Trial Outcomes & Findings for Treatment With Radiolabeled Monoclonal Antibody HuJ591-GS (177Lu-J591) in Patients With Metastatic Prostate Cancer (NCT NCT00195039)
NCT ID: NCT00195039
Last Updated: 2017-10-05
Results Overview
PSA response rate corresponds to change form baseline in PSA at any of the time points specified.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
47 participants
Primary outcome timeframe
At baseline, Day 1, 29, 43, 57, 85, week 18, week 24 & every 12 weeks
Results posted on
2017-10-05
Participant Flow
Participant milestones
| Measure |
All Patients
Eligible patients will receive a single dose of 177Lu-J591 (65 or 70 mCi/m2) consisting of J591 chelated at a specific activity of 12-15 mCi of 177Lu per mg of antibody plus sufficient non-radiolabeled, non-DOTA-conjugated ("naked") J591 to achieve a total antibody dose of 20 mg. Each dose will be administered by an IV infusion at a rate not to exceed 5 mg/min.
177Lu Radiolabeled Monoclonal Antibody HuJ591 (177Lu -J591): Eligible patients will receive a single dose of 177Lu-J591 (65 or 70 mCi/m2) consisting of J591 chelated at a specific activity of 12-15 mCi of 177Lu per mg of antibody plus sufficient non-radiolabeled, non-DOTA-conjugated ("naked") J591 to achieve a total antibody dose of 20 mg. Each dose will be administered by an IV infusion at a rate not to exceed 5 mg/min.
|
|---|---|
|
Overall Study
STARTED
|
47
|
|
Overall Study
COMPLETED
|
47
|
|
Overall Study
NOT COMPLETED
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Treatment With Radiolabeled Monoclonal Antibody HuJ591-GS (177Lu-J591) in Patients With Metastatic Prostate Cancer
Baseline characteristics by cohort
| Measure |
All Patients
n=47 Participants
Eligible patients will receive a single dose of 177Lu-J591 (65 or 70 mCi/m2) consisting of J591 chelated at a specific activity of 12-15 mCi of 177Lu per mg of antibody plus sufficient non-radiolabeled, non-DOTA-conjugated ("naked") J591 to achieve a total antibody dose of 20 mg. Each dose will be administered by an IV infusion at a rate not to exceed 5 mg/min.
177Lu Radiolabeled Monoclonal Antibody HuJ591 (177Lu -J591): Eligible patients will receive a single dose of 177Lu-J591 (65 or 70 mCi/m2) consisting of J591 chelated at a specific activity of 12-15 mCi of 177Lu per mg of antibody plus sufficient non-radiolabeled, non-DOTA-conjugated ("naked") J591 to achieve a total antibody dose of 20 mg. Each dose will be administered by an IV infusion at a rate not to exceed 5 mg/min.
|
|---|---|
|
Age, Continuous
|
73.9 years
n=5 Participants
|
|
Sex: Female, Male
Female
|
0 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
47 Participants
n=5 Participants
|
|
Gleason sum
6
|
6 participants
n=5 Participants
|
|
Gleason sum
7
|
10 participants
n=5 Participants
|
|
Gleason sum
8-10
|
29 participants
n=5 Participants
|
|
Gleason sum
unknown
|
2 participants
n=5 Participants
|
|
PSA (ng/mL)
|
74.4 ng/mL
n=5 Participants
|
|
Sites of metastases
Bone
|
46 Participants
n=5 Participants
|
|
Sites of metastases
Lymph Node
|
28 Participants
n=5 Participants
|
|
Sites of metastases
Lung
|
11 Participants
n=5 Participants
|
|
Sites of metastases
Liver
|
4 Participants
n=5 Participants
|
|
Sites of metastases
Other
|
3 Participants
n=5 Participants
|
|
ECOG performance scale
0
|
13 Participants
n=5 Participants
|
|
ECOG performance scale
1
|
34 Participants
n=5 Participants
|
|
ECOG performance scale
2
|
0 Participants
n=5 Participants
|
|
LDH
|
217.5 IU/L
n=5 Participants
|
|
Hemoglobin
|
11.9 g/dL
n=5 Participants
|
|
Alkaline phosphatase
|
99 IU/L
n=5 Participants
|
|
Cancer And Leukemia Group B (CALGB) prognostic score
|
149 points
n=5 Participants
|
|
No. of previous hormonal therapies
1
|
6 Participants
n=5 Participants
|
|
No. of previous hormonal therapies
2
|
21 Participants
n=5 Participants
|
|
No. of previous hormonal therapies
3
|
14 Participants
n=5 Participants
|
|
No. of previous hormonal therapies
4
|
6 Participants
n=5 Participants
|
|
No. of previous chemotherapy regimens
0
|
21 Participants
n=5 Participants
|
|
No. of previous chemotherapy regimens
1
|
19 Participants
n=5 Participants
|
|
No. of previous chemotherapy regimens
>/= 2
|
7 Participants
n=5 Participants
|
|
Prior radiation
Prostate/prostate bed
|
21 Participants
n=5 Participants
|
|
Prior radiation
Palliative to bone metastasis
|
3 Participants
n=5 Participants
|
|
Prior radiation
Other
|
1 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: At baseline, Day 1, 29, 43, 57, 85, week 18, week 24 & every 12 weeksPSA response rate corresponds to change form baseline in PSA at any of the time points specified.
