Trial Outcomes & Findings for Study of CGC-11047 When Used in Individual Combinations With 1) Gemcitabine or 2) Docetaxel or 3) Bevacizumab or 4) Erlotinib or 5) Cisplatin or 6) 5-Flurouracil or 7) Sunitinib in Patients With Advanced Solid Tumors or Lymphoma (NCT NCT00705874)
NCT ID: NCT00705874
Last Updated: 2016-07-21
Results Overview
The MTD was defined as the dose below which one-third of at least 6 patients (2/6) experienced a dose limiting toxicity (DLT). DLTs had to occur during cycle 1 of treatment and had to be considered related to PG-11047: 1. Any nonhematologic toxicity \> Grade 3 lasting \> 3 days 2. Grade 4 thrombocytopenia 3. Grade 4 Anemia on the next scheduled dosing day 4. Grade 4 Neutropenia (lasting \> than 5 days 5. Any febrile neutropenia (Grade 3 or 4)) 6. Inability to receive all scheduled doses of PG-11047 during the first dosing cycle due to drug related toxicity
Recruitment status
COMPLETED
Study phase
PHASE1
Target enrollment
172 participants
Primary outcome timeframe
End of Study
Results posted on
2016-07-21
Participant Flow
The recruitment period was June 2006 through March 2011, with last patient being treated May 2011. Patients were recruited through oncology clinics.
There was no run-in phase. Patients were assigned to treatment arm based on their cancer type and which standard of care therapy was appropriate based on Investigators' discreation.
Participant milestones
| Measure |
PG11047/Gemcitabine
PG-11047 (infusion on Days 1 and 15 of each cycle) in combination with Gemcitabine (1,000 mg/m2 administered IV over 30 minutes on Days 1, 8 and 15 of a 28-day cycle).
|
PG11047/Docetaxel
PG-11047 (infusion on Day 1 of each 21 day cycle) in combination with Docetaxel (75 mg/m2 administered IV over 60 minutes every 21 days).
|
PG11047/Bevacizumab
PG-11047 (infusion on Days 1, 8 and 15 of a 28 day cycle) in combination with Bevacizumab (5 mg/kg administered IV once every 14 days).
|
PG11047/Erlotinib
PG-11047 (infusion on Days 1, 8 and 15 of a 28 day cycle) in combination with Erlotinib (150 mg taken orally every day of each 28-day cycle).
|
PG11047/Cisplatin
Cisplatin: 80 mg/m2 administered IV over 1 hour once every 28 days. PG-11047 will be administered by infusion on Days 1, 8 and 15 of a 28 day cycle.
|
PG11047/5-Flurouracil
PG-11047 (infusion on Days 1, 8 and 15 of a 28 day cycle) in combination with 5-Flurouracil / Leucovorin (Leucovorin 500 mg/m2 IV over 2 hours with 5 - FU 500 mg/m2 IV bolus starting 1 hour into leucovorin infusion weekly for 6 weeks, repeated every 56 days).
|
PG11047/Sunitinib
PG-11047 (infusion on Days 1 and 8 of a 21 day cycle) in combination with Sunitinib (50 mg orally once daily, 4 weeks on treatment followed by 2 weeks off (42 day cycle)).
|
|---|---|---|---|---|---|---|---|
|
Overall Study
STARTED
|
12
|
9
|
34
|
34
|
48
|
32
|
3
|
|
Overall Study
COMPLETED
|
10
|
8
|
32
|
33
|
36
|
28
|
3
|
|
Overall Study
NOT COMPLETED
|
2
|
1
|
2
|
1
|
12
|
4
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Study of CGC-11047 When Used in Individual Combinations With 1) Gemcitabine or 2) Docetaxel or 3) Bevacizumab or 4) Erlotinib or 5) Cisplatin or 6) 5-Flurouracil or 7) Sunitinib in Patients With Advanced Solid Tumors or Lymphoma
Baseline characteristics by cohort
| Measure |
PG11047/Gemcitabine
n=12 Participants
PG-11047 (infusion on Days 1 and 15 of each cycle) in combination with Gemcitabine (1,000 mg/m2 administered IV over 30 minutes on Days 1, 8 and 15 of a 28-day cycle).
|
PG11047/Docetaxel
n=9 Participants
PG-11047 (infusion on Day 1 of each 21 day cycle) in combination with Docetaxel (75 mg/m2 administered IV over 60 minutes every 21 days).
|
PG11047/Bevacizumab
n=34 Participants
PG-11047 (infusion on Days 1, 8 and 15 of a 28 day cycle) in combination with Bevacizumab (5 mg/kg administered IV once every 14 days).
|
PG11047/Erlotinib
n=34 Participants
PG-11047 (infusion on Days 1, 8 and 15 of a 28 day cycle) in combination with Erlotinib (150 mg taken orally every day of each 28-day cycle).
|
PG11047/Cisplatin
n=48 Participants
Cisplatin: 80 mg/m2 administered IV over 1 hour once every 28 days. PG-11047 will be administered by infusion on Days 1, 8 and 15 of a 28 day cycle.
|
PG11047/5-Flurouracil
n=32 Participants
PG-11047 (infusion on Days 1, 8 and 15 of a 28 day cycle) in combination with 5-Flurouracil / Leucovorin (Leucovorin 500 mg/m2 IV over 2 hours with 5 - FU 500 mg/m2 IV bolus starting 1 hour into leucovorin infusion weekly for 6 weeks, repeated every 56 days).
|
PG11047/Sunitinib
n=3 Participants
PG-11047 (infusion on Days 1 and 8 of a 21 day cycle) in combination with Sunitinib (50 mg orally once daily, 4 weeks on treatment followed by 2 weeks off (42 day cycle)).
