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A Study Evaluating the Safety and Pharmacokinetics of Orally Administered SM08502 in Subjects With Advanced Solid Tumors

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ClinicalTrials.gov Identifier: NCT03355066
Recruitment Status : Recruiting
First Posted : November 28, 2017
Last Update Posted : August 8, 2018
Sponsor:
Information provided by (Responsible Party):
Samumed LLC

Brief Summary:
This study is an open-label, multi-center, dose-escalation study in adult subjects with advanced solid tumors for whom standard therapy is not available for their stage of disease. The study will evaluate the safety, tolerability, pharmacokinetics, and pharmacodynamics (preliminary anti-tumor activity and gene expression analysis) of SM08502 administered orally, once daily, for 28 consecutive days. Dosing in 28-day cycles will continue within each subject, up to 6 cycles total, unless the subject is withdrawn from the study for one of many different reasons.

Condition or disease Intervention/treatment Phase
Solid Tumor, Adult Drug: SM08502 Phase 1

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 42 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase 1, Open-Label, Dose-Escalation, Dose-Finding Study Evaluating the Safety and Pharmacokinetics of Orally Administered SM08502 in Subjects With Advanced Solid Tumors
Actual Study Start Date : November 6, 2017
Estimated Primary Completion Date : October 2019
Estimated Study Completion Date : October 2019

Arm Intervention/treatment
Experimental: Active Treatment
SM08502 tablet, dosed once per day in 28-day cycles, dose determined by dose escalation scheme (10 mg, 20 mg, 40 mg, 60 mg, 80 mg, 120 mg, 160 mg, 200 mg)
Drug: SM08502
tablet, dosed once daily




Primary Outcome Measures :
  1. Safety and tolerability: treatment-emergent adverse events (TEAEs) [ Time Frame: Cycle 6, Day 29 (approximately Day 180) ]
    Evaluate the safety and tolerability of SM08502 as measured by TEAEs during the entire treatment period

  2. Safety and tolerability: change from baseline in Eastern Cooperative Oncology Group (ECOG) performance [ Time Frame: Cycle 6, Day 29 (approximately Day 180) ]
    Evaluate the safety and tolerability of SM08502 as measured by change from baseline in ECOG performance

  3. Safety and tolerability: number of subjects with a clinically significant change from baseline in electrocardiogram (ECG) parameters [ Time Frame: Cycle 6, Day 29 (approximately Day 180) ]
    Evaluate the safety and tolerability of SM08502 as measured by the number of subjects with a clinically significant change from baseline in ECG parameters

  4. Safety and tolerability: number of subjects with a clinically significant change from baseline in physical examination [ Time Frame: Cycle 6, Day 29 (approximately Day 180) ]
    Evaluate the safety and tolerability of SM08502 as measured by the number of subjects with a clinically significant change from baseline in physical examination

  5. Safety and tolerability: number of subjects with a clinically significant change from baseline in ophthalmic examination [ Time Frame: Cycle 6, Day 29 (approximately Day 180) ]
    Evaluate the safety and tolerability of SM08502 as measured by the number of subjects with a clinically significant change from baseline in ophthalmic examination

  6. Safety and tolerability: number of subjects with a clinically significant change from baseline in clinical laboratory tests [ Time Frame: Cycle 6, Day 29 (approximately Day 180) ]
    Evaluate the safety and tolerability of SM08502 as measured by the number of subjects with a clinically significant change from baseline in clinical laboratory tests

  7. Safety and tolerability: number of subjects with a clinically significant change from baseline in vital signs [ Time Frame: Cycle 6, Day 29 (approximately Day 180) ]
    Evaluate the safety and tolerability of SM08502 as measured by the number of subjects with a clinically significant change from baseline in vital signs


Secondary Outcome Measures :
  1. Tumor response [ Time Frame: Cycle 3, Day 1 (approximately Day 60) ]
    Evaluate change from baseline in tumor characteristics as measured by RECIST 1.1 (Response Evaluation Criteria In Solid Tumors)

  2. Tumor response [ Time Frame: Cycle 5, Day 1 (approximately Day 120) ]
    Evaluate change from baseline in tumor characteristics as measured by RECIST 1.1

