Trial Outcomes & Findings for Study of CBP501 + Pemetrexed + Cisplatin on MPM (Phase I/II) (NCT NCT00700336)
NCT ID: NCT00700336
Last Updated: 2021-07-20
Results Overview
Planned: Forty-two patients were to be treated in Arm A. If ≥ 23 patients (\>54%) were free of progression and death at 4 months, then the study regimen would be considered for further evaluation in this indication.
Recruitment status
COMPLETED
Study phase
PHASE1/PHASE2
Target enrollment
69 participants
Primary outcome timeframe
End of study
Results posted on
2021-07-20
Participant Flow
Participant milestones
| Measure |
Pemetrexed, Cisplatin and CBP501: Phase 2
pemetrexed, cisplatin and CBP501: CBP501 for injection is provided in single dose vials (20 mg) containing a sterile lyophilized powder comprising CBP501 peptide acetate salt (peptide base units). For administration, vial contents are reconstituted in 5% Dextrose Injection, USP, and added to a 100 mL IV bag of 5% Dextrose Injection, USP.
Pemetrexed: A commercial formulation of pemetrexed will be used, with reconstitution in 20mL 0.9% sodium chloride solution for injection, then dilution to 100mL.
Cisplatin: A commercial formulation will be used and will be diluted in 250 mL of normal saline for administration.
|
Pemetrexed and Cisplatin: Phase 2
pemetrexed and cisplatin: Pemetrexed: A commercial formulation of pemetrexed will be used, with reconstitution in 20mL 0.9% sodium chloride solution for injection, then dilution to 100mL.
Cisplatin: A commercial formulation will be used and will be diluted in 250 mL of normal saline for administration.
|
Pemetrexed, Cisplatin and CBP501: Phase 1
DL1: CBP501 16mg/m2, pemetrexed 500mg/m2, cisplatin 75mg/m2 DL2: CBP501 25mg/m2, pemetrexed 500mg/m2, cisplatin 75mg/m2
|
|---|---|---|---|
|
Overall Study
STARTED
|
40
|
23
|
6
|
|
Overall Study
COMPLETED
|
40
|
23
|
6
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Study of CBP501 + Pemetrexed + Cisplatin on MPM (Phase I/II)
Baseline characteristics by cohort
| Measure |
Pemetrexed, Cisplatin, and CBP501: Phase 2
n=40 Participants
pemetrexed, cisplatin and CBP501
pemetrexed, cisplatin and CBP501: CBP501 for injection is provided in single dose vials (20 mg) containing a sterile lyophilized powder comprising CBP501 peptide acetate salt (peptide base units). For administration, vial contents are reconstituted in 5% Dextrose Injection, USP, and added to a 100 mL IV bag of 5% Dextrose Injection, USP.
Pemetrexed: A commercial formulation of pemetrexed will be used, with reconstitution in 20mL 0.9% sodium chloride solution for injection, then dilution to 100mL.
Cisplatin: A commercial formulation will be used and will be diluted in 250 mL of normal saline for administration.
|
Pemetrexed and Cisplatin: Phase 2
n=23 Participants
pemetrexed and cisplatin
pemetrexed and cisplatin: Pemetrexed: A commercial formulation of pemetrexed will be used, with reconstitution in 20mL 0.9% sodium chloride solution for injection, then dilution to 100mL.
Cisplatin: A commercial formulation will be used and will be diluted in 250 mL of normal saline for administration.
|
Pemetrexed, Cisplatin, and CBP501: Phase 1
n=6 Participants
DL1: CBP501 16mg/m2, Alimta 500mg/m2, cisplatin 75mg/m2 DL2: CBP501 25mg/m2, Alimta 500mg/m2, cisplatin 75mg/m2
|
Total
n=69 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
63 years
STANDARD_DEVIATION 10.03 • n=5 Participants
|
66.3 years
STANDARD_DEVIATION 12.10 • n=7 Participants
|
62.8 years
STANDARD_DEVIATION 13.61 • n=5 Participants
|
64.2 years
STANDARD_DEVIATION 10.86 • n=4 Participants
|
|
Sex: Female, Male
Female
|
8 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
12 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
32 Participants
n=5 Participants
|
20 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
57 Participants
n=4 Participants
|
PRIMARY outcome
Timeframe: End of studyPlanned: Forty-two patients were to be treated in Arm A. If ≥ 23 patients (\>54%) were free of progression and death at 4 months, then the study regimen would be considered for further evaluation in this indication.
