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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

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ClinicalTrials.gov Identifier: NCT00705874
Recruitment Status : Completed
First Posted : June 26, 2008
Results First Posted : February 27, 2012
Last Update Posted : July 21, 2016
Sponsor:
Information provided by (Responsible Party):
Progen Pharmaceuticals

Study Type Interventional
Study Design Allocation: Non-Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Cancer
Interventions Drug: CGC-11047 and gemcitabine
Drug: CGC-11047 and docetaxel
Drug: CGC-11047 and bevacizumab
Drug: CGC-11047 and erlotinib
Drug: CGC-11047 and cisplatin
Drug: CGC-11047 and 5-flurouracil / leucovorin
Drug: CGC-11047 and sunitinib
Enrollment 172
Recruitment Details The recruitment period was June 2006 through March 2011, with last patient being treated May 2011. Patients were recruited through oncology clinics.
Pre-assignment Details 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.
Arm/Group Title PG11047/Gemcitabine PG11047/Docetaxel PG11047/Bevacizumab PG11047/Erlotinib PG11047/Cisplatin PG11047/5-Flurouracil PG11047/Sunitinib
Hide Arm/Group Description 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). 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). 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). 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). 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. 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). 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)).
Period Title: Overall Study
Started 12 9 34 34 48 32 3
Completed 10 8 32 33 36 28 3
Not Completed 2 1 2 1 12 4 0
Arm/Group Title PG11047/Gemcitabine PG11047/Docetaxel PG11047/Bevacizumab PG11047/Erlotinib PG11047/Cisplatin PG11047/5-Flurouracil PG11047/Sunitinib Total
Hide Arm/Group Description 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). 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). 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). 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). 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. 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). 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 of all reporting groups
Overall Number of Baseline Participants 12 9 34 34 48 32 3 172
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 12 participants 9 participants 34 participants 34 participants 48 participants 32 participants 3 participants 172 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
8
  66.7%
4
  44.4%
26
  76.5%
20
  58.8%
31
  64.6%
20
  62.5%
1
  33.3%
110
  64.0%
>=65 years
4
  33.3%
5
  55.6%
8
  23.5%
14
  41.2%
17
  35.4%
12
  37.5%
2
  66.7%
62
  36.0%
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 12 participants 9 participants 34 participants 34 participants 48 participants 32 participants 3 participants 172 participants
58.3  (10.8) 63.2  (13.1) 56.3  (12.8) 62.8  (11.0) 59.8  (10.1) 60.2  (12.2) 60.0  (24.4) 59.8  (11.7)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 12 participants 9 participants 34 participants 34 participants 48 participants 32 participants 3 participants 172 participants
Female
7
  58.3%
5
  55.6%
15
  44.1%
18
  52.9%
19
  39.6%
14
  43.8%
2
  66.7%
80
  46.5%
Male
5
  41.7%
4
  44.4%
19
  55.9%
16
  47.1%
29
  60.4%
18
  56.3%
1
  33.3%
92
  53.5%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 12 participants 9 participants 34 participants 34 participants 48 participants 32 participants 3 participants 172 participants
12 9 34 34 48 32 3 172
1.Primary Outcome
Title Maximum Tolerated Dose (MTD)
Hide Description

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
Time Frame End of Study
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title PG11047/Gemcitabine PG11047/Docetaxel PG11047/Bevacizumab PG11047/Erlotinib PG11047/Cisplatin PG11047/5-Flurouracil PG11047/Sunitinib
Hide Arm/Group Description:
PG-11047 in combination with Gemcitabine
PG-11047 in combination with Docetaxel
PG-11047 in combination with Bevacizumab
PG-11047 in combination with Erlotinib
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.
CGC-11047 in combination with 5-Flurouracil / Leucovorin

PG-11047 in combination with Sunitinib.

The MTD of PG-11047 was undetermineable due to only 2 evaluable patients in this treatment group

Overall Number of Participants Analyzed 12 9 34 34 48 32 3
Measure Type: Number
Unit of Measure: mg
NA [1]  NA [1]  590 590 590 590 NA [1] 
[1]
MTD not determined due to toxicities leading to study arm being prematurely stopped.
2.Secondary Outcome
Title Drug Safety
Hide Description [Not Specified]
Time Frame Ongoing
Outcome Measure Data Not Reported
3.Secondary Outcome
Title Pharmacokinetics
Hide Description [Not Specified]
Time Frame End of Study
Outcome Measure Data Not Reported
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title PG11047/Gemcitabine PG11047/Docetaxel PG11047/Bevacizumab PG11047/Erlotinib PG11047/Cisplatin PG11047/5-Flurouracil PG11047/Sunitinib
Hide Arm/Group Description 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). 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). 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). 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). 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. 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). 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)).
