Pancreatic Cancer
Conditions
Keywords
pancreatic cancer, asparaginase
Brief summary
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.
Interventions
DRUGGRASPA
Each patient will receive one administration of GRASPA . A stepwise increase of 4 single doses of GRASPA will be administered to cohorts of 3 patients per dose
Sponsors
ERYtech Pharma
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No
Inclusion criteria
* Exocrine pancreatic adenocarcinoma cytologically or histologically confirmed * Locally advanced and non-resectable with invasion of the superior mesenteric artery (stage III) or metastatic (stage IV) as defined by TNM (primary tumor, regional nodes, metastasis) 2002 classification (UICC 2002) * resistant to a first or second line chemotherapy with gemcitabine * Patient aged between 18 to 70 years * Signed Informed Consent Form * Life expectancy ≥ 12 weeks * Accurate measurement of tumor volume by imagery (in at least one dimension) * Presence of one or several tumor markers (carcinoembryonic antigen \[CEA\] and cancer antigen \[CA\] 19.9) * Eastern Cooperative Oncology Group \[ECOG\] Prognostic Score : 0, 1 or 2 * Patient beneficiary of a Social Security Insurance
Exclusion criteria
* Patient with an endocrine or acinar pancreatic tumor * Patient with known or suspected cerebro-meningeal metastases * Haemoglobin level greater than 13 g/L * Patient hypersensitive to L-asparaginase or have had prior exposure to any form of L-asparaginase * Splenic vein thrombosis \< 3 months or under active treatment * Anti-vitamin K treatment * Hepatic Insufficiency unrelated to pancreatic cancer * Renal insufficiency unrelated to pancreatic cancer * Pancreatitis or pancreatitis history unrelated to pancreatic cancer * Insulin-dependant diabetes mellitus unrelated to pancreatic cancer * Current or prior coagulopathy disorders unrelated to pancreatic cancer * ECOG Prognostic Score 3 or 4 * History of grade 3 blood transfusion reaction (life threatening situation) * Presence of rare and dangerous anti-erythrocyte antibodies preventing from getting a compatible packed Red Blood Cells for the patient * Patient already included in another clinical trial * Pregnancy, breast-feeding or absence of secured contraception * Unwillingness to sign the informed consent form
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Patients With Dose-limiting Toxicities up to Week 4 After Treatment | 4 weeks | Dose limiting toxicities were defined according to CTCAE v3.0 as follow: Known toxicities related to asparaginase: * Pancreatic grade 2, 3 or 4 * Allergic, Neurological, Hepatic, Coagulation grade 3 or 4 an any other toxicity of grade 4 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Encapsulated L-asparaginase Pharmacokinetic Parameters Terminal Half-life | Days 0, 1, 3, 7, 14, 21, 28, 35, 42, 56 | Pharmacokinetic (PK) parameters were analyzed for encapsulated asparaginase concentration data using Phoenix® WinNonlin® 6.3. Free and total L-asparaginase activity was measured during the study and encapsulated asparaginase was defined as the difference between total asparaginase and plasmatic asparaginase. |
| Encapsulated L-asparaginase Pharmacokinetic Parameters Cmax | Days 0, 1, 3, 7, 14, 21, 28, 35, 42, 56 | Pharmacokinetic (PK) parameters were analyzed for encapsulated asparaginase concentration data using Phoenix® WinNonlin® 6.3. Free and total L-asparaginase activity was measured during the study and encapsulated asparaginase was defined as the difference between total asparaginase and plasmatic asparaginase. |
| Encapsulated L-asparaginase Pharmacokinetic Parameters Area Under the Curve to Infinity | Days 0, 1, 3, 7, 14, 21, 28, 35, 42, 56 | Pharmacokinetic (PK) parameters were analyzed for encapsulated asparaginase concentration data using Phoenix® WinNonlin® 6.3. Free and total L-asparaginase activity was measured during the study and encapsulated asparaginase was defined as the difference between total asparaginase and plasmatic asparaginase. |
| Number of Patients With Limiting Toxicities From Week 4 to Week 8 (End of Study) | 8 weeks | Limiting toxicities were defined according to CTCAE v3.0 as follow: Known toxicities related to asparaginase: * Pancreatic grade 2, 3 or 4 * Allergic, Neurological, Hepatic, Coagulation grade 3 or 4 Any other toxicity of grade 4 |
| Number of Patient Positive for Anti-L-asparaginase Antibodies | Day 0, 1, 28 and 56 | Titers of E. coli anti-asparaginase antibodies evaluated over time to assess immunogenicity |
| Summary of CEA Level Over Time | Day 0, 28, 56 | Assess tumor response, evaluated by carcinoembryonic antigen (CEA) tumor marker evolution |
