CancerPhase 1NCT01300026
AMG 319 Lymphoid Malignancy FIH
A Phase 1 study testing AMG 319 in people with Cancer and Chronic Lymphocytic Leukemia, run by Amgen at 3 sites in United States.
Trial summary
This is a multi-center, phase 1, open-label first-in-human study of AMG 319 in subjects with relapsed or refractory lymphoid malignancies. This study consists of two parts. The dose exploration in part 1, studies cohorts of 3 subjects with relapsed or refractory lymphoid malignancies and uses a practical continuous… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cancer, Chronic Lymphocytic Leukemia, Diffuse Large Cell Lymphoma
- What is being tested?
- AMG 319
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 28 participants
- Where
- 3 sitesUnited States
- Study dates
- Apr 2011to Dec 2016
- 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
- Part 1 (Dose Exploration): Relapsed or refractory lymphoid malignancy of the following type for which standard treatment does not exist or is no longer effective:
- B-cell Chronic Lymphocytic Leukemia (CLL) confirmed by immunophenotype or Non-Hodgkin Lymphoma: Low or intermediate grade B-cell NHL, mantle cell lymphoma, non-cutaneous T-cell NHL confirmed by histology and/or immunophenotype
- Part 2 (Dose Expansion): Subjects must have relapsed or refractory B-cell Chronic Lymphocytic Leukemia confirmed by immunophenotype for which standard treatment does not exist or is no longer effective.
- Eastern Cooperative Oncology Group (ECOG) Performance Status ≤ 2
- Life expectancy of > 3 months, in the opinion of the investigator
- Men or women ≥ 18 years old
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- Hematological function, as follows:
- Absolute neutrophil count (ANC) ≥ 1.5 x 109/L (unless due to disease-related bone marrow involvement as documented by bone marrow biopsy, ≥ 0.5 x 109/L) Platelet count ≥ 50 x 109/L (without a transfusion within 14 days before enrollment) Hemoglobin ≥ 9 g/dL
- Hepatic function, as follows: Aspartate aminotransferase (AST) < 3.0 x ULN Alanine aminotransferase (ALT) < 3.0 x ULN Alkaline phosphatase (ALP) < 2.0 x ULN (< 5 x ULN in subjects whom the PI and sponsor agree that clinical data suggest an extrahepatic source of elevation) 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) Amylase ≤ 2.0 x IULN Lipase ≤ 2.0 x IULN
Who cannot join
- Primary or disseminated tumor involving the central nervous system (CNS)
- A history of other malignancies, except: adequately treated non-melanoma skin cancer, curatively treated in-situ cancer, or other solid tumors curatively treated with no evidence of disease for ≥ 2 years
- History of allogeneic stem-cell (or other organ) transplantation
- Clinically significant ECG changes which obscure the ability to assess the PR, QT, and QRS interval; congenital long QT syndrome
- QTcF interval > 470 msec
- Active or chronic hepatitis B or hepatitis C infection, determined by serologic tests
- Recent infection requiring intravenous anti-infective treatment that was completed ≤ 14 days before enrollment
Trial locations and contacts
3 sites in 1 country.
United States3 sites
Research Site
Durham, North Carolina, 27710
Research Site
Hackensack, New Jersey, 07601
Research Site
Salt Lake City, Utah, 84112
About this study
Official title: A Phase 1, First-in-Human Study Evaluating the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of AMG 319 in Adult Subjects With Relapsed or Refractory Lymphoid Malignancies
This is a multi-center, phase 1, open-label first-in-human study of AMG 319 in subjects with relapsed or refractory lymphoid malignancies. This study consists of two parts. The dose exploration in part 1, studies cohorts of 3 subjects with relapsed or refractory lymphoid malignancies and uses a practical continuous reassessment model [CRM] to guide dose escalation and to define the MTD. The dose expansion in part 2 will enroll 20 subjects with CLL at a dose no higher than the MTD and further explore the safety, PK, and clinical activity of AMG 319 in this patient population.
- Conditions
- Cancer, Chronic Lymphocytic Leukemia, Diffuse Large Cell Lymphoma, Hematologic Malignancies, Hematology, Leukemia
- Being tested
- AMG 319
- Keywords
- Low intermediate grade B cell Lymphoma, Non-cutaneous T-cell NHL, Mantle Cell Lymphoma, PI3K delta, Lymphoid, NHL, MCL, Hematologic, CLL, Chronic Lymphocytic Leukemia
- Medical subject headings
- Neoplasms, Leukemia, Lymphocytic, Chronic, B-Cell, Lymphoma, Large B-Cell, Diffuse, Hematologic Neoplasms, Leukemia, Lymphoma, Non-Hodgkin, Lymphoma, Lymphoma, Mantle-Cell
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AMG 319Drug
AMG 319 is a highly selective, orally bioavailable and potent small molecule inhibitor of PI3Kδ.
| Study group | Role | What they receive |
|---|---|---|
| Part II Dose Expansion | Experimental | Dose selected from Part I dose exploration Receives: Drug: AMG 319 |
| Part I Dose Exploration | Experimental | The AMG 319 doses proposed for this study are 25, 50, 100, 200, 300 and 400 mg administered by mouth once daily. Receives: Drug: AMG 319 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Clinically significant or > or = to Grade 3 CTCAE changes in safety laboratory tests, physical exams, ECGs or vital signs
Measured: 28 Days after last subject enrolled per each cohort
PK parameters
Measured: 28 Days after last subject enrolled per each cohort
Clinical/radiological response rate for CLL subjects
Measured: With primary analysis
Treatment-emergent adverse events
Measured: 28 Days after last subject enrolled per each cohort
Secondary outcomes (2)
Phospho-AKT level in circulating CLL cells
Measured: With primary analysis
Number of patients with clinical/radiological response
Measured: With primary analysis
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Feb 2011 (estimated)
- Study startApr 2011
- Primary completionOct 2013
- Study completionDec 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CancerStudies of the same condition, open and under way.
