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Solid TumorsPhase 1NCT02667873

A Trial of a Novel XPO1 Inhibitor in Participants With Advanced Solid Tumors

A Phase 1 study testing SL-801 in people with Solid Tumors, run by Stemline Therapeutics, Inc. at 6 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

Study SL-801-0115 is a dose-escalation study evaluating multiple doses and schedules of orally administered SL-801 in participants with advanced solid tumors. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Solid Tumors
What is being tested?
SL-801
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
72 participants
Where
6 sitesUnited States
Study dates
23 Feb 2016to 13 Oct 2021
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

  • The participant must have histologic or cytologic evidence of a malignant solid tumor and must have disease that is resistant to or relapsed following available standard systemic therapy, or for which there is no standard systemic therapy or reasonable therapy likely to result in clinical benefit.
  • The participant must have advanced disease, defined as cancer that is either metastatic, or locally advanced and unresectable (and for which additional radiation therapy or other locoregional therapies are not considered feasible).
  • The participant must have disease that is measurable by standard imaging techniques, per the Response Evaluation Criteria in Solid Tumors, version 1.1 (RECIST 1.1), or evaluable per RECIST 1.1. (For participants with prior radiation therapy, measurable lesions must be outside of any prior radiation field[s], unless disease progression has been documented at that disease site subsequent to radiation.)
  • The participant is ≥18 years old.
  • The participant has an Eastern Cooperative Oncology Group Performance Status of 0-2.
  • The participant has adequate baseline organ function, as demonstrated by the following:
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  • Serum creatinine ≤1.5 × institutional upper limit of normal (ULN) or calculated creatinine clearance >30 milliliters (mL)/minute.
  • Serum albumin ≥2.5 grams/deciliter (g/dL).
  • Bilirubin ≤1.5 × institutional ULN.
  • Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤2.5 × institutional ULN (participants with hepatic metastases must have AST/ALT ≤5 times ULN).
  • International normalized ratio ≤1.5 or prothrombin time ≤1.5 × ULN; and either partial thromboplastin time or activated partial thromboplastin time (partial thromboplastin time or activated partial thromboplastin time) ≤1.5 × ULN.
  • The participant has adequate baseline hematologic function, as demonstrated by the following:
  • Absolute neutrophil count ≥1.5×10^9/liter (L)
  • Hemoglobin ≥8 g/dL, with no red blood cell transfusions within the prior 14 days.
  • Platelet count ≥100×10^9/L, with no platelet transfusions within the prior 14 days.
  • If the participant is a woman of childbearing potential, she has had a negative serum or urine pregnancy test within 1 week prior to treatment.
  • The participant (male and female) agrees to use acceptable contraceptive methods for the duration of time on the study and continue to use acceptable contraceptive methods for 1 month after the last dose of SL-801.
  • The participant has signed informed consent prior to initiation of any study-specific procedures or treatment.
  • The participant is able to adhere to the study visit schedule and other protocol requirements, including follow-up for survival assessment.

Who cannot join

  • The participant has persistent clinically significant ≥Grade 2 toxicities from previous anticancer therapy (excluding Grade 2 chemotherapy-related neuropathy which is permitted, and excluding Grade 2-3 laboratory abnormalities if they are not associated with symptoms, are not considered clinically significant by the Investigator, and can be managed with available medical therapies).
  • The participant has received treatment with chemotherapy, external-beam radiation, or other systemic anticancer therapy within 28 days prior to study entry (Participants with advanced prostate cancer who are receiving luteinizing hormone releasing hormone [LHRH] agonists are permitted onto the study and should continue use of these agents during study treatment).
  • The participant has received treatment with an investigational systemic anticancer agent within 28 days prior to C1D1.
  • The participant has previously received treatment with SL-801 or another investigational agent that inhibits the XPO1/CRM1 pathway.
  • The participant has an additional active malignancy that may confound the assessment of the study endpoints. Participants with a past cancer history (active malignancy within 2 years prior to study entry) with substantial potential for recurrence must be discussed with the Sponsor before study entry. Participants with the following concomitant neoplastic diagnoses are eligible: non-melanoma skin cancer, carcinoma in situ (including transitional cell carcinoma, cervical intraepithelial neoplasia), organ-confined prostate cancer with no evidence of progressive disease.
  • The participant has clinically significant cardiovascular disease (for example, uncontrolled or any New York Heart Association Class 3 or 4 congestive heart failure, uncontrolled angina, history of myocardial infarction, unstable angina or stroke within 6 months prior to study entry, uncontrolled hypertension or clinically significant arrhythmias not controlled by medication).
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  • The participant has uncontrolled, clinically significant pulmonary disease (for example, chronic obstructive pulmonary disease, pulmonary hypertension) that, in the Investigator's opinion, would put the participant at significant risk for pulmonary complications during the study.
  • The participant has known active or suspected brain or leptomeningeal metastases. (Central nervous system [CNS] imaging is not required prior to study entry unless there is a clinical suspicion of CNS involvement). Participants with stable, treated brain metastases are eligible provided there is no evidence of CNS disease growth on imaging for at least 3 months following radiation therapy or other locoregional ablative therapy to the CNS.
  • The participant is receiving immunosuppressive therapy for prophylaxis following a prior organ transplant (solid organ or allogeneic stem cell) or management of immune-mediated toxicities due to immunotherapy. Low-dose corticosteroid (defined as < 10 mg/day of prednisone or equivalent) therapy is permitted.
  • The participant has uncontrolled intercurrent illness including, but not limited to, uncontrolled infection, disseminated intravascular coagulation, or psychiatric illness/social situations that would limit compliance with study requirements.
  • The participant is pregnant or breast feeding.
  • The participant has known positive status for human immunodeficiency virus active or chronic Hepatitis B or Hepatitis C.
  • The participant is oxygen dependent.
  • The participant has any medical condition which in the opinion of the Investigator places the patient at an unacceptably high risk for toxicities.