All-Cause Mortality
PG11047/Gemcitabine PG11047/Docetaxel PG11047/Bevacizumab PG11047/Erlotinib PG11047/Cisplatin PG11047/5-Flurouracil PG11047/Sunitinib
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--      --/--      --/--      --/--      --/--      --/--    
Show Serious Adverse Events Hide Serious Adverse Events
PG11047/Gemcitabine PG11047/Docetaxel PG11047/Bevacizumab PG11047/Erlotinib PG11047/Cisplatin PG11047/5-Flurouracil PG11047/Sunitinib
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   7/12 (58.33%)      5/9 (55.56%)      11/34 (32.35%)      13/34 (38.24%)      22/48 (45.83%)      18/32 (56.25%)      1/3 (33.33%)    
Blood and lymphatic system disorders               
Neutropenia * 1 [1]  0/12 (0.00%)  0 2/9 (22.22%)  2 0/34 (0.00%)  0 0/34 (0.00%)  0 0/48 (0.00%)  0 0/32 (0.00%)  0 0/3 (0.00%)  0
Neutroponic fever * 1 [2]  0/12 (0.00%)  0 1/9 (11.11%)  1 0/34 (0.00%)  0 0/34 (0.00%)  0 0/48 (0.00%)  0 1/32 (3.13%)  1 0/3 (0.00%)  0
Anemia * 1 [3]  0/12 (0.00%)  0 0/9 (0.00%)  0 0/34 (0.00%)  0 0/34 (0.00%)  0 2/48 (4.17%)  2 0/32 (0.00%)  0 0/3 (0.00%)  0
Thrombocytopenia * 1 [4]  0/12 (0.00%)  0 0/9 (0.00%)  0 0/34 (0.00%)  0 0/34 (0.00%)  0 1/48 (2.08%)  1 1/32 (3.13%)  1 0/3 (0.00%)  0
Coagulopathy * 1 [5]  0/12 (0.00%)  0 0/9 (0.00%)  0 0/34 (0.00%)  0 1/34 (2.94%)  1 1/48 (2.08%)  1 0/32 (0.00%)  0 0/3 (0.00%)  0
Volume depletion * 1 [6]  0/12 (0.00%)  0 0/9 (0.00%)  0 0/34 (0.00%)  0 1/34 (2.94%)  1 0/48 (0.00%)  0 2/32 (6.25%)  2 0/3 (0.00%)  0
Cardiac disorders               
Myocardial infarction * 1 [7]  0/12 (0.00%)  0 0/9 (0.00%)  0 1/34 (2.94%)  1 0/34 (0.00%)  0 0/48 (0.00%)  0 0/32 (0.00%)  0 0/3 (0.00%)  0
Superventricular tachycardia * 1 [8]  0/12 (0.00%)  0 0/9 (0.00%)  0 1/34 (2.94%)  1 0/34 (0.00%)  0 1/48 (2.08%)  1 0/32 (0.00%)  0 0/3 (0.00%)  0
Atrial flutter * 1 [9]  0/12 (0.00%)  0 0/9 (0.00%)  0 0/34 (0.00%)  0 1/34 (2.94%)  1 1/48 (2.08%)  1 0/32 (0.00%)  0 0/3 (0.00%)  0
Pulmonary embolism * 1 [10]  0/12 (0.00%)  0 0/9 (0.00%)  0 0/34 (0.00%)  0 2/34 (5.88%)  2 2/48 (4.17%)  2 0/32 (0.00%)  0 0/3 (0.00%)  0
Cardiac arrest * 1 [11]  0/12 (0.00%)  0 0/9 (0.00%)  0 0/34 (0.00%)  0 0/34 (0.00%)  0 1/48 (2.08%)  2 0/32 (0.00%)  0 0/3 (0.00%)  0
Cardiopulmonary failure * 1 [12]  0/12 (0.00%)  0 0/9 (0.00%)  0 0/34 (0.00%)  0 1/34 (2.94%)  1 0/48 (0.00%)  0 0/32 (0.00%)  0 0/3 (0.00%)  0
Gastrointestinal disorders               
Nausea * 1 [13]  3/12 (25.00%)  3 0/9 (0.00%)  0 2/34 (5.88%)  2 0/34 (0.00%)  0 1/48 (2.08%)  1 2/32 (6.25%)  2 0/3 (0.00%)  0
Vomitting * 1 [14]  2/12 (16.67%)  2 0/9 (0.00%)  0 1/34 (2.94%)  1 0/34 (0.00%)  0 3/48 (6.25%)  3 3/32 (9.38%)  3 0/3 (0.00%)  0
Diarrhea * 1 [15]  1/12 (8.33%)  1 0/9 (0.00%)  0 0/34 (0.00%)  0 0/34 (0.00%)  0 0/48 (0.00%)  0 1/32 (3.13%)  1 0/3 (0.00%)  0
Right upper quadrant pain * 1 [16]  1/12 (8.33%)  1 0/9 (0.00%)  0 0/34 (0.00%)  0 0/34 (0.00%)  0 0/48 (0.00%)  0 0/32 (0.00%)  0 0/3 (0.00%)  0