Outcome measures
| Measure |
All Patients
n=47 Participants
Eligible patients will receive a single dose of 177Lu-J591 (65 or 70 mCi/m2) consisting of J591 chelated at a specific activity of 12-15 mCi of 177Lu per mg of antibody plus sufficient non-radiolabeled, non-DOTA-conjugated ("naked") J591 to achieve a total antibody dose of 20 mg. Each dose will be administered by an IV infusion at a rate not to exceed 5 mg/min.
177Lu Radiolabeled Monoclonal Antibody HuJ591 (177Lu -J591): Eligible patients will receive a single dose of 177Lu-J591 (65 or 70 mCi/m2) consisting of J591 chelated at a specific activity of 12-15 mCi of 177Lu per mg of antibody plus sufficient non-radiolabeled, non-DOTA-conjugated ("naked") J591 to achieve a total antibody dose of 20 mg. Each dose will be administered by an IV infusion at a rate not to exceed 5 mg/min.
|
|---|---|
|
Define the PSA Response Rate.
>/= 50% decline in PSA
|
5 Participants
|
|
Define the PSA Response Rate.
>/= 30% decline in PSA
|
17 Participants
|
|
Define the PSA Response Rate.
Any PSA decline
|
25 Participants
|
PRIMARY outcome
Timeframe: Disease will be assessed at baseline and day 85.Population: Only 12 patients had measurable disease
Complete Response (CR): Disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to \<10 mm. Partial Response (PR): At least a 30% decrease in the sum of diameters of target lesions Progressive Disease (PD): At least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study (this includes the baseline sum if that is the smallest on study). In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. (Note: the appearance of one or more new lesions is also considered progression). Stable Disease (SD): Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum diameters while on study
Outcome measures
| Measure |
All Patients
n=12 Participants
Eligible patients will receive a single dose of 177Lu-J591 (65 or 70 mCi/m2) consisting of J591 chelated at a specific activity of 12-15 mCi of 177Lu per mg of antibody plus sufficient non-radiolabeled, non-DOTA-conjugated ("naked") J591 to achieve a total antibody dose of 20 mg. Each dose will be administered by an IV infusion at a rate not to exceed 5 mg/min.
177Lu Radiolabeled Monoclonal Antibody HuJ591 (177Lu -J591): Eligible patients will receive a single dose of 177Lu-J591 (65 or 70 mCi/m2) consisting of J591 chelated at a specific activity of 12-15 mCi of 177Lu per mg of antibody plus sufficient non-radiolabeled, non-DOTA-conjugated ("naked") J591 to achieve a total antibody dose of 20 mg. Each dose will be administered by an IV infusion at a rate not to exceed 5 mg/min.
|
|---|---|
|
Define the Measurable Disease Response Rate.
Partial Response
|
1 Participants
|
|
Define the Measurable Disease Response Rate.
Stable Disease
|
8 Participants
|
|
Define the Measurable Disease Response Rate.
Progressive Disease
|
2 Participants
|
|
Define the Measurable Disease Response Rate.
Lost to follow-up before repeat imaging
|
1 Participants
|
SECONDARY outcome
Timeframe: At baseline, and up to deathPer Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions, Complete Response (CR) = Disappearance of all target lesions, Partial Response (PR) = A \</=30% decrease in the sum of the longest diameter of target lesions, taking as reference the Baseline sum longest diameter, Stable Disease (SD) = Neither sufficient shrinkage to qualify for partial response nor sufficient increase to qualify for progressive disease, taking as reference the smallest sum longest diameter since the treatment started, Progressive Disease (PD) = A \>/=20% increase in the sum of the longest diameter of target lesions, taking as reference the smallest sum longest diameter recorded since the treatment started, or the appearance of one or more new lesions
Outcome measures
| Measure |
All Patients
n=47 Participants
Eligible patients will receive a single dose of 177Lu-J591 (65 or 70 mCi/m2) consisting of J591 chelated at a specific activity of 12-15 mCi of 177Lu per mg of antibody plus sufficient non-radiolabeled, non-DOTA-conjugated ("naked") J591 to achieve a total antibody dose of 20 mg. Each dose will be administered by an IV infusion at a rate not to exceed 5 mg/min.
