Neoplasms

Digestive System Diseases

All Conditions

Gland and Hormone Related Diseases

Respiratory Tract (Lung and Bronchial) Diseases

Rare Diseases

Esophageal Neoplasms

Pancreatic Neoplasms

Lung Neoplasms

Esophageal Cancer

Pancreatic Cancer

Antineoplastic Agents

All Drugs and Chemicals

Gemcitabine

Cisplatin

Panitumumab

Imetelstat

Motesanib diphosphate

Antimetabolites

Antineoplastic Agents, Immunological

Protein Kinase Inhibitors

Enzyme Inhibitors

Panitumumab 9 mg/kg intravenously on Day 1 + gemcitabine (gem) 1250 mg/m\^2 on Day 1 and Day 8, and cisplatin (cis) 75 mg/m\^2 on Day 1 of each 3-week cycle.

AMG 706 50 mg administered orally once daily (QD) + panitumumab 9 mg/kg intravenously on Day 1 + gemcitabine (gem) 1250 mg/m\^2 on Day 1 and Day 8, and cisplatin (cis) 75 mg/m\^2 on Day 1 of each 3-week cycle.

AMG 706 75 mg administered orally once daily (QD) + panitumumab 9 mg/kg intravenously on Day 1 + gemcitabine (gem) 1250 mg/m\^2 on Day 1 and Day 8, and cisplatin (cis) 75 mg/m\^2 on Day 1 of each 3-week cycle.

AMG 706 100 mg administered orally once daily (QD) + panitumumab 9 mg/kg intravenously on Day 1 + gemcitabine (gem) 1250 mg/m\^2 on Day 1 and Day 8, and cisplatin (cis) 75 mg/m\^2 on Day 1 of each 3-week cycle.

AMG 706 125 mg administered orally once daily (QD) + panitumumab 9 mg/kg intravenously on Day 1 + gemcitabine (gem) 1250 mg/m\^2 on Day 1 and Day 8, and cisplatin (cis) 75 mg/m\^2 on Day 1 of each 3-week cycle.

AMG 706 75 mg administered orally twice daily (BID) + panitumumab 9 mg/kg intravenously on Day 1 + gemcitabine (gem) 1250 mg/m\^2 on Day 1 and Day 8, and cisplatin (cis) 75 mg/m\^2 on Day 1 of each 3-week cycle.

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.

AMG 706

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

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 will be administered intravenously on Day 1 of each 3-week cycle at a dose of 75 mg/m\^2.

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.

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

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.

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.

Time after dosing when maximum plasma concentration was observed for AMG 706

The maximum observed plasma concentration after AMG 706 dosing

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.

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.

Amgen

The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.

Panitumumab 9 mg/kg intravenously (IV) on Day 1 + gemcitabine (gem) 1250 mg/m\^2 IV on Day 1 and Day 8, and cisplatin (cis) 75 mg/m\^2 IV on Day 1 of each 3-week cycle.

Panitumumab + Gem/Cis

AMG 706 50 mg administered orally once daily (QD) + panitumumab 9 mg/kg on Day 1 + gemcitabine 1250 mg/m\^2 on Day 1 and Day 8, and cisplatin 75 mg/m\^2 on Day 1 of each 3-week cycle.

50 mg QD AMG 706 + Panitumumab + Gem/Cis

AMG 706 75 mg administered orally once daily (QD) + panitumumab 9 mg/kg on Day 1 + gemcitabine 1250 mg/m\^2 on Day 1 and Day 8, and cisplatin 75 mg/m\^2 on Day 1 of each 3-week cycle.

75 mg QD AMG 706 + Panitumumab + Gem/Cis

AMG 706 100 mg administered orally once daily (QD) + panitumumab 9 mg/kg on Day 1 + gemcitabine 1250 mg/m\^2 on Day 1 and Day 8, and cisplatin 75 mg/m\^2 on Day 1 of each 3-week cycle.

100 mg QD AMG 706 + Panitumumab + Gem/Cis

AMG 706 125 mg administered orally once daily (QD) + panitumumab 9 mg/kg on Day 1 + gemcitabine 1250 mg/m\^2 on Day 1 and Day 8, and cisplatin 75 mg/m\^2 on Day 1 of each 3-week cycle.

125 mg QD AMG 706 + Panitumumab + Gem/CisEdit

AMG 706 75 mg administered orally twice daily (BID) + panitumumab 9 mg/kg on Day 1 + gemcitabine 1250 mg/m\^2 on Day 1 and Day 8, and cisplatin 75 mg/m\^2 on Day 1 of each 3-week cycle.

75 mg BID AMG 706 + Panitumumab + Gem/CisEdit

Panitumumab 9 mg/kg on Day 1 + gemcitabine (gem) 1250 mg/m\^2 on Day 1 and Day 8, and cisplatin (cis) 75 mg/m\^2 on Day 1 of each 3-week cycle.

AMG 706 100 mg administered orally once daily + panitumumab 9 mg/kg on Day 1 + gemcitabine 1250 mg/m\^2 on Day 1 and Day 8, and cisplatin 75 mg/m\^2 on Day 1 of each 3-week cycle.

AMG 706 125 mg administered orally once daily + panitumumab 9 mg/kg on Day 1 + gemcitabine 1250 mg/m\^2 on Day 1 and Day 8, and cisplatin 75 mg/m\^2 on Day 1 of each 3-week cycle.

125 mg QD AMG 706 + Panitumumab + Gem/Cis

75 mg BID AMG 706 + Panitumumab + Gem/Cis

Total

Age, Continuous

Sex: Female, Male

Black or African American

Hispanic or Latino

White or Caucasian

Race/Ethnicity, Customized

Study Director

AMG 706 50 mg administered orally once daily (QD) + panitumumab 9 mg/kg intravenously on Day 1 + gemcitabine 1250 mg/m\^2 on Day 1 and Day 8, and cisplatin 75 mg/m\^2 on Day 1 of each 3-week cycle.

Efficacy Analysis Set, defined as defined as patients who received at least 1 dose of AMG 706 for AMG 706 treatment groups and patients who received at least 1 dose of panitumumab for the panitumumab-only treatment group.

Number of Participants With an Objective Tumor Response

The Pharmacokinetic (PK) Analysis Set consists of patients who had dosing and PK sampling times recorded on the day of PK sample collection and no significant protocol deviations that impacted the quality of the PK data (for example, sample processing errors and/or inaccurate dosing on the day of the PK sampling).

Tmax

Cmax

PK Analysis set; Patients with elevated AMG 706 concentrations at 24 hours were excluded from the AUC summary statistics calculations.

AUC0-24

PK analysis set. Patients with elevated AMG 706 concentrations at 24 hours were excluded from the AUC summary statistics calculations.

AUC0-inf

AMG 706 100 mg administered orally once daily (QD) + panitumumab 9 mg/kg intravenously on Day 1 + gemcitabine 1250 mg/m\^2 on Day 1 and Day 8, and cisplatin 75 mg/m\^2 on Day 1 of each 3-week cycle.

Safety Analysis Set, composed of all participants in the AMG 706 treatment groups who received at least one dose of AMG 706 and all participants in the panitumumab-only treatment group who received at least one dose of panitumumab.

Spots Global Cancer Trial Database for Safety of AMG 706 Plus Panitumumab Plus Gemcitabine-Cisplatin in the Treatment of Patients With Advanced Cancer

Trial Identification

Conditions

Interventions

Study Description

Keywords

Eligibility

Locations

Contact Details

Useful links and downloads for this trial