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Pasireotide in Combination With RAD001 in Patients With Advanced Neuroendocrine Tumors

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00804336
First Posted: December 8, 2008
Last Update Posted: October 19, 2016
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborators:
Beth Israel Deaconess Medical Center
Brigham and Women's Hospital
Massachusetts General Hospital
Novartis
Information provided by (Responsible Party):
Jennifer Chan, MD, MPH, Dana-Farber Cancer Institute
  Purpose
The purpose of this research study is to determine the safety of the combination of SOM230 and RAD001, as well as determine the highest dose of this combination that can be given to people safely. SOM230 is an investigational drug that is similar to Sandostatin LAR. Sandostatin is an approved drug for the use of treating symptoms of neuroendocrine tumors. SOM230 has shown to be effective in patients who have become resistant to Sandostatin and may also stop cancer cells from growing. RAD001 is an investigational drug that also may stop cancer cells from growing.

Condition Intervention Phase
Neuroendocrine Tumor Carcinoid Tumor Pancreatic Neuroendocrine Tumor Drug: SOM230 Drug: RAD001 Phase 1

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Phase I Study of Pasireotide (SOM230) in Combination With RAD001 in Patients With Advanced Neuroendocrine Tumors

Resource links provided by NLM:


Further study details as provided by Jennifer Chan, MD, MPH, Dana-Farber Cancer Institute:

Primary Outcome Measures:
  • To determine the maximum tolerated dose for pasireotide (SOM230) in combination with RAD001 in this patient population. [ Time Frame: 2 years ]
  • To determine the dose-limiting toxicities of the combination in this patient population. [ Time Frame: 2 years ]

Secondary Outcome Measures:
  • To determine the pharmacokinetics of combined treatment [ Time Frame: 2 years ]
  • To make a preliminary assessment of the anti-tumor activity of the combination in this patient population [ Time Frame: 2 years ]
  • To determine the objective response rate [ Time Frame: 3 years ]
  • To determine the duration of response [ Time Frame: 3 years ]
  • To determine the progression free survival and overall survival of patients receiving this combination. [ Time Frame: 5 years ]

Enrollment: 22
Study Start Date: October 2008
Study Completion Date: April 2015
Primary Completion Date: September 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Pasireotide and RAD001
RAD001 was administered orally as a once-daily dose. Pasireotide s.c. was self-administered s.c. twice daily for 4 weeks. If pasireotide s.c. was tolerated, patients received pasireotide LAR i.m. at the corresponding dose level. Pasireotide s.c. was continued for an additional 2 weeks after administration of pasireotide LAR until anticipated steady-state levels of pasireotide LAR were achieved. Pasireotide LAR was administered every 28 days. Cycles for everolimus and pasireotide LAR were repeated every 28 days.
Drug: SOM230
Given subcutaneously twice a day for four weeks then given intramuscularly once every four weeks thereafter
Other Name: pasireotide
Drug: RAD001
Given orally once a day

Detailed Description:
  • Participants will be receiving two study medications, SOM230 and RAD001, during each treatment cycle. Each treatment cycle lasts 4 weeks.
  • For the first four weeks of treatment, the participant will self-administer the SOM230 twice a day by subcutaneous injection. If they tolerate the SOM230 after 4 weeks, they will switched to the long-acting SOM230 which will be administered during scheduled treatment visits once every 4 weeks. For the first two weeks after switching to the long-acting SOM230, participants will continue to self-administer the short-acting SOM230 twice a day.
  • RAD001 will be taken orally once every day.
  • On Day 1 of every cycle, a physical exam and blood tests will be performed. Following every 2 cycles of treatment an assessment of the tumor by CT scan wil be performed.
  • Pharmacokinetic (pK) blood samples will be taken on days 1 and 15 of cycle one. The pK samples will be taken right before the study drug is administered and then 1, 2, 3, and 5 hours later.
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Locally unresectable or metastatic neuroendocrine tumor. Patients must have confirmed low-grade or intermediate-grade neuroendocrine carcinoma. Patients with poorly differentiated neuroendocrine carcinoma, high-grade neuroendocrine carcinoma, adenocarcinoid, goblet cell carcinoid, and small cell carcinoma are not eligible.
  • 18 years of age or older
  • Minimum of four weeks since any major surgery, completion of radiation, of completion of all prior systemic anticancer therapy.
  • ECOG Performance Status 0,1, or 2.
  • Life expectancy 12 weeks or more.
  • Adequate bone marrow, liver and renal function as outlined in the protocol
  • Negative serum pregnancy test for women of childbearing potential.
  • Fasting serum cholesterol less than or equal to 300mg/dL or less than or equal to 7.75mml/L AND fasting triglycerides of less than or equal to 2.5 x ULN.

