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Lung CancerPhase 1NCT00101907

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

A Phase 1 study testing AMG 706, Panitumumab and Gemcitabine in people with Lung Cancer and Pancreatic Cancer, run by Amgen.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Lung Cancer, Pancreatic Cancer, Esophageal Cancer
What is being tested?
AMG 706, Panitumumab and Gemcitabine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
41 participants
Where
No sites listed yet
Study dates
Dec 2004to Apr 2008
Phase
Phase 1
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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
Show all 10Show fewer
  • 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)

About this study

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

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.

Being tested
AMG 706, Panitumumab, Gemcitabine, Cisplatin
Keywords
Advanced Cancer, AMG 706, Panitumumab, Gemcitabine-Cisplatin
Medical subject headings
Lung Neoplasms, Pancreatic Neoplasms, Esophageal Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • 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.

  • PanitumumabBiological

    Also called Vectibix

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

  • GemcitabineDrug

    Also called Gemzar

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

  • CisplatinDrug

    Also called cisplatinum, cis-diamminedichloridoplatinum(II) (CDDP)

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

Study groups in NCT00101907
Study groupRoleWhat they receive
Panitumumab + Gem/CisExperimentalPanitumumab 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.
Receives: Biological: Panitumumab; Drug: Gemcitabine; Drug: Cisplatin
50 mg QD AMG 706 + panitumumab + Gem/CisExperimentalAMG 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.
Receives: Drug: AMG 706; Biological: Panitumumab; Drug: Gemcitabine; Drug: Cisplatin
75 mg QD AMG 706 + panitumumab + Gem/CisExperimentalAMG 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.
Receives: Drug: AMG 706; Biological: Panitumumab; Drug: Gemcitabine; Drug: Cisplatin
100 mg QD AMG 706 + panitumumab + Gem/CisExperimentalAMG 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.
Receives: Drug: AMG 706; Biological: Panitumumab; Drug: Gemcitabine; Drug: Cisplatin
125 mg QD AMG 706 + panitumumab + Gem/CisExperimentalAMG 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.
Receives: Drug: AMG 706; Biological: Panitumumab; Drug: Gemcitabine; Drug: Cisplatin
75 mg BID AMG 706 + panitumumab + Gem/CisExperimentalAMG 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.
Receives: Drug: AMG 706; Biological: Panitumumab; Drug: Gemcitabine; Drug: Cisplatin

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: 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)

  1. 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.

    Measured: 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.

  2. Tmax

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

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

  3. Cmax

    The maximum observed plasma concentration after AMG 706 dosing

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

  4. 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.

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

  5. 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.

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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted19 Jan 2005 (estimated)
  2. Study startDec 2004
  3. Primary completionJun 2007
  4. Study completionApr 2008

Why it stopped: Study terminated per recommendation of Data Review Team

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1
Primary purpose
Treatment
Allocation
Non-randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
41 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00101907
Sponsor's protocol ID
20040206
Status last verified
Feb 2014
First submitted
18 Jan 2005
Last updated
20 Mar 2014

Publications

  • 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.

    PubMed 21559248

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing AMG 706, Panitumumab and Gemcitabine in people with Lung Cancer and Pancreatic Cancer, run by Amgen.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 20 Mar 2014. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 20 Mar 2014). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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.). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00101907, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Mar 2014.

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