177Lu Radiolabeled Monoclonal Antibody HuJ591 (177Lu -J591): Eligible patients will receive a single dose of 177Lu-J591 (65 or 70 mCi/m2) consisting of J591 chelated at a specific activity of 12-15 mCi of 177Lu per mg of antibody plus sufficient non-radiolabeled, non-DOTA-conjugated ("naked") J591 to achieve a total antibody dose of 20 mg. Each dose will be administered by an IV infusion at a rate not to exceed 5 mg/min.
|
|---|---|
|
Define the Duration of Biochemical PSA and/or Measurable Disease Response.
Any PSA decline
|
22.2 months
Interval 18.6 to 25.7
|
|
Define the Duration of Biochemical PSA and/or Measurable Disease Response.
Without PSA decline
|
11.4 months
Interval 8.4 to 14.4
|
SECONDARY outcome
Timeframe: From baseline until end of treatment phase (12 weeks)Grade 1 Mild; asymptomatic or mild symptoms; clinical or diagnostic observations only; intervention not indicated. Grade 2 Moderate; minimal, local or noninvasive intervention indicated; limiting age-appropriate instrumental ADL\*. Grade 3 Severe or medically significant but not immediately life-threatening hospitalization or prolongation of hospitalization indicated; disabling; limiting self care ADL\*\*. Grade 4 Life-threatening consequences; urgent intervention indicated. Grade 5 Death related to AE.
Outcome measures
| Measure |
All Patients
n=47 Participants
Eligible patients will receive a single dose of 177Lu-J591 (65 or 70 mCi/m2) consisting of J591 chelated at a specific activity of 12-15 mCi of 177Lu per mg of antibody plus sufficient non-radiolabeled, non-DOTA-conjugated ("naked") J591 to achieve a total antibody dose of 20 mg. Each dose will be administered by an IV infusion at a rate not to exceed 5 mg/min.
177Lu Radiolabeled Monoclonal Antibody HuJ591 (177Lu -J591): Eligible patients will receive a single dose of 177Lu-J591 (65 or 70 mCi/m2) consisting of J591 chelated at a specific activity of 12-15 mCi of 177Lu per mg of antibody plus sufficient non-radiolabeled, non-DOTA-conjugated ("naked") J591 to achieve a total antibody dose of 20 mg. Each dose will be administered by an IV infusion at a rate not to exceed 5 mg/min.
|
|---|---|
|
Define the Toxicity of 177Lu-J591 Given as Single Dose.
Nonhematologic : Petechiae/purpura · Grade 1-2
|
1 Participants
|
|
Define the Toxicity of 177Lu-J591 Given as Single Dose.
Nonhematologic : Petechiae/purpura · Grade 3
|
0 Participants
|
|
Define the Toxicity of 177Lu-J591 Given as Single Dose.
Nonhematologic : Bruising (no thrombocytopenia) · No toxicity
|
45 Participants
|
|
Define the Toxicity of 177Lu-J591 Given as Single Dose.
Nonhematologic : Constipation · Grade 1-2
|
5 Participants
|
|
Define the Toxicity of 177Lu-J591 Given as Single Dose.
Nonhematologic : Constipation · Grade 3
|
0 Participants
|
|
Define the Toxicity of 177Lu-J591 Given as Single Dose.
Nonhematologic : Constipation · Grade 4
|
0 Participants
|
|
Define the Toxicity of 177Lu-J591 Given as Single Dose.
Nonhematologic : Constipation · No toxicity
|
42 Participants
|
|
Define the Toxicity of 177Lu-J591 Given as Single Dose.
Nonhematologic : Creatinine · Grade 1-2
|
5 Participants
|
|
Define the Toxicity of 177Lu-J591 Given as Single Dose.
Nonhematologic : Creatinine · Grade 3
|
0 Participants
|
|
Define the Toxicity of 177Lu-J591 Given as Single Dose.
Nonhematologic : Creatinine · Grade 4
|
0 Participants
|
|
Define the Toxicity of 177Lu-J591 Given as Single Dose.
Nonhematologic : Creatinine · No toxicity
|
42 Participants
|
|
Define the Toxicity of 177Lu-J591 Given as Single Dose.
Nonhematologic : Diarrhea · Grade 1-2
|
4 Participants
|
|
Define the Toxicity of 177Lu-J591 Given as Single Dose.
Nonhematologic : Diarrhea · Grade 3
|
0 Participants
|
|
Define the Toxicity of 177Lu-J591 Given as Single Dose.
Nonhematologic : Diarrhea · Grade 4
|
0 Participants
|
|
Define the Toxicity of 177Lu-J591 Given as Single Dose.
Nonhematologic : Diarrhea · No toxicity
|
43 Participants
|
|
Define the Toxicity of 177Lu-J591 Given as Single Dose.
Nonhematologic : Dizziness · Grade 1-2
|
1 Participants
|
|
Define the Toxicity of 177Lu-J591 Given as Single Dose.
