Clinical trialPhase 1Completed
Administration of GRASPA (Suspension of Erythrocytes Encapsulating L-asparaginase)in Patients With Pancreatic Cancer
Phase I, Dose Escalation Clinical Trial of GRASPA (Red Blood Cells Encapsulating L-Asparaginase) in Patients With Pancreatic Carcinoma
- Outcome
- Outcome unknown
- Phase
- Phase 1
- Status
- Completed
- Study type
- Interventional
- Start
- November 2009
- Expected end
- March 2011
- Enrollment
- 12 participants
- Sites
- 0
- Primary outcomes
- Number of Patients With Dose-limiting Toxicities up to Week 4 After Treatment
- Sponsor
- Industry
- Results posted
- 2021-10-15
- Last update
- 15 October 2021
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Brief summary public domain (ClinicalTrials.gov)
The interest in using L-asparaginase in pancreatic cancer arose from in vitro and in vivo studies data showing an anti-neoplastic effect on pancreatic tumor cell lines. Interestingly, these studies suggest an additional effect of L-asparaginase associated to gemcitabine.GRASPA is a suspension of red blood cells encapsulating L-asparaginase. The aim of this phase I clinical trial is to evaluate the Maximum Tolerated Dose (MTD) of GRASPA on locally advanced or metastatic pancreatic tumors, after therapy failure of first or second line chemotherapy using gemcitabine.
Posted results (ClinicalTrials.gov registry) · primary outcome public domain (ClinicalTrials.gov)
Number of Patients With Dose-limiting Toxicities up to Week 4 After Treatment [4 weeks]. Number, participants. GRASPA 25 (n=3): 0; GRASPA 50 (n=3): 0; GRASPA 100 (n=3): 0; GRASPA 150 (n=3): 0.
Posted results (ClinicalTrials.gov registry) · secondary outcome public domain (ClinicalTrials.gov)
Number of Patients With Limiting Toxicities From Week 4 to Week 8 (End of Study) [8 weeks]. Count Of Participants, Participants. GRASPA 25 (n=3): 0; GRASPA 50 (n=3): 0; GRASPA 100 (n=3): 0; GRASPA 150 (n=3): 0.
Posted results (ClinicalTrials.gov registry) · secondary outcome public domain (ClinicalTrials.gov)
Encapsulated L-asparaginase Pharmacokinetic Parameters Terminal Half-life [Days 0, 1, 3, 7, 14, 21, 28, 35, 42, 56]. Mean, days (Standard Deviation). GRASPA 25 (n=1): 19.34; GRASPA 150 (n=3): 22.71 (10.48).
Posted results (ClinicalTrials.gov registry) · secondary outcome public domain (ClinicalTrials.gov)
Encapsulated L-asparaginase Pharmacokinetic Parameters Cmax [Days 0, 1, 3, 7, 14, 21, 28, 35, 42, 56]. Mean, IU/L (Standard Deviation). GRASPA 25 (n=1): 255.33; GRASPA 150 (n=3): 1812.57 (203.12).
Posted results (ClinicalTrials.gov registry) · secondary outcome public domain (ClinicalTrials.gov)
Encapsulated L-asparaginase Pharmacokinetic Parameters Area Under the Curve to Infinity [Days 0, 1, 3, 7, 14, 21, 28, 35, 42, 56]. Mean, hr*IU/L (Standard Deviation). GRASPA 25 (n=1): 189363.84; GRASPA 150 (n=3): 1331430.20 (258279.50).
