Study of SM-88 in Advanced Cancers

NCT02562612 | Withdrawn Phase 1 FDA Drug

• 1 other identifier: SM-88-001
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Breast Cancer

Outcome Measures

Primary Outcomes (2)

• 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)

  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)

  6-12 months

Secondary Outcomes (2)

• Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]

  30 days

• Blood concentration of SM-88

  168 hours

Study Arms (1)

SM-88

EXPERIMENTAL

SM-88 multiple ascending doses

Drug: SM-88

Interventions

SM-88 DRUG

Daily SM-88 in multiple ascending doses over 6 months

SM-88

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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).

Sponsors & Collaborators

• Tyme, Inc: lead

MeSH Terms

Conditions

Breast Neoplasms

Interventions

racemetyrosine

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 26, 2015
• First Posted: September 29, 2015
• Study Start: October 1, 2022
• Primary Completion: October 1, 2023
• Study Completion: October 1, 2023
• Last Updated: July 1, 2022

Record last verified: 2021-03