Solid TumorPhase 1NCT01473095
Phase 1 Dose Escalation Study of ARQ 092 in Adult Subjects With Advanced Solid Tumors and Recurrent Malignant Lymphoma
A Phase 1 study testing ARQ 092 in people with Solid Tumor and Malignant Lymphoma, run by ArQule, Inc., a subsidiary of Merck Sharp & Dohme LLC, a subsidiary of Merck & Co., Inc. (Rahway, NJ USA) at 7 sites in United States.
Trial summary
This is an open-label, Phase 1, dose escalation study of oral ARQ 092 administered to subjects with advanced solid tumors and recurrent malignant lymphoma. The study is designed to explore the safety, tolerability, pharmacokinetics, and pharmacodynamics of ARQ 092 and to define a recommended Phase 2 dose of ARQ 092. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Solid Tumor, Malignant Lymphoma, Tumor
- What is being tested?
- ARQ 092
- Type of treatment
- Pill or oral medicine
- How many people
- 120 participants
- Where
- 7 sitesUnited States
- Study dates
- Nov 2011to 7 Aug 2017
- 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
- Histologically or cytologically documented, incurable, locally advanced or metastatic solid tumors or recurrent malignant lymphoma in subjects who failed standard therapy or for whom standard or curative therapy does not exist or is not tolerable.
- Evaluable or measurable disease
- Life expectancy greater than three months
- ECOG performance status ≤2
- Hemoglobin (Hgb) ≥9.5 g/dl
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- Absolute neutrophil count (ANC) ≥1.5 x 10^9/L
- Platelet count ≥75 x 10^9/L
- Total bilirubin ≤1.5 × upper limit of normal (ULN)
- Aspartate transaminase (AST) and alanine transaminase (ALT) ≤3 × ULN
- Serum creatinine ≤1.5 x ULN or creatinine clearance > 60 mL/min/1.73 m^2 for subjects with creatinine levels >1.5 x ULN
- Agree to use double-barrier contraceptive measures or avoid intercourse during the study and for 90 days after the last dose of study drug
Who cannot join
- History of Type 1 or 2 diabetes mellitus requiring regular medication (other than metformin or other oral hypoglycemic agents) or fasting glucose ≥160 mg/dL at the prestudy visit. If a diabetic cohort is enrolled, only subjects with a medical history of controlled Type 1 or 2 diabetes mellitus will be enrolled in the cohort.
- Grade 2 or worse hypercholesterolemia or hypertriglyceridemia or >8% glycated Hb (HbA1C)
- Malabsorption syndrome
- Known brain metastases not radiographically stable for ≥3 months or leptomeningeal disease
- History of myocardial infarction (MI) or NYHA Class II-IV congestive heart failure within 6 months of the administration of the first dose of ARQ 092 (MI occurring >6 months of the first dose of ARQ 092 will be permitted); Grade 2 or worse conduction defect (eg right or left bundle branch block); left ventricular ejection fraction (LVEF) < 50% assessed by echocardiogram/MUGA scan
- Anti-cancer chemotherapy, radiotherapy, immunotherapy, or investigational agents within four weeks of the first dose of ARQ 092 (within 2 weeks for orally administered drugs)
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- Major surgery within four weeks of the first dose of ARQ 092
- Previous treatment with AKT inhibitors
- Concurrent severe uncontrolled illness not related to cancer
- Ongoing or active known infection, including human immunodeficiency virus (HIV) infection or bleeding
- Psychiatric illness/substance abuse/social situation that would limit compliance with study requirements.
- Blood transfusion within 5 days prior to blood draw being used to confirm eligibility
- Pregnant or breastfeeding
- Previous other malignancy within 2 years prior to the first dose of ARQ 092, with the exception of carcinoma in-situ of the cervix, basal cell carcinoma and superficial bladder tumors curatively treated.
Trial locations and contacts
7 sites in 1 country.
