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A Phase I, Exploratory, Intra-patient Dose Escalation Study to Investigate the Preliminary Safety, Pharmacokinetics, and Anti-tumor Activity of Pasireotide (SOM230) s.c. in Patients With Metastatic Melanoma or Metastatic Merkel Cell Carcinoma

Phase 1
18 Years
Open (Enrolling)
Metastatic Melanoma and Merkel Cell Carcinoma

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Trial Information

A Phase I, Exploratory, Intra-patient Dose Escalation Study to Investigate the Preliminary Safety, Pharmacokinetics, and Anti-tumor Activity of Pasireotide (SOM230) s.c. in Patients With Metastatic Melanoma or Metastatic Merkel Cell Carcinoma

Inclusion Criteria

Inclusion criteria:

1. Patients must have histologically or cytologically confirmed unresectable (stage III)
and/or metastatic (stage IV) melanoma or unresectable and/or metastatic Merkel cell

2. Melanoma patients should have no mutation in BRAF and NRAS genes

3. Patients should have skin lesions that can be biopsied, in addition measurable and
non-measurable metastatic lesions and at 1 lesion suitable for 18FDG-PET scan.

4. ECOG Performance Status of 0 or 1

5. Adequate organ function: adequate bone marrow 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
or estimated glomerular filtration rate (eGFR) > 40 ml/min/m2; serum lipase ≤ 1.5 ULN

Exclusion criteria:

1. Patient with primary ocular melanoma

2. Patients with symptomatic CNS metastases who are neurologically unstable or requiring
increasing doses of steroids to control their CNS disease

3. Patient who have been previously treated with somatostatin analogue or radiolabeled
somatostatin analogs or patients with a known hypersensitivity to somatostatin
analogs or any component of the pasireotide s.c. formulations or their excipients

4. Patients for whom standard treatment is available and indicated due to rapidly
progressive or aggressive disease

5. Patients who received more than 2 prior lines of systemic therapy for the treatment
of the disease.

6. Patients receiving any anti-neoplastic therapy within the 4 weeks prior to baseline

7. Patients receiving an investigational drug within 1 month prior to baseline

8. Patients who have undergone major surgery/surgical therapy for any cause within 1
month prior to baseline. Patients must have recovered from the treatment and have a
stable clinical condition before entering this study

9. Patients who have received prior radiation therapy ≤ 4 weeks, or limited field
radiation ≤ 2 weeks, prior to baseline or the side effects of such therapy have not
resolved to ≤ grade 1.

10. Patients unwilling to perform repeated biopsies

11. Patients with known gallbladder or bile duct disease, acute or chronic pancreatitis
(patients with asymptomatic cholelithiasis and asymptomatic bile duct dilation can be

12. Patients with abnormal coagulation (PT or PTT elevated by 30% above normal limits)

13. Patients on continuous anticoagulation therapy. Patients who were on anticoagulant
therapy must complete a washout period of at least 10 days prior to baseline and have
confirmed normal coagulation parameters before study inclusion

14. Patients who are not biochemically euthyroid

15. Patients with known history of hypothyroidism are eligible if they are on adequate
and stable replacement thyroid hormone therapy for at least 3 months prior to

16. Patients with QT-related exclusion criteria

17. 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

- Patients with risk factors for torsades de pointes such as uncorrected
hypokalemia, uncorrected hypomagnesemia, clinically relevant cardiac failure
(NYHA class III or IV), clinically significant/symptomatic bradycardia or
high-grade AV block

- Concomitant medications known to prolong the QT interval

- Known concomitant disease(s) that could prolong QT such as autonomic neuropathy
(caused by diabetes mellitus or Parkinson's disease), HIV, liver cirrhosis,
uncontrolled hypothyroidism or cardiac failure

- Patients with unstable angina, sustained ventricular tachycardia, ventricular
fibrillation, high grade (NOT advanced!) heart block or history of acute
myocardial infarction less than one year prior to baseline

18. Patients with any of the following severe and/or uncontrolled medical conditions:

- Uncontrolled diabetes as defined by HbA1c > 8% despite adequate therapy

- Patients with the presence of active or suspected acute or chronic uncontrolled
infection or with a history of immunodeficiency, including a positive HIV test
result (ELISA and Western blot)

- Liver disease or history of liver disease such as cirrhosis, decompensated liver
disease, or chronic active hepatitis B and C or chronic persistent hepatitis

- Life-threatening autoimmune and ischemic disorders

19. Patients who have a history of another primary malignancy, with the exception of
locally excised non-melanoma skin cancer and carcinoma in situ of uterine cervix.
Patients who had no evidence of disease from another primary cancer for 3 or more
years are allowed to participate in the study

20. Pregnant or nursing (lactating) women

21. Women of child-bearing potential

22. Patients with baseline ALT or AST > 3 x ULN or baseline total bilirubin > 1.5x ULN

23. Patients with presence of Hepatitis B surface antigen (HbsAg) or presence of
Hepatitis C antibody test (anti-HCV)

24. History of, or current alcohol misuse/abuse within the past 12 months prior to visit
1 (baseline)

Other protocol-defined inclusion/exclusion criteria may apply.

Type of Study:


Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Number of patients with AEs, SAEs

Outcome Description:

Number of patients with AEs (overall and by severity) SAEs according to the Common Terminology Criteria for Adverse Events (CTCAE) version 3.0.

Outcome Time Frame:

Week 8

Safety Issue:


Principal Investigator

Novartis Pharmaceuticals

Investigator Role:

Study Director

Investigator Affiliation:

Novartis Pharmaceuticals


Switzerland: Swissmedic

Study ID:




Start Date:

November 2012

Completion Date:

January 2015

Related Keywords:

  • Metastatic Melanoma and Merkel Cell Carcinoma
  • Melanoma
  • Merkel cell carcinoma
  • Metastatic skin cancer
  • Carcinoma
  • Carcinoma, Merkel Cell
  • Melanoma