| Summary of CA 19.9 Over Time | Day 0, 28 and 56 | Tumor response Evaluation by cancer antigen (CA)19.9 evolution over time |
| Change of Asparagine Levels From Baseline (Pharmacodynamics) | Days 0, 1, 3, 7, 14, 21, 28, 35, 42, 56 | Duration of plasma asparagine depletion (less than or equal to 2 micromoles/Liter or deamination greater than 90% compared to baseline levels and serum concentrations of L-asparagine, L-aspartate, L-glutamine, and L-glutamate. For pharmacodynamic data, the administration date of the investigational treatment was considered as the reference date for duration calculation. All patients having received a single dose of studied drug GRASPA have been analyzed. |
Participant flow
Recruitment details
Participants were recruited at 3 investigational sites in France between November 2009 and February 2011. The first participant was enrolled in the study on 27 November 2009 and the last patient exited the study on 30 March 2011.
Pre-assignment details
This was not a randomized study. No washout or run-in was required. Assignment of patients to treatment groups followed study design rules, per protocol.
Participants by arm
| Arm | Count |
|---|---|
| GRASPA 25 Participants received one administration of GRASPA . A stepwise increase of 4 single doses of GRASPA was administered to cohorts of 3 patients per dose
3 subjects enrolled; 0 subjects completed | 3 |
| GRASPA 50 Each patient will receive one administration of GRASPA . A stepwise increase of 4 single doses of GRASPA was administered to cohorts of 3 patients per dose
3 subjects enrolled; 3 subjects completed | 3 |
| GRASPA 100 Each patient will receive one administration of GRASPA . A stepwise increase of 4 single doses of GRASPA was administered to cohorts of 3 patients per dose
3 subjects enrolled; 1 subject completed | 3 |
| GRASPA 150 Each patient will receive one administration of GRASPA . A stepwise increase of 4 single doses of GRASPA was administered to cohorts of 3 patients per dose
3 subjects enrolled; 0 subjects completed | 3 |
| Total | 12 |
Baseline characteristics
| Characteristic | GRASPA 50 | GRASPA 100 | GRASPA 25 | GRASPA 150 | Total |
|---|---|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 2 Participants | 0 Participants | 0 Participants | 2 Participants | 4 Participants |
| Age, Categorical Between 18 and 65 years | 1 Participants | 3 Participants | 3 Participants | 1 Participants | 8 Participants |
| Age, Continuous | 67 years | 51 years | 56 years | 68 years | 60 years |
| Region of Enrollment France | 3 Participants | 3 Participants | 3 Participants | 3 Participants | 12 Participants |
| Sex: Female, Male Female | 1 Participants | 1 Participants | 0 Participants | 1 Participants | 3 Participants |
| Sex: Female, Male Male | 2 Participants | 2 Participants | 3 Participants | 2 Participants | 9 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk |
|---|---|---|---|---|
| deaths Total, all-cause mortality | 1 / 3 | 0 / 3 | 1 / 3 | 1 / 3 |
| other Total, other adverse events | 3 / 3 | 3 / 3 | 2 / 3 | 2 / 3 |
| serious Total, serious adverse events | 3 / 3 | 0 / 3 | 0 / 3 | 0 / 3 |
Outcome results
Primary
Number of Patients With Dose-limiting Toxicities up to Week 4 After Treatment
Dose limiting toxicities were defined according to CTCAE v3.0 as follow: Known toxicities related to asparaginase: * Pancreatic grade 2, 3 or 4 * Allergic, Neurological, Hepatic, Coagulation grade 3 or 4 an any other toxicity of grade 4
Time frame: 4 weeks
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| GRASPA 25 | Number of Patients With Dose-limiting Toxicities up to Week 4 After Treatment | 0 participants |
| GRASPA 50 | Number of Patients With Dose-limiting Toxicities up to Week 4 After Treatment | 0 participants |
| GRASPA 100 | Number of Patients With Dose-limiting Toxicities up to Week 4 After Treatment | 0 participants |
| GRASPA 150 | Number of Patients With Dose-limiting Toxicities up to Week 4 After Treatment | 0 participants |
Secondary
Change of Asparagine Levels From Baseline (Pharmacodynamics)
Duration of plasma asparagine depletion (less than or equal to 2 micromoles/Liter or deamination greater than 90% compared to baseline levels and serum concentrations of L-asparagine, L-aspartate, L-glutamine, and L-glutamate. For pharmacodynamic data, the administration date of the investigational treatment was considered as the reference date for duration calculation. All patients having received a single dose of studied drug GRASPA have been analyzed.
