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This study will aims to determine the maximum tolerated dose of CGC-11047 when used in individual combinations with gemcitabine, or docetaxel, or bevacizumab, or erlotinib or cisplatin or 5-flurouracil or sunitinib in one of 7 treatment arms. The dose of CGC-11047 will be escalated until the maximum tolerated dose is established.
This study will use a dose escalation design to determine the MTD of CGC-11047 when used in individual combinations with gemcitabine, or docetaxel, or bevacizumab, or erlotinib or cisplatin or 5-flurouracil or sunitinib in one of 7 treatment arms. The dose of CGC-11047 will be escalated in cohorts of 3 patients and dose escalation can proceed in each treatment group independent of dose escalation in the other treatment groups. CGC-11047 will be administered IV over 60 minutes and the doses of gemcitabine, docetaxel, bevacizumab, cisplatin, 5-flurouracil or sunitinib will remain fixed according to their respective product labeling.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Experimental | CGC-11047 in combination with Gemcitabine |
|
| 2 | Experimental | CGC-11047 in combination with Docetaxel |
|
| 3 | Experimental | CGC-11047 in combination with Bevacizumab |
|
| 4 | Experimental | CGC-11047 in combination with Erlotinib |
|
| 5 | Experimental | Cisplatin: 80 mg/m2 administered IV over 1 hour once every 28 days. CGC-11047 will be administered on Days 1, 8 and 15 of a 28 day cycle. |
|
| 6 | Experimental | CGC-11047 in combination with 5-Flurouracil / Leucovorin |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| CGC-11047 and gemcitabine | Drug | Gemcitabine: (Closed to enrollment) 1,000 mg/m2 administered IV over 30 minutes on Days 1, 8 and 15 of a 28-day cycle. CGC-11047 will only be given on days 1 and 15 of each cycle and will start at dose level -1 (50 mg). |
| Measure | Description | Time Frame |
|---|---|---|
| Maximum Tolerated Dose (MTD) | 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:
| End of Study |
| Measure | Description | Time Frame |
|---|---|---|
| Drug Safety | Ongoing | |
| Pharmacokinetics | End of Study |
Not provided
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Joe Stephenson, MD | Cancer Centres of the Carolinas, Greenville, SC 29605 | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Rocky Mountain Cancer Centre | Denver | Colorado | United States | |||
| Cancer Centres of Florida |
Not provided
| Label | URL |
|---|---|
| Progen Pharmaceuticals website | View source |
Not provided
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.
The recruitment period was June 2006 through March 2011, with last patient being treated May 2011. Patients were recruited through oncology clinics.
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| ID | Title | Description |
|---|---|---|
| FG000 | 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). |
| FG001 | PG11047/Docetaxel |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| 7 | Experimental | CGC-11047 in combination with Sunitinib |
|
|
| CGC-11047 and docetaxel | Drug | Docetaxel: (Closed to enrollment) 75 mg/m2 administered IV over 60 minutes every 21 days. CGC-11047 will be administered only on Day 1 of each 21-day cycle and will start at dose level -1 (50 mg). |
|
|
| CGC-11047 and bevacizumab | Drug | Bevacizumab: 5 mg/kg administered IV once every 14 days. CGC-11047 will be administered on Days 1, 8 and 15 of a 28 day cycle. |
|
|
| CGC-11047 and erlotinib | Drug | Erlotinib: 150 mg taken orally every day of each 28-day cycle. CGC-11047 will be administered on Days 1, 8 and 15 of a 28 day cycle. |
|
|
| CGC-11047 and cisplatin | Drug | Cisplatin: 80 mg/m2 administered IV over 1 hour once every 28 days. CGC-11047 will be administered on Days 1, 8 and 15 of a 28 day cycle. |
|
| CGC-11047 and 5-flurouracil / leucovorin | Drug | 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 wks, repeated every 56 days. CGC-11047 will be administered on Days 1, 8 and 15 of a 28 day cycle. |
|
|
| CGC-11047 and sunitinib | Drug | Sunitinib: 50 mg orally once daily, 4 weeks on treatment followed by 2 weeks off (42 day cycle). CGC-11047 will be administered on Days 1 and 8 of a 21 day cycle. |
|
|
| Ocoee |
| Florida |
| 34761 |
| United States |
| Central Indiana Cancer Centres | Indianapolis | Indiana | 46219 | United States |
| Comprehensive Cancer Centres of Nevada | Las Vegas | Nevada | 89169 | United States |
| New York Oncology Hematology PC | Albany | New York | 12206 | United States |
| Dayton Oncology and Hematology, PA | Kettering | Ohio | 45409 | United States |
| Cancer Centres of the Carolinas | Greenville | South Carolina | 29605 | United States |
| Texas Oncology, PA | Dallas | Texas | 75246 | United States |
| Tyler Cancer Centre | Tyler | Texas | 75702 | United States |
| Virginia Oncology Associates | Norfolk | Virginia | 23502 | United States |
| Northwest Cancer Specialists - Vancouver Cancer Centre | Vancouver | Washington | 98684 | United States |
| North Star Lodge Cancer Centre | Yakima | Washington | 98902 | United States |
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).