|
Total
n=172 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|---|---|
|
Age, Categorical
>=65 years
|
4 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
8 Participants
n=5 Participants
|
14 Participants
n=4 Participants
|
17 Participants
n=21 Participants
|
12 Participants
n=10 Participants
|
2 Participants
n=115 Participants
|
62 Participants
n=24 Participants
|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=115 Participants
|
0 Participants
n=24 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
8 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
26 Participants
n=5 Participants
|
20 Participants
n=4 Participants
|
31 Participants
n=21 Participants
|
20 Participants
n=10 Participants
|
1 Participants
n=115 Participants
|
110 Participants
n=24 Participants
|
|
Age, Continuous
|
58.3 years
STANDARD_DEVIATION 10.8 • n=5 Participants
|
63.2 years
STANDARD_DEVIATION 13.1 • n=7 Participants
|
56.3 years
STANDARD_DEVIATION 12.8 • n=5 Participants
|
62.8 years
STANDARD_DEVIATION 11.0 • n=4 Participants
|
59.8 years
STANDARD_DEVIATION 10.1 • n=21 Participants
|
60.2 years
STANDARD_DEVIATION 12.2 • n=10 Participants
|
60.0 years
STANDARD_DEVIATION 24.4 • n=115 Participants
|
59.8 years
STANDARD_DEVIATION 11.7 • n=24 Participants
|
|
Sex: Female, Male
Female
|
7 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
15 Participants
n=5 Participants
|
18 Participants
n=4 Participants
|
19 Participants
n=21 Participants
|
14 Participants
n=10 Participants
|
2 Participants
n=115 Participants
|
80 Participants
n=24 Participants
|
|
Sex: Female, Male
Male
|
5 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
19 Participants
n=5 Participants
|
16 Participants
n=4 Participants
|
29 Participants
n=21 Participants
|
18 Participants
n=10 Participants
|
1 Participants
n=115 Participants
|
92 Participants
n=24 Participants
|
|
Region of Enrollment
United States
|
12 participants
n=5 Participants
|
9 participants
n=7 Participants
|
34 participants
n=5 Participants
|
34 participants
n=4 Participants
|
48 participants
n=21 Participants
|
32 participants
n=10 Participants
|
3 participants
n=115 Participants
|
172 participants
n=24 Participants
|
PRIMARY outcome
Timeframe: End of StudyPopulation: Cohorts comprised 3 patients. When a patient experienced a treatment related toxicity qualifying as a DLT, up to 3 additional patients were to be enrolled at that dose. Patients who completed cycle 1 per protocol were evaluable.
The MTD was defined as the dose below which one-third of at least 6 patients (2/6) experienced a dose limiting toxicity (DLT). DLTs had to occur during cycle 1 of treatment and had to be considered related to PG-11047: 1. Any nonhematologic toxicity \> Grade 3 lasting \> 3 days 2. Grade 4 thrombocytopenia 3. Grade 4 Anemia on the next scheduled dosing day 4. Grade 4 Neutropenia (lasting \> than 5 days 5. Any febrile neutropenia (Grade 3 or 4)) 6. Inability to receive all scheduled doses of PG-11047 during the first dosing cycle due to drug related toxicity
Outcome measures
| Measure |
PG11047/Gemcitabine
n=12 Participants
PG-11047 in combination with Gemcitabine
|
PG11047/Docetaxel
n=9 Participants
PG-11047 in combination with Docetaxel
|
PG11047/Bevacizumab
n=34 Participants
PG-11047 in combination with Bevacizumab
|
PG11047/Erlotinib
n=34 Participants
PG-11047 in combination with Erlotinib
|
PG11047/Cisplatin
n=48 Participants
Cisplatin: 80 mg/m2 administered IV over 1 hour once every 28 days. PG-11047 will be administered on Days 1, 8 and 15 of a 28 day cycle.
|
PG11047/5-Flurouracil
n=32 Participants
CGC-11047 in combination with 5-Flurouracil / Leucovorin
|
PG11047/Sunitinib
n=3 Participants
PG-11047 in combination with Sunitinib.
The MTD of PG-11047 was undetermineable due to only 2 evaluable patients in this treatment group
|
|---|---|---|---|---|---|---|---|
|
Maximum Tolerated Dose (MTD)
|
NA mg
MTD not determined due to toxicities leading to study arm being prematurely stopped.
|
NA mg
MTD not determined due to toxicities leading to study arm being prematurely stopped.
|
590 mg
|
590 mg
|
590 mg
|
590 mg
|
NA mg
MTD not determined due to toxicities leading to study arm being prematurely stopped.
|
SECONDARY outcome
Timeframe: OngoingOutcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: End of StudyOutcome measures
Outcome data not reported
Adverse Events
PG11047/Gemcitabine
Serious events: 7 serious events
Other events: 5 other events
Deaths: 0 deaths
PG11047/Docetaxel
Serious events: 5 serious events
Other events: 8 other events
Deaths: 0 deaths
PG11047/Bevacizumab
Serious events: 11 serious events
Other events: 15 other events
Deaths: 0 deaths
PG11047/Erlotinib
Serious events: 13 serious events
Other events: 22 other events
Deaths: 0 deaths
PG11047/Cisplatin
Serious events: 22 serious events
Other events: 31 other events
Deaths: 0 deaths
PG11047/5-Flurouracil
Serious events: 18 serious events
Other events: 16 other events
Deaths: 0 deaths
PG11047/Sunitinib
Serious events: 1 serious events
Other events: 3 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
PG11047/Gemcitabine
n=12 participants at risk
PG-11047 (infusion on Days 1 and 15 of each cycle) in combination with Gemcitabine (1,000 mg/m2 administered IV over 30 minutes on Days 1, 8 and 15 of a 28-day cycle).
|
PG11047/Docetaxel
n=9 participants at risk
PG-11047 (infusion on Day 1 of each 21 day cycle) in combination with Docetaxel (75 mg/m2 administered IV over 60 minutes every 21 days).