Nonhematologic : Dizziness · Grade 3
|
0 Participants
|
|
Define the Toxicity of 177Lu-J591 Given as Single Dose.
Nonhematologic : Dizziness · Grade 4
|
0 Participants
|
|
Define the Toxicity of 177Lu-J591 Given as Single Dose.
Nonhematologic : Dizziness · No toxicity
|
46 Participants
|
|
Define the Toxicity of 177Lu-J591 Given as Single Dose.
Nonhematologic : Dyspepsia · Grade 1-2
|
2 Participants
|
|
Define the Toxicity of 177Lu-J591 Given as Single Dose.
Nonhematologic : Dyspepsia · Grade 3
|
0 Participants
|
|
Define the Toxicity of 177Lu-J591 Given as Single Dose.
Nonhematologic : Dyspepsia · Grade 4
|
0 Participants
|
|
Define the Toxicity of 177Lu-J591 Given as Single Dose.
Nonhematologic : Dyspepsia · No toxicity
|
45 Participants
|
|
Define the Toxicity of 177Lu-J591 Given as Single Dose.
Nonhematologic : Dyspnea · Grade 1-2
|
3 Participants
|
|
Define the Toxicity of 177Lu-J591 Given as Single Dose.
Nonhematologic : Dyspnea · Grade 3
|
0 Participants
|
|
Define the Toxicity of 177Lu-J591 Given as Single Dose.
Nonhematologic : Dyspnea · Grade 4
|
0 Participants
|
|
Define the Toxicity of 177Lu-J591 Given as Single Dose.
Nonhematologic : Dyspnea · No toxicity
|
44 Participants
|
|
Define the Toxicity of 177Lu-J591 Given as Single Dose.
Nonhematologic : Edema: limb · Grade 1-2
|
1 Participants
|
|
Define the Toxicity of 177Lu-J591 Given as Single Dose.
Nonhematologic : Edema: limb · Grade 3
|
0 Participants
|
|
Define the Toxicity of 177Lu-J591 Given as Single Dose.
Nonhematologic : Edema: limb · Grade 4
|
0 Participants
|
|
Define the Toxicity of 177Lu-J591 Given as Single Dose.
Nonhematologic : Edema: limb · No toxicity
|
46 Participants
|
|
Define the Toxicity of 177Lu-J591 Given as Single Dose.
Nonhematologic : Fatigue · Grade 1-2
|
17 Participants
|
|
Define the Toxicity of 177Lu-J591 Given as Single Dose.
Nonhematologic : Fatigue · Grade 3
|
0 Participants
|
|
Define the Toxicity of 177Lu-J591 Given as Single Dose.
Nonhematologic : Fatigue · Grade 4
|
0 Participants
|
|
Define the Toxicity of 177Lu-J591 Given as Single Dose.
Nonhematologic : Fatigue · No toxicity
|
30 Participants
|
|
Define the Toxicity of 177Lu-J591 Given as Single Dose.
Nonhematologic : Fever (without neutropenia) · Grade 1-2
|
1 Participants
|
|
Define the Toxicity of 177Lu-J591 Given as Single Dose.
Nonhematologic : Fever (without neutropenia) · Grade 3
|
0 Participants
|
|
Define the Toxicity of 177Lu-J591 Given as Single Dose.
Nonhematologic : Fever (without neutropenia) · Grade 4
|
0 Participants
|
|
Define the Toxicity of 177Lu-J591 Given as Single Dose.
Nonhematologic : Fever (without neutropenia) · No toxicity
|
46 Participants
|
|
Define the Toxicity of 177Lu-J591 Given as Single Dose.
Nonhematologic : Hemorrhage, GI: oral cavity · Grade 1-2
|
1 Participants
|
|
Define the Toxicity of 177Lu-J591 Given as Single Dose.
Nonhematologic : Hemorrhage, GI: oral cavity · Grade 3
|
0 Participants
|
|
Define the Toxicity of 177Lu-J591 Given as Single Dose.
Nonhematologic : Hemorrhage, GI: oral cavity · Grade 4
|
0 Participants
|
|
Define the Toxicity of 177Lu-J591 Given as Single Dose.
Nonhematologic : Hemorrhage, GI: oral cavity · No toxicity
|
46 Participants
|
|
Define the Toxicity of 177Lu-J591 Given as Single Dose.
Nonhematologic: Hypersensitivity,infusion reaction · Grade 1-2
|
11 Participants
|
|
Define the Toxicity of 177Lu-J591 Given as Single Dose.
Nonhematologic: Hypersensitivity,infusion reaction · Grade 3
|
0 Participants
|
|
Define the Toxicity of 177Lu-J591 Given as Single Dose.
Nonhematologic: Hypersensitivity,infusion reaction · Grade 4
|
0 Participants
|
|
Define the Toxicity of 177Lu-J591 Given as Single Dose.
Nonhematologic: Hypersensitivity,infusion reaction · No toxicity
|
36 Participants
|
|
Define the Toxicity of 177Lu-J591 Given as Single Dose.
