Solid TumorsPhase 1NCT02683395
A Study of PLX51107 in Advanced Malignancies
A Phase 1 study testing PLX51107 in people with Solid Tumors and Acute Myeloid Leukemia, run by Plexxikon at 5 sites in United States.
Trial summary
The purpose of this research study is to evaluate safety, pharmacokinetics, pharmacodynamics, and preliminary efficacy of the investigational drug PLX51107 in subjects with advanced solid tumors (including lymphoma), and advanced hematological malignancies Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Solid Tumors, Acute Myeloid Leukemia, Myelodysplastic Syndrome
- What is being tested?
- PLX51107
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 5 sitesUnited States
- Study dates
- Mar 2016to Sep 2018
- 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
- Confirmed diagnosis of a relapsed or refractory malignancy in 1 of 2 treatment groups:
- Group A: Subjects with any solid tumor (including lymphomas).
- Group B: Subjects with relapsed or refractory AML, Subjects with relapsed or refractory high-risk MDS, defined as revised International Prognostic Scoring System (IPSS-R) intermediate or greater disease.
- Age ≥18 years.
- Eastern Cooperative Oncology Group (ECOG) performance status 0 to 2.
- Life expectancy ≥3 months in the judgment of the investigator.
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- Adequate organ function.
- Group A subjects must have measurable or evaluable disease per the appropriate disease criteria.
- Women of child-bearing potential must have a negative serum pregnancy test at Screening and must agree to use an effective form of contraception from the time of the negative pregnancy test up to 6 months after the last dose of study drug. Effective forms of contraception include abstinence, hormonal contraceptive in conjunction with a barrier method, or a double barrier method. Women of non-child-bearing potential may be included if they are either surgically sterile or have been postmenopausal for ≥1 year.
- Fertile men must agree to use an effective method of birth control during the study and for up to 6 months after the last dose of study drug.
- All associated clinically significant toxicity from previous cancer therapy must be resolved (to ≤Grade 1 or baseline) prior to study treatment administration (Grade 2 alopecia is allowed).
- Willingness and ability to provide written informed consent prior to any study-related procedures and to comply with all study requirements.
Who cannot join
- Prior exposure to a bromodomain inhibitor, such as OTX-015 or CPI-0610.
- Allogenic or autologous transplant for hematological malignancy with infusion of stem cells within 90 days before Cycle 1 Day 1, or on active immunosuppressive therapy for graft-versus-host disease (GVHD) or GVHD prophylaxis within 2 weeks of Cycle 1 Day 1.
- Known uncontrolled fungal, bacterial, and/or viral infection ≥Grade 2.
- Uncontrolled autoimmune hemolytic anemia or thrombocytopenia.
- For Group A: Subjects with a history of brain metastases are ineligible. This includes previously treated brain metastases. For Group B (subjects with AML): Active symptomatic CNS involvement of AML. Subjects with previously treated leptomeningeal disease that has been effectively treated are eligible.
- A diagnosis of acute promyelocytic leukemia (APL) or chronic myeloid leukemia (CML) in blast crisis.
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- Known or suspected allergy to the investigational agent or any agent given in association with this trial.
- Women who are pregnant or are breast feeding.
- Clinically significant cardiac disease
- Inability to take oral medication or significant nausea and vomiting, malabsorption, or significant small bowel resection that, in the opinion of the Investigator, would preclude adequate absorption.
- Subject with known human immunodeficiency virus (HIV), hepatitis B virus (HBV), or hepatitis C virus (HCV) infection or is known to be a carrier of hepatitis B or C.
- Strong CYP3A4 and CYP2C8 inhibitors or inducers or CYP3A4 substrate drugs with a narrow therapeutic range taken within 14 days or 5 drug half-lives before start of study drug.
- Active secondary malignancy
- Major surgery or significant traumatic injury within 14 days prior to therapy
- Receipt of anti-cancer therapy 14 days prior to Cycle 1 Day 1
- Presence of any other medical, psychological, familial, sociological, or geographic condition potentially hampering compliance with the study protocol Subjects who are participating in any other therapeutic clinical study (observational or registry trials are allowed).
- Subjects who have Burkitt's lymphoma or Burkitt-like lymphoma.
- Subjects on active anticoagulation therapy including warfarin, factor Xa inhibitors, thrombin inhibitors, or heparin.
- Subjects with documented hepatic metastases involving >50% of the hepatic parenchyma.
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
United States5 sites
MUSC/ Hollings Cancer Center
Charleston, South Carolina, 29425
The Ohio State University Stephanie Spielman Comprehensive Breast Center
Columbus, Ohio, 43212
Columbia University Medical Center
New York, New York, 10032
Thomas Jefferson University
Philadelphia, Pennsylvania, 19107
South Texas Accelerated Research Therapeutics
San Antonio, Texas, 78229
About this study
Official title: A Phase 1b/2a, Two-Part, Dose Escalation and Expansion Study to Assess the Safety, Pharmacokinetics, Pharmacodynamics, and Preliminary Efficacy of PLX51107 in Subjects With Advanced Hematological Malignancies and Solid Tumors
The purpose of this research study is to evaluate safety, pharmacokinetics, pharmacodynamics, and preliminary efficacy of the investigational drug PLX51107 in subjects with advanced solid tumors (including lymphoma), and advanced hematological malignancies
- Being tested
- PLX51107
- Keywords
- PLX51107, Acute Myeloid Leukemia, Myelodysplastic Syndrome, Non-Hodgkin's Lymphoma
- Medical subject headings
- Leukemia, Myeloid, Acute, Myelodysplastic Syndromes, Lymphoma, Non-Hodgkin
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PLX51107Drug
| Study group | Role | What they receive |
|---|---|---|
| Treatment Group A | Experimental | Open label, sequential PLX51107 dose escalation in approximately 30 solid tumor subjects. Receives: Drug: PLX51107 |
| Treatment Group B | Experimental | Open label, sequential PLX51107 dose escalation in approximately 30 subjects with acute myeloid leukemia (AML) or high-risk myelodysplastic syndrome (MDS). Receives: Drug: PLX51107 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety of PLX51107 as measured by adverse events and serious adverse events.
