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

This study has been terminated.
(Study terminated per recommendation of Data Review Team)
Sponsor:
Information provided by (Responsible Party):
Amgen
ClinicalTrials.gov Identifier:
NCT00101907
First received: January 18, 2005
Last updated: February 3, 2014
Last verified: February 2014
  Purpose

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.


Condition Intervention Phase
Lung Cancer
Pancreatic Cancer
Esophageal Cancer
Drug: AMG 706
Biological: Panitumumab
Drug: Gemcitabine
Drug: Cisplatin
Phase 1

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

Resource links provided by NLM:


Further study details as provided by Amgen:

Primary Outcome Measures:
  • Participant Incidence of Adverse Events [ Time Frame: 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. ] [ Designated as safety issue: Yes ]
    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.


Secondary Outcome Measures:
  • Number of Participants With an Objective Tumor Response [ Time Frame: 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. ] [ Designated as safety issue: No ]
    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.

  • Tmax [ Time Frame: Day 1, pre-dose and at 1, 3, 6,12 (BID cohort only) and 24 hours post-dose. ] [ Designated as safety issue: No ]
    Time after dosing when maximum plasma concentration was observed for AMG 706

  • Cmax [ Time Frame: Day 1, pre-dose and at 1, 3, 6,12 (BID cohort only) and 24 hours post-dose. ] [ Designated as safety issue: No ]
    The maximum observed plasma concentration after AMG 706 dosing

  • AUC0-24 [ Time Frame: Day 1, pre-dose and at 1, 3, 6,12 (BID cohort only) and 24 hours post-dose. ] [ Designated as safety issue: No ]
    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.

  • AUC0-inf [ Time Frame: Day 1, pre-dose and at 1, 3, 6,12 (BID cohort only) and 24 hours post-dose. ] [ Designated as safety issue: No ]
    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.


Enrollment: 41
Study Start Date: December 2004
Study Completion Date: April 2008
Primary Completion Date: June 2007 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Panitumumab + Gem/Cis
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.
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.
Other Name: Vectibix
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.
Other Name: Gemzar
Drug: Cisplatin
Cisplatin will be administered intravenously on Day 1 of each 3-week cycle at a dose of 75 mg/m^2.
Other Names:
  • cisplatinum
  • cis-diamminedichloridoplatinum(II) (CDDP)
Experimental: 50 mg QD AMG 706 + panitumumab + Gem/Cis
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.
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.
Other Name: Vectibix
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.
Other Name: Gemzar
Drug: Cisplatin
Cisplatin will be administered intravenously on Day 1 of each 3-week cycle at a dose of 75 mg/m^2.
Other Names:
  • cisplatinum
  • cis-diamminedichloridoplatinum(II) (CDDP)
Experimental: 75 mg QD AMG 706 + panitumumab + Gem/Cis
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.
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.
Other Name: Vectibix
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.
Other Name: Gemzar
Drug: Cisplatin
Cisplatin will be administered intravenously on Day 1 of each 3-week cycle at a dose of 75 mg/m^2.
Other Names:
  • cisplatinum
  • cis-diamminedichloridoplatinum(II) (CDDP)
Experimental: 100 mg QD AMG 706 + panitumumab + Gem/Cis
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.
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.
Other Name: Vectibix
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.
Other Name: Gemzar
Drug: Cisplatin
Cisplatin will be administered intravenously on Day 1 of each 3-week cycle at a dose of 75 mg/m^2.
Other Names:
  • cisplatinum
  • cis-diamminedichloridoplatinum(II) (CDDP)
Experimental: 125 mg QD AMG 706 + panitumumab + Gem/Cis
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.
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.
Other Name: Vectibix
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.
Other Name: Gemzar
Drug: Cisplatin
Cisplatin will be administered intravenously on Day 1 of each 3-week cycle at a dose of 75 mg/m^2.
Other Names:
  • cisplatinum
  • cis-diamminedichloridoplatinum(II) (CDDP)
Experimental: 75 mg BID AMG 706 + panitumumab + Gem/Cis
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.
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.
Other Name: Vectibix
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.
Other Name: Gemzar
Drug: Cisplatin
Cisplatin will be administered intravenously on Day 1 of each 3-week cycle at a dose of 75 mg/m^2.
Other Names:
  • cisplatinum
  • cis-diamminedichloridoplatinum(II) (CDDP)

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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)
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00101907

Sponsors and Collaborators
Amgen
Investigators
Study Director: MD Amgen
  More Information

Additional Information:
No publications provided

Responsible Party: Amgen
ClinicalTrials.gov Identifier: NCT00101907     History of Changes
Other Study ID Numbers: 20040206
Study First Received: January 18, 2005
Results First Received: August 13, 2010
Last Updated: February 3, 2014
Health Authority: United States: Food and Drug Administration

Keywords provided by Amgen:
Advanced Cancer
AMG 706
Panitumumab
Gemcitabine-Cisplatin

Additional relevant MeSH terms:
Esophageal Neoplasms
Lung Neoplasms
Pancreatic Neoplasms
Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Head and Neck Neoplasms
Digestive System Diseases
Esophageal Diseases
Gastrointestinal Diseases
Respiratory Tract Neoplasms
Thoracic Neoplasms
Lung Diseases
Respiratory Tract Diseases
Endocrine Gland Neoplasms
Pancreatic Diseases
Endocrine System Diseases
Gemcitabine
Cisplatin
Antibodies, Monoclonal
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Radiation-Sensitizing Agents
Physiological Effects of Drugs
Antimetabolites, Antineoplastic
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Antiviral Agents

ClinicalTrials.gov processed this record on July 20, 2014