PER-049-22尚未招募2 期
A Randomized, Parallel Group Study to Evaluate the Safety, Pharmacokinetics, and Dose Response of Paltusotine Treatment in Subjects with Carcinoid Syndrome.
适应症
试验速览
- 阶段
- 2 期
- 状态
- 尚未招募
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 性别
- All
入选标准
- •Willing and able to comply with the study procedures as specified in the protocol,
- •including at least 70% compliance with electronic symptom diary for the 2-week
- •period prior to the S2 visit and prior to the Day 1 visit.
- •Male or female subjects =18 years of age, at the time of Screening.
- •Willing and able to provide written informed consent prior to any study-related
- •procedures.
- •Documented carcinoid syndrome requiring medical therapy including at least one
- •historical instance of an elevated 5-HIAA level. Eligible subjects fall into one of the
- •following categories:
- •? Naïve to SRLs and actively symptomatic (average of =4 BM/day or
- •>2 flushing episodes per day in at least 2 days over a period of 2 weeks)
- •? Subjects currently treated with lanreotide, octreotide LAR, or short-acting
- •octreotide (subcutaneous or oral) who are currently symptomatically
- •controlled (average <4 BM/day with =5 BMs on any single day and average
- •=2 flushing episodes/day over a 2-week period) and willing to wash out of
- •their medication. The subject must demonstrate symptomatic worsening after
- •Evaluable documentation of locally advanced or metastatic histopathologically
- •confirmed well-differentiated NET. Tumors must be Grade 1 or Grade 2 (Ki-67
- •index =20%, or a mitotic count of =20 mitoses per 10 high-power fields, if the Ki-67
- •index is not available) per the World Health Organization neuroendocrine neoplasm
- •classification (Rindi and Inzani, 2020). Grade 3 tumors are not eligible.
- •No significant disease progression* as assessed by the Investigator within the last 6
- •months before initiation of study drug dosing.
- •Historical documentation of positive SSTR tumor status by PET or somatostatin
- •receptor scintigraphy.*
- •Plasma 5-HIAA =2× ULN during Screening for naïve subjects not washing out of SRLs.
- •Females who engage in heterosexual intercourse must be of nonchildbearing
- •potential, defined as either surgically sterile (ie, hysterectomy, bilateral
- •salpingectomy, or bilateral oophorectomy), OR be postmenopausal with at least
- •1 year of amenorrhea, OR must agree to use a highly effective method of
- •contraception from the beginning of Screening to the last study visit.
- •If the subject is male, the subject should agree to use a condom when sexually active
- •with a female partner of childbearing potential from Screening until at least 30 days
- •after the last dose of study drug or be surgically sterile [ie, vasectomy with
- •documentation]; or remain abstinent [when this is in line with the preferr
排除标准
- •Any malignancy except for eligible NET, basal cell or squamous cell skin carcinoma considered clinically cured, or in situ cervical carcinoma.
- •Life expectancy <12 months from Screening.
- •Major surgery within 8 weeks before Screening.
- •Diabetes mellitus treated with insulin for less than 6 weeks prior to the study entry, or with change in total daily insulin dose by >15% within 6 weeks prior to Screening.
- •Diarrhea attributed to any condition(s) other than carcinoid syndrome (including but
- •not limited to fat malabsorption, bile acid malabsorption, short bowel syndrome,
- •pancreatic exocrine insufficiency, infections, VIPoma, Zollinger-Ellison syndrome).
- •Exception to this are subjects with prior cholecystectomy or small bowel resections,
- •provided diarrhea is controlled prior to washout or if naïve to SRLs.
- •Uncontrolled/severe diarrhea associated with significant volume contraction,
- •dehydration, or hypotension.
- •Requires second line treatments (eg, telotristat) for control of carcinoid syndrome
- •symptoms in the opinion of the Investigator
- •Treatment with tumor-directed therapy <4 weeks before Screening or hepatic
- •embolization, radiotherapy, peptide receptor radionuclide therapy (PRRT), and/or
- •tumor debulking <12 weeks before Screening.
- •Karnofsky performance status <60%.
- •History of unstable angina or acute myocardial infarction within the 12 weeks preceding the Screening Visit or other clinically significant cardiac disease (including clinically significant carcinoid heart disease) at the time of Screening as judged by the Investigator.
- •Known history of, or current alcohol or drug abuse, within the last year.
- •Concomitant mental condition rendering him/her unable to understand the nature, scope, and possible consequences of the study, and/or evidence of poor Compliance with medical instructions.
- •Current use of medications that are strong inducers of cytochrome P450 3A4 (CYP3A4) (including but not limited to carbamazepine, enzalutamide, mitotane, phenytoin, rifampin, St. John’s wort) within 2 weeks prior to Screening because they may reduce systemic e
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