Trial Outcomes & Findings for Study of CGC-11047 (PG-11047) in Subjects With Advanced Refractory Solid Tumors (NCT NCT00705653)
NCT ID: NCT00705653
Last Updated: 2012-03-27
Results Overview
The MTD was defined as the dose below one-third of at least 6 subjects (e.g., 2/6, 3/9, 4/12) experienced a Dose-limiting toxicity (DLT). Dose-limiting toxicities (DLTs) used to determine the MTD had to occur during cycle 1 of treatment and had to be considered related to PG-11047.
COMPLETED
PHASE1
46 participants
The MTD had to occur during cycle 1 of treatment
2012-03-27
Participant Flow
Participant milestones
| Measure |
PG-11047
Multiple-ascending dose of PG-11047 monotherapy. 60 minute infusion on days 1, 8 and 15 of a 28 day cycle. Dosage was escalated from 50 mg to 750 mg
|
|---|---|
|
Overall Study
STARTED
|
46
|
|
Overall Study
COMPLETED
|
46
|
|
Overall Study
NOT COMPLETED
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Study of CGC-11047 (PG-11047) in Subjects With Advanced Refractory Solid Tumors
Baseline characteristics by cohort
| Measure |
PG-11047
n=46 Participants
Multiple-ascending dose of PG-11047 monotherapy. 60 minute infusion on days 1, 8 and 15 of a 28 day cycle. Dosage was escalated from 50 mg to 750 mg
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
46 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
|
Age Continuous
|
61.2 years
STANDARD_DEVIATION 11.0 • n=5 Participants
|
|
Sex: Female, Male
Female
|
18 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
28 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
46 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: The MTD had to occur during cycle 1 of treatmentThe MTD was defined as the dose below one-third of at least 6 subjects (e.g., 2/6, 3/9, 4/12) experienced a Dose-limiting toxicity (DLT). Dose-limiting toxicities (DLTs) used to determine the MTD had to occur during cycle 1 of treatment and had to be considered related to PG-11047.
Outcome measures
| Measure |
PG-11047
n=46 Participants
Multiple-ascending dose of PG-11047 monotherapy. 60 minute infusion on days 1, 8 and 15 of a 28 day cycle. Dosage was escalated from 50 mg to 750 mg
|
|---|---|
|
Maximum Tolerated Dose (MTD)
|
610 mg
|
SECONDARY outcome
Timeframe: For the purposes of this study, patients were reevaluated radiologically every 8 weeks. In addition to a baseline scan, confirmatory scans were obtained 6-8 weeks following initial documentation of an objective response, when appropriate.Population: Patients with non-missing overall response
As per RECIST Criteria (V 1.0) by radiologic evaluations: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR) \>= 30% decrease in the sum of the longest diameter (LD) of target lesions, taking as reference the baseline sum LD; Progressive Disease (PD), \>= 20% increase in the sum of the LD of target lesions, taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions; Stable Disease (SD), neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD.