Partial bowel obstruction * 1 [16]  1/12 (8.33%)  1 0/9 (0.00%)  0 0/34 (0.00%)  0 0/34 (0.00%)  0 0/48 (0.00%)  0 0/32 (0.00%)  0 0/3 (0.00%)  0
Abdominal pain * 1 [17]  0/12 (0.00%)  0 1/9 (11.11%)  1 1/34 (2.94%)  1 2/34 (5.88%)  2 1/48 (2.08%)  1 1/32 (3.13%)  1 0/3 (0.00%)  0
Small bowel obstruction * 1 [18]  1/12 (8.33%)  1 0/9 (0.00%)  0 3/34 (8.82%)  3 1/34 (2.94%)  1 1/48 (2.08%)  2 2/32 (6.25%)  2 0/3 (0.00%)  0
Colitis * 1 [19]  0/12 (0.00%)  0 0/9 (0.00%)  0 0/34 (0.00%)  0 0/34 (0.00%)  0 1/48 (2.08%)  1 1/32 (3.13%)  1 0/3 (0.00%)  0
Bowel obstruction * 1 [20]  0/12 (0.00%)  0 0/9 (0.00%)  0 0/34 (0.00%)  0 0/34 (0.00%)  0 1/48 (2.08%)  1 1/32 (3.13%)  1 0/3 (0.00%)  0
GI bleed * 1 [21]  0/12 (0.00%)  0 0/9 (0.00%)  0 0/34 (0.00%)  0 0/34 (0.00%)  0 0/48 (0.00%)  0 1/32 (3.13%)  1 0/3 (0.00%)  0
Intestinal ileus * 1 [21]  0/12 (0.00%)  0 0/9 (0.00%)  0 0/34 (0.00%)  0 0/34 (0.00%)  0 0/48 (0.00%)  0 1/32 (3.13%)  1 0/3 (0.00%)  0
Ogilvie syndrome * 1 [22]  0/12 (0.00%)  0 0/9 (0.00%)  0 0/34 (0.00%)  0 0/34 (0.00%)  0 0/48 (0.00%)  0 1/32 (3.13%)  1 0/3 (0.00%)  0
Gastroenteritis * 1 [22]  0/12 (0.00%)  0 0/9 (0.00%)  0 0/34 (0.00%)  0 0/34 (0.00%)  0 0/48 (0.00%)  0 1/32 (3.13%)  1 0/3 (0.00%)  0
Esophageal ulcers * 1 [22]  0/12 (0.00%)  0 0/9 (0.00%)  0 0/34 (0.00%)  0 0/34 (0.00%)  0 0/48 (0.00%)  0 1/32 (3.13%)  1 0/3 (0.00%)  0
General disorders               
Uncontrolled pain * 1 [16]  2/12 (16.67%)  2 0/9 (0.00%)  0 0/34 (0.00%)  0 0/34 (0.00%)  0 0/48 (0.00%)  0 0/32 (0.00%)  0 0/3 (0.00%)  0
Right lower chest pain * 1 [16]  1/12 (8.33%)  1 0/9 (0.00%)  0 0/34 (0.00%)  0 0/34 (0.00%)  0 0/48 (0.00%)  0 0/32 (0.00%)  0 0/3 (0.00%)  0
Failure to thrive * 1 [7]  0/12 (0.00%)  0 0/9 (0.00%)  0 1/34 (2.94%)  1 0/34 (0.00%)  0 0/48 (0.00%)  0 0/32 (0.00%)  0 0/3 (0.00%)  0
Weakness * 1 [23]  0/12 (0.00%)  0 0/9 (0.00%)  0 0/34 (0.00%)  0 0/34 (0.00%)  0 3/48 (6.25%)  3 0/32 (0.00%)  0 0/3 (0.00%)  0
Unresponsive * 1 [24]  0/12 (0.00%)  0 0/9 (0.00%)  0 0/34 (0.00%)  0 0/34 (0.00%)  0 1/48 (2.08%)  1 0/32 (0.00%)  0 0/3 (0.00%)  0
Death * 1 [24]  0/12 (0.00%)  0 0/9 (0.00%)  0 0/34 (0.00%)  0 0/34 (0.00%)  0 1/48 (2.08%)  1 0/32 (0.00%)  0 0/3 (0.00%)  0
Asthenia * 1 [19]  0/12 (0.00%)  0 0/9 (0.00%)  0 0/34 (0.00%)  0 0/34 (0.00%)  0 1/48 (2.08%)  1 0/32 (0.00%)  0 0/3 (0.00%)  0
Multi-organ failure * 1 [25]  0/12 (0.00%)  0 0/9 (0.00%)  0 0/34 (0.00%)  0 1/34 (2.94%)  1 1/48 (2.08%)  1 1/32 (3.13%)  1 0/3 (0.00%)  0
Hepatobiliary disorders               
Hepatic failure * 1 [24]  0/12 (0.00%)  0 0/9 (0.00%)  0 0/34 (0.00%)  0 0/34 (0.00%)  0 1/48 (2.08%)  1 0/32 (0.00%)  0 0/3 (0.00%)  0
Jaundice * 1 [24]  0/12 (0.00%)  0 0/9 (0.00%)  0 0/34 (0.00%)  0 0/34 (0.00%)  0 1/48 (2.08%)  1 0/32 (0.00%)  0 0/3 (0.00%)  0
Biliary obstruction * 1 [24]  0/12 (0.00%)  0 0/9 (0.00%)  0 0/34 (0.00%)  0 0/34 (0.00%)  0 1/48 (2.08%)  1 0/32 (0.00%)  0 0/3 (0.00%)  0
Immune system disorders               
