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
A Phase I Open Label, Multicenter, Dose-Escalation Study to Determine the Maximum Tolerated Dose, Dose Limiting Toxicity, Safety and Pharmacokinetics 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
1 other identifier
interventional
172
1 country
12
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_1 cancer
Started May 2006
Longer than P75 for phase_1 cancer
12 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
May 1, 2006
CompletedFirst Submitted
Initial submission to the registry
June 23, 2008
CompletedFirst Posted
Study publicly available on registry
June 26, 2008
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 1, 2011
CompletedStudy Completion
Last participant's last visit for all outcomes
September 1, 2011
CompletedResults Posted
Study results publicly available
February 27, 2012
CompletedJuly 21, 2016
June 1, 2016
5.3 years
June 23, 2008
November 17, 2011
June 21, 2016
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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: 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
End of Study
Secondary Outcomes (2)
Drug Safety
Ongoing
Pharmacokinetics
End of Study
Study Arms (7)
1
EXPERIMENTALCGC-11047 in combination with Gemcitabine
2
EXPERIMENTALCGC-11047 in combination with Docetaxel
3
EXPERIMENTALCGC-11047 in combination with Bevacizumab
4
EXPERIMENTALCGC-11047 in combination with Erlotinib
5
EXPERIMENTALCisplatin: 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
EXPERIMENTALCGC-11047 in combination with 5-Flurouracil / Leucovorin
7
EXPERIMENTALCGC-11047 in combination with Sunitinib
Interventions
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).
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).
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.
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.
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.
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.
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.
Eligibility Criteria
You may qualify if:
- non-hematological advanced solid tumor malignancy or lymphoma where no curative therapy exists in which monotherapy with gemcitabine or docetaxel or bevacizumab or erlotinib or cisplatin, or 5-flurouracil or sunitinib would otherwise be warranted.
- measurable disease based on radiographic evaluation or elevated tumor markers.
- ECOG - 0 or 1 (KPS \>70).
- Life expectancy \> 3 months.
You may not qualify if:
- chemotherapy within 21 days or radiotherapy within 4 weeks prior to entering the study
- known active brain metastases or leptomeningeal carcinomatosis.
- history of a myocardial infarction within the prior 6 months or, hospitalizations for congestive heart failure within the prior 6 months, or active treatment for uncontrolled cardiac arrhythmias
- clinically significant gastrointestinal tract hemorrhage, requiring transfusion therapy, within the prior 3 months.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (12)
Rocky Mountain Cancer Centre
Denver, Colorado, United States
Cancer Centres of Florida
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
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Director of Clinical Trials
- Organization
- Progen Pharmaceuticals Pty Ltd
Study Officials
- PRINCIPAL INVESTIGATOR
Joe Stephenson, MD
Cancer Centres of the Carolinas, Greenville, SC 29605
Publication Agreements
- PI is Sponsor Employee
- No
- Restrictive Agreement
- No
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 23, 2008
First Posted
June 26, 2008
Study Start
May 1, 2006
Primary Completion
August 1, 2011
Study Completion
September 1, 2011
Last Updated
July 21, 2016
Results First Posted
February 27, 2012
Record last verified: 2016-06