- More trials run by AmgenThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- 28 participants (actual)
Sponsor and investigators
- Lead sponsor
- Amgen
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- MD, Study director, Amgen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01300026
- Sponsor's protocol ID
- 20101262
- Other IDs
- AMG 319 FIH Lymphoid
- Status last verified
- Feb 2017
- First submitted
- 6 Jan 2011
- Last updated
- 9 Feb 2017
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Feb 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1, First-in-Human Study Evaluating the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of AMG 319 in Adult Subjects With Relapsed or Refractory Lymphoid Malignancies
- ClinicalTrials.gov ID
- NCT01300026
- Acronym / sponsor ID
- 20101262
- Conditions
- Cancer, Chronic Lymphocytic Leukemia, Diffuse Large Cell Lymphoma, Hematologic Malignancies, Hematology, Leukemia
- Keywords
- Low intermediate grade B cell Lymphoma, Non-cutaneous T-cell NHL, Mantle Cell Lymphoma, PI3K delta, Lymphoid, NHL, MCL, Hematologic
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 28 participants (actual)
- Lead sponsor
- AmgenIndustry (pharma, biotech, devices)
- Study start
- Apr 2011
- Primary completion
- Oct 2013 (actual)
- Study completion
- Dec 2016 (actual)
- First posted
- 21 Feb 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a multi-center, phase 1, open-label first-in-human study of AMG 319 in subjects with relapsed or refractory lymphoid malignancies. This study consists of two parts. The dose exploration in part 1, studies cohorts of 3 subjects with relapsed or refractory lymphoid malignancies and uses a practical continuous reassessment model [CRM] to guide dose escalation and to define the MTD. The dose expansion in part 2 will enroll 20 subjects with CLL at a dose no higher than the MTD and further explore the safety, PK, and clinical activity of AMG 319 in this patient population.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Part II Dose Expansion | Experimental | Drug: AMG 319Dose selected from Part I dose exploration |
| Part I Dose Exploration | Experimental | Drug: AMG 319The AMG 319 doses proposed for this study are 25, 50, 100, 200, 300 and 400 mg administered by mouth once daily. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Part 1 (Dose Exploration): Relapsed or refractory lymphoid malignancy of the following type for which standard treatment does not exist or is no longer effective:
- B-cell Chronic Lymphocytic Leukemia (CLL) confirmed by immunophenotype or Non-Hodgkin Lymphoma: Low or intermediate grade B-cell NHL, mantle cell lymphoma, non-cutaneous T-cell NHL confirmed by histology and/or immunophenotype
- Part 2 (Dose Expansion): Subjects must have relapsed or refractory B-cell Chronic Lymphocytic Leukemia confirmed by immunophenotype for which standard treatment does not exist or is no longer effective.
- Eastern Cooperative Oncology Group (ECOG) Performance Status ≤ 2
- Life expectancy of > 3 months, in the opinion of the investigator
Key exclusion criteria (7 listed)
- Primary or disseminated tumor involving the central nervous system (CNS)
- A history of other malignancies, except: adequately treated non-melanoma skin cancer, curatively treated in-situ cancer, or other solid tumors curatively treated with no evidence of disease for ≥ 2 years
- History of allogeneic stem-cell (or other organ) transplantation
- Clinically significant ECG changes which obscure the ability to assess the PR, QT, and QRS interval; congenital long QT syndrome
- QTcF interval > 470 msec
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| AMG 319AMG 319 is a highly selective, orally bioavailable and potent small molecule inhibitor of PI3Kδ. | Drug | Part I Dose Exploration, Part II Dose Expansion |
Primary outcome
Clinically significant or > or = to Grade 3 CTCAE changes in safety laboratory tests, physical exams, ECGs or vital signs
Time frame: 28 Days after last subject enrolled per each cohort
PK parameters
Time frame: 28 Days after last subject enrolled per each cohort
Clinical/radiological response rate for CLL subjects
Time frame: With primary analysis
Treatment-emergent adverse events
Time frame: 28 Days after last subject enrolled per each cohort
2 secondary outcomes
Phospho-AKT level in circulating CLL cells
Time frame: With primary analysis
Number of patients with clinical/radiological response
Time frame: With primary analysis
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Feb 2017.
- AmgenTrials clinical trials websiteLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
MD study director
Amgen
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing AMG 319 in people with Cancer and Chronic Lymphocytic Leukemia, 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 9 inclusion and 7 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 9 Feb 2017. 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?
Clinically significant or > or = to Grade 3 CTCAE changes in safety laboratory tests, physical exams, ECGs or vital signs (time frame: 28 Days after last subject enrolled per each cohort). 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?
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 9 Feb 2017.