Measured: 1 year
Area under the concentration-time curve (AUC) of PLX51107.
Measured: 1 year
Maximum observed concentration (Cmax) of PLX51107.
Measured: 1 year
Time to peak concentration (Tmax) of PLX51107.
Measured: 1 year
Half life (t1/2) of PLX51107.
Measured: 1 year
Secondary outcomes (4)
Overall Response Rate (ORR)
ORR is defined as the total number of patients with the best overall response according to standard criteria for the relevant malignancy divided by the total number of treated patients and expressed as a percentage.
Measured: 1 year
Duration Of Response (DOR).
DOR is defined as the time from the initial objective response to disease progression or death, whichever occurs first.
Measured: 1 year
Progression-Free Survival (PFS).
PFS time is defined as the time from the first dose of PLX51107 to disease progression or death, whichever occurs first.
Measured: 1 year
Overall Survival (OS).
OS is defined as the first dose of study drug until the date of death from any cause.
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Feb 2016 (estimated)
- Study startMar 2016
- Primary completionSep 2018
- Study completionSep 2018
Why it stopped: Business Decision
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Solid TumorsStudies of the same condition, open and under way.
- 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
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Plexxikon
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02683395
- Sponsor's protocol ID
- PLX122-01
- Status last verified
- Dec 2018
- First submitted
- 12 Feb 2016
- Last updated
- 24 Dec 2018
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 24 Dec 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1b/2a, Two-Part, Dose Escalation and Expansion Study to Assess the Safety, Pharmacokinetics, Pharmacodynamics, and Preliminary Efficacy of PLX51107 in Subjects With Advanced Hematological Malignancies and Solid Tumors
- ClinicalTrials.gov ID
- NCT02683395
- Acronym / sponsor ID
- PLX122-01
- Keywords
- PLX51107, Acute Myeloid Leukemia, Myelodysplastic Syndrome, Non-Hodgkin's Lymphoma
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Business Decision
- Enrolment
- 50 participants (actual)
- Lead sponsor
- PlexxikonIndustry (pharma, biotech, devices)
- Study start
- Mar 2016
- Primary completion
- Sep 2018 (actual)
- Study completion
- Sep 2018 (actual)
- First posted
- 17 Feb 2016 (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.
The purpose of this research study is to evaluate safety, pharmacokinetics, pharmacodynamics, and preliminary efficacy of the investigational drug PLX51107 in subjects with advanced solid tumors (including lymphoma), and advanced hematological malignancies
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Treatment Group A | Experimental | Drug: PLX51107Open label, sequential PLX51107 dose escalation in approximately 30 solid tumor subjects. |
| Treatment Group B | Experimental | Drug: PLX51107Open label, sequential PLX51107 dose escalation in approximately 30 subjects with acute myeloid leukemia (AML) or high-risk myelodysplastic syndrome (MDS). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- Confirmed diagnosis of a relapsed or refractory malignancy in 1 of 2 treatment groups:
- Age ≥18 years.
- Eastern Cooperative Oncology Group (ECOG) performance status 0 to 2.
- Life expectancy ≥3 months in the judgment of the investigator.
- Adequate organ function.
Key exclusion criteria (19 listed)
- Prior exposure to a bromodomain inhibitor, such as OTX-015 or CPI-0610.
- Allogenic or autologous transplant for hematological malignancy with infusion of stem cells within 90 days before Cycle 1 Day 1, or on active immunosuppressive therapy for graft-versus-host disease (GVHD) or GVHD prophylaxis within 2 weeks of Cycle 1 Day 1.
- Known uncontrolled fungal, bacterial, and/or viral infection ≥Grade 2.
- Uncontrolled autoimmune hemolytic anemia or thrombocytopenia.
- For Group A: Subjects with a history of brain metastases are ineligible. This includes previously treated brain metastases. For Group B (subjects with AML): Active symptomatic CNS involvement of AML. Subjects with previously treated leptomeningeal disease that has been effectively treated are eligible.
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 |
|---|---|---|
| PLX51107 | Drug | Treatment Group A, Treatment Group B |
Primary outcome
Safety of PLX51107 as measured by adverse events and serious adverse events.
Time frame: 1 year
Area under the concentration-time curve (AUC) of PLX51107.
Time frame: 1 year
Maximum observed concentration (Cmax) of PLX51107.
Time frame: 1 year
Time to peak concentration (Tmax) of PLX51107.
Time frame: 1 year
Half life (t1/2) of PLX51107.
Time frame: 1 year
4 secondary outcomes
Overall Response Rate (ORR)
Time frame: 1 year
Duration Of Response (DOR).
Time frame: 1 year
Progression-Free Survival (PFS).
Time frame: 1 year
Overall Survival (OS).
Time frame: 1 year
Results and safety
The study was stopped early (reason given: Business Decision). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Dec 2018.
- Individual participant dataSharing planned: Undecided
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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.
The record lists no contact. Use the official record to reach the sponsor.
5 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 PLX51107 in people with Solid Tumors and Acute Myeloid Leukemia, run by Plexxikon at 5 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 12 inclusion and 19 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 24 Dec 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 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 was stopped early (reason given: Business Decision). Results are not available in the source record.
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?
Safety of PLX51107 as measured by adverse events and serious adverse events. (time frame: 1 year). The study lists 5 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 24 Dec 2018.