Hypersensitivity allergic reaction * 1 [24]  0/12 (0.00%)  0 0/9 (0.00%)  0 0/34 (0.00%)  0 0/34 (0.00%)  0 1/48 (2.08%)  1 0/32 (0.00%)  0 0/3 (0.00%)  0
Infections and infestations               
Bacteremia * 1 [26]  2/12 (16.67%)  2 0/9 (0.00%)  0 0/34 (0.00%)  0 0/34 (0.00%)  0 0/48 (0.00%)  0 1/32 (3.13%)  1 0/3 (0.00%)  0
Cellulitis * 1 [27]  0/12 (0.00%)  0 0/9 (0.00%)  0 1/34 (2.94%)  2 0/34 (0.00%)  0 0/48 (0.00%)  0 0/32 (0.00%)  0 0/3 (0.00%)  0
Infection with normal ANC * 1 [28]  0/12 (0.00%)  0 0/9 (0.00%)  0 1/34 (2.94%)  1 0/34 (0.00%)  0 0/48 (0.00%)  0 0/32 (0.00%)  0 0/3 (0.00%)  0
Sepsis * 1 [29]  0/12 (0.00%)  0 0/9 (0.00%)  0 0/34 (0.00%)  0 0/34 (0.00%)  0 0/48 (0.00%)  0 2/32 (6.25%)  3 0/3 (0.00%)  0
Investigations               
Elevated creatinine * 1 [30]  0/12 (0.00%)  0 0/9 (0.00%)  0 0/34 (0.00%)  0 0/34 (0.00%)  0 1/48 (2.08%)  1 0/32 (0.00%)  0 0/3 (0.00%)  0
Elevated bilirubin * 1 [31]  0/12 (0.00%)  0 0/9 (0.00%)  0 0/34 (0.00%)  0 1/34 (2.94%)  1 1/48 (2.08%)  1 0/32 (0.00%)  0 0/3 (0.00%)  0
Metabolism and nutrition disorders               
Dehydration * 1 [32]  2/12 (16.67%)  2 0/9 (0.00%)  0 2/34 (5.88%)  2 2/34 (5.88%)  2 2/48 (4.17%)  2 3/32 (9.38%)  3 0/3 (0.00%)  0
Hypercalcemia * 1 [24]  0/12 (0.00%)  0 0/9 (0.00%)  0 0/34 (0.00%)  0 0/34 (0.00%)  0 1/48 (2.08%)  1 0/32 (0.00%)  0 0/3 (0.00%)  0
Hypocalcemia * 1 [24]  0/12 (0.00%)  0 0/9 (0.00%)  0 0/34 (0.00%)  0 0/34 (0.00%)  0 1/48 (2.08%)  1 0/32 (0.00%)  0 0/3 (0.00%)  0
Hypokalemia * 1 [21]  0/12 (0.00%)  0 0/9 (0.00%)  0 0/34 (0.00%)  0 0/34 (0.00%)  0 0/48 (0.00%)  0 1/32 (3.13%)  1 0/3 (0.00%)  0
Metabolic acidosis * 1 [22]  0/12 (0.00%)  0 0/9 (0.00%)  0 0/34 (0.00%)  0 0/34 (0.00%)  0 0/48 (0.00%)  0 1/32 (3.13%)  1 0/3 (0.00%)  0
Musculoskeletal and connective tissue disorders               
Pain right hip * 1 [28]  0/12 (0.00%)  0 0/9 (0.00%)  0 1/34 (2.94%)  1 0/34 (0.00%)  0 0/48 (0.00%)  0 0/32 (0.00%)  0 0/3 (0.00%)  0
Back pain * 1 [33]  0/12 (0.00%)  0 0/9 (0.00%)  0 0/34 (0.00%)  0 1/34 (2.94%)  1 0/48 (0.00%)  0 0/32 (0.00%)  0 0/3 (0.00%)  0
Neoplasms benign, malignant and unspecified (incl cysts and polyps)               
Disease progression * 1 [34]  2/12 (16.67%)  2 0/9 (0.00%)  0 3/34 (8.82%)  3 2/34 (5.88%)  2 4/48 (8.33%)  4 5/32 (15.63%)  5 0/3 (0.00%)  0
Metastatic rectal cancer * 1 [33]  0/12 (0.00%)  0 0/9 (0.00%)  0 0/34 (0.00%)  0 1/34 (2.94%)  1 0/48 (0.00%)  0 0/32 (0.00%)  0 0/3 (0.00%)  0
Nervous system disorders               
Altered mental status * 1 [35]  1/12 (8.33%)  1 0/9 (0.00%)  0 0/34 (0.00%)  0 1/34 (2.94%)  1 1/48 (2.08%)  1 0/32 (0.00%)  0 0/3 (0.00%)  0
Encephalopathy * 1 [36]  0/12 (0.00%)  0 0/9 (0.00%)  0 0/34 (0.00%)  0 0/34 (0.00%)  0 2/48 (4.17%)  2 0/32 (0.00%)  0 0/3 (0.00%)  0
Headache * 1 [24]  0/12 (0.00%)  0 0/9 (0.00%)  0 0/34 (0.00%)  0 0/34 (0.00%)  0 1/48 (2.08%)  1 0/32 (0.00%)  0 0/3 (0.00%)  0
Increased confusion * 1 [20]  0/12 (0.00%)  0 0/9 (0.00%)  0 0/34 (0.00%)  0 0/34 (0.00%)  0 1/48 (2.08%)  1 1/32 (3.13%)  1 0/3 (0.00%)  0