| FG002 | 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). |
| FG003 | 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). |
| FG004 | 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. |
| FG005 | 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). |
| FG006 | 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)). |
| COMPLETED |
|
| NOT COMPLETED |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | 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). |
| BG001 | 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). |
| BG002 | 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). |
| BG003 | 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). |
| BG004 | 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. |
| BG005 | 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). |
| BG006 | 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)). |
| BG007 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants | Participants |
| ||||||||||||||||
| Age, Continuous | Mean | Standard Deviation | years |
| |||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||
| Region of Enrollment | Number | participants |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Maximum Tolerated Dose (MTD) | 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:
| 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. | Posted | Number | mg | End of Study |
|
|
| ||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Drug Safety | Not Posted | Ongoing | |||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Pharmacokinetics | Not Posted | End of Study |
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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). | 7 | 12 | 5 | 12 | ||
| EG001 | 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). | 5 | 9 | 8 | 9 | ||
| EG002 | 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). | 11 | 34 | 15 | 34 | ||
| EG003 | 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). | 13 | 34 | 22 | 34 | ||
| EG004 | 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. | 22 | 48 | 31 | 48 | ||
| EG005 | 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). | 18 | 32 | 16 | 32 | ||
| EG006 | 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)). | 1 | 3 | 3 | 3 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Nausea | Gastrointestinal disorders | MedDRA (Unspecified) | Non-systematic Assessment | 2 not related and 1 unlikely related (Gemcitabine), 2 not related (Bevacizumab),1 related (cisplatin), 1 not related and 1 unlikely related (5-FU) |
|
| Disease progression | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (Unspecified) | Non-systematic Assessment | Not related (2 Gemcitabine, 3 Bevacizumab, 2 Erlotinib, 4 Cisplatin, 5 5-FU) |
|
| Dehydration | Metabolism and nutrition disorders | MedDRA (Unspecified) | Non-systematic Assessment | 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) |
|
| Altered mental status | Nervous system disorders | MedDRA (Unspecified) | Non-systematic Assessment | 1 unlikely related (Gemcitabine), 1 not related (Erlotinib), 1 not related (Cisplatin) |
|
| Vomitting | Gastrointestinal disorders | MedDRA (Unspecified) | Non-systematic Assessment | Not related (2 Gemcitabine, 1 Bevacizumab, 1 5-FU), unlikely related (1 Cisplatin, 2 5-FU), 2 related (Cisplatin) |
|
| Diarrhea | Gastrointestinal disorders | MedDRA (Unspecified) | Non-systematic Assessment | 1 not related (Gemcitabine) and 1 unlikely related (5-FU) |
|
| Uncontrolled pain | General disorders | MedDRA (Unspecified) | Non-systematic Assessment | Not related (Gemcitabine) |
|
| Right upper quadrant pain | Gastrointestinal disorders | MedDRA (Unspecified) | Non-systematic Assessment | Not related (Gemcitabine) |
|
| Right lower chest pain | General disorders | MedDRA (Unspecified) | Non-systematic Assessment | Not related (Gemcitabine) |
|
