Safety of AMG 706 Plus Panitumumab Plus Gemcitabine-Cisplatin in the Treatment of Patients With Advanced Cancer

Lung Cancer Clinical Trial

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00101907
• Other study ID #: 20040206
• Status: Terminated
• Phase: Phase 1
• First received: January 18, 2005
• Last updated: February 3, 2014
• Start date: December 2004
• Est. completion date: April 2008

Study information

• Verified date: February 2014
• Source: Amgen
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 41
• Est. completion date: April 2008
• Est. primary completion date: June 2007
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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)

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Esophageal Cancer
• Esophageal Neoplasms
• Lung Cancer
• Pancreatic Cancer
• Pancreatic Neoplasms

Intervention

Drug:
• AMG 706
AMG 706 will be provided as 25-mg and 100-mg tablets and will be continuously self-administered orally once or twice daily based on cohort assignment starting on day 1 of Cycle 1.

Biological:
• Panitumumab
Panitumumab will be administered by intravenous (IV) infusion at a dose of 9 mg/kg on Day 1 of each 3-week cycle.

Drug:
• Gemcitabine
Gemcitabine will be administered intravenously on Day 1 and Day 8 of each 21-day cycle at a dose of 1250 mg/m^2.
• Cisplatin
Cisplatin will be administered intravenously on Day 1 of each 3-week cycle at a dose of 75 mg/m^2.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Amgen

References & Publications (1)

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Participant Incidence of Adverse Events	The number of participants who experienced at least one treatment-emergent adverse event. Additional details regarding specfic adverse events are provided in the Adverse Event section of this posting.	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.	Yes
Secondary	Number of Participants With an Objective Tumor Response	The number of participants with a confirmed objective tumor response, defined as a complete response (CR) or partial response (PR) throughout based on modified Response Evaluation Criteria in Solid Tumors (RECIST) criteria. Any CR or PR was to be confirmed 4 to 6 weeks after the initial CR or PR.	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.	No
Secondary	Tmax	Time after dosing when maximum plasma concentration was observed for AMG 706	Day 1, pre-dose and at 1, 3, 6,12 (BID cohort only) and 24 hours post-dose.	No
Secondary	Cmax	The maximum observed plasma concentration after AMG 706 dosing	Day 1, pre-dose and at 1, 3, 6,12 (BID cohort only) and 24 hours post-dose.	No
Secondary	AUC0-24	Area under the plasma concentration-time curve from time 0 to 24 hours postdose (AUC0-24) with AMG 706. AUC0-24 was estimated using the linear/log trapezoidal method. For the BID cohort, AUC0 24 was estimated as 2 times the AUC from time 0 to 12 hours post the first daily dose (AUC0-12) using the linear/log trapezoidal method.	Day 1, pre-dose and at 1, 3, 6,12 (BID cohort only) and 24 hours post-dose.	No
Secondary	AUC0-inf	Area under the concentration-time curve from time 0 to infinite time (AUC0-inf) postdose with AMG 706. AUC0-inf was estimated using the linear/log trapezoidal method. AUC0-inf was not calculated for the BID cohort.	Day 1, pre-dose and at 1, 3, 6,12 (BID cohort only) and 24 hours post-dose.	No

External Links

•   AmgenTrials clinical trials website