A Phase 2, Open-Label, Multi-Center, Serial Ascending-Dose, Dose Finding Study to Evaluate the Safety and Tolerability of LX1606 in Subjects with Symptomatic Carcinoid Syndrome

Recruitment & Eligibility

Status: ot Recruiting

Sex: Not specified

Target Recruitment: 15

Inclusion Criteria

1. Adult subjects aged =18 years at the time of the Screening visit.
2. Male or female; males and females of childbearing potential must agree to use an adequate method of contraception during the study and for 12 weeks after the last Follow-Up visit.
3. Biopsy-proven metastatic carcinoid tumor of the GI tract with disease extent confirmed by computed tomography (CT), magnetic resonance imaging (MRI), or radionuclide imaging.
4. Symptomatic carcinoid syndrome, defined as experiencing an average of = 4 bowel movements per day. Confirmation of eligibility will be determined by measuring the mean number of bowel movements during the Run-In period.
5. Ability and willingness to provide written informed consent prior to participation in any study-related activities and to participate in and comply with the study requirements.
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 10
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 6

Exclusion Criteria

1. Presence of volume contraction, dehydration, or hypotension compatible with a pancreatic cholera”-type clinical syndrome, as judged by the Investigator.
2. Karnofsky Performance Status = 70% (see Appendix D).
3. Clinical laboratory values for hematology (at Screening):
a. Absolute neutrophil count (ANC) = 1500 cells/mm3; or
b. Platelets = 100,000 cells/mm3; or
c. Hemoglobin (Hgb) = 9 g/dL.
4. Liver function test levels (at Screening) such that:
a. Asparate transaminase (AST), alanine aminotransferase (ALT) = five times the upper limit of normal (5 x ULN);or
b. Total bilirubin > ULN; or
c. Alkaline Phosphatase (ALP) = 3 x ULN. Higher values will be considered if the investigator deems the elevation in ALP is due to the underlying carcinoid tumor burden and not progressive liver failure.; or
d. Serum creatinine = 1.5 x ULN.
5. Any other clinically significant laboratory abnormality at Screening.
6. Any clinically significant abnormalities on resting ECG (relative to subject population) at Screening.
7. Surgery within 60 days prior to Screening.
8. A history of short bowel syndrome (SBS).
9. History of positive hepatitis B surface antigen (HBsAg), hepatitis C antibody (HCV Ab), human immunodeficiency virus (HIV) 1, or HIV 2.
10. Pregnant or nursing (lactating) women.
11. Positive pregnancy test at Screening.
12. A history of bleeding diathesis.
13. Life expectancy < 12 months from the Screening visit.
14. Presence of any clinically significant findings at Screening medical history, or physical examination (relative to subject population) that, in the Investigator’s or Sponsor’s opinion, would compromise the outcome of the study.
15. A history of, or the existence of, any surgical or medical condition that, in the judgment of the Investigator, might interfere with the absorption, distribution, metabolism, or excretion of LX1606.
16. Any concurrent conditions that could interfere with safety and/or tolerability measurements.
17. A history of substance or alcohol abuse within 2 years prior to Screening.
18. Participation in any other investigational drug study within 30 days prior to Screening.
19. Administration of any investigational agent within 30 days of Screening or any therapeutic protein or antibody within 90 days prior to Screening.

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method

Secondary Outcome Measures

Name	Time	Method

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