|
PG11047/Bevacizumab
n=34 participants at risk
PG-11047 (infusion on Days 1, 8 and 15 of a 28 day cycle) in combination with Bevacizumab (5 mg/kg administered IV once every 14 days).
|
PG11047/Erlotinib
n=34 participants at risk
PG-11047 (infusion on Days 1, 8 and 15 of a 28 day cycle) in combination with Erlotinib (150 mg taken orally every day of each 28-day cycle).
|
PG11047/Cisplatin
n=48 participants at risk
Cisplatin: 80 mg/m2 administered IV over 1 hour once every 28 days. PG-11047 will be administered by infusion on Days 1, 8 and 15 of a 28 day cycle.
|
PG11047/5-Flurouracil
n=32 participants at risk
PG-11047 (infusion on Days 1, 8 and 15 of a 28 day cycle) in combination with 5-Flurouracil / Leucovorin (Leucovorin 500 mg/m2 IV over 2 hours with 5 - FU 500 mg/m2 IV bolus starting 1 hour into leucovorin infusion weekly for 6 weeks, repeated every 56 days).
|
PG11047/Sunitinib
n=3 participants at risk
PG-11047 (infusion on Days 1 and 8 of a 21 day cycle) in combination with Sunitinib (50 mg orally once daily, 4 weeks on treatment followed by 2 weeks off (42 day cycle)).
|
|---|---|---|---|---|---|---|---|
|
Gastrointestinal disorders
Nausea
|
25.0%
3/12 • Number of events 3
|
0.00%
0/9
|
5.9%
2/34 • Number of events 2
|
0.00%
0/34
|
2.1%
1/48 • Number of events 1
|
6.2%
2/32 • Number of events 2
|
0.00%
0/3
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Disease progression
|
16.7%
2/12 • Number of events 2
|
0.00%
0/9
|
8.8%
3/34 • Number of events 3
|
5.9%
2/34 • Number of events 2
|
8.3%
4/48 • Number of events 4
|
15.6%
5/32 • Number of events 5
|
0.00%
0/3
|
|
Metabolism and nutrition disorders
Dehydration
|
16.7%
2/12 • Number of events 2
|
0.00%
0/9
|
5.9%
2/34 • Number of events 2
|
5.9%
2/34 • Number of events 2
|
4.2%
2/48 • Number of events 2
|
9.4%
3/32 • Number of events 3
|
0.00%
0/3
|
|
Nervous system disorders
Altered mental status
|
8.3%
1/12 • Number of events 1
|
0.00%
0/9
|
0.00%
0/34
|
2.9%
1/34 • Number of events 1
|
2.1%
1/48 • Number of events 1
|
0.00%
0/32
|
0.00%
0/3
|
|
Gastrointestinal disorders
Vomitting
|
16.7%
2/12 • Number of events 2
|
0.00%
0/9
|
2.9%
1/34 • Number of events 1
|
0.00%
0/34
|
6.2%
3/48 • Number of events 3
|
9.4%
3/32 • Number of events 3
|
0.00%
0/3
|
|
Gastrointestinal disorders
Diarrhea
|
8.3%
1/12 • Number of events 1
|
0.00%
0/9
|
0.00%
0/34
|
0.00%
0/34
|
0.00%
0/48
|
3.1%
1/32 • Number of events 1
|
0.00%
0/3
|
|
General disorders
Uncontrolled pain
|
16.7%
2/12 • Number of events 2
|
0.00%
0/9
|
0.00%
0/34
|
0.00%
0/34
|
0.00%
0/48
|
0.00%
0/32
|
0.00%
0/3
|
|
Gastrointestinal disorders
Right upper quadrant pain
|
8.3%
1/12 • Number of events 1
|
0.00%
0/9
|
0.00%
0/34
|
0.00%
0/34
|
0.00%
0/48
|
0.00%
0/32
|
0.00%
0/3
|
|
General disorders
Right lower chest pain
|
8.3%
1/12 • Number of events 1
|
0.00%
0/9
|
0.00%
0/34
|
0.00%
0/34
|
0.00%
0/48
|
0.00%
0/32
|
0.00%
0/3
|
|
Infections and infestations
Bacteremia
|
16.7%
2/12 • Number of events 2
|
0.00%
0/9
|
0.00%
0/34
|
0.00%
0/34
|
0.00%
0/48
|
3.1%
1/32 • Number of events 1
|
0.00%
0/3
|
|
Gastrointestinal disorders
Partial bowel obstruction
|
8.3%
1/12 • Number of events 1
|
0.00%
0/9
|
0.00%
0/34
|
0.00%
0/34
|
0.00%
0/48
|
0.00%
0/32
|
0.00%
0/3
|
|
Blood and lymphatic system disorders
Neutropenia
|
0.00%
0/12
|
22.2%
2/9 • Number of events 2
|
0.00%
0/34
|
0.00%
0/34
|
0.00%
0/48
|
0.00%
0/32
|
0.00%
0/3
|
|
Gastrointestinal disorders
Abdominal pain
|
0.00%
0/12
|
11.1%
1/9 • Number of events 1
|
2.9%
1/34 • Number of events 1
|
5.9%
2/34 • Number of events 2
|
2.1%
1/48 • Number of events 1
|
3.1%
1/32 • Number of events 1
|
0.00%
0/3
|
|
Gastrointestinal disorders
Small bowel obstruction
|
8.3%
1/12 • Number of events 1
|
0.00%
0/9
|
8.8%
3/34 • Number of events 3
|
2.9%