Time frame: Days 0, 1, 3, 7, 14, 21, 28, 35, 42, 56
Population: 12 patients were included and analyzed corresponding to 1 cohort of 3 patients per dose. Data shown is a summary of the relative change of asparagine (%) from baseline over time (analysis set)
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| GRASPA 25 | Change of Asparagine Levels From Baseline (Pharmacodynamics) | Day 14 | 3.74 UI/Kg | Standard Deviation 33.84 |
| GRASPA 25 | Change of Asparagine Levels From Baseline (Pharmacodynamics) | Day 3 | -98.10 UI/Kg | Standard Deviation 0.35 |
| GRASPA 25 | Change of Asparagine Levels From Baseline (Pharmacodynamics) | Day 35 | -15.61 UI/Kg | Standard Deviation 33.87 |
| GRASPA 25 | Change of Asparagine Levels From Baseline (Pharmacodynamics) | Day 7 | -37.65 UI/Kg | Standard Deviation 55.53 |
| GRASPA 25 | Change of Asparagine Levels From Baseline (Pharmacodynamics) | Day 28 | 8.77 UI/Kg | Standard Deviation 63.51 |
| GRASPA 25 | Change of Asparagine Levels From Baseline (Pharmacodynamics) | Day 1 | -98.10 UI/Kg | Standard Deviation 0.35 |
| GRASPA 25 | Change of Asparagine Levels From Baseline (Pharmacodynamics) | Day 0 | 0.00 UI/Kg | Standard Deviation 0 |
| GRASPA 25 | Change of Asparagine Levels From Baseline (Pharmacodynamics) | Day 21 | 1.46 UI/Kg | Standard Deviation 52.13 |
| GRASPA 50 | Change of Asparagine Levels From Baseline (Pharmacodynamics) | Day 56 | -74.80 UI/Kg | — |
| GRASPA 50 | Change of Asparagine Levels From Baseline (Pharmacodynamics) | Day 0 | 0.00 UI/Kg | Standard Deviation 0 |
| GRASPA 50 | Change of Asparagine Levels From Baseline (Pharmacodynamics) | Day 1 | -98.36 UI/Kg | Standard Deviation 0.6 |
| GRASPA 50 | Change of Asparagine Levels From Baseline (Pharmacodynamics) | Day 3 | -91.39 UI/Kg | Standard Deviation 11.49 |
| GRASPA 50 | Change of Asparagine Levels From Baseline (Pharmacodynamics) | Day 7 | -80.06 UI/Kg | Standard Deviation 15.68 |
| GRASPA 50 | Change of Asparagine Levels From Baseline (Pharmacodynamics) | Day 14 | -30.13 UI/Kg | Standard Deviation 11.06 |
| GRASPA 50 | Change of Asparagine Levels From Baseline (Pharmacodynamics) | Day 21 | -13.21 UI/Kg | Standard Deviation 41.76 |
| GRASPA 50 | Change of Asparagine Levels From Baseline (Pharmacodynamics) | Day 28 | -16.24 UI/Kg | Standard Deviation 40.46 |
| GRASPA 50 | Change of Asparagine Levels From Baseline (Pharmacodynamics) | Day 35 | -10.95 UI/Kg | Standard Deviation 18.03 |
| GRASPA 50 | Change of Asparagine Levels From Baseline (Pharmacodynamics) | Day 42 | -22.04 UI/Kg | Standard Deviation 47.31 |
| GRASPA 100 | Change of Asparagine Levels From Baseline (Pharmacodynamics) | Day 56 | -7.26 UI/Kg | — |
| GRASPA 100 | Change of Asparagine Levels From Baseline (Pharmacodynamics) | Day 0 | 0.00 UI/Kg | Standard Deviation 0 |
