Breast CancerPhase 1/2NCT02562612
Study of SM-88 in Advanced Cancers
A Phase 1/2 study testing SM-88 in people with Breast Cancer, run by Tyme, Inc.
Trial summary
The purpose of this study is to collect response and pharmacokinetic data on the oral administration of a cocktail combination of 4 drugs being developed for the indication of metastatic breast cancer. Read more about this study
- Who is it for?
- Ages 18 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Breast Cancer
- What is being tested?
- SM-88
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- Oct 2022to Oct 2023
- Phase
- Phase 1/2
- 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 to 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Healthy adult subjects, between 18 and 70 years of age, that are willing and able to give written informed consent.
- Subjects must be willing and able to comply with the clinical trial procedures and timelines as outlined in the Time and Events Table.
- Subjects should be continuous nonsmokers and have not used nicotine-containing products for at least three months prior to dosing on Day 1.
- Body mass index (BMI) between 20 and 29.
- As outlined in section 5.1.1.1, subjects of childbearing potential must agree to use an approved method of contraception for the duration of the clinical trial and for three months after the dose of the IMP.
- Must be able to swallow and retain oral medication.
- Subjects must be willing to discontinue the use of any vitamins or herbal supplements seven days prior to the IMP dosing and not resume the use of these supplements until after PK sample is collected at 168h/Day 8.
Who cannot join
- Prior medical history of any illness or injury that, in the opinion of the principal investigator (PI), that may confound the results of the clinical trial or pose an additional risk to the subject by his participation in the clinical trial.
- Current or historic drug or alcohol abuse.
- Unwillingness to discontinue alcohol intake for 24 hours prior to IMP dosing until the collection of the PK sample at 168-h/Day 8.
- Subjects should not have a history of lactose intolerance.
- Concurrent use or known history of hypersensitivity to any of the components of SM 88.
- Clinically significant abnormal laboratory test results at screening and/or baseline visit as determined by PI.
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- Participation in another clinical trial within 30 days prior to screening.
- Surgery within 90 days prior to dosing determined by the PI to be clinically relevant.
- Subjects must be considered medically healthy with no clinically significant medical history.
- Subjects cannot be taking any concomitant medications. Subjects must be willing to discontinue the use of any vitamins or herbal supplements seven days prior to the dose date of the clinical trial and remain off these supplements until the last PK sample is obtained (168h/Day 8).
- Positive urine drug screening.
- Positive results at screening for human immunodeficiency virus (HIV), hepatitis B surface antigen (HBsAg), or hepatitis C antibodies (HCV).
About this study
Official title: Ascending Multi-Dose Clinical Trial to Assess the Pharmacokinetics Efficacy of SM-88 Oral Administration in Breast Cancer Subjects
The purpose of this study is to collect response and pharmacokinetic data on the oral administration of a cocktail combination of 4 drugs being developed for the indication of metastatic breast cancer.
Read the detailed description
The primary objective of this clinical trial is to assess the response rate and PFS in previously treated breast cancer patients. Additional objectives include the pharmacokinetics of multiple ascending doses of SM-88, a cocktail combination of 4 drugs being developed for the indication of metastatic breast cancer. Secondary objectives of this study include an assessment of safety and tolerability of ascending doses of orally administered SM-88. Additional response data will also be collected.
- Conditions
- Breast Cancer
- Being tested
- SM-88
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SM-88Drug
Daily SM-88 in multiple ascending doses over 6 months
| Study group | Role | What they receive |
|---|---|---|
| SM-88 | Experimental | SM-88 multiple ascending doses Receives: Drug: SM-88 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Response Rate
Response data will be collected on SM88 in breast cancer. SM88 has previously been reported to have clinical benefit in a variety of cancers (J Clin Oncol 31, 2013. suppl; abstr e22095)
Measured: 6-12 months
PFS
PFS data will be collected on SM88 in breast cancer. SM88 has previously been reported to have clinical benefit in a variety of cancers (J Clin Oncol 31, 2013. suppl; abstr e22095)
Measured: 6-12 months
Secondary outcomes (2)
Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]
The safety of orally administered SM-88 will be assessed by collected adverse events data as determined by physical exam, laboratory parameters and subject questionnaire.