7 sites in 1 country
United States7 sites
Study site
Atlanta, Georgia, 30322
Study site
Atlanta, Georgia, 30341
Study site
Birmingham, Alabama, 35294
Study site
Lafayette, Indiana, 47905
Study site
Miami, Florida, 33136
Study site
San Antonio, Texas, 78229
Study site
Scottsdale, Arizona, 85258
About this study
Official title: A Phase 1 Dose Escalation Study of ARQ 092 in Adult Subjects With Advanced Solid Tumors and Recurrent Malignant Lymphoma
This is an open-label, Phase 1, dose escalation study of oral ARQ 092 administered to subjects with advanced solid tumors and recurrent malignant lymphoma. The study is designed to explore the safety, tolerability, pharmacokinetics, and pharmacodynamics of ARQ 092 and to define a recommended Phase 2 dose of ARQ 092.
- Conditions
- Solid Tumor, Malignant Lymphoma, Tumor
- Being tested
- ARQ 092
- Keywords
- AKT, ARQ 092, Targeted therapy, Molecular therapy, Biomarker, Phase 1, Phase I, Endometrial cancer, Lymphoma, AKT pathway, AKT signaling, AKT inhibitor, AKT pan inhibitor, AKT1, AKT2, AKT3, AKT1 mutation, AKT1-E17K, AKT1-E17K mutation, AKT 2 inhibitor
- Medical subject headings
- Lymphoma, Neoplasms, Endometrial Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ARQ 092Drug
Subjects in this study will receive ARQ 092 orally at dose levels specified for their respective dose cohorts. Dosing will begin at 10 mg every other day (QOD) and will escalate until the MTD or RP2D is determined. Cycles will be repeated in four-week (28 day) intervals until progression of disease, unacceptable toxicity, or another discontinuation criterion is met. In the case of toxicity, dose adjustment will be permitted.
What is being measured
The primary outcome is the main question the study is designed to answer.
Assess the safety and tolerability of ARQ 092 in subjects with advanced solid tumors and recurrent malignant lymphoma by monitoring frequency and severity of adverse events
Measured: Up to treatment discontinuation + 30 days with an estimated treatment duration of 4 to 16 weeks
Secondary outcomes (4)
Assess the pharmacokinetic profile (Cmax, AUC, and half-life) of ARQ 092
Measured: During the first 29 days of treatment for each dose level
Assess pharmacodynamic activity
Measured: During the first 29 days of treatment
Determine preliminary evidence of activity as defined by RECIST v 1.1
Measured: Up to treatment discontinuation + 30 days with an estimated treatment duration of 4 to 16 weeks
Determine recommended Phase 2 dose
Measured: Up to treatment discontinuation + 30 days with an estimated treatment duration of 4 to 16 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Nov 2011 (estimated)
- Study startNov 2011
- Primary completion6 Jul 2017
- Study completion7 Aug 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Solid TumorStudies 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 120 participants (actual)
Sponsor and investigators
- Lead sponsor
- ArQule, Inc., a subsidiary of Merck Sharp & Dohme LLC, a subsidiary of Merck & Co., Inc. (Rahway, NJ USA)
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01473095
- Sponsor's protocol ID
- ARQ 092-101
- Status last verified
- Oct 2017
- First submitted
- 10 Nov 2011
- Last updated
- 23 Oct 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Oct 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1 Dose Escalation Study of ARQ 092 in Adult Subjects With Advanced Solid Tumors and Recurrent Malignant Lymphoma
- ClinicalTrials.gov ID
- NCT01473095
- Acronym / sponsor ID
- ARQ 092-101
- Conditions
- Solid Tumor, Malignant Lymphoma, Tumor
- Keywords
- AKT, ARQ 092, Targeted therapy, Molecular therapy, Biomarker, Phase 1, Phase I, Endometrial cancer
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 120 participants (actual)
- Lead sponsor
- ArQule, Inc., a subsidiary of Merck Sharp & Dohme LLC, a subsidiary of Merck & Co., Inc. (Rahway, NJ USA)Industry (pharma, biotech, devices)
- Study start
- Nov 2011
- Primary completion
- 6 Jul 2017 (actual)
- Study completion
- 7 Aug 2017 (actual)
- First posted
- 17 Nov 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 an open-label, Phase 1, dose escalation study of oral ARQ 092 administered to subjects with advanced solid tumors and recurrent malignant lymphoma. The study is designed to explore the safety, tolerability, pharmacokinetics, and pharmacodynamics of ARQ 092 and to define a recommended Phase 2 dose of ARQ 092.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- Men or women ≥18 years old
- Histologically or cytologically documented, incurable, locally advanced or metastatic solid tumors or recurrent malignant lymphoma in subjects who failed standard therapy or for whom standard or curative therapy does not exist or is not tolerable.
