Copyright
©The Author(s) 2015.
World J Gastroenterol. Apr 28, 2015; 21(16): 4788-4801
Published online Apr 28, 2015. doi: 10.3748/wjg.v21.i16.4788
Published online Apr 28, 2015. doi: 10.3748/wjg.v21.i16.4788
Table 2 Selected ongoing studies of contemporary “nanoparticle albumin-paclitaxel-based” systemic therapy in borderline resectable, locally advanced and metastatic pancreatic cancer
| Title (Study ID1) | Phase | Stage | Status |
| Randomized Phase II Trial of Pre-Operative Gemcitabine and nab-Paclitaxel With or With Out Hydroxychloroquine (NCT01978184) | Phase 2 | Potentially resectable | Recruiting |
| Phase 1/2 Safety and Feasibility of Gemcitabine and nab-Paclitaxel in Combination With LDE-225 as Neoadjuvant Therapy in Patients With Borderline Resectable Pancreatic Adenocarcinoma (NCT01431794) | Phase 1Phase 2 | Resectable | Recruiting |
| A Pilot Phase II Multi Center Study of Gemcitabine and nab-Paclitaxel (Abraxane) as Preoperative Therapy for Potentially Operable Pancreatic Cancer (NCT01298011) | Phase 2 | Resectable | Active, not recruiting |
| Phase II Study of Preoperative FOLFIRINOX Versus Gemcitabine/Nab-Paclitaxel in Patients With Resectable Pancreatic Cancer (NCT02243007) | Phase 2 | Resectable | Not yet recruiting |
| Phase II Neoadjuvant Chemotheraphy (Gemcitabine and nab-Paclitaxel vs mFOLFIRINOX) and Sterotatic Body Radiation Therapy for Borderline Resectable Pancreatic Cancer (NCT02241551) | Phase 2 | BR | Not yet recruiting |
| Nab-Paclitaxel Plus Gemcitabine With Concurrent MR-Guided IMRT in Patients With Locally Advanced and Borderline Resectable Pancreatic Cancer (NCT02283372) | Phase 1 | BR or LA | Not yet recruiting |
| A Phase I Dual Dose Escalation Study of Radiation and nab-Paclitaxel in Patients With Unresectable and Borderline Resectable Pancreatic Cancer (NCT02207465) | Phase 1 | BR or LA unresectable | Recruiting |
| A Phase 2 Trial of Gemcitabine Plus nab-Paclitaxel With or Without FG-3019 as Neoadjuvant Chemotherapy in Locally Advanced, Unresectable Pancreatic Cancer (NCT02210559) | Phase 2 | LA, unresectable | Recruiting |
| A Phase I Study of Chemoradiotherapy Using Gemcitabine Plus nab-Paclitaxel for Unresectable Locally Advanced Pancreatic Adenocarcinoma (NCT02272738) | Phase 1 | LA, unresectable | Recruiting |
| A Phase 1, Multicenter, Open-label, Dose-escalation Study to Investigate the Safety and Pharmacokinetics of Nab® - Paclitaxel (ABI-007) Plus Gemcitabine in Subjects With Advanced Pancreatic Cancer Who Have Cholestatic Hyperbilirubenemia Secondary to Bile Duct Obstruction (NCT02267707) | Phase 1 | LA unresectable or metastatic | Not yet recruiting |
| Evaluation of Tumoral Perfusion Modification by Dynamic Imaging After Chemotherapy Combining Gemcitabine and nab-Paclitaxel (Abraxane) in Patients With Potentially Operable, Locally Advanced or Metastatic Pancreatic Adenocarcinoma (NCT01715142) | Phase 0 | Stage I-II-III-IV | Not yet recruiting |
| A Phase II Randomized Trial Comparing a Combination of Abraxane and Gemcitabine Versus Gemcitabine Alone as First Line Treatment in Locally Advanced Unresectable Pancreatic Cancer. GAP (Gemcitabine Abraxane Pancreas) Trial (NCT02043730) | Phase 2 | Stage III | Active, not recruiting |
| A Multicenter Phase I/II Randomized Phase II Study of Gemcitabine and nab-Paclitaxel With or Without NPC-1C in Patients With Metastatic or Locally Advanced Pancreatic Cancer (NCT01834235) | Phase 1Phase 2 | Stage III-IV | Recruiting |
| A Phase IB Study of Erlotinib in Combination With Gemcitabine and nab-Paclitaxel in Patients With Previously Untreated Advanced Pancreatic Cancer (NCT01010945) | Phase 1 | Stage III-IV | Completed |
