Prostate CancerPhase 1/2NCT02796898
Study of the Efficacy, Safety, and Pharmacokinetics of SM88 in Patients With Prostate Cancer
A Phase 1/2 study testing SM88 (Cohort 1) and SM88 (Cohort 2) in people with Prostate Cancer and Rising Prostate Specific Antigen (PSA), run by Tyme, Inc at 5 sites in United States.
Trial summary
The purpose of this study is to evaluate the safety, pharmacokinetics, and efficacy of SM88 in patients with prostate cancer Read more about this study
- Who is it for?
- Ages 18 years and older, men only
- Conditions the study is for
- Prostate Cancer, Rising Prostate Specific Antigen (PSA)
- What is being tested?
- SM88 (Cohort 1) and SM88 (Cohort 2)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 23 participants
- Where
- 5 sitesUnited States
- Study dates
- Jun 2016to 30 May 2019
- 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 years and older
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male ≥18 years of age.
- Histologically or cytologically confirmed prostate cancer (patients with neuroendocrine carcinoma of the prostate are excluded).
- Documented PSA progression. Pre-enrollment PSA progression will be as defined by the PCWG3 criteria, e.g. 3 values, increasing, each >7 days apart.
- ECOG performance status ≤1
- Life expectancy >3 months, in the judgment of the investigator.
- Adequate organ function defined as follows:
Show all 23Show fewer
- Hematologic: Platelets ≥100 x 109 /L; Absolute Neutrophil Count (ANC) ≥1.5 x 109/L (without platelet transfusion or growth factors within the 7 days prior to the screening laboratory assessment)
- Hepatic: aspartate transaminase (AST)/alanine transaminase (ALT) ≤2.5 x upper limit of normal (ULN); total or conjugated bilirubin ≤1.5 x ULN
- Renal: serum creatinine ≤1.5 x ULN or creatinine clearance (CrCl) ≥60 mL/min as calculated by the Cockroft-Gault method
- Coagulation: International normalized ratio (INR) ≤1.2
- With or without one prior line of chemotherapy
- With or without prior or current ADT or hormone based therapy (up to 2 lines total)
- Cannot tolerate standard chemotherapy, hormone based therapy or ADT, or elects to opt out of standard therapies.
- Patients who are on ADT prior to the study need not discontinue such therapy during the study, but the use of ADT during the study must be documented.
- All acute toxic effects of any prior antitumor therapy resolved to Grade ≤1 before baseline, with the exception of alopecia (Grade 1 or 2 permitted) and neurotoxicity (Grade 1 or 2 permitted)
- Male patients of fertile potential who engage in heterosexual intercourse with female partners of childbearing potential must agree to use highly effective contraception while enrolled in the study and for at least 6 months following the last dose of study drug. Highly effective birth control methods include the following (the patient should choose 2 to be used with their partner):
- Oral, injectable, or implanted hormonal contraceptives
- Condom with a spermicidal foam, gel, film, cream, or suppository
- Occlusive cap (diaphragm or cervical/vault cap) with a spermicidal foam, gel, film, cream, or suppository
- Intrauterine device
- Intrauterine system (for example, progestin-releasing coil)
- Vasectomized male (as determined by the investigator)
- Able and willing to provide written informed consent to participate in this study
Who cannot join
- PSA minimum starting value <1 ng/mL at trial entry.
- Metastatic disease as detected on bone scan, Computed Tomography (CT), Magnetic Resonance Imaging (MRI), or CT-positron emission tomography (PET) beyond the prostate or post-surgical prostate area.
- Any screening laboratory, electrocardiogram (ECG), or other findings that, in the opinion of the investigator or the sponsor, indicate an unacceptable risk for the patient's participation in the study.
- History or evidence of any clinically significant disorder, condition, or disease that, in the opinion of the investigator or medical monitor would pose a risk to the patient's safety or interfere with the study evaluations, procedures, or completion. Examples include intercurrent illness such as active uncontrolled infection, active or chronic bleeding event within 28 days of baseline, uncontrolled cardiac arrhythmia, or psychiatric illness/social situation that would limit compliance with study requirements.
- History of a concurrent or second malignancy, except for adequately treated local basal cell or squamous cell carcinoma of the skin, superficial bladder cancer, adequately treated Stage 1 or 2 cancer currently in complete remission; or any other cancer that has been in complete remission for ≥5 years
- Local therapy such as radiation or surgery within 8 weeks of study baseline.
