Status:
TERMINATED
Study of the PI3K Inhibitor SL-901 in Patients With Advanced Solid Tumors
Lead Sponsor:
Stemline Therapeutics, Inc.
Conditions:
Advanced Solid Tumor
Eligibility:
All Genders
18+ years
Phase:
PHASE1
Brief Summary
Study STML-901-0119 was a dose-escalation study evaluating multiple doses and schedules of orally administered SL-901 in patients with advanced solid tumors.
Detailed Description
Study STML-901-0119 was a multi-center, open-label, dose-escalation, and regimen-finding study aimed to investigate the safety, pharmacokinetics (PK), and pharmacodynamics of SL-901 in patients with a...
Eligibility Criteria
Inclusion
- 18 years old or older.
- Population by study stage:
- Part 1a: Patients with advanced, metastatic, and/or progressive solid tumors for whom there is no effective standard therapy available.
- Part 1b: Patients with histologically confirmed, advanced, metastatic, unresectable, and/or progressive solid tumors for whom there is no effective standard therapy available and their PI3K or DNA-PK pathway is deregulated or their tumor genetic profile has been shown to correlate with sensitivity to PI3K and/or DNA-PK inhibition based on clinical and preclinical experience. Specific criteria will be determined based on ongoing experiments and will be introduced in a future protocol amendment.
- Evaluable or measurable disease.
- Eastern Cooperative Oncology Group (ECOG) performance status ≤2.
- Able to take oral medications.
- If a woman of childbearing potential (WOCBP), the patient has a negative serum or urine pregnancy test within 1 week before Cycle 1, Day 1 (C1D1). Refer to Section 8.1.3 for further practical information about contraception.
- The patient (either male or female) agrees to use acceptable contraceptive methods for the duration of time in the study, and to continue to use acceptable contraceptive methods for 1 month after the last dose of SL-901. Refer to Section 8.1.3 for further practical information about contraception.
- Able to provide written informed consent.
- Willing to provide consent for biomarker analysis of existing paraffin-embedded tumor samples.
Exclusion
- Received an investigational anticancer drug within 4 weeks of the first planned SL-901 dose.
- Received major surgery, radiotherapy, or immunotherapy within 4 weeks of C1D1. Localized palliative radiotherapy is permitted for symptom control.
- Received chemotherapy regimens with delayed toxicity within 4 weeks (6 weeks for prior nitrosourea or mitomycin C) of C1D1.
- Received chemotherapy regimens given continuously or on a weekly basis which have limited potential for delayed toxicity within 2 weeks of C1D1.
- Clinically significant, unresolved toxicity from previous anticancer therapy ≥Grade 2 (except alopecia), as determined by the Investigator using the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE), version 5.0.
- Presence of active gastrointestinal disease or other condition that will interfere significantly with the absorption, distribution, metabolism, or excretion of drugs.
- Left ventricular ejection fraction \<50%.
- Corrected QT interval (based on Fridericia's formula) \>450 msec.
- Type 1 or 2 diabetes mellitus requiring medication. (In Part 1b, patients with type 2 diabetes mellitus controlled by medication, as indicated by a glycated hemoglobin of ≤7.5% are eligible.)
- Known active human immunodeficiency virus, hepatitis B, or hepatitis C infection.
- Ongoing systemic bacterial, fungal, or viral infection.
- History of interstitial pneumonitis.
- Absolute neutrophil count (ANC) 1.5×10⁹/L.
- Hemoglobin \<10 g/dL.
- Aspartate aminotransferase (AST) or alanine aminotransferase (ALT) \>2.5x the upper limit of normal (ULN).
- Known hypersensitivity or allergy to the active ingredient or excipients of SL-901.
- Breast-feeding females.
Key Trial Info
Start Date :
March 19 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 5 2023
Estimated Enrollment :
20 Patients enrolled
Trial Details
Trial ID
NCT05382936
Start Date
March 19 2021
End Date
May 5 2023
Last Update
January 9 2025
Active Locations (2)
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1
Royal Marsden Hospital
Sutton, Surrey, United Kingdom, SM2 5PT
2
Christie Hospital
Manchester, United Kingdom, M20 4BX