Solid TumorPhase 1NCT01553071
Phase I Trial of IV Fenretinide (4-HPR) Plus IV Safingol for Patients With Relapsed Malignancies
A Phase 1 study testing Fenretinide (4-HPR) plus Intravenous Safingol in people with Solid Tumor, run by South Plains Oncology Consortium at 3 sites in United States.
Trial summary
In preclinical studies, the anti-cancer efficacy of fenretinide, a synthetic retinoid that causes cytotoxicity by mechanisms which include increased intracellular dihydroceramides, has been shown to be enhanced by safingol, a stereochemical-variant dihydroceramide precursor. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Solid Tumor
- What is being tested?
- Fenretinide (4-HPR) plus Intravenous Safingol
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 16 participants
- Where
- 3 sitesUnited States
- Study dates
- Nov 2016to Dec 2020
- Phase
- Phase 1
- 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
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients must have histologically or cytologically confirmed malignancy that is metastatic or unresectable and for which standard curative or palliative measures do not exist or are no longer effective.
- All patients must have measurable disease documented by CT, MRI, or non-measurable disease documented by Physical Exam within 28 days prior to registration.
- Age >18 years.
- ECOG performance status of 0 - 2 (Karnofsky > 60%).
- Life expectancy of greater than 3 months.
- Patients must have adequate organ and marrow function as defined below:
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- absolute neutrophil count ≥ 1,500/μL
- platelets ≥ 100,000/μL
- total bilirubin ≤ 1.5 x institutional upper limit of normal (IULN)
- AST (SGOT) ≤ 2.5 x institutional upper limit of normal (IULN) ≤ 5 x IULN for patients with liver metastases
- ALT (SGPT) ≤ 2.5 x institutional upper limit of normal (ULN) ≤ 5 x IULN for patients with liver metastases - creatinine within institutional normal limits (WNL) OR creatinine clearance ≥ 60 mL/min/1.73 m2 for patients with creatinine levels above institutional normal
- Effects of fenretinide and safingol on the developing human fetus are unknown. For this reason, women of child-bearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry and for the duration of study participation. For women of child-bearing potential, a negative serum pregnancy test is required within 72 hours prior to receiving study drug each cycle. Should a woman become pregnant or suspect she is pregnant while she or her partner is participating in this study, she should inform her treating physician immediately.
- Ability to understand and the willingness to sign a written informed consent document.
- Patients who have received prior treatment with oral or intravenous fenretinide as a single agent are eligible, provided they did not experience severe toxicity related to fenretinide.
- Patients must have histologically or cytologically confirmed non-Hodgkin's lymphoma for which standard therapies do not exist or are no longer effective. To be eligible for this study, lymphoma patients must have no marrow involvement as documented by routine marrow aspiration and biopsy performed within 30 days of study entry.
- All patients must have measurable disease documented by CT, MRI, or non-measurable disease documented by Physical Exam within 28 days prior to registration.
- Age 18 years or greater.
- Patients must have adequate organ and marrow function as defined below:
- Absolute neutrophil count (ANC) ≥ 1500, platelets ≥ 100,000, unless due to direct bone marrow involvement of disease.
- Hemoglobin ≥ 8.0 gm/dL; transfusion permitted to achieve this level
- Serum creatinine ≤ 1.5 x the upper limits of institutional normal (IULN)
- Total bilirubin ≤ 1.5 x the IULN
- AST/ALT ≤ 2.5 x the IULN
- Or ≤ 5 x IULN for patients with liver metastases
- ECOG performance status of 0 - 2 and estimated survival of at least 3 months.
- Patients must be able to understand and agree to sign an IRB-approved informed consent form.
- The effects of fenretinide and safingol on the developing human fetus are unknown. For this reason,women of child-bearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control) prior to study entry, for the duration of study, and for two months after study participation. For women of child-bearing potential, a negative serum pregnancy test is required within 72hours prior to receiving study drug each cycle. Should a woman become pregnant or suspect she is pregnant while participating in this study, she should inform her treating physician immediately.
- Patients who have received prior treatment with oral or intravenous fenretinide as a single agent are eligible, provided they did not experience severe toxicity related to fenretinide.
Who cannot join
- Radiation therapy, chemotherapy, and other investigational agents within 3weeks (6 weeks for nitrosourea or mitomycin C) prior to starting fenretinide + safingol. Patients must have recovered from toxicities of prior therapy.