Outcome measures
| Measure |
Pemetrexed, Cisplatin, and CBP501
n=40 Participants
Pemetrexed, Cisplatin, and CBP501 administered once every 3 weeks
|
Pemetrexed and Cisplatin
n=23 Participants
Pemetrexed and Cisplatin every three weeks
|
|---|---|---|
|
4M PFS Rate of Patients With Previously Untreated, Unresectable Malignant Pleural Mesothelioma (MPM) Treated With CBP501, Pemetrexed and Cisplatin
4M PFS by Independent Image Review
|
25 participants
|
9 participants
|
|
4M PFS Rate of Patients With Previously Untreated, Unresectable Malignant Pleural Mesothelioma (MPM) Treated With CBP501, Pemetrexed and Cisplatin
4M PFS by Site assess
|
27 participants
|
13 participants
|
Adverse Events
Pemetrexed, Cisplatin, and CBP501: Phase 2
Serious events: 21 serious events
Other events: 28 other events
Deaths: 1 deaths
Pemetrexed and Cisplatin: Phase 2
Serious events: 13 serious events
Other events: 15 other events
Deaths: 1 deaths
Pemetrexed, Cisplatin, and CBP501: Phase 1
Serious events: 5 serious events
Other events: 6 other events
Deaths: 4 deaths
Serious adverse events
| Measure |
Pemetrexed, Cisplatin, and CBP501: Phase 2
n=40 participants at risk
pemetrexed, cisplatin and CBP501
pemetrexed, cisplatin and CBP501: CBP501 for injection is provided in single dose vials (20 mg) containing a sterile lyophilized powder comprising CBP501 peptide acetate salt (peptide base units). For administration, vial contents are reconstituted in 5% Dextrose Injection, USP, and added to a 100 mL IV bag of 5% Dextrose Injection, USP.
Pemetrexed: A commercial formulation of pemetrexed will be used, with reconstitution in 20mL 0.9% sodium chloride solution for injection, then dilution to 100mL.
Cisplatin: A commercial formulation will be used and will be diluted in 250 mL of normal saline for administration.
|
Pemetrexed and Cisplatin: Phase 2
n=23 participants at risk
pemetrexed and cisplatin
pemetrexed and cisplatin: Pemetrexed: A commercial formulation of pemetrexed will be used, with reconstitution in 20mL 0.9% sodium chloride solution for injection, then dilution to 100mL.
Cisplatin: A commercial formulation will be used and will be diluted in 250 mL of normal saline for administration.
|
Pemetrexed, Cisplatin, and CBP501: Phase 1
n=6 participants at risk
DL1: CBP501 16mg/m2, Alimta 500mg/m2, cisplatin 75mg/m2 DL2: CBP501 25mg/m2, Alimta 500mg/m2, cisplatin 75mg/m2
|
|---|---|---|---|
|
Blood and lymphatic system disorders
Lymphopenia
|
5.0%
2/40
|
4.3%
1/23
|
0.00%
0/6
|
|
Gastrointestinal disorders
abdominal pain
|
0.00%
0/40
|
13.0%
3/23
|
16.7%
1/6
|
|
Gastrointestinal disorders
Nausea
|
7.5%
3/40
|
8.7%
2/23
|
0.00%
0/6
|
|
Gastrointestinal disorders
Vomiting
|
10.0%
4/40
|
4.3%
1/23
|
0.00%
0/6
|
|
General disorders
Fatigue
|
17.5%
7/40
|
13.0%
3/23
|
0.00%
0/6
|
|
Investigations
Haemoglobin decreased
|
7.5%
3/40
|
0.00%
0/23
|
0.00%
0/6
|
|
Metabolism and nutrition disorders
Dehydration
|
10.0%
4/40
