Solid TumorsPhase 1/2NCT02100007
ME-344 Given in Combination With Hycamtin® in Patients With Solid Tumors
A Phase 1/2 study testing ME-344 and Topotecan in people with Solid Tumors, run by MEI Pharma, Inc. at 10 sites in 2 countries.
Trial summary
The purpose of this study is to determine the safety and tolerability of ME-344 when given in combination with Hycamtin® in patients with 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-344 and Topotecan
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 46 participants
- Where
- 10 sitesin 2 countries
- Study dates
- Apr 2014to Apr 2016
- Phase
- Phase 1/2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
- Histologic or cytologic confirmed locally advanced or metastatic small cell lung cancer, ovarian cancer, or cervical cancer (Part 1); small cell lung cancer and ovarian cancer (Part 2)
- Patients with ovarian and small cell lung cancer must have failed initial therapy
- Patients with carcinoma of the cervix must have advanced disease not amenable to curative surgery and/or radiation therapy
- Patients may not have received more than 4 prior regimens of therapy
- Patients may not previously have received irinotecan, topotecan or other topoisomerase I inhibitor
- ECOG Performance status 0-1 (Appendix B)
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- A minimum life expectancy of 12 weeks
- Adequate bone marrow, hepatic and renal function as evidenced by:
- 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) < 2.5 x ULN for the reference laboratory or < 5 x --ULN in the presence of liver metastases
- Serum creatinine < 1.5 x ULN or creatinine clearance ≥ 60 mL/min as measured by institutional standards
- At least 21 days must have elapsed prior to Day 1 Cycle 1, since any radiotherapy, immunotherapy or following major surgery; any surgical incision should be completely healed. At least 14 days must have elapsed prior to Day 1 Cycle 1 since "limited palliative radiotherapy", defined as a course of therapy encompassing <25% total bone marrow volume and not exceeding 30 GY.
Who cannot join
- Patients with tumor involvement of the Central Nervous System (CNS). SCLC patients with previously treated CNS lesions must have stable CNS disease for at least 4 weeks
- Patients with uncontrolled infection or systemic disease
- Patients with 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 who have toxicity from last prior therapy that has not recovered to at least Grade 1, with the exception of Grade 2 alopecia
- Patients who have had any chemotherapy regimens, biologic, or targeted therapies within the 2 weeks prior to Cycle 1 Day 1
- Patients with any neuropathy > Grade 1
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- Patients with known hypersensitivity to any components of ME-344 or topotecan study drug product
- Patients with known human immunodeficiency virus (HIV) or Hepatitis B or C (active, previously treated or both)
- Patients with a history of solid organ transplantation
- Patients with presence of concurrent or active malignant disease (other than disease under study) within the last 12 months with the exception of adequately treated in-situ carcinomas, basal or squamous cell carcinoma, or non-melanomatous skin cancer.
- Patients with any psychiatric disorder or social or geographic situation that would preclude study participation
Trial locations and contacts
10 sites in 2 countries.
10 sites in 2 countries
United States8 sites
University of Colorado Cancer Center
Aurora, Colorado, 80045
Medical University of South Carolina
Charleston, South Carolina, 29425
Northwestern University
Chicago, Illinois, 60611
Oncology Hematology Care
Cincinnati, Ohio, 45242
Tennessee Oncology, PLLC
Nashville, Tennessee, 37203
University of Oklahoma
Oklahoma City, Oklahoma, 73104
Pinnacle Oncology Hematology
Scottsdale, Arizona, 85258
University of WA Seattle Cancer Care Alliance
Seattle, Washington, 98109
United Kingdom2 sites
The Bays St Mary's Hospital
London, England, W2 1NY
Sarah Cannon Research Instititute UK
London, England, WIG 6AD
About this study
Official title: A Phase Ib Open Label Study of the Safety and Tolerability of ME-344 Given in Combination With Topotecan (Hycamtin®) in Patients With Solid Tumors
The purpose of this study is to determine the safety and tolerability of ME-344 when given in combination with Hycamtin® in patients with solid tumors
- Conditions
- Solid Tumors
- Being tested
- ME-344, Topotecan
- Keywords
- solid tumors, relapsed, advanced, metastatic, small cell lung cancer, ovarian cancer, refractory
- Medical subject headings
- Recurrence, Neoplasm Metastasis, Small Cell Lung Carcinoma, Ovarian Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ME-344Drug
Also called open label
Part 1: ME-344 IV at 10 mg/kg on Days 1, 8, 15, and 22 of each 28-day cycle. Part 2: ME-344 IV at the dose defined in Part 1 on Days 1, 8, 15, and 22 of each 28 day cycle.
