Clinical trialPhase 1Terminated
Safety of AMG 706 Plus Panitumumab Plus Gemcitabine-Cisplatin in the Treatment of Patients With Advanced Cancer
An Open-Label, Dose-Finding Study to Evaluate the Safety of AMG 706 Plus Panitumumab Plus Gemcitabine-Cisplatin in the Treatment of Subjects With Advanced Cancer
- Outcome
- Stopped earlyStudy terminated per recommendation of Data Review Team (Other)
- Phase
- Phase 1
- Status
- Terminated
- Study type
- Interventional
- Start
- December 2004
- Expected end
- April 2008
- Enrollment
- 41 participants
- Sites
- 0
- Primary outcomes
- Participant Incidence of Adverse Events
- Sponsor
- Industry
- Results posted
- 2014-03-20
- Last update
- 20 March 2014
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Brief summary public domain (ClinicalTrials.gov)
The purpose of this study is to characterize the safety and tolerability of AMG 706 plus panitumumab when administered with gemcitabine and cisplatin chemotherapy. This is a Phase 1b clinical study.
Posted results (ClinicalTrials.gov registry) · secondary outcome public domain (ClinicalTrials.gov)
Number of Participants With an Objective Tumor Response [From enrollment until date of last follow-up visit. The median follow-up time was 24 weeks, with a range of 3 to 73 weeks.]. Number, participants. Panitumumab + Gem/Cis (n=8): 2; 50 mg QD AMG 706 + Panitumumab + Gem/Cis (n=8): 0; 75 mg QD AMG 706 + Panitumumab + Gem/Cis (n=6): 1; 100 mg QD AMG 706 + Panitumumab + Gem/Cis (n=6): 4; 125 mg QD AMG 706 + Panitumumab + Gem/Cis (n=11): 2; 75 mg BID AMG 706 + Panitumumab + Gem/Cis (n=2): 1.
Posted results (ClinicalTrials.gov registry) · secondary outcome public domain (ClinicalTrials.gov)
Tmax [Day 1, pre-dose and at 1, 3, 6,12 (BID cohort only) and 24 hours post-dose.]. Median, hours (Full Range). 50 mg QD AMG 706 + Panitumumab + Gem/Cis (n=8): 1.00 (1.00 to 3.00); 75 mg QD AMG 706 + Panitumumab + Gem/Cis (n=6): 1.00 (1.00 to 3.00); 100 mg QD AMG 706 + Panitumumab + Gem/Cis (n=4): 1.38 (1.00 to 3.00); 125 mg QD AMG 706 + Panitumumab + Gem/Cis (n=11): 1.00 (1.00 to 3.00); 75 mg BID AMG 706 + Panitumumab + Gem/Cis (n=2): 1.00 (1.00 to 1.00).
Posted results (ClinicalTrials.gov registry) · secondary outcome public domain (ClinicalTrials.gov)
Cmax [Day 1, pre-dose and at 1, 3, 6,12 (BID cohort only) and 24 hours post-dose.]. Mean, ng/mL (Standard Deviation). 50 mg QD AMG 706 + Panitumumab + Gem/Cis (n=8): 152 (78); 75 mg QD AMG 706 + Panitumumab + Gem/Cis (n=6): 186 (92); 100 mg QD AMG 706 + Panitumumab + Gem/Cis (n=4): 278 (90); 125 mg QD AMG 706 + Panitumumab + Gem/Cis (n=11): 458 (208); 75 mg BID AMG 706 + Panitumumab + Gem/Cis (n=2): 268 (NA) [Standard deviation could not be calculated due to sample size of 2.].
Posted results (ClinicalTrials.gov registry) · secondary outcome public domain (ClinicalTrials.gov)
AUC0-24 [Day 1, pre-dose and at 1, 3, 6,12 (BID cohort only) and 24 hours post-dose.]. Mean, μg*hr/mL (Standard Deviation). 50 mg QD AMG 706 + Panitumumab + Gem/Cis (n=7): 1.03 (0.50); 75 mg QD AMG 706 + Panitumumab + Gem/Cis (n=4): 1.31 (0.51); 100 mg QD AMG 706 + Panitumumab + Gem/Cis (n=2): 2.38 (NA) [Standard deviation could not be calculated due to sample size of 2.]; 125 mg QD AMG 706 + Panitumumab + Gem/Cis (n=11): 2.82 (1.02); 75 mg BID AMG 706 + Panitumumab + Gem/Cis (n=2): 2.54 (NA) [Standard deviation could not be calculated due to sample size of 2.].
Posted results (ClinicalTrials.gov registry) · secondary outcome public domain (ClinicalTrials.gov)
AUC0-inf [Day 1, pre-dose and at 1, 3, 6,12 (BID cohort only) and 24 hours post-dose.]. Mean, μg*hr/mL (Standard Deviation). 50 mg QD AMG 706 + Panitumumab + Gem/Cis (n=7): 1.12 (0.52); 75 mg QD AMG 706 + Panitumumab + Gem/Cis (n=3): 1.64 (0.48); 100 mg QD AMG 706 + Panitumumab + Gem/Cis (n=2): 2.59 (NA) [Standard deviation not calculated due to sample size of 2.]; 125 mg QD AMG 706 + Panitumumab + Gem/Cis (n=9): 3.05 (1.34).
Posted results (ClinicalTrials.gov registry) · primary outcome public domain (ClinicalTrials.gov)
Participant Incidence of Adverse Events [From the first dose of any study treatment until 30 days after the last dose of study treatment, up to a maximum of 509 days.]. Number, Participants. Panitumumab + Gem/Cis (n=8): 8; 50 mg QD AMG 706 + Panitumumab + Gem/Cis (n=8): 8; 75 mg QD AMG 706 + Panitumumab + Gem/Cis (n=6): 6; 100 mg QD AMG 706 + Panitumumab + Gem/Cis (n=6): 6; 125 mg QD AMG 706 + Panitumumab + Gem/Cis (n=11): 11; 75 mg BID AMG 706 + Panitumumab + Gem/Cis (n=2): 2.