Posted results (ClinicalTrials.gov registry) · secondary outcome public domain (ClinicalTrials.gov)
Change of Asparagine Levels From Baseline (Pharmacodynamics) [Days 0, 1, 3, 7, 14, 21, 28, 35, 42, 56]. Mean, UI/Kg (Standard Deviation). Day 0: GRASPA 25 (n=3): 0.00 (0.00); GRASPA 50 (n=3): 0.00 (0.00); GRASPA 100 (n=3): 0.00 (0.00); GRASPA 150 (n=3): 0.00 (0.00). Day 1: GRASPA 25 (n=3): -98.10 (0.35); GRASPA 50 (n=3): -98.36 (0.60); GRASPA 100 (n=3): -80.22 (31.67); GRASPA 150 (n=3): -97.26 (0.02). Day 3: GRASPA 25 (n=3): -98.10 (0.35); GRASPA 50 (n=3): -91.39 (11.49); GRASPA 100 (n=3): -72.66 (44.77); GRASPA 150 (n=3): -97.36 (0.18). Day 7: GRASPA 25 (n=3): -37.65 (55.53); GRASPA 50 (n=3): -80.06 (15.68); GRASPA 100 (n=3): -49.97 (52.19); GRASPA 150 (n=3): -93.02 (7.35). Day 14: GRASPA 25 (n=3): 3.74 (33.84); GRASPA 50 (n=3): -30.13 (11.06); GRASPA 100 (n=3): -6.63 (8.46); GRASPA 150 (n=3): -65.91 (54.30). Day 21: GRASPA 25 (n=3): 1.46 (52.13); GRASPA 50 (n=3): -13.21 (41.76); GRASPA 100 (n=3): -12.93 (9.87); GRASPA 150 (n=3): -31.64 (41.65). Day 28: GRASPA 25 (n=3): 8.77 (63.51); GRASPA 50 (n=3): -16.24 (40.46); GRASPA 100 (n=3): 0.94 (2.65); GRASPA 150 (n=3): -6.55 (8.54). Day 35: GRASPA 25 (n=3): -15.61 (33.87); GRASPA 50 (n=3): -10.95 (18.03); GRASPA 100 (n=3): 7.50; GRASPA 150 (n=3): 43.08. Day 42: GRASPA 50 (n=3): -22.04 (47.31); GRASPA 100 (n=3): -7.81; GRASPA 150 (n=3): -1.82. Day 56: GRASPA 50 (n=3): -74.80; GRASPA 100 (n=3): -7.26.
Posted results (ClinicalTrials.gov registry) · secondary outcome public domain (ClinicalTrials.gov)
Number of Patient Positive for Anti-L-asparaginase Antibodies [Day 0, 1, 28 and 56]. Count Of Participants, Participants. Day 0: GRASPA 25 (n=3): 0; GRASPA 50 (n=3): 0; GRASPA 100 (n=3): 1; GRASPA 150 (n=3): 0. Day 1: GRASPA 25 (n=3): 0; GRASPA 50 (n=3): 0; GRASPA 100 (n=3): 0; GRASPA 150 (n=3): 0. Day 28: GRASPA 25 (n=3): 2; GRASPA 50 (n=3): 3; GRASPA 100 (n=3): 3; GRASPA 150 (n=3): 0. Day 56: GRASPA 50 (n=3): 2; GRASPA 100 (n=3): 1; GRASPA 150 (n=3): 2.
Posted results (ClinicalTrials.gov registry) · secondary outcome public domain (ClinicalTrials.gov)
Summary of CEA Level Over Time [Day 0, 28, 56]. Median, ng/ml (Full Range). Day 0: GRASPA 25 (n=3): 21.3 (13.5 to 29.0); GRASPA 50 (n=3): 10.2 (10.0 to 19.0); GRASPA 100 (n=3): 6.4 (3.0 to 9.7); GRASPA 150 (n=3): 354.8 (12.5 to 488.2). Day 28: GRASPA 25 (n=3): 22.8 (7.5 to 38.0); GRASPA 50 (n=3): 26.3 (7.5 to 30.9); GRASPA 100 (n=3): 3.1 (3.0 to 3.1); GRASPA 150 (n=3): 967.9 (14.2 to 995.4). Day 56: GRASPA 50 (n=3): 9.0 (9.0 to 9.0); GRASPA 100 (n=3): 3.4 (3.4 to 3.4).
Posted results (ClinicalTrials.gov registry) · secondary outcome public domain (ClinicalTrials.gov)
Summary of CA 19.9 Over Time [Day 0, 28 and 56]. Median, u/ml (Full Range). Day 0: GRASPA 25 (n=3): 18440.0 (5605.0 to 36802.0); GRASPA 50 (n=3): 184.3 (59.8 to 4751.0); GRASPA 100 (n=3): 1625.0 (73.2 to 2835.0); GRASPA 150 (n=3): 54.5 (3.5 to 1784.0). Day 28: GRASPA 25 (n=3): 37196.5 (14310.0 to 60083); GRASPA 50 (n=3): 748.3 (187.2 to 12375.0); GRASPA 100 (n=3): 3136.0 (122.0 to 6150.0); GRASPA 150 (n=3): 124.1 (5.3 to 2395.0). Day 56: GRASPA 50 (n=3): 561.8 (561.8 to 561.8); GRASPA 100 (n=3): 195.5 (195.5 to 195.5).