Patients will be allowed to continue receiving ME-344 infusions weekly according to the assigned dose level as long as there is clinical benefit to the patient as assessed by the Investigator.
TopotecanDrug
Also called Hycamtin®
Part 1: Topotecan 4 mg/m2 i.v. weekly on Days 1, 8 and 15 of each 28-day cycle. Part 2: Topotecan 4 mg/m2 i.v. weekly on Days 1, 8 and 15 of each 28-day cycle.
| Study group | Role | What they receive |
|---|---|---|
| ME-344 | Experimental | ME-344 IV, 10 mg/kg on Days 1, 8, 15 and 22 of each 28 day cycle Topotecan IV, 4 mg/m2 on Days 1, 8 and 15 of each 28 day cycle Receives: Drug: ME-344; Drug: Topotecan |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Adverse Events
The AE Profile will be determined by the number of AEs regardless of severity
Measured: Through study completion- an average of 2 years
Number of Serious Adverse Events
The SAE Profile will be determined by the number of SAEs
Measured: Through study completion- an average of 2 years
Secondary outcomes (6)
Maximum Plasma Concentration (Cmax)
Peak Plasma Concentration (Cmax) of ME-344 in combination with topotecan
Measured: Cycle 1 Day 1, at 0, .5, 1, 2, 4, 6 and 24 hours post-dose and Day 15 at 0 and end of infusion
Time to Maximum Plasma Concentration for ME-344 (Tmax)
Various pharmacokinetic parameters for ME-344 in plasma were calculated based on the plasma concentration data.
Measured: Cycle 1 Day 1, at 0, .5, 1, 2, 4, 6 and 24 hours post-dose and Day 15 at 0 and end of infusion
Minimum Plasma Concentration (Cmin) of ME-344
Various pharmacokinetic parameters for ME-344 in plasma were calculated based on the plasma concentration data.
Measured: Cycle 1 Day 1, at 0, .5, 1, 2, 4, 6 and 24 hours post-dose and Day 15 at 0 and end of infusion
Mean Terminal Half-life (t 1/2)
Various pharmacokinetic parameters for ME-344 in plasma were calculated based on the plasma concentration data.
Measured: Cycle 1 Day 1, at 0, .5, 1, 2, 4, 6 and 24 hours post-dose and Day 15 at 0 and end of infusion
Estimate Overall Response Rate for ME-344 Given in Combination With Topotecan
Overall response rate was defined as the total number of patients with Complete Response plus Partial Response. All efficacy assessments were to include a baseline assessment and follow-up assessments at a minimum of every 8 weeks for the first 6 cycles, then every 12 weeks thereafter, while receiving study drug. Tumor response and progression-free survival were assessed using RECIST 1.1 criteria or GCIG criteria for CA-125 levels.
Measured: Response was assessed throughout the trial up to 13 months
Estimate the Overall Survival (OS)
41 subjects were analysed. Overall survival is defined as the first day of study drug administration to death.
