Back to resultsStudy of SM-88 in Advanced Cancers
Primary Purpose
Breast Cancer
Status
Withdrawn
Phase
Phase 1
Locations
Study Type
Interventional
Intervention
SM-88
Sponsored by
About this trial
This is an interventional treatment trial for Breast Cancer
Eligibility Criteria
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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.
- 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).
Sites / Locations
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
SM-88
Arm Description
SM-88 multiple ascending doses
Outcomes
Primary Outcome Measures
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)
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)
Secondary Outcome Measures
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.
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.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02562612
Brief Title
Study of SM-88 in Advanced Cancers
Official Title
Ascending Multi-Dose Clinical Trial to Assess the Pharmacokinetics Efficacy of SM-88 Oral Administration in Breast Cancer Subjects
Study Type
Interventional
2. Study Status
Record Verification Date
March 2021
Overall Recruitment Status
Withdrawn
Why Stopped
Study was never initiated. Never established sites or enrolled subjects.
Study Start Date
October 2022 (Anticipated)
Primary Completion Date
October 2023 (Anticipated)
Study Completion Date
October 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Tyme, Inc
4. Oversight
Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief 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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Breast Cancer
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
0 (Actual)
8. Arms, Groups, and Interventions
Arm Title
SM-88
Arm Type
Experimental
Arm Description
SM-88 multiple ascending doses
Intervention Type
Drug
Intervention Name(s)
SM-88
Intervention Description
Daily SM-88 in multiple ascending doses over 6 months
Primary Outcome Measure Information:
Title
Response Rate
Description
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)
Time Frame
6-12 months
Title
PFS
Description
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)
Time Frame
6-12 months
Secondary Outcome Measure Information:
Title
Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]
Description
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.
Time Frame
30 days
Title
Blood concentration of SM-88
Description
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.
Time Frame
168 hours
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
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.
Exclusion Criteria:
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.
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).
12. IPD Sharing Statement
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Study of SM-88 in Advanced Cancers
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