1/34 • Number of events 1
|
2.1%
1/48 • Number of events 2
|
6.2%
2/32 • Number of events 2
|
0.00%
0/3
|
|
Blood and lymphatic system disorders
Neutroponic fever
|
0.00%
0/12
|
11.1%
1/9 • Number of events 1
|
0.00%
0/34
|
0.00%
0/34
|
0.00%
0/48
|
3.1%
1/32 • Number of events 1
|
0.00%
0/3
|
|
Vascular disorders
Deep vain thrombosis
|
0.00%
0/12
|
11.1%
1/9 • Number of events 1
|
0.00%
0/34
|
0.00%
0/34
|
2.1%
1/48 • Number of events 1
|
0.00%
0/32
|
0.00%
0/3
|
|
Infections and infestations
Cellulitis
|
0.00%
0/12
|
0.00%
0/9
|
2.9%
1/34 • Number of events 2
|
0.00%
0/34
|
0.00%
0/48
|
0.00%
0/32
|
0.00%
0/3
|
|
Cardiac disorders
Myocardial infarction
|
0.00%
0/12
|
0.00%
0/9
|
2.9%
1/34 • Number of events 1
|
0.00%
0/34
|
0.00%
0/48
|
0.00%
0/32
|
0.00%
0/3
|
|
Infections and infestations
Infection with normal ANC
|
0.00%
0/12
|
0.00%
0/9
|
2.9%
1/34 • Number of events 1
|
0.00%
0/34
|
0.00%
0/48
|
0.00%
0/32
|
0.00%
0/3
|
|
Cardiac disorders
Superventricular tachycardia
|
0.00%
0/12
|
0.00%
0/9
|
2.9%
1/34 • Number of events 1
|
0.00%
0/34
|
2.1%
1/48 • Number of events 1
|
0.00%
0/32
|
0.00%
0/3
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
0.00%
0/12
|
0.00%
0/9
|
2.9%
1/34 • Number of events 1
|
5.9%
2/34 • Number of events 2
|
4.2%
2/48 • Number of events 2
|
3.1%
1/32 • Number of events 1
|
0.00%
0/3
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
0.00%
0/12
|
0.00%
0/9
|
2.9%
1/34 • Number of events 2
|
0.00%
0/34
|
0.00%
0/48
|
6.2%
2/32 • Number of events 2
|
0.00%
0/3
|
|
Musculoskeletal and connective tissue disorders
Pain right hip
|
0.00%
0/12
|
0.00%
0/9
|
2.9%
1/34 • Number of events 1
|
0.00%
0/34
|
0.00%
0/48
|
0.00%
0/32
|
0.00%
0/3
|
|
General disorders
Failure to thrive
|
0.00%
0/12
|
0.00%
0/9
|
2.9%
1/34 • Number of events 1
|
0.00%
0/34
|
0.00%
0/48
|
0.00%
0/32
|
0.00%
0/3
|
|
Renal and urinary disorders
Acute renal failure
|
0.00%
0/12
|
0.00%
0/9
|
0.00%
0/34
|
8.8%
3/34 • Number of events 3
|
8.3%
4/48 • Number of events 5
|
6.2%
2/32 • Number of events 2
|
0.00%
0/3
|
|
Gastrointestinal disorders
Colitis
|
0.00%
0/12
|
0.00%
0/9
|
0.00%
0/34
|
0.00%
0/34
|
2.1%
1/48 • Number of events 1
|
3.1%
1/32 • Number of events 1
|
0.00%
0/3
|
|
Respiratory, thoracic and mediastinal disorders
Hemoptysis
|
0.00%
0/12
|
0.00%
0/9
|
0.00%
0/34
|
0.00%
0/34
|
2.1%
1/48 • Number of events 1
|
0.00%
0/32
|
0.00%
0/3
|
|
Investigations
Elevated creatinine
|
0.00%
0/12
|
0.00%
0/9
|
0.00%
0/34
|
0.00%
0/34
|
2.1%
1/48 • Number of events 1
|
0.00%
0/32
|
0.00%
0/3
|
|
General disorders
Weakness
|
0.00%
0/12
|
0.00%
0/9
|
0.00%
0/34
|
0.00%
0/34
|
6.2%
3/48 • Number of events 3
|
0.00%
0/32
|
0.00%
0/3
|
|
Respiratory, thoracic and mediastinal disorders
Aspiration
|
0.00%
0/12
|
0.00%
0/9
|
0.00%
0/34
|
0.00%
0/34
|
2.1%
1/48 • Number of events 1
|
3.1%
1/32 • Number of events 1
|
0.00%
0/3
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory arrest
|
0.00%
0/12
|
0.00%
0/9
|
0.00%
0/34
|
2.9%
1/34 • Number of events 1
|
4.2%
2/48 • Number of events 2
|
6.2%
2/32 • Number of events 2
|
0.00%
0/3
|
|
Cardiac disorders
Atrial flutter
|
0.00%
0/12
|
0.00%
0/9
|
0.00%
0/34
|
2.9%
1/34 • Number of events 1
|
2.1%
1/48 • Number of events 1
|
0.00%
0/32
|
0.00%
0/3
|
|
Gastrointestinal disorders
Bowel obstruction
|
0.00%
0/12
|
0.00%
0/9
|
0.00%
0/34
|
0.00%
0/34
|
2.1%
1/48 • Number of events 1
|
3.1%
1/32 • Number of events 1
|
0.00%
0/3
|
|
Surgical and medical procedures
Oversedation
|
0.00%
0/12
|
0.00%
0/9
|
0.00%
0/34
|
0.00%
0/34
|
2.1%
1/48 • Number of events 1
|
0.00%
0/32
|
0.00%
0/3
|
|
Nervous system disorders
Encephalopathy
|
0.00%
0/12
|
0.00%
0/9
|
0.00%
0/34
|
0.00%
0/34
|
4.2%
2/48 • Number of events 2
|
0.00%
0/32
|
0.00%
0/3
|
|
Hepatobiliary disorders
Hepatic failure