|
17.4%
4/23
|
0.00%
0/6
|
|
Metabolism and nutrition disorders
Hyperglycemia
|
7.5%
3/40
|
4.3%
1/23
|
0.00%
0/6
|
|
Metabolism and nutrition disorders
Hyponatremia
|
5.0%
2/40
|
8.7%
2/23
|
0.00%
0/6
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Malignant neoplasm progressed
|
5.0%
2/40
|
4.3%
1/23
|
0.00%
0/6
|
|
Renal and urinary disorders
renal failure
|
5.0%
2/40
|
0.00%
0/23
|
0.00%
0/6
|
|
Respiratory, thoracic and mediastinal disorders
dyspnea
|
7.5%
3/40
|
0.00%
0/23
|
0.00%
0/6
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
5.0%
2/40
|
0.00%
0/23
|
0.00%
0/6
|
|
Respiratory, thoracic and mediastinal disorders
pulmonary embolism
|
5.0%
2/40
|
8.7%
2/23
|
33.3%
2/6
|
|
Vascular disorders
deep vein thrombosis
|
5.0%
2/40
|
4.3%
1/23
|
16.7%
1/6
|
|
General disorders
Chest pain
|
0.00%
0/40
|
0.00%
0/23
|
16.7%
1/6
|
|
Infections and infestations
Pneumonia
|
0.00%
0/40
|
0.00%
0/23
|
16.7%
1/6
|
|
Vascular disorders
Syncope
|
0.00%
0/40
|
0.00%
0/23
|
33.3%
2/6
|
Other adverse events
| Measure |
Pemetrexed, Cisplatin, and CBP501: Phase 2
n=40 participants at risk
pemetrexed, cisplatin and CBP501
pemetrexed, cisplatin and CBP501: CBP501 for injection is provided in single dose vials (20 mg) containing a sterile lyophilized powder comprising CBP501 peptide acetate salt (peptide base units). For administration, vial contents are reconstituted in 5% Dextrose Injection, USP, and added to a 100 mL IV bag of 5% Dextrose Injection, USP.
Pemetrexed: A commercial formulation of pemetrexed will be used, with reconstitution in 20mL 0.9% sodium chloride solution for injection, then dilution to 100mL.
Cisplatin: A commercial formulation will be used and will be diluted in 250 mL of normal saline for administration.
|
Pemetrexed and Cisplatin: Phase 2
n=23 participants at risk
pemetrexed and cisplatin
pemetrexed and cisplatin: Pemetrexed: A commercial formulation of pemetrexed will be used, with reconstitution in 20mL 0.9% sodium chloride solution for injection, then dilution to 100mL.
Cisplatin: A commercial formulation will be used and will be diluted in 250 mL of normal saline for administration.
|
Pemetrexed, Cisplatin, and CBP501: Phase 1
n=6 participants at risk
DL1: CBP501 16mg/m2, Alimta 500mg/m2, cisplatin 75mg/m2 DL2: CBP501 25mg/m2, Alimta 500mg/m2, cisplatin 75mg/m2
|
|---|---|---|---|
|
Blood and lymphatic system disorders
anemia
|
17.5%
7/40
|
34.8%
8/23
|
50.0%
3/6
|
|
Blood and lymphatic system disorders
leukopenia
|
5.0%
2/40
|
4.3%
1/23
|
0.00%
0/6
|
|
Blood and lymphatic system disorders
lymphopenia
|
12.5%
5/40
|
4.3%
1/23
|
0.00%
0/6
|
|
Blood and lymphatic system disorders
neutropenia
|
5.0%
2/40
|
8.7%
2/23
|
16.7%
1/6
|
|
Ear and labyrinth disorders
tinnitus
|
12.5%
5/40
|
8.7%
2/23
|
0.00%
0/6
|
|
Eye disorders
lacrimation increased
|
5.0%
2/40
|
8.7%
2/23
|
16.7%
1/6
|
|
Eye disorders
vision blurred
|
5.0%
2/40
|
0.00%
0/23
|
16.7%
1/6
|
|