  3. Tumor response [ Time Frame: Cycle 6, Day 29 (approximately Day 180) ]
    Evaluate change from baseline in tumor characteristics as measured by RECIST 1.1

  4. Change in expression of Wnt pathway-related genes [ Time Frame: Cycle 2, Days 1 and 2 (approximately Day 30) ]
    Evaluate change from Cycle 1, Days 1 and 2 in Wnt-pathway related gene expression as measured using RNA isolated from whole blood



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Subjects with advanced solid tumors who are refractory to or intolerant of established therapy known to provide clinical benefit for their condition (i.e., subjects must not be candidates for regimens known to provide clinical benefit).
  • Measurable or evaluable disease
  • Subjects must have recovered from all toxicity associated with previous chemotherapy, targeted therapy, experimental therapy, biological therapy, immuno-oncology therapy, surgery, radiotherapy, or other locoregional therapy. (Exception: Subjects may enter with continuing alopecia.) The following intervals must elapse between end of last treatment and receiving the first dose of SM08502:

    1. Chemotherapy: 3 weeks
    2. Mitomycin C or a nitrosourea: 6 weeks
    3. Radiotherapy: 6 weeks
    4. Major surgery: 6 weeks
    5. Targeted therapy, including monoclonal antibodies and immuno-oncology therapies: 4 weeks or 5 half-lives, whichever is shortest
    6. Hormonal therapy: 4 weeks or 5 half-lives, whichever is shortest
    7. Experimental therapy: 4 weeks or 5 half-lives, whichever is shortest
    8. Other locoregional therapy [e.g., radiofrequency ablation (RFA), TACE (transarterial chemoembolization), TARE (transarterial radioembolization), DEB-TACE (drug eluting bead transarterial chemoembolization)]: 6 weeks
  • Life expectancy > 3 months
  • Subjects must have no uncontrolled intercurrent illness
  • Subjects must have the ability to swallow and retain oral medication
  • Subjects must be willing to avoid extensive sun exposure, phototherapy, and use of a tanning salon during trial participation.
  • Subjects must be willing to sign and provide informed consent and be capable of giving informed consent in accordance with the Institutional Review Board/Ethics Committee policy

Exclusion Criteria:

  • Women who are pregnant or lactating
  • Women of childbearing potential who are sexually active and are not willing to use a highly effective method of birth control during the study period
  • Males who are sexually active and not willing to use a condom, and have a partner who is capable of becoming pregnant, if neither has had surgery to become sterilized, and/or who are not willing to use double barrier or whose partner is not using a highly effective method of birth control
  • Subjects with myocardial infarction (heart attack) within 1 year
  • Subjects using agents known to inhibit or induce CYP3A4, such as ketoconazole, itraconazole, erythromycin, or rifampin, within 7 days prior to study start
  • Subjects with active infection requiring antibiotic therapy
  • Organ transplant recipients
  • Subjects with brain metastasis
  • Subjects with history of osteoporosis
  • Subjects with known active human immunodeficiency virus, hepatitis B virus, or hepatitis C virus infection
  • Subjects with any retinal abnormalities, including subjects with diabetic retinopathy, macular degeneration, or other known forms of retinal degenerative disease
  • Subjects with chronic liver disease or dysfunction

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03355066


Contacts
Contact: Samumed Clinical Trials 1-855-222-0515 clinicaltrials@samumed.com

Locations
United States, Arizona
HonorHealth Research Institute Recruiting
Scottsdale, Arizona, United States, 85258
Contact: Samumed Clinical Trials    855-222-0515    clinicaltrials@samumed.com   
United States, California
City of Hope Recruiting
Duarte, California, United States, 91010
Contact: Samumed Clinical Trials    855-222-0515    clinicaltrials@samumed.com   
Sponsors and Collaborators
Samumed LLC
Investigators
Study Director: Yusuf Yazici, M.D. Samumed LLC

Responsible Party: Samumed LLC
ClinicalTrials.gov Identifier: NCT03355066     History of Changes
Other Study ID Numbers: SM08502-ONC-01
First Posted: November 28, 2017    Key Record Dates
Last Update Posted: August 8, 2018
Last Verified: August 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Samumed LLC:
Wnt pathway
Wnt inhibition
SM08502