| GRASPA 100 | Change of Asparagine Levels From Baseline (Pharmacodynamics) | Day 21 | -12.93 UI/Kg | Standard Deviation 9.87 |
| GRASPA 100 | Change of Asparagine Levels From Baseline (Pharmacodynamics) | Day 14 | -6.63 UI/Kg | Standard Deviation 8.46 |
| GRASPA 100 | Change of Asparagine Levels From Baseline (Pharmacodynamics) | Day 3 | -72.66 UI/Kg | Standard Deviation 44.77 |
| GRASPA 100 | Change of Asparagine Levels From Baseline (Pharmacodynamics) | Day 35 | 7.50 UI/Kg | — |
| GRASPA 100 | Change of Asparagine Levels From Baseline (Pharmacodynamics) | Day 7 | -49.97 UI/Kg | Standard Deviation 52.19 |
| GRASPA 100 | Change of Asparagine Levels From Baseline (Pharmacodynamics) | Day 1 | -80.22 UI/Kg | Standard Deviation 31.67 |
| GRASPA 100 | Change of Asparagine Levels From Baseline (Pharmacodynamics) | Day 42 | -7.81 UI/Kg | — |
| GRASPA 100 | Change of Asparagine Levels From Baseline (Pharmacodynamics) | Day 28 | 0.94 UI/Kg | Standard Deviation 2.65 |
| GRASPA 150 | Change of Asparagine Levels From Baseline (Pharmacodynamics) | Day 1 | -97.26 UI/Kg | Standard Deviation 0.02 |
| GRASPA 150 | Change of Asparagine Levels From Baseline (Pharmacodynamics) | Day 14 | -65.91 UI/Kg | Standard Deviation 54.3 |
| GRASPA 150 | Change of Asparagine Levels From Baseline (Pharmacodynamics) | Day 21 | -31.64 UI/Kg | Standard Deviation 41.65 |
| GRASPA 150 | Change of Asparagine Levels From Baseline (Pharmacodynamics) | Day 0 | 0.00 UI/Kg | Standard Deviation 0 |
| GRASPA 150 | Change of Asparagine Levels From Baseline (Pharmacodynamics) | Day 28 | -6.55 UI/Kg | Standard Deviation 8.54 |
| GRASPA 150 | Change of Asparagine Levels From Baseline (Pharmacodynamics) | Day 42 | -1.82 UI/Kg | — |
| GRASPA 150 | Change of Asparagine Levels From Baseline (Pharmacodynamics) | Day 3 | -97.36 UI/Kg | Standard Deviation 0.18 |
| GRASPA 150 | Change of Asparagine Levels From Baseline (Pharmacodynamics) | Day 7 | -93.02 UI/Kg | Standard Deviation 7.35 |
| GRASPA 150 | Change of Asparagine Levels From Baseline (Pharmacodynamics) | Day 35 | 43.08 UI/Kg | — |
Secondary
Encapsulated L-asparaginase Pharmacokinetic Parameters Area Under the Curve to Infinity
Pharmacokinetic (PK) parameters were analyzed for encapsulated asparaginase concentration data using Phoenix® WinNonlin® 6.3. Free and total L-asparaginase activity was measured during the study and encapsulated asparaginase was defined as the difference between total asparaginase and plasmatic asparaginase.
Time frame: Days 0, 1, 3, 7, 14, 21, 28, 35, 42, 56
Population: Data were available for dose levels (no. of patients) of 25 IU/kg (n=1), 50 IU/kg (n=0), 100 IU/kg (n=0), and 150 IU/kg (n=3).