Show all 16Show fewer
- Current use of a prohibited medication (see Section 8.5) or requires any of these medications during treatment phase
- Major surgery, defined as any surgical procedure that involves general anesthesia and a significant incision (i.e., larger than that required for placement of central venous access, percutaneous feeding tube, or biopsy) within 28 days of the first dose of study drug
- Minor surgical procedures within 7 days of baseline, or not yet recovered from prior surgery
- Impairment of gastrointestinal (GI) function or GI disease that may significantly alter the absorption of any of the components of SM88, e.g. cirrhosis
- Known human immunodeficiency (HIV) virus infection
- Hepatitis B surface antigen (HBsAg) positive
- Hepatitis C virus (HCV) antibody positive
- Have previously been enrolled in this study or any other study investigating SM88
- History of any drug allergies or significant adverse reactions to any of the components of SM88.
- Are currently enrolled in, or have discontinued within 30 days of screening, from a clinical trial involving an investigational product or non-approved use of a drug or device.
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
United States5 sites
MidLantic Urology
Bala-Cynwyd, Pennsylvania, 19004
AccuMed Research Associates
Garden City, New York, 11530-1664
AdvanceMed Research
Lawrence, New Jersey, 08648
Montefiore Medical Center- Montefiore Medical Park
The Bronx, New York, 10461
Eastchester Center for Cancer Care
The Bronx, New York, 10469
About this study
Official title: A Phase 1b/2, Open-Label, Dose Escalation Study to Evaluate the Safety, Pharmacokinetics, and Efficacy of SM88 in Patients With Prostate Cancer
The purpose of this study is to evaluate the safety, pharmacokinetics, and efficacy of SM88 in patients with prostate cancer
Read the detailed description
This is an open-label, multi-center, dose-escalating, dose-expansion study of SM88 in patients with prostate cancer. This study includes 2 phases, a dose-escalation phase that includes PK evaluation, and a dose-expansion phase.
During the first stage, at up to 2 institutions, up to 2 cohorts of 1 to 6 patients each will be enrolled.
During the second stage, the dose selected for evaluation from the Phase 1b will be administered for a total of 30 evaluable patients (inclusive of those treated at the same dose during the dose selection phase) for 6 cycles or until unacceptable toxicity, disease progression, or until any of the treatment discontinuation criteria are met.
- Being tested
- SM88 (Cohort 1), SM88 (Cohort 2)
- Keywords
- Prostate Cancer, PSA, Androgen Deprivation Therapy (ADT)
- Medical subject headings
- Prostatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SM88 (Cohort 1)Drug
Also called SM88
- Tyrosine Isomers - 230 mg qd
- Phenytoin - 50 mg qd.
- Methoxsalen - 10 mg qd
- Sirolimus - 0.5 mg qd
SM88 (Cohort 2)Drug
Also called SM88
- Tyrosine Isomers - 460 mg (230 mg bid)
- Phenytoin - 50 mg qd
- Methoxsalen - 10 mg qd
- Sirolimus - 0.5 mg qd
| Study group | Role | What they receive |
|---|---|---|
| Treated Group | Experimental | SM88 is a combination therapy consisting of 4 agents. One agent, the tyrosine isomer will be increased in each of 2 dose cohorts as follows:
Cohort 1:
* Tyrosine isomers - 230 mg qd
* Phenytoin - 50 mg qd.
* Methoxsalen - 10 mg qd
* Sirolimus - 0.5 mg qd
Cohort 2:
Cohort 2 has increasing tyrosine isomer from q.d. to b.i.d.
Expansion Cohort:
The optimum dose will be expanded in 2nd stage of the study to 30 subjects. Receives: Drug: SM88 (Cohort 1); Drug: SM88 (Cohort 2) |
What is being measured
The primary outcome is the main question the study is designed to answer.
The dose limiting toxicity (DLT), and maximum tolerated dose (MTD) or minimum effective optimum dose of SM88, when 2 dose levels of SM88 are evaluated.
During 4 days of single dose PK evaluations [Phase 1b only], and six 4-week treatment cycles, we will determine if patients in consecutive cohorts experience any dose limiting toxicity to determine MTD, or a complete response with no DLTs observed to determine the optimum dose.
Measured: Six months
Secondary outcomes (10)
Single dose pharmacokinetics (PK) of tyrosine based isomer alone and as a component of SM88 in patients with prostate cancer.
After a single dose of tyrosine based isomer alone on PK Day 1, and a single dose of SM88 on PK Day 3, the plasma concentrations of tyrosine isomers in patients with prostate cancer will be assayed.
Measured: Six months
Multi-dose PK of the individual isomers of tyrosine.