Gastrointestinal disorders
abdominal discomfort
|
5.0%
2/40
|
4.3%
1/23
|
0.00%
0/6
|
|
Gastrointestinal disorders
abdominal distension
|
2.5%
1/40
|
13.0%
3/23
|
33.3%
2/6
|
|
Gastrointestinal disorders
abdominal pain
|
10.0%
4/40
|
4.3%
1/23
|
16.7%
1/6
|
|
Gastrointestinal disorders
constipation
|
52.5%
21/40
|
65.2%
15/23
|
66.7%
4/6
|
|
Gastrointestinal disorders
diarrhea
|
20.0%
8/40
|
17.4%
4/23
|
33.3%
2/6
|
|
Gastrointestinal disorders
dry mouth
|
5.0%
2/40
|
8.7%
2/23
|
0.00%
0/6
|
|
Gastrointestinal disorders
dyspepsia
|
12.5%
5/40
|
8.7%
2/23
|
16.7%
1/6
|
|
Gastrointestinal disorders
nausea
|
60.0%
24/40
|
56.5%
13/23
|
83.3%
5/6
|
|
Gastrointestinal disorders
stomatitis
|
5.0%
2/40
|
4.3%
1/23
|
50.0%
3/6
|
|
Gastrointestinal disorders
vomiting
|
20.0%
8/40
|
39.1%
9/23
|
16.7%
1/6
|
|
General disorders
asthenia
|
5.0%
2/40
|
0.00%
0/23
|
0.00%
0/6
|
|
General disorders
chest discomfort
|
5.0%
2/40
|
4.3%
1/23
|
0.00%
0/6
|
|
General disorders
chest pain
|
17.5%
7/40
|
17.4%
4/23
|
0.00%
0/6
|
|
General disorders
chills
|
5.0%
2/40
|
0.00%
0/23
|
33.3%
2/6
|
|
General disorders
fatigue
|
60.0%
24/40
|
65.2%
15/23
|
83.3%
5/6
|
|
General disorders
infusion related reactions
|
70.0%
28/40
|
0.00%
0/23
|
33.3%
2/6
|
|
General disorders
infusion site rash
|
5.0%
2/40
|
0.00%
0/23
|
0.00%
0/6
|
|
General disorders
mucosal inflammation
|
5.0%
2/40
|
4.3%
1/23
|
0.00%
0/6
|
|
General disorders
oedema peripheral
|
12.5%
5/40
|
26.1%
6/23
|
0.00%
0/6
|
|
General disorders
pain
|
2.5%
1/40
|
8.7%
2/23
|
0.00%
0/6
|
|
General disorders
pyrexia
|
15.0%
6/40
|
13.0%
3/23
|
16.7%
1/6
|
|
Immune system disorders
hypersensitivity
|
0.00%
0/40
|
8.7%
2/23
|
0.00%
0/6
|
|
Infections and infestations
oral candidiasis
|
5.0%
2/40
|
0.00%
0/23
|
0.00%
0/6
|
|
Investigations
blood albumin decreased
|
5.0%
2/40
|
0.00%
0/23
|
0.00%
0/6
|
|
Investigations
blood creatinine increased
|
17.5%
7/40
|
13.0%
3/23
|
16.7%
1/6
|
|
Investigations
blood glucose increased
|
5.0%
2/40
|
0.00%
0/23
|
0.00%
0/6
|
|
Investigations
blood sodium decreased
|
5.0%
2/40
|
0.00%
0/23
|
0.00%
0/6
|
|
Investigations
ECG QT prolonged
|
5.0%
2/40
|
4.3%
1/23
|
16.7%
1/6
|
|
Investigations
hemoglobin decreased
|
17.5%
7/40
|
0.00%
0/23
|
0.00%
0/6
|
|
Investigations
neutrophil count decreased
|
5.0%
2/40
|
0.00%
0/23
|
0.00%
0/6
|
|
Investigations
platelet count decreased
|
7.5%
3/40
|
4.3%
1/23
|
0.00%
0/6
|
|
Investigations
prothrombin time prolonged
|
5.0%
2/40
|
0.00%
0/23
|
0.00%
0/6
|
|
Investigations
weight decreased
|
12.5%
5/40
|
4.3%
1/23
|
0.00%
0/6
|
|
Investigations
WBC decreased
|
10.0%
4/40
|
0.00%
0/23
|
0.00%
0/6
|
|
Metabolism and nutrition disorders
decreased apetite
|
45.0%
18/40
|
52.2%
12/23
|
0.00%
0/6
|
|
Metabolism and nutrition disorders
dehydration
|
15.0%
6/40
|
8.7%
2/23
|
0.00%
0/6
|
|
Metabolism and nutrition disorders
hyperglycemia
|
10.0%
4/40
|
8.7%
2/23
|
0.00%
0/6
|
|
Metabolism and nutrition disorders