Syncope * 1 [37]  0/12 (0.00%)  0 0/9 (0.00%)  0 0/34 (0.00%)  0 0/34 (0.00%)  0 1/48 (2.08%)  1 1/32 (3.13%)  1 0/3 (0.00%)  0
Acute CVA * 1 [22]  0/12 (0.00%)  0 0/9 (0.00%)  0 0/34 (0.00%)  0 0/34 (0.00%)  0 0/48 (0.00%)  0 1/32 (3.13%)  1 0/3 (0.00%)  0
Hemorrhage CNS * 1 [38]  0/12 (0.00%)  0 0/9 (0.00%)  0 0/34 (0.00%)  0 0/34 (0.00%)  0 0/48 (0.00%)  0 0/32 (0.00%)  0 1/3 (33.33%)  1
Renal and urinary disorders               
Acute renal failure * 1 [39]  0/12 (0.00%)  0 0/9 (0.00%)  0 0/34 (0.00%)  0 3/34 (8.82%)  3 4/48 (8.33%)  5 2/32 (6.25%)  2 0/3 (0.00%)  0
Ureteral obstruction * 1 [24]  0/12 (0.00%)  0 0/9 (0.00%)  0 0/34 (0.00%)  0 0/34 (0.00%)  0 1/48 (2.08%)  1 0/32 (0.00%)  0 0/3 (0.00%)  0
Respiratory, thoracic and mediastinal disorders               
Dyspnea * 1 [40]  0/12 (0.00%)  0 0/9 (0.00%)  0 1/34 (2.94%)  1 2/34 (5.88%)  2 2/48 (4.17%)  2 1/32 (3.13%)  1 0/3 (0.00%)  0
Hypoxia * 1 [41]  0/12 (0.00%)  0 0/9 (0.00%)  0 1/34 (2.94%)  2 0/34 (0.00%)  0 0/48 (0.00%)  0 2/32 (6.25%)  2 0/3 (0.00%)  0
Hemoptysis * 1 [19]  0/12 (0.00%)  0 0/9 (0.00%)  0 0/34 (0.00%)  0 0/34 (0.00%)  0 1/48 (2.08%)  1 0/32 (0.00%)  0 0/3 (0.00%)  0
Aspiration * 1 [20]  0/12 (0.00%)  0 0/9 (0.00%)  0 0/34 (0.00%)  0 0/34 (0.00%)  0 1/48 (2.08%)  1 1/32 (3.13%)  1 0/3 (0.00%)  0
Respiratory arrest * 1 [42]  0/12 (0.00%)  0 0/9 (0.00%)  0 0/34 (0.00%)  0 1/34 (2.94%)  1 2/48 (4.17%)  2 2/32 (6.25%)  2 0/3 (0.00%)  0
Bronchospasm * 1 [22]  0/12 (0.00%)  0 0/9 (0.00%)  0 0/34 (0.00%)  0 0/34 (0.00%)  0 0/48 (0.00%)  0 1/32 (3.13%)  1 0/3 (0.00%)  0
Skin and subcutaneous tissue disorders               
Angioedema * 1 [43]  0/12 (0.00%)  0 0/9 (0.00%)  0 0/34 (0.00%)  0 2/34 (5.88%)  2 0/48 (0.00%)  0 0/32 (0.00%)  0 0/3 (0.00%)  0
Surgical and medical procedures               
Oversedation * 1 [24]  0/12 (0.00%)  0 0/9 (0.00%)  0 0/34 (0.00%)  0 0/34 (0.00%)  0 1/48 (2.08%)  1 0/32 (0.00%)  0 0/3 (0.00%)  0
Tracheostomy * 1 [24]  0/12 (0.00%)  0 0/9 (0.00%)  0 0/34 (0.00%)  0 0/34 (0.00%)  0 1/48 (2.08%)  1 0/32 (0.00%)  0 0/3 (0.00%)  0
Post operative trachea hemorrhage * 1 [24]  0/12 (0.00%)  0 0/9 (0.00%)  0 0/34 (0.00%)  0 0/34 (0.00%)  0 1/48 (2.08%)  1 0/32 (0.00%)  0 0/3 (0.00%)  0
Vascular disorders               
Deep vain thrombosis * 1 [44]  0/12 (0.00%)  0 1/9 (11.11%)  1 0/34 (0.00%)  0 0/34 (0.00%)  0 1/48 (2.08%)  1 0/32 (0.00%)  0 0/3 (0.00%)  0
Hypotension * 1 [21]  0/12 (0.00%)  0 0/9 (0.00%)  0 0/34 (0.00%)  0 0/34 (0.00%)  0 0/48 (0.00%)  0 1/32 (3.13%)  1 0/3 (0.00%)  0
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, MedDRA (Unspecified)
[1]
1 not related and 1 related (Docetaxel)
[2]
Not related (1 Docetaxel), related (1 5-FU)
[3]
Unlikely related (1 Cisplatin), related (1 Cisplatin)
[4]
Not related (1 Cisplatin), unlikely related (1 5-FU)
[5]
Not related (1 Erlotinib and 1Cisplatin)
[6]
Unlikely related (1 Erlotinib, 2 5-FU)
[7]
Unlikely related (Bevacizumab)
