitabine, and capecitabine (PEXG), perioperative PEXG, or adjuvant gemcitabine alone. The primary outcome measure is overall survival and the proportion of patients who are event-free at 1 year after neoadjuvant therapy. Some of the secondary outcome measures include radiologic, biochemical, and pathologic response rates; lymph node status; and tolerability. This study expects to enroll 370 patients in Italy. For more information, contact Michele Reni at This email address is being protected from spambots. You need JavaScript enabled to view it.. 10. Neoadjuvant Treatment in Resectable Pancreatic Cancer This open-label, parallel-assignment, randomized, phase 3 clinical trial is evaluating the efficacy of sequential neoadjuvant chemoradiotherapy followed by curative surgery versus primary surgery alone for resectable, nonmetastatic pancreatic cancer. Men and women aged ≥18 years with a Karnofsky performance status of ≥80% and a serum creatinine level of ≤3.0 mg/dL may be eligible for enrollment if other criteria are met. Eligible patients will be randomized to receive neoadjuvant chemoradiotherapy followed by curative surgery or primary surgery alone. The primary outcome measure is the 3-year survival rate. Some of the secondary outcome measures include postoperative complications, disease progression during neoadjuvant therapy, and disease-free survival. This study plans to enroll 410 patients in Germany. For more information, contact Jakob R. Izbicki, MD, FACS, at This email address is being protected from spambots. You need JavaScript enabled to view it.. The NLM Identifier is NCT01900327. 11. Chemotherapy plus Proton Chemotherapy for Locally Advanced Pancreatic Cancer This phase 2, open-label, single-group assignment study will provide important data on the recurrence rates and patterns of failure using state-of-the-art target agents, chemotherapy, and proton beam technology for patients with locally advanced pancreatic cancer. Men and women aged ≥18 years with histologically or cytologically confirmed unresectable nonmetastatic adenocarcinoma of the pancreas and with an ECOG performance status of ≤2 may be eligible for enrollment if other criteria are met. Eligible patients will undergo proton radiation with proton, gemcitabine, erlotinib, and capecitabine. The primary outcome measure is the 1-year survival rate. A median survival of 10 months or longer would be considered evidence of a regimen that is potentially worthy of further study as a new treatment paradigm in a future phase 3 clinical trial. The secondary outcome measure is the frequency of serious adverse events. This study plans to enroll 43 patients in California. For more information, contact Gary Yang, MD, at 909-558-4280 or This email address is being protected from spambots. You need JavaScript enabled to view it.. The NLM Identifier is NCT01683422. 12. High- or Standard-Intensity Radiation Therapy After Gemcitabine Hydrochloride and Nab-Paclitaxel in Patients with Unresectable Pancreatic Cancer This open-label, randomized, parallel-assignment, phase 2 clinical trial is evaluating the addition of high- or standard-intensity radiation to gemcitabine and nab-paclitaxel for locally advanced pancreatic cancer. Men and women aged ≥18 years with a histologically or cytologically confirmed diagnosis of adenocarcinoma of the pancreas and with a Zubrod performance status of 0 to 1 within 30 days before registration may be eligible for enrollment if other criteria are met. Eligible patients will receive gemcitabine, nab-paclitaxel, and high-dose intensity-modulated radiation therapy; gemcitabine, nab-paclitaxel, and standard-dose 3-dimensional conformal radiation therapy; or gemcitabine and nab-paclitaxel. The primary outcome measures are the 2-year overall survival rates with intensified radiochemotherapy and with standard radiochemotherapy. Some of the secondary outcome measures include patterns of failure by SMAD family member 4 (SMAD4) status and intensity of radiation therapy, adverse events associated with the treatments, and the impact of radiochemotherapy on overall survival for the subset of SMAD4-intact patients. This study expects to enroll 346 patients at multiple locations in the United States. The NLM Identifier is NCT01921751. 