| Bacteremia | Infections and infestations | MedDRA (Unspecified) | Non-systematic Assessment | 1 not related (Gemcitabine), unlikely related (1 Gemcitabine, 1 5-FU) |
|
| Partial bowel obstruction | Gastrointestinal disorders | MedDRA (Unspecified) | Non-systematic Assessment | Not related (Gemcitabine) |
|
| Neutropenia | Blood and lymphatic system disorders | MedDRA (Unspecified) | Non-systematic Assessment | 1 not related and 1 related (Docetaxel) |
|
| Abdominal pain | Gastrointestinal disorders | MedDRA (Unspecified) | Non-systematic Assessment | Not related (1 Cisplatin, 1 Bevacizumab, 1 Erlotinib, 1 Cisplatin, 1 5-FU), unlikely related (1 Erlotinib) |
|
| Small bowel obstruction | Gastrointestinal disorders | MedDRA (Unspecified) | Non-systematic Assessment | Not related (3 Bevacizumab, 2 Cisplatin, 2 5-FU), unlikely related (1 Gemcitabine, 1 Erlotinib) |
|
| Neutroponic fever | Blood and lymphatic system disorders | MedDRA (Unspecified) | Non-systematic Assessment | Not related (1 Docetaxel), related (1 5-FU) |
|
| Deep vain thrombosis | Vascular disorders | MedDRA (Unspecified) | Non-systematic Assessment | Not related (1 Docetaxel), related (1 Cisplatin) |
|
| Cellulitis | Infections and infestations | MedDRA (Unspecified) | Non-systematic Assessment | 1 not related and 1 unlikely related (Bevacizumab) |
|
| Myocardial infarction | Cardiac disorders | MedDRA (Unspecified) | Non-systematic Assessment | Unlikely related (Bevacizumab) |
|
| Infection with normal ANC | Infections and infestations | MedDRA (Unspecified) | Non-systematic Assessment | Not related (Bevacizumab) |
|
| Superventricular tachycardia | Cardiac disorders | MedDRA (Unspecified) | Non-systematic Assessment | Not related (1 Cisplatin), 1 unlikely related (Bevacizumab) |
|
| Dyspnea | Respiratory, thoracic and mediastinal disorders | MedDRA (Unspecified) | Non-systematic Assessment | Not related (2 Erlotinib, 1 Cisplatin, 1 5-FU), related (1 Bevacizumab, 1 Cisplatin) |
|
| Hypoxia | Respiratory, thoracic and mediastinal disorders | MedDRA (Unspecified) | Non-systematic Assessment | Not related (2 5-FU), unlikely related (2 Bevacizumab) |
|
| Pain right hip | Musculoskeletal and connective tissue disorders | MedDRA (Unspecified) | Non-systematic Assessment | Not related (Bevacizumab) |
|
| Failure to thrive | General disorders | MedDRA (Unspecified) | Non-systematic Assessment | Unlikely related (Bevacizumab) |
|
| Acute renal failure | Renal and urinary disorders | MedDRA (Unspecified) | Non-systematic Assessment | Not related (2 Erlotinib, 2 Cisplatin), unlikely related (1 Cisplatin, 2 5-FU), related (1 Erlotinib, 2 Cisplatin) |
|
| Colitis | Gastrointestinal disorders | MedDRA (Unspecified) | Non-systematic Assessment | Unlikely related (Cisplatin) |
|
| Hemoptysis | Respiratory, thoracic and mediastinal disorders | MedDRA (Unspecified) | Non-systematic Assessment | Unlikely related (Cisplatin) |
|
| Elevated creatinine | Investigations | MedDRA (Unspecified) | Non-systematic Assessment | Related (Cisplatin) |
|
| Weakness | General disorders | MedDRA (Unspecified) | Non-systematic Assessment | 2 not related and 1 unlikely related (Cisplatin) |
|
| Aspiration | Respiratory, thoracic and mediastinal disorders | MedDRA (Unspecified) | Non-systematic Assessment | Not related (1 Cisplatin, 1 5-FU) |
|
| Respiratory arrest | Respiratory, thoracic and mediastinal disorders | MedDRA (Unspecified) | Non-systematic Assessment | Not related (2 Cisplatin, 2 5-FU), unlikely related (1 Erlotinib) |
|
| Atrial flutter | Cardiac disorders | MedDRA (Unspecified) | Non-systematic Assessment | Not related (1 Cisplatin), related (1 Erlotinib) |
|
| Bowel obstruction | Gastrointestinal disorders | MedDRA (Unspecified) | Non-systematic Assessment | Not related (1 Cisplatin, 1 5-FU) |
|
| Oversedation | Surgical and medical procedures | MedDRA (Unspecified) | Non-systematic Assessment | Not related (Cisplatin) |