Measured: 30 days
Blood concentration of SM-88
Blood sampling will be performed to establish the pharmacokinetic profile of SM-88. Time sampling will be at 0.5, 1.0, 1.5, 2.0, 2.5, 3.0, 3.5, 4.0, 5, 6, 8, 12, 48, and 168 hours post dose.
Measured: 168 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Sep 2015 (estimated)
- Study startOct 2022 (estimated)
- Primary completionOct 2023 (estimated)
- Study completionOct 2023 (estimated)
Why it stopped: Study was never initiated. Never established sites or enrolled subjects.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast CancerStudies 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
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Tyme, Inc
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02562612
- Sponsor's protocol ID
- SM-88-001
- Status last verified
- Mar 2021
- First submitted
- 26 Sep 2015
- Last updated
- 1 Jul 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Jul 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Ascending Multi-Dose Clinical Trial to Assess the Pharmacokinetics Efficacy of SM-88 Oral Administration in Breast Cancer Subjects
- ClinicalTrials.gov ID
- NCT02562612
- Acronym / sponsor ID
- SM-88-001
- Conditions
- Breast Cancer
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Study was never initiated. Never established sites or enrolled subjects.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Tyme, IncIndustry (pharma, biotech, devices)
- Study start
- Oct 2022 (estimated)
- Primary completion
- Oct 2023 (estimated)
- Study completion
- Oct 2023 (estimated)
- First posted
- 29 Sep 2015 (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 collect response and pharmacokinetic data on the oral administration of a cocktail combination of 4 drugs being developed for the indication of metastatic breast cancer.
Detailed description
The primary objective of this clinical trial is to assess the response rate and PFS in previously treated breast cancer patients. Additional objectives include the pharmacokinetics of multiple ascending doses of SM-88, a cocktail combination of 4 drugs being developed for the indication of metastatic breast cancer. Secondary objectives of this study include an assessment of safety and tolerability of ascending doses of orally administered SM-88. Additional response data will also be collected.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| SM-88 | Experimental | Drug: SM-88SM-88 multiple ascending doses |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Healthy adult subjects, between 18 and 70 years of age, that are willing and able to give written informed consent.
- Subjects must be willing and able to comply with the clinical trial procedures and timelines as outlined in the Time and Events Table.
- Subjects should be continuous nonsmokers and have not used nicotine-containing products for at least three months prior to dosing on Day 1.
- Body mass index (BMI) between 20 and 29.
- As outlined in section 5.1.1.1, subjects of childbearing potential must agree to use an approved method of contraception for the duration of the clinical trial and for three months after the dose of the IMP.
Key exclusion criteria (12 listed)
- Prior medical history of any illness or injury that, in the opinion of the principal investigator (PI), that may confound the results of the clinical trial or pose an additional risk to the subject by his participation in the clinical trial.
- Current or historic drug or alcohol abuse.
- Unwillingness to discontinue alcohol intake for 24 hours prior to IMP dosing until the collection of the PK sample at 168-h/Day 8.
- Subjects should not have a history of lactose intolerance.
- Concurrent use or known history of hypersensitivity to any of the components of SM 88.
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 |
|---|---|---|
| SM-88Daily SM-88 in multiple ascending doses over 6 months | Drug | SM-88 |
Primary outcome
Response Rate
Time frame: 6-12 months
Response data will be collected on SM88 in breast cancer. SM88 has previously been reported to have clinical benefit in a variety of cancers (J Clin Oncol 31, 2013. suppl; abstr e22095)
PFS
Time frame: 6-12 months
PFS data will be collected on SM88 in breast cancer. SM88 has previously been reported to have clinical benefit in a variety of cancers (J Clin Oncol 31, 2013. suppl; abstr e22095)
2 secondary outcomes
Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]
Time frame: 30 days
Blood concentration of SM-88
Time frame: 168 hours
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Jul 2022.
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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.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing SM-88 in people with Breast Cancer, run by Tyme, Inc.
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 7 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: withdrawn, as of the sponsor's last update on 1 Jul 2022. Status can change between updates, so confirm with the study contact before making plans.
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?
The study was withdrawn before enrolling participants, so there are no results.
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?
Response Rate (time frame: 6-12 months). 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 1 Jul 2022.