13. Metformin Combined with Gemcitabine as Adjuvant Therapy for Pancreatic Cancer After Curative Resection The purpose of this double-blind, randomized, placebo-controlled, phase 2 study is to investigate the activity and safety of the combination of gemcitabine and metformin in treating patients with pancreatic cancer that has been removed by surgery. Men and women aged 18 to 80 years with an ECOG performance status of 0 to 2 may be eligible for enrollment if other criteria are met. Eligible patients are randomized to receive gemcitabine plus placebo or gemcitabine plus metformin. The primary outcome measure is recurrence-free survival at 1 year after curative resection. The secondary outcome measures include overall survival after curative resection, quality-of-life score after curative resection, and the number of grades 3 and 4 adverse reactions. This study plans to enroll 300 patients in China. For more information contact Xianjun Yu, MD, PhD, at This email address is being protected from spambots. You need JavaScript enabled to view it.. The NLM Identifier is NCT02005419. 14. First-Line Treatment of Metastatic Pancreatic Cancer with Nab-Paclitaxel and Gemcitabine The purpose of this interventional, multicenter, open-label, randomized, active-controlled phase 2 study is to investigate the efficacy of the combination of fluorouracil plus irinotecan hydrochloride and oxaliplatin compared with gemcitabine hydrochloride, and paclitaxel albumin-stabilized nanoparticle formulation before surgery in patients with resectable pancreatic cancer. Men and women aged ≥18 years with a Karnofsky performance status of ≥70% may be eligible for enrollment if other criteria are met. Eligible patients are randomized to receive induction treatment with nab-paclitaxel plus gemcitabine followed by alternating gemcitabine monotherapy and nab-paclitaxel plus gemcitabine or by continuing nab-paclitaxel and gemcitabine. The primary outcome measure is overall survival assessed for up to 38.5 months. Some of the secondary outcome measures include progression-free survival, quality of life, and adverse events. This study plans to enroll 325 patients in Germany. For more information, contact Saskia Schulze, MSc, at This email address is being protected from spambots. You need JavaScript enabled to view it.. The NLM Identifier is NCT02564146. 15. Chemotherapy with FOLFIRINOX versus Gemcitabine in Locally Advanced Pancreatic Cancer The purpose of this randomized, open-label, parallel-assignment, phase 3 study is to evaluate chemotherapy with FOLFIRINOX or gemcitabine in locally advanced pancreatic carcinoma. Men and women aged ≥18 years with locally advanced and unresectable tumors and with World Health Organization performance status of 0 to 1 may be eligible for enrollment if other criteria are met. Eligible patients are randomized to receive gemcitabine or FOLFIRINOX. The primary outcome measure is progression-free survival assessed at 128 weeks. Some secondary outcome measures include the composite index for early severe toxicity after treatment, overall survival, and time to treatment failure. This study plans to enroll 170 patients in France. For more information, contact Trevor V. Stanbury, PhD, at t-stanbury@uni-cancer. fr. The NLM Identifier is NCT02539537. 16. Nimotuzumab Combined with Gemcitabine in KRAS Wild-Type Locally Advanced and Metastatic Pancreatic Cancer The purpose of this parallel assignment, double-blind, randomized, phase 3 study is to assess the overall survival of patients receiving nimotuzumab concurrently with gemcitabine in patients with RAS wild-type locally advanced or metastatic pancreatic cancer. Men and women aged 18 to 75 years with a Karnofsky performance status of ≥60%, with wild-type KRAS tumor tissue, and a life expectancy of ≥12 weeks may be eligible for enrollment if other criteria are met. Eligible patients are randomized to receive nimotuzumab plus gemcitabine or placebo plus gemcitabine. The primary outcome measure is overall survival. The secondary outcome measures include time to progression, progression-free survival, objective response rate, disease control rate, clinical benefit response, and safety. This study plans to enroll 276 patients in China. For more information, contact Shukui Qin, MD, PhD, at This email address is being protected from spambots. You need JavaScript enabled to view it.. The NLM Identifier is NCT02395016.

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