Dose Escalation Study of Pasireotide (SOM230) in Patients With Advanced Neuroendocrine Tumors (NETs)

• ClinicalTrials.gov Identifier: NCT01364415
• Recruitment Status: Completed
• First Posted: June 2, 2011
• Last Update Posted: June 28, 2016
• Sponsor: Novartis Pharmaceuticals
• Information provided by (Responsible Party): Novartis ( Novartis Pharmaceuticals )

Tracking Information

• First Submitted Date: May 18, 2011
• First Posted Date: June 2, 2011
• Last Update Posted Date: June 28, 2016
• Study Start Date: August 2011
• Actual Primary Completion Date: April 2016 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: June 1, 2011)

Determine the MTD/RP2D of pasireotide LAR when administered i.m. q28 days to patients with advanced NETs [ Time Frame: Sequentiona 56 day cohorts until the MTD is determined ]

Frequency of dose-limiting toxicities (DLTs) at each dose level associated with q28 days administration of pasireotide LAR during the first 2 treatment cycles.

• Original Primary Outcome Measures: Same as current
• Change History: Complete list of historical versions of study NCT01364415 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures (submitted: June 1, 2011)

• assess the safety and tolerability of pasireotide LAR [ Time Frame: minimum of twelve 28 day cycles to approximately eighteen 28 day cycles ]
  Incidence of adverse drug events, overall and by severity and incidence of serious adverse events and laboratory abnormalities. Also, changes in laboratory assessments, electrocardiograms, Holter monitor, imaging for gallstones, and assessment of physical examinations such as vital signs
• assess the pharmacokinetics (PK) of pasireotide LAR [ Time Frame: minimum of twelve 28 day cycles to approximately eighteen 28 day cycles ]
  Pasireotide Cmax and Ctrough
• assess the pharmacodynamics (PD) of pasireotide LAR [ Time Frame: minimum of twelve 28 day cycles to approximately eighteen 28 day cycles ]
  Changes from baseline values in IGF-1, chromogranin A and neuron-specific enolase
• assess the preliminary efficacy (anti-tumor activity) of pasireotide LAR. [ Time Frame: minimum of twelve 28 day cycles to approximately eighteen 28 day cycles ]
  Disease control rate (CR+PR+SD as assessed by RECIST 1.0). Also measure progression free survival (PFS).

• Original Secondary Outcome Measures: Same as current
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: Dose Escalation Study of Pasireotide (SOM230) in Patients With Advanced Neuroendocrine Tumors (NETs)
• Official Title: A Phase I, Multi-center, Open-label, Dose Escalation Study of Pasireotide (SOM230) LAR in Patients With Advanced Neuroendocrine Tumors (NETs)
• Brief Summary: This study designed to determine the Maximum Tolerated Dose (MTD) for patients with advanced Neuroendocrine Tumors (NETs) and to characterize the safety, tolerability, Pharmacokinetics and preliminary efficacy of pasireotide LAR administered i.m. once every 28 days.
• Detailed Description: Not Provided
• Study Type: Interventional
• Study Phase: Phase 1
• Study Design: Intervention Model: Single Group Assignment; Masking: None (Open Label); Primary Purpose: Treatment
• Condition: Neuroendocrine Tumors

Intervention

Drug: Pasireotide LAR

Other Name: SOM230

Study Arms

Experimental: Pasireotide LAR

Intervention: Drug: Pasireotide LAR

• Publications *: Yao JC, Chan JA, Mita AC, Kundu MG, Hermosillo Reséndiz K, Hu K, Ravichandran S, Strosberg JR, Wolin EM. Phase I dose-escalation study of long-acting pasireotide in patients with neuroendocrine tumors. Onco Targets Ther. 2017 Jun 27;10:3177-3186. doi: 10.2147/OTT.S128547. eCollection 2017.

Recruitment Information

• Recruitment Status: Completed
• Actual Enrollment (submitted: October 13, 2015): 29
• Original Estimated Enrollment (submitted: June 1, 2011): 42
• Actual Study Completion Date: April 2016
• Actual Primary Completion Date: April 2016 (Final data collection date for primary outcome measure)

Eligibility Criteria

Inclusion Criteria:

• ≥18 yrs old, histologically confirmed advanced well or moderately differentiated neuroendocrine tumor/carcinoma
• unresectable metastatic NET tumor with measurable disease
• life expectancy ≥ 12 weeks

Exclusion Criteria:

• Patients with CNS metastases who are neurologically unstable or requiring increasing doses of steroids to control their CNS disease
• patients with known hypersensitivity to somatostatin analogs
• patients with symptomatic cholelithiasis in the past 2 months
• patients with history of another known primary malignancy with exception of non-melanoma skin cancer or carcinoma in situ of uterine cervix
• patients with known history of hepatitis C or chronic active hepatitis B
• patients with diagnosis of HIV.

Other protocol-defined inclusion/exclusion criteria may apply

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: United States

Administrative Information

• NCT Number: NCT01364415
• Other Study ID Numbers: CSOM230D2101
• Has Data Monitoring Committee: Not Provided
• U.S. FDA-regulated Product: Not Provided
• IPD Sharing Statement: Not Provided
• Responsible Party: Novartis ( Novartis Pharmaceuticals )
• Study Sponsor: Novartis Pharmaceuticals
• Collaborators: Not Provided

Investigators

• Study Director: Novartis Pharmaceuticals; Novartis Pharmaceuticals

• PRS Account: Novartis
• Verification Date: June 2016