Clinical trial NCT00101907: Safety of AMG 706 Plus Panitumumab Plus Gemcitabine-Cisplatin in the Treatment of Patients With Advanced Cancer
Official title: 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
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE1
Conditions: Lung Cancer
Pancreatic Cancer
Esophageal Cancer
Keywords: Advanced Cancer
AMG 706
Panitumumab
Gemcitabine-Cisplatin
Lead sponsor: Amgen
Sponsor class: INDUSTRY
First posted: 2005-01-19
Enrollment: 41
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.


Eligibility criteria: For complete inclusion and exclusion, please refer to the investigator.

Inclusion Criteria:

* Competent to comprehend, sign, and date an Institutional Review Board (IRB) approved informed consent form
* Subjects with advanced cancer in whom the gemcitabine and cisplatin chemotherapy regimen is clinically indicated
* Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
* Adequate hematological function
* Adequate renal function
* Adequate hepatic function
* Life expectancy of greater than or equal to 3 months as documented by the investigator

Exclusion Criteria:

* More than 1 prior chemotherapy regimen
* History of venous thrombosis
* Myocardial infarction, cerebrovascular accident, transient ischemic attack, percutaneous transluminal coronary angioplasty/stent, or unstable angina within 1 year before study enrollment
* History of interstitial pneumonitis or pulmonary fibrosis or evidence of interstitial pneumonitis or pulmonary fibrosis on screening chest computed tomograph (CT) scan
* Average systolic blood pressure of greater than 145 mm Hg or average diastolic blood pressure of greater than 85 mm Hg
* Radiotherapy within 28 days of study enrollment or within 14 days of study enrollment for peripheral lesions
* Prior AMG 706, panitumumab, or another anti-EGFr monoclonal antibody (mAb) (e.g., cetuximab \[Erbitux®\] or EMD 72000)
* Systemic chemotherapy within 28 days before study enrollment
* Major surgery within 28 days or minor surgery within 14 days of study enrollment
* Central nervous system metastases (Exception: subjects with treated asymptomatic central nervous system metastases, those who have been clinically stable in the judgment of the investigator and off steroids for at least 30 days before the study enrollment are eligible)

Primary outcomes:
measure: Participant Incidence of Adverse Events
timeFrame: 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.
Secondary outcomes:
measure: Number of Participants With an Objective Tumor Response
timeFrame: 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.
measure: Tmax
timeFrame: Day 1, pre-dose and at 1, 3, 6,12 (BID cohort only) and 24 hours post-dose.
measure: Cmax
timeFrame: Day 1, pre-dose and at 1, 3, 6,12 (BID cohort only) and 24 hours post-dose.
measure: AUC0-24
timeFrame: Day 1, pre-dose and at 1, 3, 6,12 (BID cohort only) and 24 hours post-dose.
measure: AUC0-inf
timeFrame: Day 1, pre-dose and at 1, 3, 6,12 (BID cohort only) and 24 hours post-dose.
Other outcomes:
Locations:
Study officials:
affiliation: Amgen
name: MD
role: STUDY_DIRECTOR
References:
citation: Burris H, Stephenson J, Otterson GA, Stein M, McGreivy J, Sun YN, Ingram M, Ye Y, Schwartzberg LS. Safety and pharmacokinetics of motesanib in combination with panitumumab and gemcitabine-Cisplatin in patients with advanced cancer. J Oncol. 2011;2011:853931. doi: 10.1155/2011/853931. Epub 2011 Apr 14.