Nonhematologic : Nausea · Grade 1-2
|
5 Participants
|
|
Define the Toxicity of 177Lu-J591 Given as Single Dose.
Nonhematologic : Nausea · Grade 3
|
0 Participants
|
|
Define the Toxicity of 177Lu-J591 Given as Single Dose.
Nonhematologic : Nausea · Grade 4
|
0 Participants
|
|
Define the Toxicity of 177Lu-J591 Given as Single Dose.
Nonhematologic : Nausea · No toxicity
|
42 Participants
|
|
Define the Toxicity of 177Lu-J591 Given as Single Dose.
Nonhematologic : Pain - abdomen NOS · Grade 1-2
|
2 Participants
|
|
Define the Toxicity of 177Lu-J591 Given as Single Dose.
Nonhematologic : Pain - abdomen NOS · Grade 3
|
0 Participants
|
|
Define the Toxicity of 177Lu-J591 Given as Single Dose.
Nonhematologic : Pain - abdomen NOS · Grade 4
|
0 Participants
|
|
Define the Toxicity of 177Lu-J591 Given as Single Dose.
Nonhematologic : Pain - abdomen NOS · No toxicity
|
45 Participants
|
|
Define the Toxicity of 177Lu-J591 Given as Single Dose.
Nonhematologic : Pain - joint · Grade 1-2
|
1 Participants
|
|
Define the Toxicity of 177Lu-J591 Given as Single Dose.
Nonhematologic : Pain - joint · Grade 3
|
0 Participants
|
|
Define the Toxicity of 177Lu-J591 Given as Single Dose.
Nonhematologic : Pain - joint · Grade 4
|
0 Participants
|
|
Define the Toxicity of 177Lu-J591 Given as Single Dose.
Nonhematologic : Pain - joint · No toxicity
|
46 Participants
|
|
Define the Toxicity of 177Lu-J591 Given as Single Dose.
Nonhematologic : Petechiae/purpura · Grade 4
|
0 Participants
|
|
Define the Toxicity of 177Lu-J591 Given as Single Dose.
Nonhematologic : Petechiae/purpura · No toxicity
|
46 Participants
|
|
Define the Toxicity of 177Lu-J591 Given as Single Dose.
Nonhematologic : Rash/desquamation · Grade 1-2
|
1 Participants
|
|
Define the Toxicity of 177Lu-J591 Given as Single Dose.
Nonhematologic : Rash/desquamation · Grade 3
|
0 Participants
|
|
Define the Toxicity of 177Lu-J591 Given as Single Dose.
Nonhematologic : Rash/desquamation · Grade 4
|
0 Participants
|
|
Define the Toxicity of 177Lu-J591 Given as Single Dose.
Nonhematologic : Rash/desquamation · No toxicity
|
46 Participants
|
|
Define the Toxicity of 177Lu-J591 Given as Single Dose.
Nonhematologic : Rigors/chills · Grade 1-2
|
1 Participants
|
|
Define the Toxicity of 177Lu-J591 Given as Single Dose.
Nonhematologic : Rigors/chills · Grade 3
|
0 Participants
|
|
Define the Toxicity of 177Lu-J591 Given as Single Dose.
Nonhematologic : Rigors/chills · Grade 4
|
0 Participants
|
|
Define the Toxicity of 177Lu-J591 Given as Single Dose.
Nonhematologic : Rigors/chills · No toxicity
|
46 Participants
|
|
Define the Toxicity of 177Lu-J591 Given as Single Dose.
Nonhematologic : Taste alteration (dysquesia) · Grade 1-2
|
1 Participants
|
|
Define the Toxicity of 177Lu-J591 Given as Single Dose.
Nonhematologic : Taste alteration (dysquesia) · Grade 3
|
0 Participants
|
|
Define the Toxicity of 177Lu-J591 Given as Single Dose.
Nonhematologic : Taste alteration (dysquesia) · Grade 4
|
0 Participants
|
|
Define the Toxicity of 177Lu-J591 Given as Single Dose.
Nonhematologic : Taste alteration (dysquesia) · No toxicity
|
46 Participants
|
|
Define the Toxicity of 177Lu-J591 Given as Single Dose.
Nonhematologic : Weight loss · Grade 1-2
|
1 Participants
|
|
Define the Toxicity of 177Lu-J591 Given as Single Dose.
Nonhematologic : Weight loss · Grade 3
|
0 Participants
|
|
Define the Toxicity of 177Lu-J591 Given as Single Dose.
Nonhematologic : Weight loss · Grade 4
|
0 Participants
|
|
Define the Toxicity of 177Lu-J591 Given as Single Dose.
Nonhematologic : Weight loss · No toxicity
|
46 Participants
|
|
Define the Toxicity of 177Lu-J591 Given as Single Dose.