Exclusion Criteria:

  • Chronic treatment with systemic steroids or another immunosuppressive agent.
  • Immunization with attenuated live vaccines during study or within 1 week of study entry.
  • Uncontrolled brain or leptomeningeal metastases, including patients who continue to require glucocorticoids for brain or leptomeningeal metastases.
  • Prior or concurrent malignancy, except for the following: adequately treated basal cell or squamous cell skin cancer, or other adequately treated in situ cancer, or any other cancer from which the patient has been disease free for five years.
  • Uncontrolled diabetes mellitus or a fasting plasma glucose of > 1.5 ULN.
  • Symptomatic cholelithiasis
  • Congestive heart failure, unstable angina, sustained ventricular tachycardia, ventricular fibrillation, clinically significant bradycardia, advanced heart block or a history of acute myocardial infarction within the six months preceding enrollment.
  • Presence of active or suspected acute or chronic uncontrolled infection or with a history of immunocompromise, including a positive HIV test result.
  • Any severe and/or uncontrolled medical condition or other conditions that could affect their participation in the study such as: severely impaired lung function; active or uncontrolled infection/disorders; nonmalignant medical illnesses that are uncontrolled or whose control may be jeopardized by treatment with the study therapy; impairment of gastrointestinal function or gastrointestinal disease that may significantly alter the absorption of RAD001; history of alcohol or drug abuse in the 6 month period prior to receiving treatment.
  • Known hypersensitivity to RAD001 or other rapamycins or its excipients.
  • Known hypersensitivity to somatostatin analogues or any component of the pasireotide or octreotide LAR or s.c. formulations.
  • History of non-compliance to medical regimens.
  • Patients taking medication known to inhibit, induce, or be a substrate to isoenzyme CYP3A.
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00804336


Locations
United States, Massachusetts
Beth Israel Deaconess Medical Center
Boston, Massachusetts, United States, 02115
Dana-Farber Cancer Institute
Boston, Massachusetts, United States, 02115
Massachusetts General Hospital
Boston, Massachusetts, United States, 02214
Sponsors and Collaborators
Dana-Farber Cancer Institute
Beth Israel Deaconess Medical Center
Brigham and Women's Hospital
Massachusetts General Hospital
Novartis
Investigators
Principal Investigator: Jennifer Ang Chan, MD, MPH Dana-Farber Cancer Institute
  More Information

Publications:
Responsible Party: Jennifer Chan, MD, MPH, Principal Investigator, Dana-Farber Cancer Institute
ClinicalTrials.gov Identifier: NCT00804336     History of Changes
Other Study ID Numbers: 08-087
First Submitted: December 5, 2008
First Posted: December 8, 2008
Last Update Posted: October 19, 2016
Last Verified: October 2016

Keywords provided by Jennifer Chan, MD, MPH, Dana-Farber Cancer Institute:
pasireotide
SOM230
RAD001

Additional relevant MeSH terms:
Neoplasms
Neuroendocrine Tumors
Carcinoid Tumor
Adenoma, Islet Cell
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Neoplasms, Nerve Tissue
Adenocarcinoma
Carcinoma
Neoplasms, Glandular and Epithelial
Adenoma
Pancreatic Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Endocrine Gland Neoplasms
Digestive System Diseases
Pancreatic Diseases
Endocrine System Diseases
Everolimus
Sirolimus
Pasireotide
Antineoplastic Agents
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Anti-Bacterial Agents
Anti-Infective Agents
Antibiotics, Antineoplastic
Antifungal Agents