|
| Encephalopathy | Nervous system disorders | MedDRA (Unspecified) | Non-systematic Assessment | Not related and unlikely related (Cisplatin) |
|
| Hepatic failure | Hepatobiliary disorders | MedDRA (Unspecified) | Non-systematic Assessment | Not related (Cisplatin) |
|
| Unresponsive | General disorders | MedDRA (Unspecified) | Non-systematic Assessment | Not related (Cisplatin) |
|
| Death | General disorders | MedDRA (Unspecified) | Non-systematic Assessment | Not related (Cisplatin) |
|
| Jaundice | Hepatobiliary disorders | MedDRA (Unspecified) | Non-systematic Assessment | Not related (Cisplatin) |
|
| Biliary obstruction | Hepatobiliary disorders | MedDRA (Unspecified) | Non-systematic Assessment | Not related (Cisplatin) |
|
| Elevated bilirubin | Investigations | MedDRA (Unspecified) | Non-systematic Assessment | Not related (1 Erlotinib, 1 Cisplatin) |
|
| Asthenia | General disorders | MedDRA (Unspecified) | Non-systematic Assessment | Unlikely related (Cisplatin) |
|
| Pulmonary embolism | Cardiac disorders | MedDRA (Unspecified) | Non-systematic Assessment | Not related (2 Erlotinib, 1 Cisplatin), related (1 Cisplatin) |
|
| Hypercalcemia | Metabolism and nutrition disorders | MedDRA (Unspecified) | Non-systematic Assessment | Not related (Cisplatin) |
|
| Headache | Nervous system disorders | MedDRA (Unspecified) | Non-systematic Assessment | Not related (Cisplatin) |
|
| Anemia | Blood and lymphatic system disorders | MedDRA (Unspecified) | Non-systematic Assessment | Unlikely related (1 Cisplatin), related (1 Cisplatin) |
|
| Thrombocytopenia | Blood and lymphatic system disorders | MedDRA (Unspecified) | Non-systematic Assessment | Not related (1 Cisplatin), unlikely related (1 5-FU) |
|
| Increased confusion | Nervous system disorders | MedDRA (Unspecified) | Non-systematic Assessment | Not related (1 Cisplatin, 1 5-FU) |
|
| Tracheostomy | Surgical and medical procedures | MedDRA (Unspecified) | Non-systematic Assessment | Not related (Cisplatin) |
|
| Post operative trachea hemorrhage | Surgical and medical procedures | MedDRA (Unspecified) | Non-systematic Assessment | Not related (Cisplatin) |
|
| Hypersensitivity allergic reaction | Immune system disorders | MedDRA (Unspecified) | Non-systematic Assessment | Not related (Cisplatin) |
|
| Ureteral obstruction | Renal and urinary disorders | MedDRA (Unspecified) | Non-systematic Assessment | Not related (Cisplatin) |
|
| Syncope | Nervous system disorders | MedDRA (Unspecified) | Non-systematic Assessment | Not related (1 Cisplatin and 1 5-FU) |
|
| Cardiac arrest | Cardiac disorders | MedDRA (Unspecified) | Non-systematic Assessment | Unlikely related (2 Cisplatin) |
|
| Coagulopathy | Blood and lymphatic system disorders | MedDRA (Unspecified) | Non-systematic Assessment | Not related (1 Erlotinib and 1Cisplatin) |
|
| Hypocalcemia | Metabolism and nutrition disorders | MedDRA (Unspecified) | Non-systematic Assessment | Not related (Cisplatin) |
|
| Multi-organ failure | General disorders | MedDRA (Unspecified) | Non-systematic Assessment | Not related (1 Erlotinib, 1 Cisplatin, 1 5-FU) |
|
| Sepsis | Infections and infestations | MedDRA (Unspecified) | Non-systematic Assessment | Unlikely related (2 5-FU), related (5-FU) |
|
| Hypokalemia | Metabolism and nutrition disorders | MedDRA (Unspecified) | Non-systematic Assessment | Unlikely related (5-FU) |
|
| GI bleed | Gastrointestinal disorders | MedDRA (Unspecified) | Non-systematic Assessment | Unlikely related (5-FU) |
|
| Hypotension | Vascular disorders | MedDRA (Unspecified) | Non-systematic Assessment | Unlikely related (5-FU) |
|
| Metabolic acidosis | Metabolism and nutrition disorders | MedDRA (Unspecified) | Non-systematic Assessment | Not related (5-FU) |
|
| Bronchospasm | Respiratory, thoracic and mediastinal disorders | MedDRA (Unspecified) | Non-systematic Assessment | Not related (5-FU) |