Outcome measures
| Measure |
PG-11047
n=30 Participants
Multiple-ascending dose of PG-11047 monotherapy. 60 minute infusion on days 1, 8 and 15 of a 28 day cycle. Dosage was escalated from 50 mg to 750 mg
|
|---|---|
|
Preliminary Efficacy
|
30 percentage (of participants)
|
Adverse Events
PG-11047
Serious adverse events
| Measure |
PG-11047
n=46 participants at risk
Multiple-ascending dose of PG-11047 monotherapy. 60 minute infusion on days 1, 8 and 15 of a 28 day cycle. Dosage was escalated from 50 mg to 750 mg
|
|---|---|
|
Gastrointestinal disorders
Abdominal pain
|
6.5%
3/46 • Number of events 3
|
|
Nervous system disorders
Alteration in mental status
|
2.2%
1/46 • Number of events 1
|
|
Blood and lymphatic system disorders
Anemia
|
4.3%
2/46 • Number of events 2
|
|
Skin and subcutaneous tissue disorders
Angioedema
|
2.2%
1/46 • Number of events 1
|
|
Infections and infestations
Aspiration pneumonitis
|
2.2%
1/46 • Number of events 1
|
|
Gastrointestinal disorders
Bowel obstruction
|
8.7%
4/46 • Number of events 5
|
|
Cardiac disorders
Bradycardia
|
2.2%
1/46 • Number of events 1
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Brain metastases
|
2.2%
1/46 • Number of events 1
|
|
Musculoskeletal and connective tissue disorders
Chest pain
|
2.2%
1/46 • Number of events 1
|
|
Nervous system disorders
Confusion
|
2.2%
1/46 • Number of events 1
|
|
Gastrointestinal disorders
Constipation
|
2.2%
1/46 • Number of events 1
|
|
Gastrointestinal disorders
Diarrhea
|
2.2%
1/46 • Number of events 1
|
|
Gastrointestinal disorders
Duodenal stricture
|
2.2%
1/46 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
15.2%
7/46 • Number of events 7
|
|
Investigations
Elevated amylase
|
2.2%
1/46 • Number of events 1
|
|
Investigations
Elevated bilirubin
|
2.2%
1/46 • Number of events 2
|
|
Investigations
Elevated lipase
|
2.2%
1/46 • Number of events 1
|
|
General disorders
Fatigue
|
2.2%
1/46 • Number of events 1
|
|
Gastrointestinal disorders
GI bleed
|
2.2%
1/46 • Number of events 1
|
|
Infections and infestations
Gram negative bacteremia
|
2.2%
1/46 • Number of events 1
|
|
Infections and infestations
Infection
|
2.2%
1/46 • Number of events 1
|
|
General disorders
Nausea
|
4.3%
2/46 • Number of events 2
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
2.2%
1/46 • Number of events 1
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Progressive disease
|
6.5%
3/46 • Number of events 3
|
|
Cardiac disorders
Pulmonary embolism
|
2.2%
1/46 • Number of events 1
|
|
Skin and subcutaneous tissue disorders
Rash
|
2.2%
1/46 • Number of events 1
|
|
Musculoskeletal and connective tissue disorders
Right arm pain
|
2.2%
1/46 • Number of events 1
|
|
General disorders
Vomitting
|
4.3%
2/46 • Number of events 3
|
Other adverse events
| Measure |
PG-11047
n=46 participants at risk
Multiple-ascending dose of PG-11047 monotherapy. 60 minute infusion on days 1, 8 and 15 of a 28 day cycle. Dosage was escalated from 50 mg to 750 mg
|
|---|---|
|
Gastrointestinal disorders
Constipation
|
6.5%
3/46 • Number of events 3
|
|
General disorders
Dizziness
|
8.7%
4/46 • Number of events 4
|
|
General disorders
Fatigue
|
34.8%
16/46 • Number of events 24
|
|
Cardiac disorders
Hypotension
|
17.4%
8/46 • Number of events 8
|
|
Gastrointestinal disorders
Mucosal Inflammation
|
26.1%
12/46 • Number of events 14
|
|
Gastrointestinal disorders
Nausea
|
28.3%
13/46 • Number of events 14
|
|
Nervous system disorders
Paraesthesia Oral
|
6.5%
3/46 • Number of events 3
|
|
Nervous system disorders
Parasethesia
|
10.9%
5/46 • Number of events 5
|
|
Gastrointestinal disorders
Vomiting
|
8.7%
4/46 • Number of events 4
|
|
Blood and lymphatic system disorders
anemia
|
19.6%
9/46 • Number of events 11
|
|
Metabolism and nutrition disorders
anorexia
|
21.7%
10/46 • Number of events 12
|
|
Respiratory, thoracic and mediastinal disorders
dysponea
|
8.7%
4/46 • Number of events 7
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee Any formal presentation or publication of data collected from this trial will be considered as a joint publication by the investigator(s) and the appropriate personnel of Progen. Authorship will be determined by mutual agreement.
- Publication restrictions are in place
Restriction type: OTHER