|
0.00%
0/12
|
0.00%
0/9
|
0.00%
0/34
|
0.00%
0/34
|
2.1%
1/48 • Number of events 1
|
0.00%
0/32
|
0.00%
0/3
|
|
General disorders
Unresponsive
|
0.00%
0/12
|
0.00%
0/9
|
0.00%
0/34
|
0.00%
0/34
|
2.1%
1/48 • Number of events 1
|
0.00%
0/32
|
0.00%
0/3
|
|
General disorders
Death
|
0.00%
0/12
|
0.00%
0/9
|
0.00%
0/34
|
0.00%
0/34
|
2.1%
1/48 • Number of events 1
|
0.00%
0/32
|
0.00%
0/3
|
|
Hepatobiliary disorders
Jaundice
|
0.00%
0/12
|
0.00%
0/9
|
0.00%
0/34
|
0.00%
0/34
|
2.1%
1/48 • Number of events 1
|
0.00%
0/32
|
0.00%
0/3
|
|
Hepatobiliary disorders
Biliary obstruction
|
0.00%
0/12
|
0.00%
0/9
|
0.00%
0/34
|
0.00%
0/34
|
2.1%
1/48 • Number of events 1
|
0.00%
0/32
|
0.00%
0/3
|
|
Investigations
Elevated bilirubin
|
0.00%
0/12
|
0.00%
0/9
|
0.00%
0/34
|
2.9%
1/34 • Number of events 1
|
2.1%
1/48 • Number of events 1
|
0.00%
0/32
|
0.00%
0/3
|
|
General disorders
Asthenia
|
0.00%
0/12
|
0.00%
0/9
|
0.00%
0/34
|
0.00%
0/34
|
2.1%
1/48 • Number of events 1
|
0.00%
0/32
|
0.00%
0/3
|
|
Cardiac disorders
Pulmonary embolism
|
0.00%
0/12
|
0.00%
0/9
|
0.00%
0/34
|
5.9%
2/34 • Number of events 2
|
4.2%
2/48 • Number of events 2
|
0.00%
0/32
|
0.00%
0/3
|
|
Metabolism and nutrition disorders
Hypercalcemia
|
0.00%
0/12
|
0.00%
0/9
|
0.00%
0/34
|
0.00%
0/34
|
2.1%
1/48 • Number of events 1
|
0.00%
0/32
|
0.00%
0/3
|
|
Nervous system disorders
Headache
|
0.00%
0/12
|
0.00%
0/9
|
0.00%
0/34
|
0.00%
0/34
|
2.1%
1/48 • Number of events 1
|
0.00%
0/32
|
0.00%
0/3
|
|
Blood and lymphatic system disorders
Anemia
|
0.00%
0/12
|
0.00%
0/9
|
0.00%
0/34
|
0.00%
0/34
|
4.2%
2/48 • Number of events 2
|
0.00%
0/32
|
0.00%
0/3
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
0.00%
0/12
|
0.00%
0/9
|
0.00%
0/34
|
0.00%
0/34
|
2.1%
1/48 • Number of events 1
|
3.1%
1/32 • Number of events 1
|
0.00%
0/3
|
|
Nervous system disorders
Increased confusion
|
0.00%
0/12
|
0.00%
0/9
|
0.00%
0/34
|
0.00%
0/34
|
2.1%
1/48 • Number of events 1
|
3.1%
1/32 • Number of events 1
|
0.00%
0/3
|
|
Surgical and medical procedures
Tracheostomy
|
0.00%
0/12
|
0.00%
0/9
|
0.00%
0/34
|
0.00%
0/34
|
2.1%
1/48 • Number of events 1
|
0.00%
0/32
|
0.00%
0/3
|
|
Surgical and medical procedures
Post operative trachea hemorrhage
|
0.00%
0/12
|
0.00%
0/9
|
0.00%
0/34
|
0.00%
0/34
|
2.1%
1/48 • Number of events 1
|
0.00%
0/32
|
0.00%
0/3
|
|
Immune system disorders
Hypersensitivity allergic reaction
|
0.00%
0/12
|
0.00%
0/9
|
0.00%
0/34
|
0.00%
0/34
|
2.1%
1/48 • Number of events 1
|
0.00%
0/32
|
0.00%
0/3
|
|
Renal and urinary disorders
Ureteral obstruction
|
0.00%
0/12
|
0.00%
0/9
|
0.00%
0/34
|
0.00%
0/34
|
2.1%
1/48 • Number of events 1
|
0.00%
0/32
|
0.00%
0/3
|
|
Nervous system disorders
Syncope
|
0.00%
0/12
|
0.00%
0/9
|
0.00%
0/34
|
0.00%
0/34
|
2.1%
1/48 • Number of events 1
|
3.1%
1/32 • Number of events 1
|
0.00%
0/3
|
|
Cardiac disorders
Cardiac arrest
|
0.00%
0/12
|
0.00%
0/9
|
0.00%
0/34
|
0.00%
0/34
|
2.1%
1/48 • Number of events 2
|
0.00%
0/32
|
0.00%
0/3
|
|
Blood and lymphatic system disorders
Coagulopathy
|
0.00%
0/12
|
0.00%
0/9
|
0.00%
0/34
|
2.9%
1/34 • Number of events 1
|
2.1%
1/48 • Number of events 1
|
0.00%
0/32
|
0.00%
0/3
|
|
Metabolism and nutrition disorders
Hypocalcemia
|
0.00%
0/12
|
0.00%
0/9
|
0.00%
0/34
|
0.00%
0/34
|
2.1%
1/48 • Number of events 1
|
0.00%
0/32
|
0.00%
0/3
|
|
General disorders
Multi-organ failure
|
0.00%
0/12
|
0.00%
0/9
|
0.00%
0/34
|
2.9%
1/34 • Number of events 1
|
2.1%
1/48 • Number of events 1
|
3.1%
1/32 • Number of events 1
|
0.00%
0/3
|
|
Infections and infestations
Sepsis
|
0.00%
0/12
|
0.00%
0/9
|
0.00%
0/34
|
0.00%
0/34
|
0.00%
0/48
|
6.2%
2/32 • Number of events 3
|
0.00%
0/3
|
|
Metabolism and nutrition disorders
Hypokalemia
|
0.00%
0/12
|
0.00%
0/9
|
0.00%
0/34
|
0.00%
0/34
|
0.00%