|
| Intestinal ileus | Gastrointestinal disorders | MedDRA (Unspecified) | Non-systematic Assessment | Unlikely related (5-FU) |
|
| Volume depletion | Blood and lymphatic system disorders | MedDRA (Unspecified) | Non-systematic Assessment | Unlikely related (1 Erlotinib, 2 5-FU) |
|
| Ogilvie syndrome | Gastrointestinal disorders | MedDRA (Unspecified) | Non-systematic Assessment | Not related (5-FU) |
|
| Acute CVA | Nervous system disorders | MedDRA (Unspecified) | Non-systematic Assessment | Not related (5-FU) |
|
| Gastroenteritis | Gastrointestinal disorders | MedDRA (Unspecified) | Non-systematic Assessment | Not related (5-FU) |
|
| Esophageal ulcers | Gastrointestinal disorders | MedDRA (Unspecified) | Non-systematic Assessment | Not related (5-FU) |
|
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA (Unspecified) | Non-systematic Assessment | Not related (Erlotinib) |
|
| Cardiopulmonary failure | Cardiac disorders | MedDRA (Unspecified) | Non-systematic Assessment | Unlikely related (Erlotinib) |
|
| Angioedema | Skin and subcutaneous tissue disorders | MedDRA (Unspecified) | Non-systematic Assessment | Related (2 Erlotinib) |
|
| Metastatic rectal cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (Unspecified) | Non-systematic Assessment | Not related (Erlotinib) |
|
| Hemorrhage CNS | Nervous system disorders | MedDRA (Unspecified) | Non-systematic Assessment | Related (Sunitinib) |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Fatigue | General disorders | MedDRA (Unspecified) | Non-systematic Assessment |
| |
| Neutropenia | Blood and lymphatic system disorders | MedDRA (Unspecified) | Non-systematic Assessment |
| |
| Anaemia | Blood and lymphatic system disorders | MedDRA (Unspecified) | Non-systematic Assessment |
| |
| Muscular weakness | Musculoskeletal and connective tissue disorders | MedDRA (Unspecified) | Non-systematic Assessment |
| |
| Retching | Gastrointestinal disorders | MedDRA (Unspecified) | Non-systematic Assessment |
| |
| Thrombocytopenia | Blood and lymphatic system disorders | MedDRA (Unspecified) | Non-systematic Assessment |
| |
| Constipation | Gastrointestinal disorders | MedDRA (Unspecified) | Non-systematic Assessment |
| |
| Hypoaesthesia facial | Skin and subcutaneous tissue disorders | MedDRA (Unspecified) | Non-systematic Assessment |
| |
| Hypotension | Vascular disorders | MedDRA (Unspecified) | Non-systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA (Unspecified) | Non-systematic Assessment |
| |
| Dyspnoea | Cardiac disorders | MedDRA (Unspecified) | Non-systematic Assessment |
| |
| Candidiasis | Infections and infestations | MedDRA (Unspecified) | Non-systematic Assessment |
| |
| Central line infection | Infections and infestations | MedDRA (Unspecified) | Non-systematic Assessment |
| |
| Dysgeusia | Gastrointestinal disorders | MedDRA (Unspecified) | Non-systematic Assessment |
| |
| Leukopenia | Blood and lymphatic system disorders | MedDRA (Unspecified) | Non-systematic Assessment |
| |
| Alopecia | Skin and subcutaneous tissue disorders | MedDRA (Unspecified) | Non-systematic Assessment |
| |
| Mucosal inflammation | Infections and infestations | MedDRA (Unspecified) | Non-systematic Assessment |
| |
| Musculoskeletal pain | Musculoskeletal and connective tissue disorders | MedDRA (Unspecified) | Non-systematic Assessment |
| |
| Myalgia | Musculoskeletal and connective tissue disorders | MedDRA (Unspecified) | Non-systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA (Unspecified) | Non-systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA (Unspecified) | Non-systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDRA (Unspecified) | Non-systematic Assessment |
| |
| Anorexia | Metabolism and nutrition disorders | MedDRA (Unspecified) | Non-systematic Assessment |
| |