Hematologic : Hemoglobin · Grade 1-2
|
19 Participants
|
|
Define the Toxicity of 177Lu-J591 Given as Single Dose.
Hematologic : Hemoglobin · Grade 3
|
5 Participants
|
|
Define the Toxicity of 177Lu-J591 Given as Single Dose.
Hematologic : Hemoglobin · Grade 4
|
0 Participants
|
|
Define the Toxicity of 177Lu-J591 Given as Single Dose.
Hematologic : Hemoglobin · No toxicity
|
23 Participants
|
|
Define the Toxicity of 177Lu-J591 Given as Single Dose.
Hematologic : Leukocytes (total WBC) · Grade 1-2
|
14 Participants
|
|
Define the Toxicity of 177Lu-J591 Given as Single Dose.
Hematologic : Leukocytes (total WBC) · Grade 3
|
22 Participants
|
|
Define the Toxicity of 177Lu-J591 Given as Single Dose.
Hematologic : Leukocytes (total WBC) · Grade 4
|
4 Participants
|
|
Define the Toxicity of 177Lu-J591 Given as Single Dose.
Hematologic : Leukocytes (total WBC) · No toxicity
|
7 Participants
|
|
Define the Toxicity of 177Lu-J591 Given as Single Dose.
Hematologic : Neutrophils (ANC) · Grade 1-2
|
7 Participants
|
|
Define the Toxicity of 177Lu-J591 Given as Single Dose.
Hematologic : Neutrophils (ANC) · Grade 3
|
17 Participants
|
|
Define the Toxicity of 177Lu-J591 Given as Single Dose.
Hematologic : Neutrophils (ANC) · Grade 4
|
12 Participants
|
|
Define the Toxicity of 177Lu-J591 Given as Single Dose.
Hematologic : Neutrophils (ANC) · No toxicity
|
11 Participants
|
|
Define the Toxicity of 177Lu-J591 Given as Single Dose.
Hematologic : Febrile neutropenia · Grade 1-2
|
0 Participants
|
|
Define the Toxicity of 177Lu-J591 Given as Single Dose.
Hematologic : Febrile neutropenia · Grade 3
|
1 Participants
|
|
Define the Toxicity of 177Lu-J591 Given as Single Dose.
Hematologic : Febrile neutropenia · Grade 4
|
0 Participants
|
|
Define the Toxicity of 177Lu-J591 Given as Single Dose.
Hematologic : Febrile neutropenia · No toxicity
|
46 Participants
|
|
Define the Toxicity of 177Lu-J591 Given as Single Dose.
Hematologic : Platelets · Grade 1-2
|
4 Participants
|
|
Define the Toxicity of 177Lu-J591 Given as Single Dose.
Hematologic : Platelets · Grade 3
|
10 Participants
|
|
Define the Toxicity of 177Lu-J591 Given as Single Dose.
Hematologic : Platelets · Grade 4
|
22 Participants
|
|
Define the Toxicity of 177Lu-J591 Given as Single Dose.
Hematologic : Platelets · No toxicity
|
11 Participants
|
|
Define the Toxicity of 177Lu-J591 Given as Single Dose.
Nonhematologic : ALT · Grade 1-2
|
6 Participants
|
|
Define the Toxicity of 177Lu-J591 Given as Single Dose.
Nonhematologic : ALT · Grade 3
|
0 Participants
|
|
Define the Toxicity of 177Lu-J591 Given as Single Dose.
Nonhematologic : ALT · Grade 4
|
0 Participants
|
|
Define the Toxicity of 177Lu-J591 Given as Single Dose.
Nonhematologic : ALT · No toxicity
|
41 Participants
|
|
Define the Toxicity of 177Lu-J591 Given as Single Dose.
Nonhematologic : Anorexia · Grade 1-2
|
11 Participants
|
|
Define the Toxicity of 177Lu-J591 Given as Single Dose.
Nonhematologic : Anorexia · Grade 3
|
0 Participants
|
|
Define the Toxicity of 177Lu-J591 Given as Single Dose.
Nonhematologic : Anorexia · Grade 4
|
0 Participants
|
|
Define the Toxicity of 177Lu-J591 Given as Single Dose.
Nonhematologic : Anorexia · No toxicity
|
36 Participants
|
|
Define the Toxicity of 177Lu-J591 Given as Single Dose.
Nonhematologic : AST · Grade 1-2
|
9 Participants
|
|
Define the Toxicity of 177Lu-J591 Given as Single Dose.
Nonhematologic : AST · Grade 3
|
0 Participants
|
|
Define the Toxicity of 177Lu-J591 Given as Single Dose.
Nonhematologic : AST · Grade 4
|
0 Participants
|
|
Define the Toxicity of 177Lu-J591 Given as Single Dose.
Nonhematologic : AST · No toxicity
|
38 Participants
|
|
Define the Toxicity of 177Lu-J591 Given as Single Dose.