Trial locations and contacts

6 sites in 1 country.

6 sites in 1 country

United States6 sites

  • Mary Crowely Cancer Research Centers- Medical City

    Dallas, Texas, 75230

  • University of Texas Southwestern Medical Center

    Dallas, Texas, 75390

  • Sarah Cannon Research Institute

    Nashville, Tennessee, 37203

  • Yale Cancer Center

    New Haven, Connecticut, 06520

  • Florida Cancer Specialist

    Sarasota, Florida, 34236

  • University of Washington, Seattle Cancer Care Alliance

    Seattle, Washington, 98109

Other trials in United States

About this study

Official title: A Phase 1 Trial of SL-801, a Novel Inhibitor of XPO1 Nuclear Export, in Patients With Advanced Solid Tumors

Study SL-801-0115 is a dose-escalation study evaluating multiple doses and schedules of orally administered SL-801 in participants with advanced solid tumors.

Read the detailed description

Study SL-801-0115 is a first-in-human, dose-escalation study in participants with advanced (that is, metastatic or locally advanced and unresectable) solid tumors that are resistant to or relapsed following available standard systemic therapy or for which there is no standard systemic therapy and additional radiation therapy, or other loco-regional therapies are not considered feasible. Eligible participants will be enrolled and receive treatment with SL-801. SL-801 will be administered orally, and the dose regimen will depend on the cohort in which the participant is enrolled.

The study plans to enroll approximately 70 adult participants at multiple study centers in the United States.

Conditions
Solid Tumors
Being tested
SL-801

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • SL-801Drug

    Also called Felezonexor

    SL-801 is a small-molecule inhibitor of the nuclear export protein Exportin-1 (XPO1).

Study groups in NCT02667873
Study groupRoleWhat they receive
SL-801ExperimentalThe starting dose regimen of SL-801 (that is, the dose regimen in Cohort 1) is 5 milligrams (mg)/day on Days 1-4 and 8-11 every 21 days. In the second portion of the dose escalation stage, participants receive SL-801 orally once daily on days 1-2, 8-9, 15-16 and 22-23 every 28 days. The starting dose will be 70 mg/day (the next planned dose level). The SL-801 dose regimen for a particular participant is dependent on the cohort in which the participant is enrolled.
Receives: Drug: SL-801

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. safety and tolerability: percentage of patients experiencing treatment-related and treatment-emergent adverse events

    The percentage of patients experiencing treatment-related and treatment-emergent adverse events

    Measured: up to 5 years

  2. maximum tolerated dose

    To identify the maximum tolerated dose (MTD) of SL-801 or determine the maximum tested dose at which multiple dose-limiting toxicities (DLTs) are not observed.

    Measured: up to 5 years

Secondary outcomes (5)

  1. Duration of Response

    to evaluate the duration of response

    Measured: up to 5 years

  2. Progression Free Survival

    to evaluate progression free survive

    Measured: up to 5 years

  3. Overall Response Rate

    to evaluate overall response rate

    Measured: up to 5 years

  4. Overall Survival

    to evaluate overall survival

    Measured: up to 5 years

  5. Pharmacokinetic Profile

    Determine the maximum concentration of SL-801 in plasma

    Measured: up to 5 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted29 Jan 2016 (estimated)
  2. Study start23 Feb 2016
  3. Primary completion6 Oct 2021
  4. Study completion13 Oct 2021

Resources

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
72 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02667873
Sponsor's protocol ID
STML-801-0115
Status last verified
Feb 2025
First submitted
3 Nov 2015
Last updated
10 Feb 2025
Results posted
No
Data monitoring committee
No

Publications

  • Ahn C. An evaluation of phase I cancer clinical trial designs. Stat Med. 1998 Jul 30;17(14):1537-49. doi: 10.1002/(sici)1097-0258(19980730)17:143.0.co;2-f.

    PubMed 9699228

  • Arnaoutov A, Azuma Y, Ribbeck K, Joseph J, Boyarchuk Y, Karpova T, McNally J, Dasso M. Crm1 is a mitotic effector of Ran-GTP in somatic cells. Nat Cell Biol. 2005 Jun;7(6):626-32. doi: 10.1038/ncb1263.