0/48
|
3.1%
1/32 • Number of events 1
|
0.00%
0/3
|
|
Gastrointestinal disorders
GI bleed
|
0.00%
0/12
|
0.00%
0/9
|
0.00%
0/34
|
0.00%
0/34
|
0.00%
0/48
|
3.1%
1/32 • Number of events 1
|
0.00%
0/3
|
|
Vascular disorders
Hypotension
|
0.00%
0/12
|
0.00%
0/9
|
0.00%
0/34
|
0.00%
0/34
|
0.00%
0/48
|
3.1%
1/32 • Number of events 1
|
0.00%
0/3
|
|
Metabolism and nutrition disorders
Metabolic acidosis
|
0.00%
0/12
|
0.00%
0/9
|
0.00%
0/34
|
0.00%
0/34
|
0.00%
0/48
|
3.1%
1/32 • Number of events 1
|
0.00%
0/3
|
|
Respiratory, thoracic and mediastinal disorders
Bronchospasm
|
0.00%
0/12
|
0.00%
0/9
|
0.00%
0/34
|
0.00%
0/34
|
0.00%
0/48
|
3.1%
1/32 • Number of events 1
|
0.00%
0/3
|
|
Gastrointestinal disorders
Intestinal ileus
|
0.00%
0/12
|
0.00%
0/9
|
0.00%
0/34
|
0.00%
0/34
|
0.00%
0/48
|
3.1%
1/32 • Number of events 1
|
0.00%
0/3
|
|
Blood and lymphatic system disorders
Volume depletion
|
0.00%
0/12
|
0.00%
0/9
|
0.00%
0/34
|
2.9%
1/34 • Number of events 1
|
0.00%
0/48
|
6.2%
2/32 • Number of events 2
|
0.00%
0/3
|
|
Gastrointestinal disorders
Ogilvie syndrome
|
0.00%
0/12
|
0.00%
0/9
|
0.00%
0/34
|
0.00%
0/34
|
0.00%
0/48
|
3.1%
1/32 • Number of events 1
|
0.00%
0/3
|
|
Nervous system disorders
Acute CVA
|
0.00%
0/12
|
0.00%
0/9
|
0.00%
0/34
|
0.00%
0/34
|
0.00%
0/48
|
3.1%
1/32 • Number of events 1
|
0.00%
0/3
|
|
Gastrointestinal disorders
Gastroenteritis
|
0.00%
0/12
|
0.00%
0/9
|
0.00%
0/34
|
0.00%
0/34
|
0.00%
0/48
|
3.1%
1/32 • Number of events 1
|
0.00%
0/3
|
|
Gastrointestinal disorders
Esophageal ulcers
|
0.00%
0/12
|
0.00%
0/9
|
0.00%
0/34
|
0.00%
0/34
|
0.00%
0/48
|
3.1%
1/32 • Number of events 1
|
0.00%
0/3
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.00%
0/12
|
0.00%
0/9
|
0.00%
0/34
|
2.9%
1/34 • Number of events 1
|
0.00%
0/48
|
0.00%
0/32
|
0.00%
0/3
|
|
Cardiac disorders
Cardiopulmonary failure
|
0.00%
0/12
|
0.00%
0/9
|
0.00%
0/34
|
2.9%
1/34 • Number of events 1
|
0.00%
0/48
|
0.00%
0/32
|
0.00%
0/3
|
|
Skin and subcutaneous tissue disorders
Angioedema
|
0.00%
0/12
|
0.00%
0/9
|
0.00%
0/34
|
5.9%
2/34 • Number of events 2
|
0.00%
0/48
|
0.00%
0/32
|
0.00%
0/3
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastatic rectal cancer
|
0.00%
0/12
|
0.00%
0/9
|
0.00%
0/34
|
2.9%
1/34 • Number of events 1
|
0.00%
0/48
|
0.00%
0/32
|
0.00%
0/3
|
|
Nervous system disorders
Hemorrhage CNS
|
0.00%
0/12
|
0.00%
0/9
|
0.00%
0/34
|
0.00%
0/34
|
0.00%
0/48
|
0.00%
0/32
|
33.3%
1/3 • Number of events 1
|
Other adverse events
| Measure |
PG11047/Gemcitabine
n=12 participants at risk
PG-11047 (infusion on Days 1 and 15 of each cycle) in combination with Gemcitabine (1,000 mg/m2 administered IV over 30 minutes on Days 1, 8 and 15 of a 28-day cycle).
|
PG11047/Docetaxel
n=9 participants at risk
PG-11047 (infusion on Day 1 of each 21 day cycle) in combination with Docetaxel (75 mg/m2 administered IV over 60 minutes every 21 days).
|
PG11047/Bevacizumab
n=34 participants at risk
PG-11047 (infusion on Days 1, 8 and 15 of a 28 day cycle) in combination with Bevacizumab (5 mg/kg administered IV once every 14 days).
|
PG11047/Erlotinib
n=34 participants at risk
PG-11047 (infusion on Days 1, 8 and 15 of a 28 day cycle) in combination with Erlotinib (150 mg taken orally every day of each 28-day cycle).
|
PG11047/Cisplatin
n=48 participants at risk
Cisplatin: 80 mg/m2 administered IV over 1 hour once every 28 days. PG-11047 will be administered by infusion on Days 1, 8 and 15 of a 28 day cycle.
|
PG11047/5-Flurouracil
n=32 participants at risk
PG-11047 (infusion on Days 1, 8 and 15 of a 28 day cycle) in combination with 5-Flurouracil / Leucovorin (Leucovorin 500 mg/m2 IV over 2 hours with 5 - FU 500 mg/m2 IV bolus starting 1 hour into leucovorin infusion weekly for 6 weeks, repeated every 56 days).
