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CancerPhase 1NCT00813384

A Phase 1 Study of AMG 208 in Subjects With Advanced Solid Tumors

A Phase 1 study testing AMG 208 in people with Cancer and Oncology, run by Amgen at 3 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

First in human, open-label, sequential dose escalation and expansion study of AMG 208 in subjects with advanced solid tumors. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Cancer, Oncology, Tumors
What is being tested?
AMG 208
Could I receive a placebo?
No, everyone receives an active treatment
How many people
54 participants
Where
3 sitesUnited States
Study dates
Dec 2008to Dec 2014
Phase
Phase 1
Are there results?
None posted in the registry

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

  • Men or women ≥ 18 years old
  • Subjects must have a pathologically documented, definitively diagnosed, advanced solid tumor that is refractory to standard treatment, for which no standard therapy is available or the subject refuses standard therapy
  • Measurable disease per RECIST guidelines (subjects with non-measurable, but evaluable disease are also eligible for Part 1 of the study)
  • Eastern Cooperative Oncology Group (ECOG) Performance Status of ≤ 2
  • Life expectancy of > 3 months, in the opinion of the investigator
  • Female subjects who are post-menopausal (no menstrual period for a minimum of 12 months), or surgically sterilized. Female subjects of child bearing potential must remain abstinent or use double-barrier birth control method during the period of therapy and must be willing to use contraception 2 weeks following the last study drug administration and have a negative serum pregnancy test upon entry into this study
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  • Male subject is willing to use contraception upon enrollment, during the course of the study and for 12 weeks following the last study drug administration
  • Willing to provide tumor samples and / or slides
  • Competent to sign and date an Institutional Review Board approved informed consent form
  • Hematological function, as follows:
  • Absolute neutrophil count (ANC) ≥ 1.5 x 109/L Platelet count ≥ 100 x 109/L Hemoglobin > 9 g/dL Prothrombin time (PT) or partial thromboplastin time (PTT) < 1.5 x institutional upper limit of normal (IULN)
  • Renal function, as follows:
  • Serum creatinine < 2.0 mg/dL
  • Hepatic function, as follows:
  • AST/ALT < 3x ULN and total bilirubin < 1.5x ULN in all subjects Alkaline phosphatase < 2.0 x ULN (if liver or bone metastases are present, ≤ 5 x ULN)

Who cannot join

  • Any disorder that compromises the ability of the subject to give written informed consent and/or to comply with the study procedures.
  • Primary central nervous system (CNS) tumors or metastases
  • History of bleeding diathesis
  • Myocardial infarction within 6 months of study day 1, symptomatic congestive heart failure (New York Heart Association > class II), unstable angina, or unstable cardiac arrhythmia requiring medication, or uncontrolled hypertension in the opinion of the investigator
  • A baseline ECG QTc > 480 ms
  • Active infection within 2 weeks of study enrollment (day 1)
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  • Significant gastrointestinal disorder(s), in the opinion of the investigator, (e.g. Crohn's disease, ulcerative colitis, extensive gastrointestinal resection) that may influence drug absorption
  • Known positive test for HIV
  • Known acute or chronic hepatitis B or hepatitis C infection, determined by serologic tests
  • Unresolved toxicities from prior anti-tumor therapy, defined as not having resolved to CTCAE grade 0 or 1, or to levels dictated in the eligibility criteria with the exception of alopecia
  • Anti-tumor therapy (chemotherapy, antibody therapy, molecular targeted therapy, retinoid therapy, hormonal therapy, or investigational agent) within 28 days of study day 1 (six weeks for nitrosureas, mitomycin C, or antibody or molecular targeted agents with t1/2 > 10 days); concurrent use of hormone deprivation therapy for hormone-refractory prostate cancer or breast cancer is permitted
  • Treatment with immune modulators including, but not limited to, systemic corticosteroids, cyclosporine and tacrolimus within two weeks prior to enrollment
  • Therapeutic or palliative radiation therapy within 2 weeks of study day 1
  • Concurrent or prior (within 7 days of study day 1) anticoagulation therapy (low-dose warfarin [≤ 2 mg/day] or low molecular weight heparins for prophylaxis against central venous catheter thrombosis or aspirin [81 mg/day] is allowed)
  • Prior participation in an investigational study and/or procedure within 28 days of study day 1
  • Major surgery within 30 days of study day 1
  • Any co-morbid medical disorder that may increase the risk of toxicity, in the opinion of the investigator or sponsor

Trial locations and contacts

3 sites in 1 country.