| Dermatitis acneiform | Skin and subcutaneous tissue disorders | MedDRA (Unspecified) | Non-systematic Assessment |
| |
| Angioedema | Skin and subcutaneous tissue disorders | MedDRA (Unspecified) | Non-systematic Assessment |
| |
| Drug eruption | Skin and subcutaneous tissue disorders | MedDRA (Unspecified) | Non-systematic Assessment |
| |
| Hypokalaemia | Metabolism and nutrition disorders | MedDRA (Unspecified) | Non-systematic Assessment |
| |
| Dehydration | Metabolism and nutrition disorders | MedDRA (Unspecified) | Non-systematic Assessment |
| |
| Paraesthesia | Nervous system disorders | MedDRA (Unspecified) | Non-systematic Assessment |
| |
| Weight decreased | Investigations | MedDRA (Unspecified) | Non-systematic Assessment |
| |
| Blood creatinine increased | Investigations | MedDRA (Unspecified) | Non-systematic Assessment |
| |
| Lipase increased | Investigations | MedDRA (Unspecified) | Non-systematic Assessment |
| |
| Hypomagnesaemia | Metabolism and nutrition disorders | MedDRA (Unspecified) | Non-systematic Assessment |
| |
| Blood amylase increased | Investigations | MedDRA (Unspecified) | Non-systematic Assessment |
| |
| Cerebral haemorrhage | Vascular disorders | MedDRA (Unspecified) | Non-systematic Assessment |
| |
| Infusion related reaction | General disorders | MedDRA (Unspecified) | Non-systematic Assessment |
| |
| Swelling face | Skin and subcutaneous tissue disorders | MedDRA (Unspecified) | Non-systematic Assessment |
| |
| Hypertension | Vascular disorders | MedDRA (Unspecified) | Non-systematic Assessment |
| |
| Oral pain | Gastrointestinal disorders | MedDRA (Unspecified) | Non-systematic Assessment |
| |
| Platelet count decreased | Investigations | MedDRA (Unspecified) | Non-systematic Assessment |
|
Not provided
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Director of Clinical Trials | Progen Pharmaceuticals Pty Ltd | +61 7 32739133 | darrynb@progen-pharma.com |
| ID | Term |
|---|---|
| D009369 | Neoplasms |
| D008223 | Lymphoma |
| ID | Term |
|---|---|
| D009370 | Neoplasms by Histologic Type |
| D008232 | Lymphoproliferative Disorders |
| D008206 | Lymphatic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D007160 | Immunoproliferative Disorders |
| D007154 | Immune System Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| C515675 | CGC 11047 |
| D000093542 | Gemcitabine |
| D000077143 | Docetaxel |
| D000068258 | Bevacizumab |
| D000069347 | Erlotinib Hydrochloride |
| D002945 | Cisplatin |
| D002955 | Leucovorin |
| D005472 | Fluorouracil |
| D000077210 | Sunitinib |
| ID | Term |
|---|---|
| D006571 | Heterocyclic Compounds |
| D003841 | Deoxycytidine |
| D003562 | Cytidine |
| D011741 | Pyrimidine Nucleosides |
| D011743 | Pyrimidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D043823 | Taxoids |
| D043822 | Cyclodecanes |
| D003516 | Cycloparaffins |
| D006840 | Hydrocarbons, Alicyclic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
| D004224 | Diterpenes |
| D013729 | Terpenes |
| D061067 | Antibodies, Monoclonal, Humanized |
| D000911 | Antibodies, Monoclonal |
| D000906 | Antibodies |
| D007136 | Immunoglobulins |
| D007162 | Immunoproteins |
| D001798 | Blood Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D012712 | Serum Globulins |
| D005916 | Globulins |
| D011799 | Quinazolines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D017606 | Chlorine Compounds |
| D007287 | Inorganic Chemicals |
| D017672 | Nitrogen Compounds |
| D017671 | Platinum Compounds |
| D005575 | Formyltetrahydrofolates |
| D013763 | Tetrahydrofolates |
| D005492 | Folic Acid |
| D011622 | Pterins |
| D011621 | Pteridines |
| D003067 | Coenzymes |
| D045762 | Enzymes and Coenzymes |
| D014498 | Uracil |
| D011744 | Pyrimidinones |
| D011758 | Pyrroles |
| D001393 | Azoles |
| D007211 | Indoles |
Not provided
Not provided
| Between 18 and 65 years |
|
| >=65 years |
|
| Male |
|