EUCTR2021-000617-16-GR进行中（未招募）1 期
Open-Label, Phase 1/2 Study Evaluating the Relative Bioavailability/Bioequivalence of Different Formulations of Selinexor, the Impact of Hepatic Impairment on Selinexor Pharmacokinetics and the Tolerability and Antitumor Activity of Selinexor Combination Treatment (SPRINT).
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 16
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •Common inclusion criteria for all patients:
- •1. Are =18 years of age.
- •2. Have histologically confirmed solid tumor (any type of advanced or metastatic solid tumor for the Hepatic Impairment Arm of the Monotherapy Part), advanced or metastatic NSCLC or CRC and evidence of measurable disease per Response Evaluation Criteria in Solid Tumors (RECIST v1.1).
- •3. Willing to provide signed written informed consent in accordance with federal, local, and institutional guidelines and comply with all requirements of the study.
- •4. Female patients of childbearing potential must have a negative serum pregnancy test at screening and agree to use highly effective (dual methods of) contraception throughout the study and for 4 months following the last dose of study drug; and male patients must use an effective barrier method of contraception throughout the study and for 4 months following the last dose of study drug if sexually active.
- •For the Monotherapy Part only:
- •5. Have received at least 1 line of systemic anticancer treatment unless there is no first-line standard of care therapy or standard of care therapy is contraindicated adjuvant or neoadjuvant therapy is not counted as one line of systemic therapy). Patients must have failed prior standard curative therapy for their disease, must be intolerant to or be ineligible for any potentially curative approved treatment, irrespective of line of therapy.
- •6. Must have moderate or severe hepatic impairment (as defined by the NCI organ dysfunction working group (NCI-ODWG) criteria.
- •Note: Patients with mild hepatic dysfunction (total bilirubin >1 to 1.5 × ULN OR AST > ULN) may be included if liver function tests are stable for the past 3 months and enrollment is approved in writing by the Sponsor’s Medical Monitor.
- •a) Moderate Hepatic dysfunction arm: =1 week of documented moderate hepatic impairment (total bilirubin>1.5–3 × ULN, any level of AST).
- •b) Severe Hepatic dysfunction arm: =1 week of documented severe hepatic impairment (total bilirubin >3–10 × ULN, any level of AST).
- •For Combination Therapy Part only:
- •7.Previous treatment lines (adjuvant or neoadjuvant therapy is not counted as one line of systemic
- •a) Arm A: For patients with NSCLC, have received 1-2 prior line(s) of systemic
- •anti-cancer treatment with 1 regimen including an anti-PD-1/L1 mAb.
- •b) Arm C: For patients with CRC participating in the combination arm with
- •FOLFIRI, 1-2 prior lines of systemic therapy are allowed. Patient with CRC is not a candidate for curative resection of metastatic lesions.
- •8. Must have hepatic function as follows:
- •a) Arm A (combination with docetaxel): Patients with NSCLC who are to receive docetaxel and have bilirubin = ULN, and AST and/or ALT = 1.5 x ULN.
- •b) Arm C: total bilirubin = 1.5 × ULN and AST = 2.5 x ULN, AST = 2.5 x ULN.
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 50
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 50
排除标准
- •Common exclusion criteria for all patients:
- •1. Have inadequate hematopoietic function defined as (without transfusion or growth factor
- •support within 7 days prior to first dose):
- •a. absolute neutrophil count (ANC) <1.5 × 109/L; platelet count (PLT) <100 × 109/L; or hemoglobin (Hb) <9 g/dL. (Note: This does not apply to the
- •MHI and SHI arms.)
- •2. Have inadequate renal function defined as a calculated creatinine clearance (CrCl) of <20 mL/min using the formula of Cockcroft and Gault.
- •3. Have any other medical condition especially any gastrointestinal (GI) dysfunctions or GI disease that could interfere with the absorption of selinexor (e.g., inability to swallow or retain oral medications, malabsorption syndrome, a history of GI surgery which may result in intestinal blind loop, significant gastroparesis, unresolved nausea, vomiting, or diarrhea [National Cancer Institute (NCI) Common Terminology Criteria for Adverse
- •Events (CTCAE) Grade >1]).
- •4. Ongoing infection requiring parenteral antibiotics, antivirals, or antifungals on Day 1 dosing.
- •5. Prior exposure to a SINE compound or selinexor.
- •6. Insufficient time since or not recovered from procedures or anti-cancer therapy, defined as:
- •a. Not recovered from major surgery =21 days prior to Day 1 dosing. Minor procedures, such as biopsies, dental work, or placement of a port or intravenous (IV) line for infusion are permitted.
- •b. Have ongoing clinically significant anti-cancer therapy-related toxicities CTCAE Grade >1. Patients with any of the following will not be excluded: immune checkpoint-related endocrinopathies that are well controlled with hormonal supplements, patients with electrolyte abnormalities that are well-managed with supplementation, patients with Grade 2 lymphopenia, or patients with alopecia of any grade. In specific cases, patients whose toxicity has stabilized or with Grade 2 non-hematologic toxicities can be allowed following documented approval by the Sponsor’s Medical Monitor.
- •Had last dose of previous anti-cancer therapy =14 days prior to Day 1 dosing.
- •d. Radiotherapy within 4 weeks before the study. Palliative radiotherapy >14 days prior to the study is allowed.
- •e. Received investigational drugs in other clinical trials within 28 days, or 5 half-lives of the investigational drug (whichever is shorter), prior to C1D1.
- •7. Serious active psychiatric or active medical condition that could interfere with participation in the study or in the opinion of the Investigator would make study involvement unreasonably hazardous.
- •8. In the opinion of the Investigator, patients who are below their ideal body weight and would be unduly impacted by changes in their weight.
- •9. Known allergy to selinexor (all patients), docetaxel (NSCLC Arm A only), OR 5-FU, leucovorin, or irinotecan (CRC Arm C only).
- •10. Female patients who are pregnant or breastfeeding.
- •For Monotherapy Part only:
- •11. Have ECOG performance status =4 for patients to be enrolled into the MHI and SHI arms of the study.
- •12. For MHI and SHI arms: ANC <1 × 109/L; PLT <75 × 109/L; or Hb <8 g/dL.
- •13. Received strong cytochrome P450 3A (CYP3A) inhibitors =7 days prior to Day 1 dosing OR strong CYP3A inducers =14 days prior to Day 1 dosing.
- •14. Inability or unwillingness to undergo a series of PK sampling.
- •For Combination Therapy Part only:
- •15. Have ECOG performance status of =3 for Arms A and ECOG =2 for Arm C.
- •16. Arm C: Patients with known dihydropyrimidine dehydrogenase (DPD) deficiency.
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