[8]
Not related (1 Cisplatin), 1 unlikely related (Bevacizumab)
[9]
Not related (1 Cisplatin), related (1 Erlotinib)
[10]
Not related (2 Erlotinib, 1 Cisplatin), related (1 Cisplatin)
[11]
Unlikely related (2 Cisplatin)
[12]
Unlikely related (Erlotinib)
[13]
2 not related and 1 unlikely related (Gemcitabine), 2 not related (Bevacizumab),1 related (cisplatin), 1 not related and 1 unlikely related (5-FU)
[14]
Not related (2 Gemcitabine, 1 Bevacizumab, 1 5-FU), unlikely related (1 Cisplatin, 2 5-FU), 2 related (Cisplatin)
[15]
1 not related (Gemcitabine) and 1 unlikely related (5-FU)
[16]
Not related (Gemcitabine)
[17]
Not related (1 Cisplatin, 1 Bevacizumab, 1 Erlotinib, 1 Cisplatin, 1 5-FU), unlikely related (1 Erlotinib)
[18]
Not related (3 Bevacizumab, 2 Cisplatin, 2 5-FU), unlikely related (1 Gemcitabine, 1 Erlotinib)
[19]
Unlikely related (Cisplatin)
[20]
Not related (1 Cisplatin, 1 5-FU)
[21]
Unlikely related (5-FU)
[22]
Not related (5-FU)
[23]
2 not related and 1 unlikely related (Cisplatin)
[24]
Not related (Cisplatin)
[25]
Not related (1 Erlotinib, 1 Cisplatin, 1 5-FU)
[26]
1 not related (Gemcitabine), unlikely related (1 Gemcitabine, 1 5-FU)
[27]
1 not related and 1 unlikely related (Bevacizumab)
[28]
Not related (Bevacizumab)
[29]
Unlikely related (2 5-FU), related (5-FU)
[30]
Related (Cisplatin)
[31]
Not related (1 Erlotinib, 1 Cisplatin)
[32]
2 unlikely related (Gemcitabine), 2 not related (Bevacizumab), 1 not related and 1 related (Erlotinib), 1 not related and 1 related (Cisplatin), 3 unlikely related (5-FU)
[33]
Not related (Erlotinib)
[34]
Not related (2 Gemcitabine, 3 Bevacizumab, 2 Erlotinib, 4 Cisplatin, 5 5-FU)
[35]
1 unlikely related (Gemcitabine), 1 not related (Erlotinib), 1 not related (Cisplatin)
[36]
Not related and unlikely related (Cisplatin)
[37]
Not related (1 Cisplatin and 1 5-FU)
[38]
Related (Sunitinib)
[39]
Not related (2 Erlotinib, 2 Cisplatin), unlikely related (1 Cisplatin, 2 5-FU), related (1 Erlotinib, 2 Cisplatin)
[40]
Not related (2 Erlotinib, 1 Cisplatin, 1 5-FU), related (1 Bevacizumab, 1 Cisplatin)
[41]
Not related (2 5-FU), unlikely related (2 Bevacizumab)
[42]
Not related (2 Cisplatin, 2 5-FU), unlikely related (1 Erlotinib)
[43]
Related (2 Erlotinib)
[44]
Not related (1 Docetaxel), related (1 Cisplatin)
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
PG11047/Gemcitabine PG11047/Docetaxel PG11047/Bevacizumab PG11047/Erlotinib PG11047/Cisplatin PG11047/5-Flurouracil PG11047/Sunitinib
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   5/12 (41.67%)      8/9 (88.89%)      15/34 (44.12%)      22/34 (64.71%)      31/48 (64.58%)      16/32 (50.00%)      3/3 (100.00%)    
Blood and lymphatic system disorders               
Neutropenia * 1  2/12 (16.67%)  6 5/9 (55.56%)  16 0/34 (0.00%)  0 0/34 (0.00%)  0 3/48 (6.25%)  12 3/32 (9.38%)  7 0/3 (0.00%)  0
Anaemia * 1  1/12 (8.33%)  1 2/9 (22.22%)  2 0/34 (0.00%)  0 6/34 (17.65%)  12 8/48 (16.67%)  9 4/32 (12.50%)  5 0/3 (0.00%)  0