- Concurrent administration of any other investigational agents
- Uncontrolled intercurrent illnesses including, but not limited to, ongoing or active systemic infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, coagulation disorders; other major medical illnesses of the cardiovascular or respiratory systems or psychiatric illness/social situations that would limit compliance with study requirements.
- Pregnant women are excluded from this study because the effects of fenretinide and safingol on the developing human fetus are unknown. Because there is an unknown but potential risk for adverse events in nursing infants secondary to treatment of the mother with fenretinide and safingol, breastfeeding must be discontinued.
- Major surgery in the last three weeks due to unknown effects of fenretinide and safingol on wound healing.
- Patients with previously untreated brain metastases (including parenchymal, meningeal or dural-based CNS lesions) are excluded. However, patients with previously treated (surgery, radiation or both), clinically inactive brain metastases, who have not received corticosteroid therapy within three weeks of starting protocol therapy, are eligible.
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- Known allergy to egg products or soy bean oil.
- Patients known to be HIV-positive receiving anti-retroviral therapy are excluded from the study because of possible pharmacokinetic interactions.
- Baseline fasting triglycerides > 2.5 institutional upper limit of normal (IULN) or hypertriglyceridemia requiring medication. Patients requiring medication for other dyslipidemias (i.e., elevated LDL cholesterol) are eligible.
- Concomitant use of the following drugs (see Concomitant Medications, Section 3.3): antioxidants; herbal or other alternative therapy medications; vitamin supplements (especially vitamins A, C, and E) other than a standard dose multivitamin, acetaminophen, cyclosporine A or analogue; verapamil; tamoxifen or analogue, ketoconazole, chlorpromazine; RU486; indomethacin; or sulfinpyrazone, tetracycline, nalidixic acid, nitrofurantoin, phenytoin, sulfonamides, lithium, ceftriaxone, and amiodarone.
- If the patients discontinue usage of the above drugs, they can be eligible for enrollment into the study after a washout period of four half-lives.
- Poorly-controlled diabetes mellitus, as defined as fasting serum glucose concentration over 200 mg/dl or a hemoglobin A1C over 7.5%.
- Patients with an identified familial hyperlipidemia disorder.
- Known history of allergic reactions attributed to compounds of similar chemical or biologic composition to fenretinide, such as 13-cis-retinoic acid, retinol, or all-trans-retinoic acid.
- Patients with esophageal cancer with unresected or recurrent primary tumors in the esophagus are only permitted after discussion of patient with Study Chair due to concern of tumor necrosis and esophageal perforation.
- Baseline (pre-treatment) serum troponin T (TnT) ≥ 0.03 ng/mL. Troponin T levels may be rechecked and therapy given if levels decrease to < 0.03 ng/mL.
- Baseline (pre-treatment) EKG with any of the following changes consistent with cardiac ischemia:
- significant ST depression (ST depression of ≥2 mm, measured from isoelectric line to the ST segment at a point 60 msec from the end of the QRS complex)
- significant ST elevation (> 1mm in limb lead or 2 mm in precordial lead measured at a point 0.04 sec (1 mm) after the J-point [the end of the QRS complex] and compared to baseline [line drawn from P start to T end])
Trial locations and contacts
3 sites in 1 country.
United States3 sites
University of Texas Southwestern
Dallas, Texas, 75390
Joe Arrington Cancer Center/Covenant Children's Hospital
Lubbock, Texas, 79410
University Medical Center
Lubbock, Texas, 79415
About this study
Official title: Phase I Trial of Intravenous Fenretinide (4-HPR) Plus Intravenous Safingol for Patients With Relapsed Malignancies
In preclinical studies, the anti-cancer efficacy of fenretinide, a synthetic retinoid that causes cytotoxicity by mechanisms which include increased intracellular dihydroceramides, has been shown to be enhanced by safingol, a stereochemical-variant dihydroceramide precursor. This phase I study represents the first clinical trial employing this promising combination. The drug administration schedule (fenretinide given on Days 1-5, safingol given on Days 1-2 of each 21-day cycle) reflects the in vitro observation that tumor cell exposure to safingol increased fenretinide efficacy both during and after safingol administration. The total dose of fenretinide, 4600 mg/m2 over 5 days, represents a 30% total dose reduction from the single agent MTD dose of 1280 mg/m2/day x 5 days determined on the PhI-42 study. This fenretinide dose is expected to produce plasma levels in the 30?s ?M. This dose reduction has been employed to reduce the potential for overlapping hepatic toxicities between these two agents.
