NCT00101907

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.

Trial Health

55
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
41

participants targeted

Target at P50-P75 for phase_1 lung-cancer

Timeline
Completed

Started Dec 2004

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2004

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

January 18, 2005

Completed
1 day until next milestone

First Posted

Study publicly available on registry

January 19, 2005

Completed
2.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2007

Completed
10 months until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2008

Completed
6 years until next milestone

Results Posted

Study results publicly available

March 20, 2014

Completed
Last Updated

March 20, 2014

Status Verified

February 1, 2014

Enrollment Period

2.5 years

First QC Date

January 18, 2005

Results QC Date

August 13, 2010

Last Update Submit

February 3, 2014

Conditions

Lung CancerPancreatic CancerEsophageal Cancer

Keywords

Advanced CancerAMG 706PanitumumabGemcitabine-Cisplatin

Outcome Measures

Primary Outcomes (1)

  • 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.

Secondary Outcomes (5)

  • Number of Participants With an Objective Tumor Response

    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.

  • Tmax

    Day 1, pre-dose and at 1, 3, 6,12 (BID cohort only) and 24 hours post-dose.

  • Cmax

    Day 1, pre-dose and at 1, 3, 6,12 (BID cohort only) and 24 hours post-dose.

  • AUC0-24

    Day 1, pre-dose and at 1, 3, 6,12 (BID cohort only) and 24 hours post-dose.

  • AUC0-inf

    Day 1, pre-dose and at 1, 3, 6,12 (BID cohort only) and 24 hours post-dose.

Study Arms (6)

Panitumumab + Gem/Cis

EXPERIMENTAL

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: PanitumumabDrug: GemcitabineDrug: Cisplatin

50 mg QD AMG 706 + panitumumab + Gem/Cis

EXPERIMENTAL

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 706Biological: PanitumumabDrug: GemcitabineDrug: Cisplatin

75 mg QD AMG 706 + panitumumab + Gem/Cis

EXPERIMENTAL

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 706Biological: PanitumumabDrug: GemcitabineDrug: Cisplatin

100 mg QD AMG 706 + panitumumab + Gem/Cis

EXPERIMENTAL

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 706Biological: PanitumumabDrug: GemcitabineDrug: Cisplatin

125 mg QD AMG 706 + panitumumab + Gem/Cis

EXPERIMENTAL

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 706Biological: PanitumumabDrug: GemcitabineDrug: Cisplatin

75 mg BID AMG 706 + panitumumab + Gem/Cis

EXPERIMENTAL

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 706Biological: PanitumumabDrug: GemcitabineDrug: Cisplatin

Interventions

AMG 706DRUG

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.

100 mg QD AMG 706 + panitumumab + Gem/Cis125 mg QD AMG 706 + panitumumab + Gem/Cis50 mg QD AMG 706 + panitumumab + Gem/Cis75 mg BID AMG 706 + panitumumab + Gem/Cis75 mg QD AMG 706 + panitumumab + Gem/Cis
PanitumumabBIOLOGICAL

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

Also known as: Vectibix
100 mg QD AMG 706 + panitumumab + Gem/Cis125 mg QD AMG 706 + panitumumab + Gem/Cis50 mg QD AMG 706 + panitumumab + Gem/Cis75 mg BID AMG 706 + panitumumab + Gem/Cis75 mg QD AMG 706 + panitumumab + Gem/CisPanitumumab + Gem/Cis
GemcitabineDRUG

Gemcitabine will be administered intravenously on Day 1 and Day 8 of each 21-day cycle at a dose of 1250 mg/m\^2.

Also known as: Gemzar
100 mg QD AMG 706 + panitumumab + Gem/Cis125 mg QD AMG 706 + panitumumab + Gem/Cis50 mg QD AMG 706 + panitumumab + Gem/Cis75 mg BID AMG 706 + panitumumab + Gem/Cis75 mg QD AMG 706 + panitumumab + Gem/CisPanitumumab + Gem/Cis
CisplatinDRUG

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

Also known as: cisplatinum, cis-diamminedichloridoplatinum(II) (CDDP)
100 mg QD AMG 706 + panitumumab + Gem/Cis125 mg QD AMG 706 + panitumumab + Gem/Cis50 mg QD AMG 706 + panitumumab + Gem/Cis75 mg BID AMG 706 + panitumumab + Gem/Cis75 mg QD AMG 706 + panitumumab + Gem/CisPanitumumab + Gem/Cis

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related 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.

    PMID: 21559248BACKGROUND

Related Links

MeSH Terms

Conditions

Lung NeoplasmsPancreatic NeoplasmsEsophageal Neoplasms

Interventions

motesanib diphosphatePanitumumabGemcitabineCisplatin

Condition Hierarchy (Ancestors)

Respiratory Tract NeoplasmsThoracic NeoplasmsNeoplasms by SiteNeoplasmsLung DiseasesRespiratory Tract DiseasesDigestive System NeoplasmsEndocrine Gland NeoplasmsDigestive System DiseasesPancreatic DiseasesEndocrine System DiseasesGastrointestinal NeoplasmsHead and Neck NeoplasmsEsophageal DiseasesGastrointestinal Diseases

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, HumanizedAntibodies, MonoclonalAntibodiesImmunoglobulinsImmunoproteinsBlood ProteinsProteinsAmino Acids, Peptides, and ProteinsSerum GlobulinsGlobulinsHeterocyclic CompoundsDeoxycytidineCytidinePyrimidine NucleosidesPyrimidinesHeterocyclic Compounds, 1-RingChlorine CompoundsInorganic ChemicalsNitrogen CompoundsPlatinum Compounds

Results Point of Contact

Title
Study Director
Organization
Amgen Inc.
866-572-6436

Study Officials

  • MD

    Amgen

    STUDY DIRECTOR

Publication Agreements

PI is Sponsor Employee
No
Restriction Type
OTHER
Restrictive Agreement
Yes

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 18, 2005

First Posted

January 19, 2005

Study Start

December 1, 2004

Primary Completion

June 1, 2007

Study Completion

April 1, 2008

Last Updated

March 20, 2014

Results First Posted

March 20, 2014

Record last verified: 2014-02