|
PG11047/Sunitinib
n=3 participants at risk
PG-11047 (infusion on Days 1 and 8 of a 21 day cycle) in combination with Sunitinib (50 mg orally once daily, 4 weeks on treatment followed by 2 weeks off (42 day cycle)).
|
|---|---|---|---|---|---|---|---|
|
General disorders
Fatigue
|
16.7%
2/12 • Number of events 2
|
33.3%
3/9 • Number of events 7
|
5.9%
2/34 • Number of events 2
|
11.8%
4/34 • Number of events 4
|
22.9%
11/48 • Number of events 18
|
25.0%
8/32 • Number of events 11
|
66.7%
2/3 • Number of events 2
|
|
Blood and lymphatic system disorders
Neutropenia
|
16.7%
2/12 • Number of events 6
|
55.6%
5/9 • Number of events 16
|
0.00%
0/34
|
0.00%
0/34
|
6.2%
3/48 • Number of events 12
|
9.4%
3/32 • Number of events 7
|
0.00%
0/3
|
|
Blood and lymphatic system disorders
Anaemia
|
8.3%
1/12 • Number of events 1
|
22.2%
2/9 • Number of events 2
|
0.00%
0/34
|
17.6%
6/34 • Number of events 12
|
16.7%
8/48 • Number of events 9
|
12.5%
4/32 • Number of events 5
|
0.00%
0/3
|
|
Musculoskeletal and connective tissue disorders
Muscular weakness
|
8.3%
1/12 • Number of events 1
|
0.00%
0/9
|
0.00%
0/34
|
0.00%
0/34
|
0.00%
0/48
|
0.00%
0/32
|
0.00%
0/3
|
|
Gastrointestinal disorders
Retching
|
8.3%
1/12 • Number of events 1
|
0.00%
0/9
|
0.00%
0/34
|
0.00%
0/34
|
0.00%
0/48
|
0.00%
0/32
|
0.00%
0/3
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
8.3%
1/12 • Number of events 2
|
22.2%
2/9 • Number of events 2
|
8.8%
3/34 • Number of events 4
|
0.00%
0/34
|
18.8%
9/48 • Number of events 16
|
6.2%
2/32 • Number of events 4
|
33.3%
1/3 • Number of events 1
|
|
Gastrointestinal disorders
Constipation
|
0.00%
0/12
|
0.00%
0/9
|
11.8%
4/34 • Number of events 5
|
5.9%
2/34 • Number of events 2
|
0.00%
0/48
|
0.00%
0/32
|
0.00%
0/3
|
|
Skin and subcutaneous tissue disorders
Hypoaesthesia facial
|
0.00%
0/12
|
0.00%
0/9
|
8.8%
3/34 • Number of events 3
|
5.9%
2/34 • Number of events 2
|
0.00%
0/48
|
0.00%
0/32
|
0.00%
0/3
|
|
Vascular disorders
Hypotension
|
0.00%
0/12
|
0.00%
0/9
|
8.8%
3/34 • Number of events 6
|
8.8%
3/34 • Number of events 4
|
0.00%
0/48
|
0.00%
0/32
|
0.00%
0/3
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/12
|
11.1%
1/9 • Number of events 1
|
8.8%
3/34 • Number of events 3
|
14.7%
5/34 • Number of events 7
|
25.0%
12/48 • Number of events 14
|
6.2%
2/32 • Number of events 2
|
0.00%
0/3
|
|
Cardiac disorders
Dyspnoea
|
25.0%
3/12 • Number of events 4
|
0.00%
0/9
|
5.9%
2/34 • Number of events 2
|
0.00%
0/34
|
0.00%
0/48
|
0.00%
0/32
|
33.3%
1/3 • Number of events 1
|
|
Infections and infestations
Candidiasis
|
0.00%
0/12
|
22.2%
2/9 • Number of events 2
|
0.00%
0/34
|
0.00%
0/34
|
0.00%
0/48
|
0.00%
0/32
|
0.00%
0/3
|
|
Infections and infestations
Central line infection
|
0.00%
0/12
|
11.1%
1/9 • Number of events 1
|
0.00%
0/34
|
0.00%
0/34
|
0.00%
0/48
|
0.00%
0/32
|
0.00%
0/3
|
|
Gastrointestinal disorders
Dysgeusia
|
0.00%
0/12
|
11.1%
1/9 • Number of events 1
|
0.00%
0/34
|
5.9%
2/34 • Number of events 2
|
6.2%
3/48 • Number of events 3
|
0.00%
0/32
|
0.00%
0/3
|
|
Blood and lymphatic system disorders
Leukopenia
|
0.00%
0/12
|
11.1%
1/9 • Number of events 7
|
0.00%
0/34
|
0.00%
0/34
|
0.00%
0/48
|
0.00%
0/32
|
0.00%
0/3
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
0.00%
0/12
|
22.2%
2/9 • Number of events 2
|
0.00%
0/34
|
0.00%
0/34
|
0.00%
0/48
|
0.00%
0/32
|
0.00%
0/3
|
|
Infections and infestations
Mucosal inflammation
|
0.00%
0/12
|
11.1%
1/9 • Number of events 1
|
0.00%
0/34
|
0.00%
0/34
|
0.00%
0/48
|
9.4%
3/32 • Number of events 3
|
0.00%
0/3
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal pain
|
0.00%
0/12
|
11.1%
1/9 • Number of events 1
|
0.00%
0/34
|
0.00%
0/34
|
0.00%
0/48
|
0.00%
0/32
|
0.00%
0/3
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