| A Phase 1 Study to Assess Safety, Pharmacokinetics, and Pharmacodynamics of PLX7486 as a Single Agent and in Combination With Gemcitabine and nab-Paclitaxel in Patients With Advanced Solid Tumors (NCT01804530) | Phase 1 | Stage III-IV | Recruiting |
| An Open-Label, Phase I Dose Escalation Trial of TH-302 in Combination With Gemcitabine and Nab-Paclitaxel in Previously Untreated Subjects With Metastatic or Locally Advanced Unresectable Pancreatic Adenocarcinoma (NCT02047500) | Phase 1 | Stage III-IV | Recruiting |
| Phase II Study Evaluating Bi-weekly Dosing of Gemcitabine Plus nab-Paclitaxel in the Treatment of Surgically Unresectable/Metastatic Pancreatic Cancer (NCT01851174) | Phase 2 | Stage III-IV | Recruiting |
| Phase 1B Trial of ADI-PEG 20 Plus nab-Paclitaxel and Gemcitabine in Subjects With Advanced Pancreatic Cancer (NCT02101580) | Phase 1 | Stage III-IV | Not yet recruiting |
| Phase II Trial of Abraxane® in the Treatment of Patients With Pancreatic Cancer Who Have Failed First-Line Treatment With Gemcitabine-Based Therapy (NCT00691054) | Phase 2 | Stage III-IV | Completed |
| A Phase I/II/Pharmacodynamic Study of Hydroxychloroquine in Combination With Gemcitabine/Abraxane to Inhibit Autophagy in Pancreatic Cancer (NCT01506973) | Phase 1Phase 2 | Stage III-IV | Recruiting |
| BYL719 in Combination With Gemcitabine and (Nab)-Paclitaxel in Locally Advanced and Metastatic Pancreatic Cancer (NCT02155088) | Phase 1 | Stage III-IV | Recruiting |
| A Phase I and Randomized, Double-Blinded Phase II Study of nab-paclitaxel/Gemcitabine Plus AZD1775 or Placebo in Treatment-Naïve Metastatic Adenocarcinoma of the Pancreas (NCT02194829) | Phase 1Phase 2 | Stage III-IV | Suspended |
| A Phase Ib Study of Dovitinib in Combination With Gemcitabine and nab-Paclitaxel in Patients With Advanced Solid Tumors and Pancreatic Cancer (NCT02048943) | Phase 1 | Stage III-IV-recurrent | Not yet recruiting |
| Phase I-II Trial of Gemcitabine Plus nab-Paclitaxel (GemBrax) Followed by Folfirinox as First Line Treatment of Patients With Metastatic Pancreatic Adenocarcinoma (NCT01964287) | Phase 1Phase 2 | Stage IV | Recruiting |
| A Phase 1b Dose Escalation Study of Vantictumab (OMP-18R5) in Combination With nab-Paclitaxel and Gemcitabine in Patients With Previously Untreated Stage IV Pancreatic Cancer (NCT02005315) | Phase 1 | Stage IV | Recruiting |
| A Phase 1b Dose Escalation Study of OMP-54F28 in Combination With nab-Paclitaxel and Gemcitabine in Patients With Previously Untreated Stage IV Pancreatic Cancer (NCT02050178) | Phase 1 | Stage IV | Recruiting |
| A Phase 2, Randomized, Multicenter Study of PEGPH20 (PEGylated Recombinant Human Hyaluronidase) Combined With nab-Paclitaxel Plus Gemcitabine Compared With nab-Paclitaxel Plus Gemcitabine in Subjects With Stage IV Previously Untreated Pancreatic Cancer (NCT01839487) | Phase 2 | Stage IV | Recruiting |
| A Phase I/II Study of Indoximod in Combination With Gemcitabine and nab-Paclitaxel in Patients With Metastatic Adenocarcinoma of the Pancreas (NCT02077881) | Phase 1Phase 2 | Stage IV | Not yet recruiting |
| A Phase 1b/2 Study of OMP-59R5 in Combination With nab-Paclitaxel and Gemcitabine in Subjects With Previously Untreated Stage IV Pancreatic Cancer (NCT01647828) | Phase 1Phase 2 | Stage IV | Recruiting |
| Phase I Trial of the Proapoptotic Agonist, LCL161, and Gemcitabine Plus nab-Paclitaxel in Patients With Metastatic Pancreatic Cancer (NCT01934634) | Phase 1 | Stage IV | Recruiting |