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| GRASPA 25 | Encapsulated L-asparaginase Pharmacokinetic Parameters Area Under the Curve to Infinity | 189363.84 hr*IU/L | — |
| GRASPA 50 | Encapsulated L-asparaginase Pharmacokinetic Parameters Area Under the Curve to Infinity | 1331430.20 hr*IU/L | Standard Deviation 258279.5 |
Secondary
Encapsulated L-asparaginase Pharmacokinetic Parameters Cmax
Pharmacokinetic (PK) parameters were analyzed for encapsulated asparaginase concentration data using Phoenix® WinNonlin® 6.3. Free and total L-asparaginase activity was measured during the study and encapsulated asparaginase was defined as the difference between total asparaginase and plasmatic asparaginase.
Time frame: Days 0, 1, 3, 7, 14, 21, 28, 35, 42, 56
Population: Data were available for dose levels (no. of patients) of 25 IU/kg (n=1), 50 IU/kg (n=0), 100 IU/kg (n=0), and 150 IU/kg (n=3).
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| GRASPA 25 | Encapsulated L-asparaginase Pharmacokinetic Parameters Cmax | 255.33 IU/L | — |
| GRASPA 50 | Encapsulated L-asparaginase Pharmacokinetic Parameters Cmax | 1812.57 IU/L | Standard Deviation 203.12 |
Secondary
Encapsulated L-asparaginase Pharmacokinetic Parameters Terminal Half-life
Pharmacokinetic (PK) parameters were analyzed for encapsulated asparaginase concentration data using Phoenix® WinNonlin® 6.3. Free and total L-asparaginase activity was measured during the study and encapsulated asparaginase was defined as the difference between total asparaginase and plasmatic asparaginase.
Time frame: Days 0, 1, 3, 7, 14, 21, 28, 35, 42, 56
Population: Data were available for dose levels (no. of patients) of 25 IU/kg (n=1), 50 IU/kg (n=0), 100 IU/kg (n=0), and 150 IU/kg (n=3).
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| GRASPA 25 | Encapsulated L-asparaginase Pharmacokinetic Parameters Terminal Half-life | 19.34 days | — |
| GRASPA 50 | Encapsulated L-asparaginase Pharmacokinetic Parameters Terminal Half-life | 22.71 days | Standard Deviation 10.48 |
Secondary
Number of Patient Positive for Anti-L-asparaginase Antibodies
Titers of E. coli anti-asparaginase antibodies evaluated over time to assess immunogenicity
Time frame: Day 0, 1, 28 and 56
Population: Summary of anti-L-asparaginase antibodies over time by number of patients
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| GRASPA 25 | Number of Patient Positive for Anti-L-asparaginase Antibodies | Day 0 | 0 Participants |
| GRASPA 25 | Number of Patient Positive for Anti-L-asparaginase Antibodies | Day 1 | 0 Participants |
| GRASPA 25 | Number of Patient Positive for Anti-L-asparaginase Antibodies | Day 28 | 2 Participants |
| GRASPA 50 | Number of Patient Positive for Anti-L-asparaginase Antibodies | Day 0 | 0 Participants |
| GRASPA 50 | Number of Patient Positive for Anti-L-asparaginase Antibodies | Day 56 | 2 Participants |
| GRASPA 50 | Number of Patient Positive for Anti-L-asparaginase Antibodies | Day 1 | 0 Participants |
| GRASPA 50 | Number of Patient Positive for Anti-L-asparaginase Antibodies | Day 28 | 3 Participants |
| GRASPA 100 | Number of Patient Positive for Anti-L-asparaginase Antibodies | Day 0 | 1 Participants |
| GRASPA 100 | Number of Patient Positive for Anti-L-asparaginase Antibodies | Day 56 | 1 Participants |
| GRASPA 100 | Number of Patient Positive for Anti-L-asparaginase Antibodies | Day 28 | 3 Participants |
| GRASPA 100 | Number of Patient Positive for Anti-L-asparaginase Antibodies | Day 1 | 0 Participants |
