NCT03127124

QUILT-2.022 NANT-008 in Combination w/ 5-fluorouracil, Bevacizumab, Leucovorin & Oxaliplatin in Subjects With Pancreatic Cancer

An Open-label, Multicenter, Single-arm, Phase 1b/2 Study of NANT-008 in Combination With 5-fluorouracil, Bevacizumab, Leucovorin, and Oxaliplatin in Patients With Metastatic Pancreatic Adenocarcinoma.

• Status: Withdrawn
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: NantPharma, LLC · Industry
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

Summary

This is a phase 1b/2 study to evaluate the safety and efficacy of NANT-008 in combination with 5-fluorouracil, bevacizumab, leucovorin, and oxaliplatin in patients with metastatic pancreatic adenocarcinoma.

Detailed description

Phase 1b is designed to evaluate the recommended phase 2 dose (RP2D) of NANT-008 and dose-limiting toxicities (DLTs) of NANT-008 in combination with metronomic 5-FU, bevacizumab, leucovorin, and oxaliplatin in subjects with advanced metastatic pancreatic carcinoma. In phase 2, subjects will receive the combination of RP2D of NANT-008 from phase 1b in combination with metronomic 5-FU, bevacizumab, leucovorin, and oxaliplatin. Phase 2 is designed to evaluate the efficacy of the tested regimen as assessed by 1-year survival rate in subjects with advanced metastatic pancreatic adenocarcinoma.

Conditions

• Pancreatic Adenocarcinoma Metastatic

Interventions

Type	Name	Description
DRUG	NANT-008	Paclitaxel: benzenepropanoic acid, β-(benzoylamino)-α-hydroxy-(2aR, 4S, 4aS, 6R, 9S, 11S, 12S, 12aR, 12bS)-6,12b-bis(acetyloxy)-12-(benzoyloxy)-2a, 3, 4, 4a, 5, 6, 9, 10, 11, 12, 12a, 12b-dodecahydro-4,11-dihydroxy-4a, 8, 13, 13-tetramethyl-5-oxo-7,11-methano-1H-cyclodeca\[3,4\]benz\[1,2-b\]oxet-9-y1ester,(αR,βS)-(9CI)
DRUG	Fluorouracil Injectable Product	5-fluoro-2,4 (1H,3H)-pyrimidinedione.
DRUG	Avastin Injectable Product	Recombinant humanized monoclonal IgG1 antibody
DRUG	Leucovorin Calcium Injection	Calcium N -\[p -\[\[\[(6RS )-2-amino-5-formyl-5,6,7,8-tetrahydro-4-hydroxy-6-pteridinyl\]methyl\]amino\]benzoyl\]-L-glutamate (1:1).
DRUG	Eloxatin Injectable Product	cis-\[(1 R,2 R)-1,2-cyclohexanediamine-N,N'\] \[oxalato(2-)- O,O'\] platinum.

Timeline

• Start date: 2018-02-27
• Primary completion: 2023-12-06
• Completion: 2023-12-06
• First posted: 2017-04-25
• Last updated: 2024-04-02

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study