Thrombocytopenia * 1  1/12 (8.33%)  2 2/9 (22.22%)  2 3/34 (8.82%)  4 0/34 (0.00%)  0 9/48 (18.75%)  16 2/32 (6.25%)  4 1/3 (33.33%)  1
Leukopenia * 1  0/12 (0.00%)  0 1/9 (11.11%)  7 0/34 (0.00%)  0 0/34 (0.00%)  0 0/48 (0.00%)  0 0/32 (0.00%)  0 0/3 (0.00%)  0
Cardiac disorders               
Dyspnoea * 1  3/12 (25.00%)  4 0/9 (0.00%)  0 2/34 (5.88%)  2 0/34 (0.00%)  0 0/48 (0.00%)  0 0/32 (0.00%)  0 1/3 (33.33%)  1
Gastrointestinal disorders               
Retching * 1  1/12 (8.33%)  1 0/9 (0.00%)  0 0/34 (0.00%)  0 0/34 (0.00%)  0 0/48 (0.00%)  0 0/32 (0.00%)  0 0/3 (0.00%)  0
Constipation * 1  0/12 (0.00%)  0 0/9 (0.00%)  0 4/34 (11.76%)  5 2/34 (5.88%)  2 0/48 (0.00%)  0 0/32 (0.00%)  0 0/3 (0.00%)  0
Nausea * 1  0/12 (0.00%)  0 1/9 (11.11%)  1 3/34 (8.82%)  3 5/34 (14.71%)  7 12/48 (25.00%)  14 2/32 (6.25%)  2 0/3 (0.00%)  0
Dysgeusia * 1  0/12 (0.00%)  0 1/9 (11.11%)  1 0/34 (0.00%)  0 2/34 (5.88%)  2 3/48 (6.25%)  3 0/32 (0.00%)  0 0/3 (0.00%)  0
Vomiting * 1  0/12 (0.00%)  0 1/9 (11.11%)  1 0/34 (0.00%)  0 3/34 (8.82%)  3 6/48 (12.50%)  7 0/32 (0.00%)  0 0/3 (0.00%)  0
Diarrhoea * 1  0/12 (0.00%)  0 0/9 (0.00%)  0 0/34 (0.00%)  0 6/34 (17.65%)  9 0/48 (0.00%)  0 3/32 (9.38%)  5 0/3 (0.00%)  0
Oral pain * 1  0/12 (0.00%)  0 0/9 (0.00%)  0 0/34 (0.00%)  0 0/34 (0.00%)  0 0/48 (0.00%)  0 0/32 (0.00%)  0 1/3 (33.33%)  1
General disorders               
Fatigue * 1  2/12 (16.67%)  2 3/9 (33.33%)  7 2/34 (5.88%)  2 4/34 (11.76%)  4 11/48 (22.92%)  18 8/32 (25.00%)  11 2/3 (66.67%)  2
Pyrexia * 1  0/12 (0.00%)  0 1/9 (11.11%)  1 0/34 (0.00%)  0 0/34 (0.00%)  0 0/48 (0.00%)  0 2/32 (6.25%)  4 0/3 (0.00%)  0
Infusion related reaction * 1  0/12 (0.00%)  0 0/9 (0.00%)  0 0/34 (0.00%)  0 0/34 (0.00%)  0 0/48 (0.00%)  0 2/32 (6.25%)  4 0/3 (0.00%)  0
Infections and infestations               
Candidiasis * 1  0/12 (0.00%)  0 2/9 (22.22%)  2 0/34 (0.00%)  0 0/34 (0.00%)  0 0/48 (0.00%)  0 0/32 (0.00%)  0 0/3 (0.00%)  0
Central line infection * 1  0/12 (0.00%)  0 1/9 (11.11%)  1 0/34 (0.00%)  0 0/34 (0.00%)  0 0/48 (0.00%)  0 0/32 (0.00%)  0 0/3 (0.00%)  0
Mucosal inflammation * 1  0/12 (0.00%)  0 1/9 (11.11%)  1 0/34 (0.00%)  0 0/34 (0.00%)  0 0/48 (0.00%)  0 3/32 (9.38%)  3 0/3 (0.00%)  0
Investigations               
Weight decreased * 1  0/12 (0.00%)  0 0/9 (0.00%)  0 0/34 (0.00%)  0 2/34 (5.88%)  2 0/48 (0.00%)  0 0/32 (0.00%)  0 0/3 (0.00%)  0
Blood creatinine increased * 1  0/12 (0.00%)  0 0/9 (0.00%)  0 0/34 (0.00%)  0 0/34 (0.00%)  0 5/48 (10.42%)  12 0/32 (0.00%)  0 0/3 (0.00%)  0
Lipase increased * 1  0/12 (0.00%)  0 0/9 (0.00%)  0 0/34 (0.00%)  0 0/34 (0.00%)  0 4/48 (8.33%)  7 6/32 (18.75%)  7 0/3 (0.00%)  0
Blood amylase increased * 1  0/12 (0.00%)  0 0/9 (0.00%)  0 0/34 (0.00%)  0 0/34 (0.00%)  0 0/48 (0.00%)  0 3/32 (9.38%)  5 0/3 (0.00%)  0
Platelet count decreased * 1  0/12 (0.00%)  0 0/9 (0.00%)  0 0/34 (0.00%)  0 0/34 (0.00%)  0 0/48 (0.00%)  0 0/32 (0.00%)  0 1/3 (33.33%)  2
Metabolism and nutrition disorders               