The administration of a reduced fenretinide dose on Day 1 (600 mg/m2 on Day 1, escalated to 1000 mg/m2/day on Days 2-5) has been selected due to earlier observations that initial exposure to the soy bean oil vehicle in the fenretinide emulsion may induce endogenous lipases, thereby permitting tolerance of higher total doses fenretinide emulsion subsequently administered. The starting dose of safingol in this study, 210 mg/m2/day x 2 days (420 mg/m2 total), corresponds to 50% of the recommended Phase II safingol dose (bolus) determined in the Schwartz, et al, Phase I study of safingol plus cisplatin 60 mg/m2 (the MTD of single-agent, intravenous (emulsion) safingol was not reached in the Phase I safingol run-in monotherapy portion of this study), and was selected to provide an adequate safety margin against the potential for overlapping toxicities (such as hepatic transaminitis).
The study has been designed to optimize the safety of this novel combination. Treatment will be administered in the inpatient setting. Central venous access will be mandated to avoid the potential for hemolysis and thrombophlebitis associated with the preclinical peripheral administration of a previous safingol formulation in rats. To reduce the incidence of hypertriglyceridemia, a revised fenretinide delivery schedule will be employed. Patients will also be encouraged to maintain a low-fat diet during fenretinide administration. Serum triglycerides will be monitored every 12 hours. To monitor for cardiac toxicity, which was noted in canine studies at the highest dose of safingol plus fenretinide tested, serum troponin T levels will be monitored daily. To limit the potential for hepatotoxicity resulting from a possible drug interaction observed between intravenous fenretinide, ceftriaxone and acetaminophen in a pediatric patient, the concurrent administration of ceftriaxone, or acetaminophen, with the fenretinide emulsion infusion will be prohibited.
- Conditions
- Solid Tumor
- Being tested
- Fenretinide (4-HPR) plus Intravenous Safingol
- Keywords
- Malignancy, Relapsed, Chemotherapy, Intravenous
- Medical subject headings
- Neoplasms, Recurrence
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Fenretinide (4-HPR) plus Intravenous SafingolDrug
A course for this study is defined as the 5 days of treatment with Fenretinide (4-HPR) plus Safingol followed by 16 days of rest. A course is repeated every 21 days if there is no clinical evidence of disease progression for a maximum of six 5-day infusions.
Days 1-5 of every cycle: Day 1 Fenretinide (4-HPR) intravenous emulsion: 600 mg/m2 for 24 hours Given concurrently (at the same time) with: Safingol intravenous 210 mg/m2 for 24 hours Day 2 Fenretinide (4-HPR) intravenous emulsion: 1000 mg/m2 for 24 hours Given concurrently (at the same time) with: Safingol intravenous 210 mg/m2 for 24 hours Days 3-5 Fenretinide (4-HPR) intravenous emulsion: 1000 mg/m2 continuously for 3 days Days 8 and 15 : Weekly blood draw to monitor side effects requires a clinic visit for approximately 1 hour Days 6,7,9-14, 16-21 Rest and monitor side effects.
| Study group | Role | What they receive |
|---|---|---|
| Investigational | Experimental | Fenretinide (4-HPR) plus Intravenous Safingol Receives: Drug: Fenretinide (4-HPR) plus Intravenous Safingol |
What is being measured
The primary outcome is the main question the study is designed to answer.
Determine the maximum tolerated dose of an intravenous safingol in combination with fenretinide
The primary outcome mesure of this study is to determine the maximum tolerated dose (MTD) of an intravenous (emulsion) safingol when administered as a continuous intravenous (c.i.v.) infusion for two days, once every 3 weeks, in combination with fenretinide (4-HPR) intravenous emulsion administered as a continuous intravenous infusion for five days, once every 3 weeks.
Measured: approximately 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 Mar 2012 (estimated)
- Study startNov 2016
- Primary completionDec 2020
- Study completionDec 2020
Why it stopped: drug supply issues during COVID-19
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Solid TumorStudies 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
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 16 participants (actual)
Sponsor and investigators
- Lead sponsor
- South Plains Oncology Consortium
- Sponsor type
- Research network
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01553071
- Sponsor's protocol ID
- SPOC-2010-002
- Status last verified
- Mar 2022
- First submitted
- 7 Mar 2012
- Last updated
- 31 Mar 2022
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Boulter AC, Maurer BJ, Pogue M, Kang MH, Cho H, Knight A, Reynolds CP, Quick D, Awasthi S, Gerber DE. Phase I trial of intravenous fenretinide (4-HPR) plus safingol in advanced malignancies. Cancer Chemother Pharmacol. 2023 Aug;92(2):97-105. doi: 10.1007/s00280-023-04543-6. Epub 2023 May 18.