0.00%
0/12
|
11.1%
1/9 • Number of events 1
|
0.00%
0/34
|
0.00%
0/34
|
0.00%
0/48
|
0.00%
0/32
|
0.00%
0/3
|
|
General disorders
Pyrexia
|
0.00%
0/12
|
11.1%
1/9 • Number of events 1
|
0.00%
0/34
|
0.00%
0/34
|
0.00%
0/48
|
6.2%
2/32 • Number of events 4
|
0.00%
0/3
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/12
|
11.1%
1/9 • Number of events 1
|
0.00%
0/34
|
8.8%
3/34 • Number of events 3
|
12.5%
6/48 • Number of events 7
|
0.00%
0/32
|
0.00%
0/3
|
|
Gastrointestinal disorders
Diarrhoea
|
0.00%
0/12
|
0.00%
0/9
|
0.00%
0/34
|
17.6%
6/34 • Number of events 9
|
0.00%
0/48
|
9.4%
3/32 • Number of events 5
|
0.00%
0/3
|
|
Metabolism and nutrition disorders
Anorexia
|
0.00%
0/12
|
0.00%
0/9
|
0.00%
0/34
|
14.7%
5/34 • Number of events 5
|
8.3%
4/48 • Number of events 9
|
12.5%
4/32 • Number of events 4
|
0.00%
0/3
|
|
Skin and subcutaneous tissue disorders
Dermatitis acneiform
|
0.00%
0/12
|
0.00%
0/9
|
0.00%
0/34
|
14.7%
5/34 • Number of events 7
|
0.00%
0/48
|
0.00%
0/32
|
0.00%
0/3
|
|
Skin and subcutaneous tissue disorders
Angioedema
|
0.00%
0/12
|
0.00%
0/9
|
0.00%
0/34
|
8.8%
3/34 • Number of events 6
|
0.00%
0/48
|
0.00%
0/32
|
0.00%
0/3
|
|
Skin and subcutaneous tissue disorders
Drug eruption
|
0.00%
0/12
|
0.00%
0/9
|
0.00%
0/34
|
8.8%
3/34 • Number of events 4
|
0.00%
0/48
|
0.00%
0/32
|
0.00%
0/3
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
0.00%
0/12
|
0.00%
0/9
|
0.00%
0/34
|
8.8%
3/34 • Number of events 4
|
0.00%
0/48
|
0.00%
0/32
|
0.00%
0/3
|
|
Metabolism and nutrition disorders
Dehydration
|
0.00%
0/12
|
0.00%
0/9
|
0.00%
0/34
|
5.9%
2/34 • Number of events 3
|
6.2%
3/48 • Number of events 3
|
0.00%
0/32
|
0.00%
0/3
|
|
Nervous system disorders
Paraesthesia
|
0.00%
0/12
|
0.00%
0/9
|
0.00%
0/34
|
5.9%
2/34 • Number of events 3
|
0.00%
0/48
|
6.2%
2/32 • Number of events 2
|
0.00%
0/3
|
|
Investigations
Weight decreased
|
0.00%
0/12
|
0.00%
0/9
|
0.00%
0/34
|
5.9%
2/34 • Number of events 2
|
0.00%
0/48
|
0.00%
0/32
|
0.00%
0/3
|
|
Investigations
Blood creatinine increased
|
0.00%
0/12
|
0.00%
0/9
|
0.00%
0/34
|
0.00%
0/34
|
10.4%
5/48 • Number of events 12
|
0.00%
0/32
|
0.00%
0/3
|
|
Investigations
Lipase increased
|
0.00%
0/12
|
0.00%
0/9
|
0.00%
0/34
|
0.00%
0/34
|
8.3%
4/48 • Number of events 7
|
18.8%
6/32 • Number of events 7
|
0.00%
0/3
|
|
Metabolism and nutrition disorders
Hypomagnesaemia
|
0.00%
0/12
|
0.00%
0/9
|
0.00%
0/34
|
0.00%
0/34
|
6.2%
3/48 • Number of events 4
|
0.00%
0/32
|
0.00%
0/3
|
|
Investigations
Blood amylase increased
|
0.00%
0/12
|
0.00%
0/9
|
0.00%
0/34
|
0.00%
0/34
|
0.00%
0/48
|
9.4%
3/32 • Number of events 5
|
0.00%
0/3
|
|
Vascular disorders
Cerebral haemorrhage
|
0.00%
0/12
|
0.00%
0/9
|
0.00%
0/34
|
0.00%
0/34
|
0.00%
0/48
|
0.00%
0/32
|
33.3%
1/3 • Number of events 1
|
|
General disorders
Infusion related reaction
|
0.00%
0/12
|
0.00%
0/9
|
0.00%
0/34
|
0.00%
0/34
|
0.00%
0/48
|
6.2%
2/32 • Number of events 4
|
0.00%
0/3
|
|
Skin and subcutaneous tissue disorders
Swelling face
|
0.00%
0/12
|
0.00%
0/9
|
0.00%
0/34
|
0.00%
0/34
|
0.00%
0/48
|
6.2%
2/32 • Number of events 2
|
0.00%
0/3
|
|
Vascular disorders
Hypertension
|
0.00%
0/12
|
0.00%
0/9
|
0.00%
0/34
|
0.00%
0/34
|
0.00%
0/48
|
0.00%
0/32
|
33.3%
1/3 • Number of events 1
|
|
Gastrointestinal disorders
Oral pain
|
0.00%
0/12
|
0.00%
0/9
|
0.00%
0/34
|
0.00%
0/34
|
0.00%
0/48
|
0.00%
0/32
|
33.3%
1/3 • Number of events 1
|
|
Investigations
Platelet count decreased
|
0.00%
0/12
|
0.00%
0/9
|
0.00%
0/34
|
0.00%
0/34
|
0.00%
0/48
|
0.00%
0/32
|
33.3%
1/3 • Number of events 2
|
Additional Information
Director of Clinical Trials
Progen Pharmaceuticals Pty Ltd
Phone: +61 7 32739133
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place