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Phase I Study of Combination of SOM 230 Long Acting Release (LAR) + Gemcitabine in Locally Advanced or Metastatic Pancreatic Cancer

Phase 1
18 Years
Open (Enrolling)
Pancreatic Cancer

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Trial Information

Phase I Study of Combination of SOM 230 Long Acting Release (LAR) + Gemcitabine in Locally Advanced or Metastatic Pancreatic Cancer

This is a single-arm, open-label, phase I study of combination therapy with SOM 230 LAR and
standard treatment with gemcitabine. We will utilize a staggered, sequential dose-escalation
design to define the maximum tolerated dose (MTD) of SOM 230 LAR when combined with standard
doses of gemcitabine. Cycle will be defined as 28 days.

Treatment will be administered on an outpatient basis. Gemcitabine is administered by IV
infusion. The dose should be based on the patient's actual baseline body weight; the dose
will be recalculated if there is a weight change of > 10% from baseline. The dose of
gemcitabine will be given over 30 minutes, weekly every 3 weeks followed by 1 week rest
period. SOM 230 LAR will be administered as an intramuscular dose determined by the dosing
schema, every month.

Inclusion Criteria:

- Cytologically or histologically confirmed evidence of epithelial cancer
(adenocarcinoma) of the exocrine pancreas

- Metastatic or locally advanced disease. Patients with measurable and with non
measurable disease, as per RECIST criteria are eligible.

- Minimum of 4 weeks since any major surgery, completion of radiation

- Prior treatment with gemcitabine alone or 5-fluorouracil (5-FU) with radiation as an
adjuvant therapy will be allowed if > 6 months

- Eastern Cooperative Oncology Group (ECOG) performance status ≤ 2

- Life expectancy ≥ 12 weeks

- Adequate bone marrow function as shown by: absolute neutrophil count (ANC) ≥ 1.0 x
10^9/L, Platelets ≥ 100 x 10^9/L, hemoglobin (Hgb) > 9 g/dL

- Adequate liver function as shown by: serum bilirubin ≤ 1.5 x upper limit of normal
(ULN), and serum transaminases activity ≤ 3 x ULN, with the exception of serum
transaminases (< 5 x ULN) if the patient has liver metastases.

- Adequate renal function as shown by serum creatinine ≤ 1.5 x ULN

- Fasting serum cholesterol ≤300 mg/dL OR ≤7.75 mmol/L AND fasting triglycerides ≤ 2.5
x ULN. NOTE: In case one or both of these thresholds are exceeded, the patient can
only be included after initiation of appropriate lipid lowering medication.

- Women of childbearing potential (WOCBP) must have a negative serum or urine pregnancy
test within 14 days of the administration of the first study treatment. Women must
not be lactating. Both men and WOCBP must be advised of the importance of using
effective birth control measures during the course of the study.

- Signed informed consent to participate in the study must be obtained from patients
after they have been fully informed of the nature and potential risks by the
investigator (or his/her designee) with the aid of written information.

- Screening electrocardiogram (ECG) with a time from electrocardiogram Q wave to the
end of the T wave corresponding to electrical systole [QT] corrected for heart rate
(QTc) < 450 msec

Exclusion Criteria:

- Prior treatment with any cytotoxic chemotherapy except as an adjuvant therapy

- Have undergone major surgery within 4 weeks prior to study enrollment

- Chronic treatment with steroids or any other immunosuppressant drugs

- Should not receive immunization with attenuated live vaccines during study period or
within 1 week of study entry.

- Untreated brain or leptomeningeal metastases, including patients who continue to
require glucocorticoids for brain or leptomeningeal metastases.

- Patients with uncontrolled diabetes mellitus or a fasting plasma glucose > 1.5 ULN or
glycosylated hemoglobin (HbA1c) >8%. Note: At the principle investigator's
discretion, non-eligible patients can be re-screened after adequate medical therapy
has been instituted

- Patients with symptomatic cholelithiasis

- QT related exclusion criteria: Fridericia Correction Formula (QTcF) at screening >
450 msec; History of syncope or family history of idiopathic sudden death; Sustained
or clinically significant cardiac arrhythmias; Risk factors for Torsades de Pointes
such as hypokalemia, hypomagnesemia, cardiac failure, clinically
significant/symptomatic bradycardia, or high-grade atrioventricular (AV) block;
Concomitant medication(s) known to prolong the QT interval (patient must be off the
drug for 2 weeks to be eligible)

- Patients who have congestive heart failure [New York Heart Association (NYHA) Class
III or IV], unstable angina, sustained ventricular tachycardia, ventricular
fibrillation, clinically significant bradycardia, advanced heart block or a history
of acute myocardial infarction within the 6 months preceding enrollment

- Known history of human immunodeficiency virus (HIV)

- Patients who have any severe and/or uncontrolled medical conditions or other
conditions that could affect their participation in the study such as: Any active
(acute or chronic) or uncontrolled infection/ disorders; Nonmalignant medical
illnesses that are uncontrolled or whose control may be jeopardized by the treatment
with the study therapy

- Women who are pregnant or breast feeding, or women/men able to conceive and unwilling
to practice an effective method of birth control. (WOCBP must have a negative serum
pregnancy test within 14 days prior to administration of pasireotide). Oral,
implantable, or injectable contraceptives may be affected by cytochrome P450
interactions, and are therefore not considered effective for this study.

- Known hypersensitivity to somatostatin analogues or any component of the pasireotide
or octreotide LAR formulations

- History of noncompliance to medical regimens

- Patients unwilling to or unable to comply with the protocol

Type of Study:


Study Design:

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

Outcome Measure:

Number of Participants With Serious Adverse Events

Outcome Description:

Safety / Tolerability (type, frequency, severity, and relationship of adverse events to study drug)

Outcome Time Frame:

The end of each participant's 28 day cycle

Safety Issue:


Principal Investigator

Richard Kim, M.D.

Investigator Role:

Principal Investigator

Investigator Affiliation:

H. Lee Moffitt Cancer Center and Research Institute


United States: Food and Drug Administration

Study ID:




Start Date:

June 2011

Completion Date:

July 2014

Related Keywords:

  • Pancreatic Cancer
  • metastatic
  • locally advanced
  • combination therapy
  • dose escalation
  • epithelial cancer
  • adenocarcinoma
  • exocrine pancreas
  • Pancreatic Neoplasms



H. Lee Moffitt Cancer Center and Research InstituteTampa, Florida  33612