The plasma concentrations of tyrosine isomers associated with morning and evening doses of tyrosine isomers on PK Day 1, and also associated with morning and evening doses of SM88, in patients with prostate cancer will be assayed.
Measured: Six months
Multi-dose steady state PK of all 4 components of SM88 in patients with prostate cancer.
After approximately 2 weeks of daily dosing of SM88, the plasma concentrations of tyrosine isomers as well as the other 3 drugs of SM88 in patients with prostate cancer will be assayed.
Measured: Six months
Safety and tolerability of SM88 in patients with prostate cancer.
Changes from baseline in blood work results and incidence of adverse events associated with treatment of SM88 in patients with prostate cancer.
Measured: Six months
Anti-cancer activities of SM88 in patients with prostate cancer.
Changes from baseline in CTCs, and PSA level per Prostate Cancer Working Group 3 (PCWG3) criteria and radiography per RECIST 1.1 criterial, stratified by circulating tumor cells (CTC) and other blood-based markers including lactate dehydrogenase (LDH), total alkaline phosphatase, bone-specific alkaline phosphatase, urine N-telopeptide, hemoglobin, and neutrophil:lymphocyte ratio (NLR).
Measured: Six Months
Correlation of toxicity and efficacy with cutaneous hyperpigmentation
The incident and severity (as assessed by CTCAE v4.0) of treatment-related adverse events and anticancer activities of SM88 are correlated with the degree of cutaneous pigmentation (measured by quantitative image analysis of subject skin color). The total number of subjects with adverse events and efficacy with changes in skin pigmentation during treatment will be reported in aggregate. We will evaluate cutaneous pigmentation as a biomarker in the treatment of prostate cancer by SM88 and stratify pigmentation and known risk factors for outcome analysis.
Measured: Six Months
Radiographic progression-free-survival (rPFS)
Duration of survival since treatment initiation with SM88 of study subjects who are without disease progression according to radiology, stratified by PSA level, CTC, and other blood-based markers (including LDH, total alkaline phosphatase, bone-specific alkaline phosphatase, urine N-telopeptide, hemoglobin, and NLR).
Measured: Six Months
PSA doubling time before, during and after SM88
PSA doubling time before, during and after SM88 treatment will be compared to evaluate disease progression rate associated with SM88 treatment.
Measured: Six Months
Effect of SM88 on patient-reported outcomes including quality of life (as measured by the EORTC QLQ-30 and EORTC QLQ-PR25) in patients with prostate cancer.
Changes from baseline in the Quality-of-Life, as measured by EORTC QLQ-30 and QLQ-PR25, stratified by PSA level, CTC, and other blood-based markers (including LDH, total alkaline phosphatase, bone-specific alkaline phosphatase, urine N-telopeptide, hemoglobin, and NLR in patients with prostate cancer).
Measured: Six Months
Effect of SM88 on performance status in patients with prostate cancer.
Changes from baseline in the performance status (as measured by Eastern Cooperative Oncology Group (ECOG) score) in patients with prostate cancer.
Measured: Six months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jun 2016 (estimated)
- Study startJun 2016
- Primary completion30 May 2019
- Study completion30 May 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Prostate 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
- 23 participants (actual)
Sponsor and investigators
- Lead sponsor
- Tyme, Inc
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Giuseppe Del Priore, MD, MPH, Study director, Chief Medical Officer TYME Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02796898
- Sponsor's protocol ID
- Tyme 2016b
- Status last verified
- Jul 2019
- First submitted
- 30 May 2016
- Last updated
- 22 Jul 2019
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- Undecided
Publications
Steve Hoffman, et al. An open-label trial of SMK treatment of advanced metastatic cancer. J Clin Oncol 31, 2013 (suppl; abstr e22095)
Steve Hoffman, et al. An Open-Label Trial of SMK Treatment of Advanced Metastatic Cancer. 18th World Congress on Controversies in Obstetrics, Gynecology & Infertility (COGI). 473-480, 2014 Monduzzi Editoriale | Proceedings.
Avi Retter. Non-Hormonal Therapy for Recurrent Non-Metastatic Prostate Cancer. Oncology Times. 40(4):29-31, February 20, 2018.
Del Priore G, Hoffman S. Timing of androgen-deprivation therapy in prostate cancer. Lancet Oncol. 2017 Nov;18(11):e633. doi: 10.1016/S1470-2045(17)30774-X. Epub 2017 Oct 31. No abstract available.
