Solid TumorsPhase 1NCT01401868
Phase I Dose Escalation Study of the Safety and Pharmacokinetics of ME-143 Single Agent for Refractory Solid Tumors
A Phase 1 study testing ME-143 in people with Solid Tumors, run by MEI Pharma, Inc. at 2 sites in United States.
Trial summary
The purpose of this study is to determine the tolerability of ME-143, find the maximum tolerated dose, and the safety profile in patients with refractory solid tumors. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Solid Tumors
- What is being tested?
- ME-143
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 18 participants
- Where
- 2 sitesUnited States
- Study dates
- Sep 2011to Jan 2013
- 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
- Provision of informed consent
- Male or female ≥18 years of age
- Histologic or cytologic confirmed locally advanced or metastatic cancer that has no standard therapeutic alternatives.
- ECOG Performance status 0-1
- A minimum life expectancy of 12 weeks
- Adequate bone marrow, hepatic and renal function as evidenced by
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- Absolute neutrophil count (ANC) > 1.5 x 109/L
- Platelet count > 100 x 109/L
- Hemoglobin > 9.0 g/dL
- Serum bilirubin < 1.5 x ULN
- AST/ALT (SGOT/SGPT) < or = 2.5 x ULN for the reference laboratory or < 5 x ULN in the presence of liver metastases
- Serum creatinine < or = 1.5 x ULN
- Follicle-Stimulating Hormone (FSH) within normal baseline levels
- Male patients should have a detectable level of testosterone
- Female patients who are known to be capable of conception should have a negative serum pregnancy test (beta-human chorionic gonadotropin β-hCG]) within 1 week of starting the study.
- All potentially fertile patients will agree to use an effective form of contraception during the study and for 90 days following the last dose of ME-143 (an effective form of contraception is defined as an oral contraceptive or a double barrier method).
- At least 4 weeks must have elapsed prior to Day 1 Cycle 1 since prior chemotherapy (6 weeks for carmustine or mitomycin C), investigational drug or biologic therapy and any toxicity associated with these treatments has recovered to ≤ NCI-CTCAE Grade 1.
- At least 21 days must have elapsed prior to Day 1 Cycle 1, radiotherapy (limited palliative radiation is allowed > 2 weeks), immunotherapy or following major surgery and any surgical incision should be completely healed
Who cannot join
- Patients who are pregnant or breastfeeding
- Tumor involvement of the Central Nervous System (CNS) Patients with treated and stable CNS metastases may be eligible to participate after discussion and approval from the Medical Monitor
- Uncontrolled infection or systemic disease.
- Clinically significant cardiac disease not well controlled with medication (e.g., congestive heart failure, symptomatic coronary artery disease e.g. angina, and cardiac arrhythmias) or myocardial infarction within the last 12 months.
- Patients with QTc of > 470 msec on screening ECG. (If a patient has QTc interval >470 msec on screening ECG, the screening ECG may be repeated twice (at least 24 hours apart). The average QTc from the 3 screening ECGs must be <470 msec in order for the patient to be eligible for the study.
- Any major surgery, radiotherapy, or immunotherapy within the last 21 days (limited palliative radiation is allowed > 2 weeks).
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- Chemotherapy regimens with delayed toxicity within the last 4 weeks (or within 6 weeks for prior nitrosourea or mitomycin C). Chemotherapy regimens given continuously or on a weekly basis with limited potential or delayed toxicity within the last 2 weeks.
- No concurrent systemic chemotherapy or biologic therapy is allowed.
- Known hypersensitivity to any components of ME-143 study drug product.
- Known human immunodeficiency virus (HIV) or Hepatitis B or C (active, previously treated or both).
- History of solid organ transplantation.
- Psychiatric disorder or social or geographic situation that would preclude study participation.
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Tennessee Oncology, PLLC
Nashville, Tennessee, 37203
Oklahoma University Cancer Institute
Oklahoma City, Oklahoma, 73104
About this study
Official title: Phase I Open Label Dose Escalation Study of the Safety and Pharmacokinetics of ME-143 as a Single Agent in Patients With Refractory Solid Tumors
The purpose of this study is to determine the tolerability of ME-143, find the maximum tolerated dose, and the safety profile in patients with refractory solid tumors.
Read the detailed description
The purpose of this study is to determine the tolerability of ME-143, find the maximum tolerated dose, dose limiting toxicities, and the safety profile in patients with refractory solid tumors. In addition, the study is planned to characterize the pharmacokinetic profile of ME-143 and describe any clinical anti-tumor activity observed in patients.
- Conditions
- Solid Tumors
- Being tested
- ME-143
- Keywords
- solid tumor, recurrent, advanced, metastatic
- Medical subject headings
- Recurrence, Neoplasm Metastasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ME-143Drug
Also called open label, single agent
experimental drug, dose escalation with 4 dose cohorts of 2.5 mg/kg, 5 mg/kg, 10 mg/kg, 20 mg/kg; Cycle 1 is 3 weekly IV infusions on Days 1, 8 and 15. If either the 10 mg/kg or 20 mg/kg dose levels are not tolerable, a 7.5 mg/kg or a 15 mg/kg dose level will be evaluated. After safety assessment, if there is clinical benefit, weekly dosing may continue until withdrawal.
