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Renal Cell AdenocarcinomaPhase 1NCT01497821

AMG 172 First in Human Study in Patients With Kidney Cancer

A Phase 1 study testing AMG 172 in people with Renal Cell Adenocarcinoma and Clear Cell Renal Carcinoma, run by Amgen at 4 sites in 3 countries.

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

This is the first-in-human (Phase I) study of AMG 172, an antibody drug conjugate (ADC), in subjects with kidney cancer [Clear Cell Renal Cell Carcinoma (ccRCC)] who have relapsed or who have refractory disease following at least two prior therapies. Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
AMG 172
Could I receive a placebo?
No, everyone receives an active treatment
How many people
37 participants
Where
4 sitesin 3 countries
Study dates
Jan 2012to Jan 2015
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

  • Subjects must have a pathologically documented, definitively diagnosed, clear cell RCC that is relapsed/refractory following at least two lines of systemic therapy (one of which must be a tyrosine kinase), or the subject refuses standard therapy
  • Measurable disease per RECIST 1.1 criteria. Subjects with non-measurable, but evaluable disease are also eligible for Part 1 of the study.
  • Eastern Cooperative Oncology Group (ECOG) Performance Status of ≤ 1
  • Willing to provide tumor samples and / or slides
  • Hematological function, as follows:
  • Absolute neutrophil count (ANC) ≥ 1.5 x 10^9/L;
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  • Platelet count ≥ 100 x 10^9/L;
  • Hemoglobin > 9 g/dL
  • Prothrombin time (PT) or partial thromboplastin time (PTT) < 1.5 x institutional upper limit of normal (IULN)
  • Hepatic function, as follows:
  • Aspartate aminotransferase (AST) or alanine aminotransferase (ALT) < 3 x ULN;
  • Total bilirubin < 1.5 x ULN (< 3.0 x ULN for subjects with documented Gilbert's Disease or for whom the indirect bilirubin level suggests an extrahepatic source of elevation);
  • Alkaline phosphatase < 2 x ULN (< 5 x ULN in subjects whom the PI and sponsor agree that clinical data suggest extrahepatic source of elevation)
  • Other inclusion criteria may apply

Who cannot join

  • Known primary central nervous system (CNS) tumors or brain 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
  • Clinically significant ECG changes which obscure the ability to assess the PR, QT, and QRS interval; congenital long QT syndrome
  • A baseline ECG QTcF > 470 msec
  • Known positive test for human immunodeficiency virus (HIV)
  • Known acute or chronic hepatitis B or hepatitis C infection as determined by serologic tests
  • Other exclusion criteria may apply

Trial locations and contacts

4 sites in 3 countries.

4 sites in 3 countries

United States2 sites

  • Research Site

    Scottsdale, Arizona, 85258

  • Research Site

    St Louis, Missouri, 63110

Other trials in United States

France1 site

  • Research Site

    Villejuif, 94805

Other trials in France

Germany1 site

  • Research Site

    Heidelberg, 69120

Other trials in Germany

About this study

Official title: A Phase 1 First-in-Human Study Evaluating Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of AMG 172 in Subjects With Relapsed / Refractory Renal Cell Carcinoma

This is the first-in-human (Phase I) study of AMG 172, an antibody drug conjugate (ADC), in subjects with kidney cancer [Clear Cell Renal Cell Carcinoma (ccRCC)] who have relapsed or who have refractory disease following at least two prior therapies. The purpose of the study is to evaluate safety and pharmacokinetics (PK) of AMG 172, and also evaluate the objective response rate in patients with ccRCC receiving AMG 172. The study will be conducted in two Parts: Part 1 will explore doses of AMG 172 given every two weeks and every three weeks to determine the safety, tolerability and pharmacokinetics to establish a maximum tolerated dose (MTD), and Part 2 (dose expansion) will examine safety, tolerability, PK and overall response rate in subjects treated at the MTD established in Part 1 for either every two week or every three week dosing.

Read the detailed description

This First in- human study of AMG 172 will be conducted in two parts: Part 1 (dose exploration) and Part 2 (dose expansion). Part 1 of the study is aimed at evaluating the safety, tolerability and PK of AMG 172 given every two weeks and every three weeks in subjects with relapsed / refractory cc RCC, and Part 2 is aimed at evaluating safety, tolerability, PK and response rate in subjects treated at the MTD established in Part 1 for either every two week or every three week dosing. Up to 48 subjects may be enrolled in Part 1, and up to 30 subjects may be enrolled in Part 2. The dose of AMG 172 utilized in Part 2 will be dependent upon data obtained in Part 1 of the study.

Being tested
AMG 172
Keywords
Amgen, Phase 1, First in Human, Relapsed / Refractory Renal Cell Carcinoma (RCC), Kidney Cancer, Clinical Trial, Antibody drug conjugate (ADC), Open-label, Oncology
Medical subject headings
Carcinoma, Renal Cell, Kidney Neoplasms, Neoplasms

What participants receive

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

  • AMG 172Drug

    AMG 172 is an antibody drug conjugate

Study groups in NCT01497821
Study groupRoleWhat they receive
Dose explorationExperimentalPre-specified nominal doses are proposed in the dose exploration at two dosing frequencies: every two weeks and every three weeks. Intermediate doses may also be used if required based on the Continuous Reassessment Method (CRM) design.
Receives: Drug: AMG 172
Dose expansionExperimentalDose and dosing frequency selected from Part 1 dose exploration.
Receives: Drug: AMG 172

What is being measured

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

  1. Clinically significant or ≥ Grade 3 CTCAE changes in safety laboratory tests, physical examinations, ECGs, or vital signs

    Measured: 28 days after the last subject enrolled of each cohort in Part 1 and every 10 subjects enrolled in Part 2 (if available)

  2. PK parameters including but not limited to, maximum observed concentration (Cmax), area under the concentration-time curve (AUC) and half life (t1/2)

    Measured: 12 time points up to 8 weeks

  3. Objective response rate for subjects treated at MTD based on RECIST 1.1

    Measured: 3 years

  4. The MTD for at least one of two dosing schedules: every two weeks or every three weeks

    Measured: 3 years

Secondary outcomes (3)

  1. Development of human anti-human antibody against AMG 172

    Measured: 1 year

  2. Objective response rate for subjects not treated at MTD based on RECIST 1.1

    Measured: 3 years

  3. Clinical benefit as measured by duration of response per RECIST 1.1

    Measured: 3 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 2011 (estimated)
  2. Study startJan 2012
  3. Primary completionNov 2014
  4. Study completionJan 2015

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
Single group
Masking
None (open label)
Enrolment
37 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01497821
Sponsor's protocol ID
20090515
Status last verified
Mar 2016
First submitted
16 Dec 2011
Last updated
25 Mar 2016
Results posted
No

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing AMG 172 in people with Renal Cell Adenocarcinoma and Clear Cell Renal Carcinoma, run by Amgen at 4 sites in 3 countries.

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 14 inclusion and 8 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 25 Mar 2016. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 4 sites in United States, France, Germany. 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?

Clinically significant or ≥ Grade 3 CTCAE changes in safety laboratory tests, physical examinations, ECGs, or vital signs (time frame: 28 days after the last subject enrolled of each cohort in Part 1 and every 10 subjects enrolled in Part 2 (if available)). 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 NCT01497821.

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 25 Mar 2016.

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