A Phase I, exploratory, intra-patient dose escalation study to investigate the preliminary safety, pharmacokinetics, and anti-tumor activity of pasireotide (SOM230) s.c. followed by pasireotide LAR in patients with metastatic melanoma or metastatic Merkel cell carcinoma

Withdrawn

• Conditions: Melanoma; Skin cancer; 10040900

• Registration Number: NL-OMON40385
• Lead Sponsor: ovartis

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 23 April 2024

Recruitment & Eligibility

• Status: Withdrawn
• Sex: Not specified
• Target Recruitment: 4

Inclusion Criteria

1. Adult male or female, age *18 years
2. Female patients of child bearing potential must have a negative pregnancy test at screening
3. Histologically or cytologically confirmed unresectable (stage III) and/or metastatic (stage IV) melanoma or unresectable and/or metastatic Merkel cell carcinoma
4. No mutation in BRAF and NRAS genes (for melanoma patients only)
5. Patients must have lesions that can be biopsied
6. Presence of measurable or non-measurable disease according to RECIST 1.0 (Appendix 14.1)
7. ECOG Performance Status of 0 or 1
8. Adequate organ function
* WBC * 2.5 x 109/L
* ANC * 1.5 x 109/L
* Platelets * 100 x 109/L
* Hemoglobin * 9 g/dL
* Serum creatinine * 1.5 mg/dL
* Serum lipase * 1.5 ULN
9. Life expectancy of at least 12 weeks

Exclusion Criteria

1. Patients with unknown BRAF or NRAS mutational status (for melanoma patients only)
2. Primary uveal melanoma
3. Patients with symptomatic CNS metastases who are neurologically unstable or requiring increasing doses of steroids to control their CNS disease
4. Prior treatment with somatostatin analogue or radiolabeled somatostatin analogs
5. Patients for whom standard treatment is available and indicated due to rapidly progressive or aggressive disease
6. Patients who received more than 3 prior lines of systemic therapy for the treatment of the disease
7. Patients receiving any anti-neoplastic therapy within the 4 weeks prior to baseline
8. Patients with known gallbladder or bile duct disease, acute or chronic pancreatitis
9. Patients with abnormal coagulation (PT or PTT elevated by 30% above normal limits)
10. Patients on continuous anticoagulation therapy.
11. Patients who are not biochemically euthyroid
12. QT-related exclusion criteria
* Baseline QTcF >450 ms
* History of syncope or family history of idiopathic sudden death
* Known history of prolong QT syndrome
* Sustained or clinically significant cardiac arrhythmias
13. Patients who have any severe and/or uncontrolled medical conditions or other conditions that could affect their participation in the study
14. Pregnant or nursing (lactating) women
15. Women of child-bearing potential, UNLESS they are
* Women whose sexual orientation precludes intercourse with a male partner
* Women whose partners have been sterilized by vasectomy or other means
* Using a highly effective method of birth control
16. Baseline ALT or AST > 3 x ULN
17. Baseline total bilirubin > 1.5x ULN
18. Presence of Hepatitis B surface antigen (HbsAg)
19. Presence of Hepatitis C antibody test (anti-HCV)
20. History of, or current alcohol misuse/abuse within the past 12 months prior to visit 1 (baseline)

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>Incidence of AEs, laboratory, vital signs and electrocardiographic<br /><br>abnormalities. Changes in laboratory values, electrocardiograms readings, and<br /><br>in vital signs values.</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>DCR (CR, PR,SD) per RECIST 1.0<br /><br><br /><br>For each cycle, PK parameters on Day 1 and on day 8 at steady state<br /><br><br /><br>Changes from baseline on melanoma response biomarkers (S100B) overtime and its<br /><br>correlation with each dose</p><br>