Once the highest tolerated dose has been determined, patients will be enrolled to receive IV infusions 2-days per week. Cycle 1 at the highest dose level is 3 weekly IV infusions on Days 1, 2, 8, 9, 15 and 16. After safety assessment, if there is clinical benefit, weekly dosing may continue until withdrawal.
| Study group | Role | What they receive |
|---|---|---|
| single arm | Experimental | dose escalation Receives: Drug: ME-143 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Dose limiting toxicity
Patients will be administered ME-143 IV infusions weekly and assessed by physical exam, vital signs, hematology and clinical chemistry, urinalysis and pharmacokinetic sampling.
Measured: within the first 28 day cycle
Secondary outcomes (1)
Response rate
radiologic assessments will be performed at baseline and a minimum of every 12 weeks
Measured: baseline and a minimum of every 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jul 2011 (estimated)
- Study startSep 2011
- Primary completionSep 2012
- Study completionJan 2013
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
- Single group
- Masking
- None (open label)
- Enrolment
- 18 participants (actual)
Sponsor and investigators
- Lead sponsor
- MEI Pharma, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- SCRI Development Innovations, LLC
- Responsible party
- Sponsor
- Investigators
- Robert D Mass, MD, Study chair, MEI Pharma, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01401868
- Sponsor's protocol ID
- ME-143-001
- Status last verified
- Jun 2013
- First submitted
- 22 Jul 2011
- Last updated
- 24 Jun 2013
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 24 Jun 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase I Open Label Dose Escalation Study of the Safety and Pharmacokinetics of ME-143 as a Single Agent in Patients With Refractory Solid Tumors
- ClinicalTrials.gov ID
- NCT01401868
- Acronym / sponsor ID
- ME-143-001
- Conditions
- Solid Tumors
- Keywords
- solid tumor, recurrent, advanced, metastatic
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 18 participants (actual)
- Lead sponsor
- MEI Pharma, Inc.Industry (pharma, biotech, devices)
- Collaborators
- SCRI Development Innovations, LLC
- Study start
- Sep 2011
- Primary completion
- Sep 2012 (actual)
- Study completion
- Jan 2013 (actual)
- First posted
- 25 Jul 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.
The purpose of this study is to determine the tolerability of ME-143, find the maximum tolerated dose, and the safety profile in patients with refractory solid tumors.
Detailed description
The purpose of this study is to determine the tolerability of ME-143, find the maximum tolerated dose, dose limiting toxicities, and the safety profile in patients with refractory solid tumors. In addition, the study is planned to characterize the pharmacokinetic profile of ME-143 and describe any clinical anti-tumor activity observed in patients.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| single arm | Experimental | Drug: ME-143dose escalation |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (18 listed)
- Provision of informed consent
- Male or female ≥18 years of age
- Histologic or cytologic confirmed locally advanced or metastatic cancer that has no standard therapeutic alternatives.
- ECOG Performance status 0-1
- A minimum life expectancy of 12 weeks
Key exclusion criteria (12 listed)
- Patients who are pregnant or breastfeeding
- Tumor involvement of the Central Nervous System (CNS) Patients with treated and stable CNS metastases may be eligible to participate after discussion and approval from the Medical Monitor
- Uncontrolled infection or systemic disease.
- Clinically significant cardiac disease not well controlled with medication (e.g., congestive heart failure, symptomatic coronary artery disease e.g. angina, and cardiac arrhythmias) or myocardial infarction within the last 12 months.
- Patients with QTc of > 470 msec on screening ECG. (If a patient has QTc interval >470 msec on screening ECG, the screening ECG may be repeated twice (at least 24 hours apart). The average QTc from the 3 screening ECGs must be <470 msec in order for the patient to be eligible for the study.
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 |
|---|---|---|
| ME-143Also: open label, single agentexperimental drug, dose escalation with 4 dose cohorts of 2.5 mg/kg, 5 mg/kg, 10 mg/kg, 20 mg/kg; Cycle 1 is 3 weekly IV infusions on Days 1, 8 and 15. If either the 10 mg/kg or 20 mg/kg dose levels are not tolerable, a 7.5 mg/kg or a 15 mg/kg dose level will be evaluated. After safety assessment, if there is clinical benefit, weekly dosing may continue until withdrawal. Once the highest tolerated dose has been determined, patients will be enrolled to receive IV infusions 2-days per week. Cycle 1 at the highest dose level is 3 weekly IV infusions on Days 1, 2, 8, 9, 15 and 16. After safety assessment, if there is clinical benefit, weekly dosing may continue until withdrawal. | Drug | single arm |
Primary outcome
Dose limiting toxicity
Time frame: within the first 28 day cycle
Patients will be administered ME-143 IV infusions weekly and assessed by physical exam, vital signs, hematology and clinical chemistry, urinalysis and pharmacokinetic sampling.
1 secondary outcome
Response rate
Time frame: baseline and a minimum of every 12 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 24 Jun 2013.
- Sponsor's web siteLink provided by the sponsor.
- manuscriptLink 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.
Robert D Mass, MD study chair
MEI Pharma, Inc.
2 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 ME-143 in people with Solid Tumors, run by MEI Pharma, Inc. at 2 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 18 inclusion and 12 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 24 Jun 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 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?
Dose limiting toxicity (time frame: within the first 28 day cycle). 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 Jun 2013.