United States3 sites

  • Research Site

    Beverly Hills, California, 90211

  • Research Site

    Houston, Texas, 77030

  • Research Site

    St Louis, Missouri, 63110

Other trials in United States

About this study

Official title: A Phase 1, First-In-Human Study Evaluating the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of AMG 208 in Adult Subjects With Advanced Solid Tumors

First in human, open-label, sequential dose escalation and expansion study of AMG 208 in subjects with advanced solid tumors.

Being tested
AMG 208
Keywords
Cancer, Solid Tumors, Phase 1, C-met inhibitor, Clinical Trial
Medical subject headings
Neoplasms

What participants receive

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

  • AMG 208Drug

    AMG 208 is a small molecule inhibitor of c-Met which is a well-characterized receptor tyrosine kinase expressed on the surface of epithelial cells. C-Met receptor signaling has been shown to play a key role in the survival of cancer cells. AMG 208 inhibits both ligand-dependent and ligand-independent c-Met cellular growth regulation. Inhibition of c-Met signaling with AMG 208 provides a potential mechanism for blocking tumor growth and survival.

Study groups in NCT00813384
Study groupRoleWhat they receive
Dose EscalationExperimentalThe dose escalation part of the study is aimed at determining the maximum tolerated dose (MTD), if feasible, and evaluating the safety, tolerability, pharmacokinetics and pharmacodynamics of AMG 208.
Receives: Drug: AMG 208
Dose ExpansionExperimentalThe dose expansion will consist of up to 30 subjects and the dose level of AMG 208 will be dependent upon emerging safety and PK data from the dose escalation part of the study.
Receives: Drug: AMG 208

What is being measured

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

  1. To determine the maximum tolerated dose (MTD) of AMG 208, if possible

    Measured: 3.5 years

  2. To evaluate for clinical responses associated with AMG 208 treatment in subjects (Dose Expansion) with advanced solid malignancies according to RECIST criteria

    Measured: 3.5 years

  3. To characterize the pharmacokinetic (PK) exposure of AMG 208 when administered orally to subjects with advanced solid malignancies

    Measured: 3.5 years

  4. To evaluate the safety and tolerability of AMG 208 in subjects with advanced solid malignancies

    Measured: 3.5 years

Secondary outcomes (4)

  1. To evaluate for a decrease in tumor cell proliferation associated with AMG 208 treatment in subjects with advanced solid malignancies according to FLT-PET scanning

    Measured: 3.5 years

  2. To assess tumor volume changes after AMG 208 treatment by computed tomography (CT) or magnetic resonance imaging (MRI)

    Measured: 3.5 years

  3. To assess skin specimens for potential biomarkers

    Measured: 3.5 years

  4. To determine whether c-Met expression, mutation, or amplification in tumor specimens correlates with a response to AMG 208

    Measured: 3.5 years

Timeline

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

  1. First posted23 Dec 2008 (estimated)
  2. Study startDec 2008
  3. Primary completionFeb 2013
  4. Study completionDec 2014

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
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
54 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00813384
Sponsor's protocol ID
20080895
Status last verified
Dec 2014
First submitted
22 Dec 2008
Last updated
16 Dec 2014
Results posted
No
Data monitoring committee
No

Publications

  • Hong DS, Rosen P, Lockhart AC, Fu S, Janku F, Kurzrock R, Khan R, Amore B, Caudillo I, Deng H, Hwang YC, Loberg R, Ngarmchamnanrith G, Beaupre DM, Lee P. A first-in-human study of AMG 208, an oral MET inhibitor, in adult patients with advanced solid tumors. Oncotarget. 2015 Jul 30;6(21):18693-706. doi: 10.18632/oncotarget.4472.

    PubMed 26155941

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing AMG 208 in people with Cancer and Oncology, run by Amgen at 3 sites in United States.

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 15 inclusion and 17 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: finished, as of the sponsor's last update on 16 Dec 2014. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 3 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

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?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

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?

To determine the maximum tolerated dose (MTD) of AMG 208, if possible (time frame: 3.5 years). The study lists 4 primary outcomes in all. 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 NCT00813384, 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 16 Dec 2014.

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