PubMed 29208387Gartrell BA, Roach M 3rd, Retter A, Sokol GH, Del Priore G, Scher HI. Phase II trial of SM-88, a cancer metabolism based therapy, in non-metastatic biochemical recurrent prostate cancer. Invest New Drugs. 2021 Apr;39(2):499-508. doi: 10.1007/s10637-020-00993-4. Epub 2020 Sep 13.
PubMed 32924093
Study at a glance
From the registry record, last updated by the sponsor on 22 Jul 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1b/2, Open-Label, Dose Escalation Study to Evaluate the Safety, Pharmacokinetics, and Efficacy of SM88 in Patients With Prostate Cancer
- ClinicalTrials.gov ID
- NCT02796898
- Acronym / sponsor ID
- Tyme 2016b
- Keywords
- Prostate Cancer, PSA, Androgen Deprivation Therapy (ADT)
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 23 participants (actual)
- Lead sponsor
- Tyme, IncIndustry (pharma, biotech, devices)
- Study start
- Jun 2016
- Primary completion
- 30 May 2019 (actual)
- Study completion
- 30 May 2019 (actual)
- First posted
- 13 Jun 2016 (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 evaluate the safety, pharmacokinetics, and efficacy of SM88 in patients with prostate cancer
Detailed description
This is an open-label, multi-center, dose-escalating, dose-expansion study of SM88 in patients with prostate cancer. This study includes 2 phases, a dose-escalation phase that includes PK evaluation, and a dose-expansion phase.
During the first stage, at up to 2 institutions, up to 2 cohorts of 1 to 6 patients each will be enrolled.
During the second stage, the dose selected for evaluation from the Phase 1b will be administered for a total of 30 evaluable patients (inclusive of those treated at the same dose during the dose selection phase) for 6 cycles or until unacceptable toxicity, disease progression, or until any of the treatment discontinuation criteria are met.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Treated Group | Experimental | Drug: SM88 (Cohort 1), Drug: SM88 (Cohort 2)SM88 is a combination therapy consisting of 4 agents. One agent, the tyrosine isomer will be increased in each of 2 dose cohorts as follows: Cohort 1: * Tyrosine isomers - 230 mg qd * Phenytoin - 50 mg qd. * Methoxsalen - 10 mg qd * Sirolimus - 0.5 mg qd Cohort 2: Cohort 2 has increasing tyrosine isomer from q.d. to b.i.d. Expansion Cohort: The optimum dose will be expanded in 2nd stage of the study to 30 subjects. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (23 listed)
- Male ≥18 years of age.
- Histologically or cytologically confirmed prostate cancer (patients with neuroendocrine carcinoma of the prostate are excluded).
- Documented PSA progression. Pre-enrollment PSA progression will be as defined by the PCWG3 criteria, e.g. 3 values, increasing, each >7 days apart.
- ECOG performance status ≤1
- Life expectancy >3 months, in the judgment of the investigator.
Key exclusion criteria (16 listed)
- PSA minimum starting value <1 ng/mL at trial entry.
- Metastatic disease as detected on bone scan, Computed Tomography (CT), Magnetic Resonance Imaging (MRI), or CT-positron emission tomography (PET) beyond the prostate or post-surgical prostate area.
- Any screening laboratory, electrocardiogram (ECG), or other findings that, in the opinion of the investigator or the sponsor, indicate an unacceptable risk for the patient's participation in the study.
- History or evidence of any clinically significant disorder, condition, or disease that, in the opinion of the investigator or medical monitor would pose a risk to the patient's safety or interfere with the study evaluations, procedures, or completion. Examples include intercurrent illness such as active uncontrolled infection, active or chronic bleeding event within 28 days of baseline, uncontrolled cardiac arrhythmia, or psychiatric illness/social situation that would limit compliance with study requirements.
- History of a concurrent or second malignancy, except for adequately treated local basal cell or squamous cell carcinoma of the skin, superficial bladder cancer, adequately treated Stage 1 or 2 cancer currently in complete remission; or any other cancer that has been in complete remission for ≥5 years
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 |
|---|---|---|
| SM88 (Cohort 1)Also: SM88* Tyrosine Isomers - 230 mg qd * Phenytoin - 50 mg qd. * Methoxsalen - 10 mg qd * Sirolimus - 0.5 mg qd | Drug | Treated Group |
| SM88 (Cohort 2)Also: SM88* Tyrosine Isomers - 460 mg (230 mg bid) * Phenytoin - 50 mg qd * Methoxsalen - 10 mg qd * Sirolimus - 0.5 mg qd | Drug | Treated Group |
Primary outcome
The dose limiting toxicity (DLT), and maximum tolerated dose (MTD) or minimum effective optimum dose of SM88, when 2 dose levels of SM88 are evaluated.