| A Phase I Study of nab-paclitaxel (Abraxane), Gemcitabine, and Capecitabine (Xeloda) (AGX) in Patients With Previously Untreated, Metastatic Pancreatic Adenocarcinoma (NCT01161186) | Phase 1 | Stage IV | Completed |
| A Phase 1b/2 Pilot Trial of nab-Paclitaxel Plus Cisplatin Plus Gemcitabine (Nabplagem) in Patients With Previously Untreated Metastatic Pancreatic Ductal Adenocarcinoma (PDA) (NCT01893801) | Phase 1Phase 2 | Stage IV | Recruiting |
| A Phase I/II, Two-Part, Multicenter Study to Evaluate the Safety and Efficacy of M402 in Combination With nab-Paclitaxel and Gemcitabine in Patients With Metastatic Pancreatic Cancer (NCT01621243) | Phase 1Phase 2 | Stage IV | Recruiting |
| A Phase 2, Randomized, Double-blind Study of Gemcitabine And nab-Paclitaxel Combined With Momelotinib in Subjects With Previously Untreated Metastatic Pancreatic Ductal Adenocarcinoma Preceded by a Dose-finding, Lead-in Phase (NCT02101021) | Phase 2 | Stage IV | Not yet recruiting |
| Phase 1/2 Study Of PF-03084014 In Combination With Gemcitabine And nab-Paclitaxel In Patients With Previously Untreated Metastatic Pancreatic Ductal Adenocarcinoma (NCT02109445) | Phase 1Phase 2 | Stage IV | Not yet recruiting |
| Phase I/II Study to Evaluate nab-Paclitaxel in Substitution of CPT11 or Oxaliplatin in FOLFIRINOX Schedule as First Line Treatment in Metastatic Pancreatic Cancer (NCT02109341) | Phase 1Phase 2 | Stage IV | Recruiting |
| A Randomized, Double-Blinded, Placebo-Controlled Phase II Trial Of Gemcitabine Plus nab-Paclitaxel Combined With OGX-427 Or Placebo In Patients With Metastatic Pancreatic Cancer (The Rainier Trial) (NCT01844817) | Phase 2 | Stage IV | Recruiting |
| A Phase II Study of Gemcitabine and Nanoparticle-Bound Paclitaxel as Second Line Therapy in Patients With Metastatic Pancreatic Cancer (NCT02242409) | Phase 2 | Stage IV | Recruiting |
| Enzalutamide in Combination With Gemcitabine and nab-Paclitaxel for the Treatment of Advanced Pancreatic Cancer (NCT02138383) | Phase 1 | Stage IV | Recruiting |
| A Phase Ib/II Study of the Selective Inhibitor of Nuclear Export (SINE) KPT-330, Gemcitabine and nab-Paclitaxel in Patients With Metastatic Pancreatic Cancer (NCT02178436) | Phase 1Phase 2 | Stage IV | Not yet recruiting |
| Phase II Trial of nab-Paclitaxel Plus S-1 in First-line Treatment of Patients With Advanced Pancreatic Cancer (NCT02124317) | Phase 2 | Stage IV | Recruiting |
| Biological Effect of nab-Paclitaxel Combined to Gemcitabine in Metastatic Pancreatic Cancer (NCT02174887) | Phase 1 | Stage IV | Not yet recruiting |
| A 3-Arm Phase 2 Double-Blind Randomized Study of Gemcitabine, Abraxane® Plus Placebo Versus Gemcitabine, Abraxane® Plus 1 or 2 Truncated Courses of Demcizumab in Subjects With 1st-Line Metastatic Pancreatic Ductal Adenocarcinoma (NCT02289898) | Phase 2 | Stage IV | Not yet recruiting |
| A Phase Ib Clinical Study of BBI608 in Combination With Gemcitabine and nab-Paclitaxel in Adult Patients With Metastatic Pancreatic Adenocarcinoma (NCT02231723) | Phase 1 | Stage IV | Recruiting |
| Nab-paclitaxel Plus Gemcitabine in Chinese Patients With Advanced Pancreatic Cancer (NCT02135822) | Phase 2 | Advanced | Recruiting |
- Citation: Vaccaro V, Sperduti I, Vari S, Bria E, Melisi D, Garufi C, Nuzzo C, Scarpa A, Tortora G, Cognetti F, Reni M, Milella M. Metastatic pancreatic cancer: Is there a light at the end of the tunnel? World J Gastroenterol 2015; 21(16): 4788-4801
- URL: https://www.wjgnet.com/1007-9327/full/v21/i16/4788.htm
- DOI: https://dx.doi.org/10.3748/wjg.v21.i16.4788