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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00101907
Recruitment Status : Terminated (Study terminated per recommendation of Data Review Team)
First Posted : January 19, 2005
Results First Posted : March 20, 2014
Last Update Posted : March 20, 2014
Sponsor:
Information provided by (Responsible Party):
Amgen

Study Description
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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.

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

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 41 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (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
Study Start Date : December 2004
Actual Primary Completion Date : June 2007
Actual Study Completion Date : April 2008

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
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)


Outcome Measures
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Primary Outcome Measures :
  1. 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. ]
    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 :
  1. 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. ]
    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.

  2. Tmax [ Time Frame: Day 1, pre-dose and at 1, 3, 6,12 (BID cohort only) and 24 hours post-dose. ]
    Time after dosing when maximum plasma concentration was observed for AMG 706

  3. Cmax [ Time Frame: Day 1, pre-dose and at 1, 3, 6,12 (BID cohort only) and 24 hours post-dose. ]
    The maximum observed plasma concentration after AMG 706 dosing

  4. AUC0-24 [ Time Frame: Day 1, pre-dose and at 1, 3, 6,12 (BID cohort only) and 24 hours post-dose. ]
    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.

  5. AUC0-inf [ Time Frame: Day 1, pre-dose and at 1, 3, 6,12 (BID cohort only) and 24 hours post-dose. ]
    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.


Eligibility Criteria
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Information from the National Library of Medicine

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, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
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
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00101907


Sponsors and Collaborators
Amgen
Investigators
Layout table for investigator information
Study Director: MD Amgen
More Information
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Additional Information:

Publications:
TBD.Safety and pharmacokinetics (PK) of AMG 706 in combination with panitumumab and gemcitabine-cisplatin in patients (pts) with advanced cancer.Journal-004521;

Layout table for additonal information
Responsible Party: Amgen
ClinicalTrials.gov Identifier: NCT00101907    
Other Study ID Numbers: 20040206
First Posted: January 19, 2005    Key Record Dates
Results First Posted: March 20, 2014
Last Update Posted: March 20, 2014
Last Verified: February 2014
Keywords provided by Amgen:
Advanced Cancer
AMG 706
Panitumumab
Gemcitabine-Cisplatin
Additional relevant MeSH terms:
Layout table for MeSH terms
Gemcitabine
Panitumumab
Motesanib diphosphate
Antineoplastic Agents
Antimetabolites, Antineoplastic
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Antiviral Agents
 Anti-Infective Agents
Enzyme Inhibitors
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Antineoplastic Agents, Immunological
Protein Kinase Inhibitors