PubMed 37199745Cho HE, Maurer BJ, Reynolds CP, Kang MH. Hydrophilic interaction liquid chromatography-tandem mass spectrometric approach for simultaneous determination of safingol and D-erythro-sphinganine in human plasma. J Chromatogr B Analyt Technol Biomed Life Sci. 2019 Apr 1;1112:16-23. doi: 10.1016/j.jchromb.2019.02.023. Epub 2019 Feb 22.
PubMed 30836314
Study at a glance
From the registry record, last updated by the sponsor on 31 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase I Trial of Intravenous Fenretinide (4-HPR) Plus Intravenous Safingol for Patients With Relapsed Malignancies
- ClinicalTrials.gov ID
- NCT01553071
- Acronym / sponsor ID
- SPOC-2010-002
- Conditions
- Solid Tumor
- Keywords
- Malignancy, Relapsed, Chemotherapy, Intravenous
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: drug supply issues during COVID-19
- Enrolment
- 16 participants (actual)
- Lead sponsor
- South Plains Oncology ConsortiumResearch network
- Study start
- Nov 2016
- Primary completion
- Dec 2020 (actual)
- Study completion
- Dec 2020 (actual)
- First posted
- 13 Mar 2012 (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.
In preclinical studies, the anti-cancer efficacy of fenretinide, a synthetic retinoid that causes cytotoxicity by mechanisms which include increased intracellular dihydroceramides, has been shown to be enhanced by safingol, a stereochemical-variant dihydroceramide precursor. This phase I study represents the first clinical trial employing this promising combination. The drug administration schedule (fenretinide given on Days 1-5, safingol given on Days 1-2 of each 21-day cycle) reflects the in vitro observation that tumor cell exposure to safingol increased fenretinide efficacy both during and after safingol administration. The total dose of fenretinide, 4600 mg/m2 over 5 days, represents a 30% total dose reduction from the single agent MTD dose of 1280 mg/m2/day x 5 days determined on the PhI-42 study. This fenretinide dose is expected to produce plasma levels in the 30?s ?M. This dose reduction has been employed to reduce the potential for overlapping hepatic toxicities between these two agents.
The administration of a reduced fenretinide dose on Day 1 (600 mg/m2 on Day 1, escalated to 1000 mg/m2/day on Days 2-5) has been selected due to earlier observations that initial exposure to the soy bean oil vehicle in the fenretinide emulsion may induce endogenous lipases, thereby permitting tolerance of higher total doses fenretinide emulsion subsequently administered. The starting dose of safingol in this study, 210 mg/m2/day x 2 days (420 mg/m2 total), corresponds to 50% of the recommended Phase II safingol dose (bolus) determined in the Schwartz, et al, Phase I study of safingol plus cisplatin 60 mg/m2 (the MTD of single-agent, intravenous (emulsion) safingol was not reached in the Phase I safingol run-in monotherapy portion of this study), and was selected to provide an adequate safety margin against the potential for overlapping toxicities (such as hepatic transaminitis).
The study has been designed to optimize the safety of this novel combination. Treatment will be administered in the inpatient setting. Central venous access will be mandated to avoid the potential for hemolysis and thrombophlebitis associated with the preclinical peripheral administration of a previous safingol formulation in rats. To reduce the incidence of hypertriglyceridemia, a revised fenretinide delivery schedule will be employed. Patients will also be encouraged to maintain a low-fat diet during fenretinide administration. Serum triglycerides will be monitored every 12 hours. To monitor for cardiac toxicity, which was noted in canine studies at the highest dose of safingol plus fenretinide tested, serum troponin T levels will be monitored daily. To limit the potential for hepatotoxicity resulting from a possible drug interaction observed between intravenous fenretinide, ceftriaxone and acetaminophen in a pediatric patient, the concurrent administration of ceftriaxone, or acetaminophen, with the fenretinide emulsion infusion will be prohibited.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Investigational | Experimental | Drug: Fenretinide (4-HPR) plus Intravenous SafingolFenretinide (4-HPR) plus Intravenous Safingol |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (28 listed)
- Patients must have histologically or cytologically confirmed malignancy that is metastatic or unresectable and for which standard curative or palliative measures do not exist or are no longer effective.