Nonhematologic : Bruising (no thrombocytopenia) · Grade 1-2
|
2 Participants
|
|
Define the Toxicity of 177Lu-J591 Given as Single Dose.
Nonhematologic : Bruising (no thrombocytopenia) · Grade 3
|
0 Participants
|
|
Define the Toxicity of 177Lu-J591 Given as Single Dose.
Nonhematologic : Bruising (no thrombocytopenia) · Grade 4
|
0 Participants
|
SECONDARY outcome
Timeframe: HAHA samples will be drawn at baseline and Day 85.Population: Samples were collected but data necessary to summarize this outcome measure was not collected because the study team felt that there was adequate data from previous phase I studies, including repeating dosing of the study drug in this study and others that were performed prior to this study's completion.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Bone scan will be performed at baseline and Day 85.Bone scan score determined for each patient and related to the degree of hematological toxicity quantified by % decline of nadir platelet count relative to baseline count.
Outcome measures
| Measure |
All Patients
n=47 Participants
Eligible patients will receive a single dose of 177Lu-J591 (65 or 70 mCi/m2) consisting of J591 chelated at a specific activity of 12-15 mCi of 177Lu per mg of antibody plus sufficient non-radiolabeled, non-DOTA-conjugated ("naked") J591 to achieve a total antibody dose of 20 mg. Each dose will be administered by an IV infusion at a rate not to exceed 5 mg/min.
177Lu Radiolabeled Monoclonal Antibody HuJ591 (177Lu -J591): Eligible patients will receive a single dose of 177Lu-J591 (65 or 70 mCi/m2) consisting of J591 chelated at a specific activity of 12-15 mCi of 177Lu per mg of antibody plus sufficient non-radiolabeled, non-DOTA-conjugated ("naked") J591 to achieve a total antibody dose of 20 mg. Each dose will be administered by an IV infusion at a rate not to exceed 5 mg/min.
|
|---|---|
|
Number of Participants With Hematological Toxicity Relative to Bone Marrow Involvement (Bone Scan Index).
|
0 participants
|
SECONDARY outcome
Timeframe: From baseline through study completionOutcome measures
| Measure |
All Patients
n=47 Participants
Eligible patients will receive a single dose of 177Lu-J591 (65 or 70 mCi/m2) consisting of J591 chelated at a specific activity of 12-15 mCi of 177Lu per mg of antibody plus sufficient non-radiolabeled, non-DOTA-conjugated ("naked") J591 to achieve a total antibody dose of 20 mg. Each dose will be administered by an IV infusion at a rate not to exceed 5 mg/min.
177Lu Radiolabeled Monoclonal Antibody HuJ591 (177Lu -J591): Eligible patients will receive a single dose of 177Lu-J591 (65 or 70 mCi/m2) consisting of J591 chelated at a specific activity of 12-15 mCi of 177Lu per mg of antibody plus sufficient non-radiolabeled, non-DOTA-conjugated ("naked") J591 to achieve a total antibody dose of 20 mg. Each dose will be administered by an IV infusion at a rate not to exceed 5 mg/min.
|
|---|---|
|
Assess the Survival Rate of Patients Following Treatment.
|
17.6 months
Interval 15.2 to 20.0
|
SECONDARY outcome
Timeframe: Scans will be performed between day 6 and 8.Outcome measures
| Measure |
All Patients
n=47 Participants
Eligible patients will receive a single dose of 177Lu-J591 (65 or 70 mCi/m2) consisting of J591 chelated at a specific activity of 12-15 mCi of 177Lu per mg of antibody plus sufficient non-radiolabeled, non-DOTA-conjugated ("naked") J591 to achieve a total antibody dose of 20 mg. Each dose will be administered by an IV infusion at a rate not to exceed 5 mg/min.
177Lu Radiolabeled Monoclonal Antibody HuJ591 (177Lu -J591): Eligible patients will receive a single dose of 177Lu-J591 (65 or 70 mCi/m2) consisting of J591 chelated at a specific activity of 12-15 mCi of 177Lu per mg of antibody plus sufficient non-radiolabeled, non-DOTA-conjugated ("naked") J591 to achieve a total antibody dose of 20 mg. Each dose will be administered by an IV infusion at a rate not to exceed 5 mg/min.
|
|---|---|
|
Number of Participants With Targeting of 177Lu-J591 to Known Tumor Sites.
|
44 Participants
|
Adverse Events
All Patients
Serious events: 9 serious events
Other events: 47 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
All Patients
n=47 participants at risk
Eligible patients will receive a single dose of 177Lu-J591 (65 or 70 mCi/m2) consisting of J591 chelated at a specific activity of 12-15 mCi of 177Lu per mg of antibody plus sufficient non-radiolabeled, non-DOTA-conjugated ("naked") J591 to achieve a total antibody dose of 20 mg. Each dose will be administered by an IV infusion at a rate not to exceed 5 mg/min.