Time frame: Six months
During 4 days of single dose PK evaluations [Phase 1b only], and six 4-week treatment cycles, we will determine if patients in consecutive cohorts experience any dose limiting toxicity to determine MTD, or a complete response with no DLTs observed to determine the optimum dose.
10 secondary outcomes
Single dose pharmacokinetics (PK) of tyrosine based isomer alone and as a component of SM88 in patients with prostate cancer.
Time frame: Six months
Multi-dose PK of the individual isomers of tyrosine.
Time frame: Six months
Multi-dose steady state PK of all 4 components of SM88 in patients with prostate cancer.
Time frame: Six months
Safety and tolerability of SM88 in patients with prostate cancer.
Time frame: Six months
Anti-cancer activities of SM88 in patients with prostate cancer.
Time frame: Six Months
Correlation of toxicity and efficacy with cutaneous hyperpigmentation
Time frame: Six Months
Radiographic progression-free-survival (rPFS)
Time frame: Six Months
PSA doubling time before, during and after SM88
Time frame: Six Months
Effect of SM88 on patient-reported outcomes including quality of life (as measured by the EORTC QLQ-30 and EORTC QLQ-PR25) in patients with prostate cancer.
Time frame: Six Months
Effect of SM88 on performance status in patients with prostate cancer.
Time frame: Six months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jul 2019.
- BackgroundSteve Hoffman, et al. An open-label trial of SMK treatment of advanced metastatic cancer. J Clin Oncol 31, 2013 (suppl; abstr e22095)
- BackgroundSteve Hoffman, et al. An Open-Label Trial of SMK Treatment of Advanced Metastatic Cancer. 18th World Congress on Controversies in Obstetrics, Gynecology & Infertility (COGI). 473-480, 2014 Monduzzi Editoriale | Proceedings.
- BackgroundAvi Retter. Non-Hormonal Therapy for Recurrent Non-Metastatic Prostate Cancer. Oncology Times. 40(4):29-31, February 20, 2018.
- Background: PubMed 29208387Del Priore G, Hoffman S. Timing of androgen-deprivation therapy in prostate cancer. Lancet Oncol. 2017 Nov;18(11):e633. doi: 10.1016/S1470-2045(17)30774-X. Epub 2017 Oct 31. No abstract available.
- Derived from this study: PubMed 32924093Gartrell BA, Roach M 3rd, Retter A, Sokol GH, Del Priore G, Scher HI. Phase II trial of SM-88, a cancer metabolism based therapy, in non-metastatic biochemical recurrent prostate cancer. Invest New Drugs. 2021 Apr;39(2):499-508. doi: 10.1007/s10637-020-00993-4. Epub 2020 Sep 13.
- Individual participant dataSharing planned: Undecided
Related trials for Prostate Cancer
Active, not recruiting
Streamlined Geriatric and Oncological Evaluation Based On IC Technology
Breast Cancer, Comorbidities and Coexisting Conditions
Active, not recruitingObservational study
MRI Fusion Biopsy vs. Micro-Ultrasound Guided Biopsy
Prostate Cancer
Enrolling by invitationObservational study
Natural History Study of Early Life Exposures in Agriculture (ELEA)
Prostate Cancer, Leukemia
Not yet recruitingPhase 1/2
STAR0602 With Nivolumab in Non Small Cell Lung Cancer and in Metastatic Castrate-Resistant Prostate Cancer, and STAR0602 Alone in Thymic Carcinoma
NSCLC, Non-Small Cell Lung Cancer
Recruiting
Rehabilitation and Sex Therapy to Optimize Recovery After Prostate Cancer Treatment
Prostate Cancer, Urinary Incontinence
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.
Giuseppe Del Priore, MD, MPH study director
Chief Medical Officer TYME Inc.
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing SM88 (Cohort 1) and SM88 (Cohort 2) in people with Prostate Cancer and Rising Prostate Specific Antigen (PSA), run by Tyme, Inc at 5 sites in United States.
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 23 inclusion and 16 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: finished, as of the sponsor's last update on 22 Jul 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in United States. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
The dose limiting toxicity (DLT), and maximum tolerated dose (MTD) or minimum effective optimum dose of SM88, when 2 dose levels of SM88 are evaluated. (time frame: Six months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02796898, which also lists 5 linked publications.
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 22 Jul 2019.