- Evaluable or measurable disease
- Life expectancy greater than three months
- ECOG performance status ≤2
Key exclusion criteria (14 listed)
- History of Type 1 or 2 diabetes mellitus requiring regular medication (other than metformin or other oral hypoglycemic agents) or fasting glucose ≥160 mg/dL at the prestudy visit. If a diabetic cohort is enrolled, only subjects with a medical history of controlled Type 1 or 2 diabetes mellitus will be enrolled in the cohort.
- Grade 2 or worse hypercholesterolemia or hypertriglyceridemia or >8% glycated Hb (HbA1C)
- Malabsorption syndrome
- Known brain metastases not radiographically stable for ≥3 months or leptomeningeal disease
- History of myocardial infarction (MI) or NYHA Class II-IV congestive heart failure within 6 months of the administration of the first dose of ARQ 092 (MI occurring >6 months of the first dose of ARQ 092 will be permitted); Grade 2 or worse conduction defect (eg right or left bundle branch block); left ventricular ejection fraction (LVEF) < 50% assessed by echocardiogram/MUGA scan
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 |
|---|---|---|
| ARQ 092Subjects in this study will receive ARQ 092 orally at dose levels specified for their respective dose cohorts. Dosing will begin at 10 mg every other day (QOD) and will escalate until the MTD or RP2D is determined. Cycles will be repeated in four-week (28 day) intervals until progression of disease, unacceptable toxicity, or another discontinuation criterion is met. In the case of toxicity, dose adjustment will be permitted. | Drug | – |
Primary outcome
Assess the safety and tolerability of ARQ 092 in subjects with advanced solid tumors and recurrent malignant lymphoma by monitoring frequency and severity of adverse events
Time frame: Up to treatment discontinuation + 30 days with an estimated treatment duration of 4 to 16 weeks
4 secondary outcomes
Assess the pharmacokinetic profile (Cmax, AUC, and half-life) of ARQ 092
Time frame: During the first 29 days of treatment for each dose level
Assess pharmacodynamic activity
Time frame: During the first 29 days of treatment
Determine preliminary evidence of activity as defined by RECIST v 1.1
Time frame: Up to treatment discontinuation + 30 days with an estimated treatment duration of 4 to 16 weeks
Determine recommended Phase 2 dose
Time frame: Up to treatment discontinuation + 30 days with an estimated treatment duration of 4 to 16 weeks
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 23 Oct 2017.
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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.
7 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 ARQ 092 in people with Solid Tumor and Malignant Lymphoma, run by ArQule, Inc., a subsidiary of Merck Sharp & Dohme LLC, a subsidiary of Merck & Co., Inc. (Rahway, NJ USA) at 7 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 14 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 23 Oct 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 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?
Assess the safety and tolerability of ARQ 092 in subjects with advanced solid tumors and recurrent malignant lymphoma by monitoring frequency and severity of adverse events (time frame: Up to treatment discontinuation + 30 days with an estimated treatment duration of 4 to 16 weeks). 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 23 Oct 2017.