177Lu Radiolabeled Monoclonal Antibody HuJ591 (177Lu -J591): Eligible patients will receive a single dose of 177Lu-J591 (65 or 70 mCi/m2) consisting of J591 chelated at a specific activity of 12-15 mCi of 177Lu per mg of antibody plus sufficient non-radiolabeled, non-DOTA-conjugated ("naked") J591 to achieve a total antibody dose of 20 mg. Each dose will be administered by an IV infusion at a rate not to exceed 5 mg/min.
|
|---|---|
|
Renal and urinary disorders
Bilateral Moderate Hydronephrosis
|
2.1%
1/47 • Number of events 1
|
|
Cardiac disorders
Chest Pain
|
2.1%
1/47 • Number of events 1
|
|
General disorders
Generalized Weakness and Fatigue
|
2.1%
1/47 • Number of events 1
|
|
Blood and lymphatic system disorders
Thrombocytopenia - grade 4
|
8.5%
4/47 • Number of events 5
|
|
Blood and lymphatic system disorders
Anemia - grade 3
|
2.1%
1/47 • Number of events 1
|
|
Renal and urinary disorders
Hematuria
|
2.1%
1/47 • Number of events 1
|
|
General disorders
Asthenia
|
2.1%
1/47 • Number of events 1
|
|
Blood and lymphatic system disorders
Thrombocytopenia - grade 3
|
4.3%
2/47 • Number of events 2
|
|
Blood and lymphatic system disorders
Neutropenic Fever
|
2.1%
1/47 • Number of events 1
|
Other adverse events
| Measure |
All Patients
n=47 participants at risk
Eligible patients will receive a single dose of 177Lu-J591 (65 or 70 mCi/m2) consisting of J591 chelated at a specific activity of 12-15 mCi of 177Lu per mg of antibody plus sufficient non-radiolabeled, non-DOTA-conjugated ("naked") J591 to achieve a total antibody dose of 20 mg. Each dose will be administered by an IV infusion at a rate not to exceed 5 mg/min.
177Lu Radiolabeled Monoclonal Antibody HuJ591 (177Lu -J591): Eligible patients will receive a single dose of 177Lu-J591 (65 or 70 mCi/m2) consisting of J591 chelated at a specific activity of 12-15 mCi of 177Lu per mg of antibody plus sufficient non-radiolabeled, non-DOTA-conjugated ("naked") J591 to achieve a total antibody dose of 20 mg. Each dose will be administered by an IV infusion at a rate not to exceed 5 mg/min.
|
|---|---|
|
Investigations
ALT increase
|
12.8%
6/47
|
|
Metabolism and nutrition disorders
Anorexia
|
23.4%
11/47
|
|
Investigations
AST increase
|
19.1%
9/47
|
|
Injury, poisoning and procedural complications
Bruising (no thrombocytopenia)
|
4.3%
2/47
|
|
Gastrointestinal disorders
Constipation
|
10.6%
5/47
|
|
Investigations
Creatinine increase
|
10.6%
5/47
|
|
Gastrointestinal disorders
Diarrhea
|
8.5%
4/47
|
|
Nervous system disorders
Dizziness
|
2.1%
1/47
|
|
Gastrointestinal disorders
Dyspepsia
|
4.3%
2/47
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
6.4%
3/47
|
|
General disorders
Edema: limb
|
2.1%
1/47
|
|
General disorders
Fatigue
|
36.2%
17/47
|
|
General disorders
Fever (without neutropenai)
|
2.1%
1/47
|
|
Gastrointestinal disorders
Hemorrhage, gastrointestinal: oral cavity
|
2.1%
1/47
|
|
General disorders
Hypersensitivity (infusion reaction)
|
23.4%
11/47
|
|
Gastrointestinal disorders
Nausea
|
10.6%
5/47
|
|
General disorders
Pain - abdomen NOS
|
4.3%
2/47
|
|
General disorders
Pain - joint
|
2.1%
1/47
|
|
Skin and subcutaneous tissue disorders
Petechiae/purpura
|
2.1%
1/47
|
|
Skin and subcutaneous tissue disorders
Rash/desquamation
|
2.1%
1/47
|
|
General disorders
Rigors/chills
|
2.1%
1/47
|
|
Nervous system disorders
Taste alteration (dysgeusia)
|
2.1%
1/47
|
|
Investigations
Weight loss
|
2.1%
1/47
|
|
Blood and lymphatic system disorders
Hemoglobin
|
51.1%
24/47
|
|
Blood and lymphatic system disorders
Leukocytes (total WBC)
|
85.1%
40/47
|
|
Blood and lymphatic system disorders
Neutrophils (ANC)
|
76.6%
36/47
|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
2.1%
1/47
|
|
Blood and lymphatic system disorders
Platelets
|
76.6%
36/47
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place