    PubMed 15908946

  • Dillman RO, Koziol JA. Phase I cancer trials: limitations and implications. Mol Biother. 1992 Sep;4(3):117-21.

    PubMed 1445664

  • Eisenhauer EA, Therasse P, Bogaerts J, Schwartz LH, Sargent D, Ford R, Dancey J, Arbuck S, Gwyther S, Mooney M, Rubinstein L, Shankar L, Dodd L, Kaplan R, Lacombe D, Verweij J. New response evaluation criteria in solid tumours: revised RECIST guideline (version 1.1). Eur J Cancer. 2009 Jan;45(2):228-47. doi: 10.1016/j.ejca.2008.10.026.

    PubMed 19097774

  • Gatsonis C, Greenhouse JB. Bayesian methods for phase I clinical trials. Stat Med. 1992 Jul;11(10):1377-89. doi: 10.1002/sim.4780111011.

    PubMed 1518998

  • Gerecitano J. SINE (selective inhibitor of nuclear export)--translational science in a new class of anti-cancer agents. J Hematol Oncol. 2014 Oct 4;7:67. doi: 10.1186/s13045-014-0067-3.

    PubMed 25281264

  • Huang WY, Yue L, Qiu WS, Wang LW, Zhou XH, Sun YJ. Prognostic value of CRM1 in pancreas cancer. Clin Invest Med. 2009 Dec 1;32(6):E315.

    PubMed 20003838

  • International Conference on Harmonisation. E8: General Considerations for Clinical Trials, July 1997.

  • Kojima K, Kornblau SM, Ruvolo V, Dilip A, Duvvuri S, Davis RE, Zhang M, Wang Z, Coombes KR, Zhang N, Qiu YH, Burks JK, Kantarjian H, Shacham S, Kauffman M, Andreeff M. Prognostic impact and targeting of CRM1 in acute myeloid leukemia. Blood. 2013 May 16;121(20):4166-74. doi: 10.1182/blood-2012-08-447581. Epub 2013 Apr 5.

    PubMed 23564911

  • Lapalombella R, Sun Q, Williams K, Tangeman L, Jha S, Zhong Y, Goettl V, Mahoney E, Berglund C, Gupta S, Farmer A, Mani R, Johnson AJ, Lucas D, Mo X, Daelemans D, Sandanayaka V, Shechter S, McCauley D, Shacham S, Kauffman M, Chook YM, Byrd JC. Selective inhibitors of nuclear export show that CRM1/XPO1 is a target in chronic lymphocytic leukemia. Blood. 2012 Nov 29;120(23):4621-34. doi: 10.1182/blood-2012-05-429506. Epub 2012 Oct 3.

    PubMed 23034282

  • Lassen UN, Mau-Soerensen M, Kung AL, Wen PY, Lee EQ, Plotkin SR, et al. A phase 2 study on efficacy, safety and intratumoral pharmacokinetics of oral selinexor (KPT-330) in patients with recurrent glioblastoma (GBM). J Clin Oncol 33, 2015 (suppl; abstr 2044)

  • Noske A, Weichert W, Niesporek S, Roske A, Buckendahl AC, Koch I, Sehouli J, Dietel M, Denkert C. Expression of the nuclear export protein chromosomal region maintenance/exportin 1/Xpo1 is a prognostic factor in human ovarian cancer. Cancer. 2008 Apr 15;112(8):1733-43. doi: 10.1002/cncr.23354.

    PubMed 18306389

  • Pathria G, Wagner C, Wagner SN. Inhibition of CRM1-mediated nucleocytoplasmic transport: triggering human melanoma cell apoptosis by perturbing multiple cellular pathways. J Invest Dermatol. 2012 Dec;132(12):2780-90. doi: 10.1038/jid.2012.233. Epub 2012 Jul 26.

    PubMed 22832492

  • Saito N, Sakakibara K, Sato T, Friedman JM, Kufe DW, VonHoff DD, Kawabe T. CBS9106-induced CRM1 degradation is mediated by cullin ring ligase activity and the neddylation pathway. Mol Cancer Ther. 2014 Dec;13(12):3013-23. doi: 10.1158/1535-7163.MCT-14-0064. Epub 2014 Sep 24.

    PubMed 25253782

  • Sakakibara K, Saito N, Sato T, Suzuki A, Hasegawa Y, Friedman JM, Kufe DW, Vonhoff DD, Iwami T, Kawabe T. CBS9106 is a novel reversible oral CRM1 inhibitor with CRM1 degrading activity. Blood. 2011 Oct 6;118(14):3922-31. doi: 10.1182/blood-2011-01-333138. Epub 2011 Aug 12.

    PubMed 21841164

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing SL-801 in people with Solid Tumors, run by Stemline Therapeutics, Inc. at 6 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 19 inclusion and 14 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 10 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 6 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 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?

safety and tolerability: percentage of patients experiencing treatment-related and treatment-emergent adverse events (time frame: up to 5 years). The study lists 2 primary outcomes in all. 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 NCT02667873, which also lists 24 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 10 Feb 2025.

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