hypoalbuminemia
|
5.0%
2/40
|
4.3%
1/23
|
0.00%
0/6
|
|
Metabolism and nutrition disorders
hypokalemia
|
5.0%
2/40
|
4.3%
1/23
|
0.00%
0/6
|
|
Metabolism and nutrition disorders
hypomagnesemia
|
10.0%
4/40
|
17.4%
4/23
|
33.3%
2/6
|
|
Metabolism and nutrition disorders
hyponatremia
|
7.5%
3/40
|
8.7%
2/23
|
16.7%
1/6
|
|
Musculoskeletal and connective tissue disorders
arthralgia
|
5.0%
2/40
|
4.3%
1/23
|
0.00%
0/6
|
|
Musculoskeletal and connective tissue disorders
back pain
|
5.0%
2/40
|
8.7%
2/23
|
16.7%
1/6
|
|
Musculoskeletal and connective tissue disorders
musculoskeletal chest pain
|
20.0%
8/40
|
8.7%
2/23
|
0.00%
0/6
|
|
Musculoskeletal and connective tissue disorders
myalgia
|
5.0%
2/40
|
4.3%
1/23
|
0.00%
0/6
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
cancer pain
|
7.5%
3/40
|
0.00%
0/23
|
0.00%
0/6
|
|
Nervous system disorders
dizziness
|
5.0%
2/40
|
8.7%
2/23
|
33.3%
2/6
|
|
Nervous system disorders
dysgeusia
|
17.5%
7/40
|
13.0%
3/23
|
0.00%
0/6
|
|
Nervous system disorders
Headache
|
12.5%
5/40
|
0.00%
0/23
|
33.3%
2/6
|
|
Nervous system disorders
neurophaty peripheral
|
17.5%
7/40
|
13.0%
3/23
|
50.0%
3/6
|
|
Nervous system disorders
peropheral sensory neuropathy
|
2.5%
1/40
|
13.0%
3/23
|
0.00%
0/6
|
|
Psychiatric disorders
anxiety
|
10.0%
4/40
|
13.0%
3/23
|
0.00%
0/6
|
|
Psychiatric disorders
insomnia
|
5.0%
2/40
|
13.0%
3/23
|
50.0%
3/6
|
|
Renal and urinary disorders
renal failure
|
2.5%
1/40
|
8.7%
2/23
|
16.7%
1/6
|
|
Respiratory, thoracic and mediastinal disorders
cough
|
17.5%
7/40
|
47.8%
11/23
|
83.3%
5/6
|
|
Respiratory, thoracic and mediastinal disorders
dyspnea
|
22.5%
9/40
|
34.8%
8/23
|
50.0%
3/6
|
|
Respiratory, thoracic and mediastinal disorders
epistaxis
|
2.5%
1/40
|
8.7%
2/23
|
16.7%
1/6
|
|
Respiratory, thoracic and mediastinal disorders
hiccups
|
12.5%
5/40
|
17.4%
4/23
|
33.3%
2/6
|
|
Respiratory, thoracic and mediastinal disorders
oropharyngeal pain
|
5.0%
2/40
|
0.00%
0/23
|
0.00%
0/6
|
|
Respiratory, thoracic and mediastinal disorders
pulmonary embolism
|
5.0%
2/40
|
0.00%
0/23
|
0.00%
0/6
|
|
Respiratory, thoracic and mediastinal disorders
rhinitis allergic
|
5.0%
2/40
|
0.00%
0/23
|
0.00%
0/6
|
|
Respiratory, thoracic and mediastinal disorders
rhinorrhea
|
2.5%
1/40
|
13.0%
3/23
|
0.00%
0/6
|
|
Skin and subcutaneous tissue disorders
alopecia
|
5.0%
2/40
|
8.7%
2/23
|
0.00%
0/6
|
|
Skin and subcutaneous tissue disorders
hyperhidrosis
|
5.0%
2/40
|
4.3%
1/23
|
0.00%
0/6
|
|
Skin and subcutaneous tissue disorders
night sweats
|
5.0%
2/40
|
4.3%
1/23
|
33.3%
2/6
|
|
Skin and subcutaneous tissue disorders
pruritus
|
5.0%
2/40
|
4.3%
1/23
|
33.3%
2/6
|
|
Skin and subcutaneous tissue disorders
rash
|
22.5%
9/40
|
4.3%
1/23
|
33.3%
2/6
|
|
Vascular disorders
hypertension
|
12.5%
5/40
|
0.00%
0/23
|
33.3%
2/6
|
|
Vascular disorders
phlebitis
|
5.0%
2/40
|
0.00%
0/23
|
16.7%
1/6
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place