Measured: Up to 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Mar 2014 (estimated)
- Study startApr 2014
- Primary completionJan 2016
- Study completionApr 2016
Why it stopped: lack of efficacy
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- 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 1/2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 46 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
- Richard Ghalie, MD, Study director, MEI Pharma, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02100007
- Sponsor's protocol ID
- ME-344-002
- Status last verified
- Aug 2015
- First submitted
- 24 Mar 2014
- Last updated
- 2 Oct 2017
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Oct 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase Ib Open Label Study of the Safety and Tolerability of ME-344 Given in Combination With Topotecan (Hycamtin®) in Patients With Solid Tumors
- ClinicalTrials.gov ID
- NCT02100007
- Acronym / sponsor ID
- ME-344-002
- Conditions
- Solid Tumors
- Keywords
- solid tumors, relapsed, advanced, metastatic, small cell lung cancer, ovarian cancer, refractory
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: lack of efficacy
- Enrolment
- 46 participants (actual)
- Lead sponsor
- MEI Pharma, Inc.Industry (pharma, biotech, devices)
- Collaborators
- SCRI Development Innovations, LLC
- Study start
- Apr 2014
- Primary completion
- Jan 2016 (actual)
- Study completion
- Apr 2016 (actual)
- First posted
- 31 Mar 2014 (estimated)
- Results
- Posted 2 Oct 2017
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 safety and tolerability of ME-344 when given in combination with Hycamtin® in patients with solid tumors
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| ME-344 | Experimental | Drug: ME-344, Drug: TopotecanME-344 IV, 10 mg/kg on Days 1, 8, 15 and 22 of each 28 day cycle Topotecan IV, 4 mg/m2 on Days 1, 8 and 15 of each 28 day cycle |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (15 listed)
- Histologic or cytologic confirmed locally advanced or metastatic small cell lung cancer, ovarian cancer, or cervical cancer (Part 1); small cell lung cancer and ovarian cancer (Part 2)
- Patients with ovarian and small cell lung cancer must have failed initial therapy
- Patients with carcinoma of the cervix must have advanced disease not amenable to curative surgery and/or radiation therapy
- Patients may not have received more than 4 prior regimens of therapy
- Patients may not previously have received irinotecan, topotecan or other topoisomerase I inhibitor
Key exclusion criteria (11 listed)
- Patients with tumor involvement of the Central Nervous System (CNS). SCLC patients with previously treated CNS lesions must have stable CNS disease for at least 4 weeks
- Patients with uncontrolled infection or systemic disease
- Patients with 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 who have toxicity from last prior therapy that has not recovered to at least Grade 1, with the exception of Grade 2 alopecia
- Patients who have had any chemotherapy regimens, biologic, or targeted therapies within the 2 weeks prior to Cycle 1 Day 1
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-344Also: open labelPart 1: ME-344 IV at 10 mg/kg on Days 1, 8, 15, and 22 of each 28-day cycle. Part 2: ME-344 IV at the dose defined in Part 1 on Days 1, 8, 15, and 22 of each 28 day cycle. Patients will be allowed to continue receiving ME-344 infusions weekly according to the assigned dose level as long as there is clinical benefit to the patient as assessed by the Investigator. | Drug | ME-344 |
| TopotecanAlso: Hycamtin®Part 1: Topotecan 4 mg/m2 i.v. weekly on Days 1, 8 and 15 of each 28-day cycle. Part 2: Topotecan 4 mg/m2 i.v. weekly on Days 1, 8 and 15 of each 28-day cycle. | Drug | ME-344 |
Primary outcome
Number of Adverse Events
Time frame: Through study completion- an average of 2 years
The AE Profile will be determined by the number of AEs regardless of severity
Number of Serious Adverse Events
Time frame: Through study completion- an average of 2 years
The SAE Profile will be determined by the number of SAEs
6 secondary outcomes
Maximum Plasma Concentration (Cmax)
Time frame: Cycle 1 Day 1, at 0, .5, 1, 2, 4, 6 and 24 hours post-dose and Day 15 at 0 and end of infusion
Time to Maximum Plasma Concentration for ME-344 (Tmax)
Time frame: Cycle 1 Day 1, at 0, .5, 1, 2, 4, 6 and 24 hours post-dose and Day 15 at 0 and end of infusion
Minimum Plasma Concentration (Cmin) of ME-344
Time frame: Cycle 1 Day 1, at 0, .5, 1, 2, 4, 6 and 24 hours post-dose and Day 15 at 0 and end of infusion
Mean Terminal Half-life (t 1/2)
Time frame: Cycle 1 Day 1, at 0, .5, 1, 2, 4, 6 and 24 hours post-dose and Day 15 at 0 and end of infusion
Estimate Overall Response Rate for ME-344 Given in Combination With Topotecan
Time frame: Response was assessed throughout the trial up to 13 months
Estimate the Overall Survival (OS)
Time frame: Up to 2 years
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Oct 2017.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Sponsor websiteLink provided by the sponsor.
- Individual participant dataSharing planned: No
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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.
Richard Ghalie, MD study director
MEI Pharma, Inc.
10 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing ME-344 and Topotecan in people with Solid Tumors, run by MEI Pharma, Inc. at 10 sites in 2 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 15 inclusion and 11 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 2 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 10 sites in United States, United Kingdom. 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 combined 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.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 2 Oct 2017). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Number of Adverse Events (time frame: Through study completion- an average of 2 years). The study lists 2 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 2 Oct 2017.