- All patients must have measurable disease documented by CT, MRI, or non-measurable disease documented by Physical Exam within 28 days prior to registration.
- Age >18 years.
- ECOG performance status of 0 - 2 (Karnofsky > 60%).
- Life expectancy of greater than 3 months.
Key exclusion criteria (19 listed)
- Radiation therapy, chemotherapy, and other investigational agents within 3weeks (6 weeks for nitrosourea or mitomycin C) prior to starting fenretinide + safingol. Patients must have recovered from toxicities of prior therapy.
- Concurrent administration of any other investigational agents
- Uncontrolled intercurrent illnesses including, but not limited to, ongoing or active systemic infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, coagulation disorders; other major medical illnesses of the cardiovascular or respiratory systems or psychiatric illness/social situations that would limit compliance with study requirements.
- Pregnant women are excluded from this study because the effects of fenretinide and safingol on the developing human fetus are unknown. Because there is an unknown but potential risk for adverse events in nursing infants secondary to treatment of the mother with fenretinide and safingol, breastfeeding must be discontinued.
- Major surgery in the last three weeks due to unknown effects of fenretinide and safingol on wound healing.
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 |
|---|---|---|
| Fenretinide (4-HPR) plus Intravenous SafingolA course for this study is defined as the 5 days of treatment with Fenretinide (4-HPR) plus Safingol followed by 16 days of rest. A course is repeated every 21 days if there is no clinical evidence of disease progression for a maximum of six 5-day infusions. Days 1-5 of every cycle: Day 1 Fenretinide (4-HPR) intravenous emulsion: 600 mg/m2 for 24 hours Given concurrently (at the same time) with: Safingol intravenous 210 mg/m2 for 24 hours Day 2 Fenretinide (4-HPR) intravenous emulsion: 1000 mg/m2 for 24 hours Given concurrently (at the same time) with: Safingol intravenous 210 mg/m2 for 24 hours Days 3-5 Fenretinide (4-HPR) intravenous emulsion: 1000 mg/m2 continuously for 3 days Days 8 and 15 : Weekly blood draw to monitor side effects requires a clinic visit for approximately 1 hour Days 6,7,9-14, 16-21 Rest and monitor side effects. | Drug | Investigational |
Primary outcome
Determine the maximum tolerated dose of an intravenous safingol in combination with fenretinide
Time frame: approximately six months
The primary outcome mesure of this study is to determine the maximum tolerated dose (MTD) of an intravenous (emulsion) safingol when administered as a continuous intravenous (c.i.v.) infusion for two days, once every 3 weeks, in combination with fenretinide (4-HPR) intravenous emulsion administered as a continuous intravenous infusion for five days, once every 3 weeks.
Results and safety
The study was stopped early (reason given: drug supply issues during COVID-19). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Mar 2022.
- Derived from this study: PubMed 37199745Boulter AC, Maurer BJ, Pogue M, Kang MH, Cho H, Knight A, Reynolds CP, Quick D, Awasthi S, Gerber DE. Phase I trial of intravenous fenretinide (4-HPR) plus safingol in advanced malignancies. Cancer Chemother Pharmacol. 2023 Aug;92(2):97-105. doi: 10.1007/s00280-023-04543-6. Epub 2023 May 18.
- Derived from this study: PubMed 30836314Cho HE, Maurer BJ, Reynolds CP, Kang MH. Hydrophilic interaction liquid chromatography-tandem mass spectrometric approach for simultaneous determination of safingol and D-erythro-sphinganine in human plasma. J Chromatogr B Analyt Technol Biomed Life Sci. 2019 Apr 1;1112:16-23. doi: 10.1016/j.jchromb.2019.02.023. Epub 2019 Feb 22.
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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.
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Fenretinide (4-HPR) plus Intravenous Safingol in people with Solid Tumor, run by South Plains Oncology Consortium at 3 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 28 inclusion and 19 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: stopped early, as of the sponsor's last update on 31 Mar 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 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 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.
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 stopped early (reason given: drug supply issues during COVID-19). Results are not available in the source record.
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?
Determine the maximum tolerated dose of an intravenous safingol in combination with fenretinide (time frame: approximately 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 NCT01553071, which also lists 2 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 31 Mar 2022.