| GRASPA 150 | Number of Patient Positive for Anti-L-asparaginase Antibodies | Day 56 | 2 Participants |
| GRASPA 150 | Number of Patient Positive for Anti-L-asparaginase Antibodies | Day 0 | 0 Participants |
| GRASPA 150 | Number of Patient Positive for Anti-L-asparaginase Antibodies | Day 1 | 0 Participants |
| GRASPA 150 | Number of Patient Positive for Anti-L-asparaginase Antibodies | Day 28 | 0 Participants |
Secondary
Number of Patients With Limiting Toxicities From Week 4 to Week 8 (End of Study)
Limiting toxicities were defined according to CTCAE v3.0 as follow: Known toxicities related to asparaginase: * Pancreatic grade 2, 3 or 4 * Allergic, Neurological, Hepatic, Coagulation grade 3 or 4 Any other toxicity of grade 4
Time frame: 8 weeks
Population: AEs that met the following criteria were considered for the primary safety criterion:~1. Grade 2 to 4 of pancreatic toxicity - no symptomatic pancreatitis occurred for any patients~2. Grade 3 or 4 of hepatic toxicity - Two patients had antithrombin III decrease, but both cases were Grade 1; no cytolytic hepatitis~3. Other grade 4 toxicities
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| GRASPA 25 | Number of Patients With Limiting Toxicities From Week 4 to Week 8 (End of Study) | 0 Participants |
| GRASPA 50 | Number of Patients With Limiting Toxicities From Week 4 to Week 8 (End of Study) | 0 Participants |
| GRASPA 100 | Number of Patients With Limiting Toxicities From Week 4 to Week 8 (End of Study) | 0 Participants |
| GRASPA 150 | Number of Patients With Limiting Toxicities From Week 4 to Week 8 (End of Study) | 0 Participants |
Secondary
Summary of CA 19.9 Over Time
Tumor response Evaluation by cancer antigen (CA)19.9 evolution over time
Time frame: Day 0, 28 and 56
Population: Sample collection not completed at each timepoint for each patient. All data available presented below.
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| GRASPA 25 | Summary of CA 19.9 Over Time | Day 28 | 37196.5 u/ml |
| GRASPA 25 | Summary of CA 19.9 Over Time | Day 0 | 18440.0 u/ml |
| GRASPA 50 | Summary of CA 19.9 Over Time | Day 28 | 748.3 u/ml |
| GRASPA 50 | Summary of CA 19.9 Over Time | Day 56 | 561.8 u/ml |
| GRASPA 50 | Summary of CA 19.9 Over Time | Day 0 | 184.3 u/ml |
| GRASPA 100 | Summary of CA 19.9 Over Time | Day 56 | 195.5 u/ml |
| GRASPA 100 | Summary of CA 19.9 Over Time | Day 28 | 3136.0 u/ml |
| GRASPA 100 | Summary of CA 19.9 Over Time | Day 0 | 1625.0 u/ml |
| GRASPA 150 | Summary of CA 19.9 Over Time | Day 28 | 124.1 u/ml |
| GRASPA 150 | Summary of CA 19.9 Over Time | Day 0 | 54.5 u/ml |
Secondary
Summary of CEA Level Over Time
Assess tumor response, evaluated by carcinoembryonic antigen (CEA) tumor marker evolution
Time frame: Day 0, 28, 56
Population: Sample collection not completed at each timepoint for each patient. All data available presented below.
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| GRASPA 25 | Summary of CEA Level Over Time | Day 0 | 21.3 ng/ml |
| GRASPA 25 | Summary of CEA Level Over Time | Day 28 | 22.8 ng/ml |
| GRASPA 50 | Summary of CEA Level Over Time | Day 28 | 26.3 ng/ml |
| GRASPA 50 | Summary of CEA Level Over Time | Day 0 | 10.2 ng/ml |
| GRASPA 50 | Summary of CEA Level Over Time | Day 56 | 9.0 ng/ml |
| GRASPA 100 | Summary of CEA Level Over Time | Day 0 | 6.4 ng/ml |
| GRASPA 100 | Summary of CEA Level Over Time | Day 28 | 3.1 ng/ml |
| GRASPA 100 | Summary of CEA Level Over Time | Day 56 | 3.4 ng/ml |
| GRASPA 150 | Summary of CEA Level Over Time | Day 28 | 967.9 ng/ml |
| GRASPA 150 | Summary of CEA Level Over Time | Day 0 | 354.8 ng/ml |