Anorexia * 1  0/12 (0.00%)  0 0/9 (0.00%)  0 0/34 (0.00%)  0 5/34 (14.71%)  5 4/48 (8.33%)  9 4/32 (12.50%)  4 0/3 (0.00%)  0
Hypokalaemia * 1  0/12 (0.00%)  0 0/9 (0.00%)  0 0/34 (0.00%)  0 3/34 (8.82%)  4 0/48 (0.00%)  0 0/32 (0.00%)  0 0/3 (0.00%)  0
Dehydration * 1  0/12 (0.00%)  0 0/9 (0.00%)  0 0/34 (0.00%)  0 2/34 (5.88%)  3 3/48 (6.25%)  3 0/32 (0.00%)  0 0/3 (0.00%)  0
Hypomagnesaemia * 1  0/12 (0.00%)  0 0/9 (0.00%)  0 0/34 (0.00%)  0 0/34 (0.00%)  0 3/48 (6.25%)  4 0/32 (0.00%)  0 0/3 (0.00%)  0
Musculoskeletal and connective tissue disorders               
Muscular weakness * 1  1/12 (8.33%)  1 0/9 (0.00%)  0 0/34 (0.00%)  0 0/34 (0.00%)  0 0/48 (0.00%)  0 0/32 (0.00%)  0 0/3 (0.00%)  0
Musculoskeletal pain * 1  0/12 (0.00%)  0 1/9 (11.11%)  1 0/34 (0.00%)  0 0/34 (0.00%)  0 0/48 (0.00%)  0 0/32 (0.00%)  0 0/3 (0.00%)  0
Myalgia * 1  0/12 (0.00%)  0 1/9 (11.11%)  1 0/34 (0.00%)  0 0/34 (0.00%)  0 0/48 (0.00%)  0 0/32 (0.00%)  0 0/3 (0.00%)  0
Nervous system disorders               
Paraesthesia * 1  0/12 (0.00%)  0 0/9 (0.00%)  0 0/34 (0.00%)  0 2/34 (5.88%)  3 0/48 (0.00%)  0 2/32 (6.25%)  2 0/3 (0.00%)  0
Skin and subcutaneous tissue disorders               
Hypoaesthesia facial * 1  0/12 (0.00%)  0 0/9 (0.00%)  0 3/34 (8.82%)  3 2/34 (5.88%)  2 0/48 (0.00%)  0 0/32 (0.00%)  0 0/3 (0.00%)  0
Alopecia * 1  0/12 (0.00%)  0 2/9 (22.22%)  2 0/34 (0.00%)  0 0/34 (0.00%)  0 0/48 (0.00%)  0 0/32 (0.00%)  0 0/3 (0.00%)  0
Dermatitis acneiform * 1  0/12 (0.00%)  0 0/9 (0.00%)  0 0/34 (0.00%)  0 5/34 (14.71%)  7 0/48 (0.00%)  0 0/32 (0.00%)  0 0/3 (0.00%)  0
Angioedema * 1  0/12 (0.00%)  0 0/9 (0.00%)  0 0/34 (0.00%)  0 3/34 (8.82%)  6 0/48 (0.00%)  0 0/32 (0.00%)  0 0/3 (0.00%)  0
Drug eruption * 1  0/12 (0.00%)  0 0/9 (0.00%)  0 0/34 (0.00%)  0 3/34 (8.82%)  4 0/48 (0.00%)  0 0/32 (0.00%)  0 0/3 (0.00%)  0
Swelling face * 1  0/12 (0.00%)  0 0/9 (0.00%)  0 0/34 (0.00%)  0 0/34 (0.00%)  0 0/48 (0.00%)  0 2/32 (6.25%)  2 0/3 (0.00%)  0
Vascular disorders               
Hypotension * 1  0/12 (0.00%)  0 0/9 (0.00%)  0 3/34 (8.82%)  6 3/34 (8.82%)  4 0/48 (0.00%)  0 0/32 (0.00%)  0 0/3 (0.00%)  0
Cerebral haemorrhage * 1  0/12 (0.00%)  0 0/9 (0.00%)  0 0/34 (0.00%)  0 0/34 (0.00%)  0 0/48 (0.00%)  0 0/32 (0.00%)  0 1/3 (33.33%)  1
Hypertension * 1  0/12 (0.00%)  0 0/9 (0.00%)  0 0/34 (0.00%)  0 0/34 (0.00%)  0 0/48 (0.00%)  0 0/32 (0.00%)  0 1/3 (33.33%)  1
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, MedDRA (Unspecified)
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Name/Title: Director of Clinical Trials
Organization: Progen Pharmaceuticals Pty Ltd
Phone: +61 7 32739133
Responsible Party: Progen Pharmaceuticals
ClinicalTrials.gov Identifier: NCT00705874     History of Changes
Other Study ID Numbers: 47-01-002
First Submitted: June 23, 2008
First Posted: June 26, 2008
Results First Submitted: November 17, 2011
Results First Posted: February 27, 2012
Last Update Posted: July 21, 2016