IGF-1 Inhibitor Pasireotide Lar in Combination With the m-TOR Inhibitor Everolimus

NCT01234974 | Withdrawn Phase 2 DMC

• 1 other identifier: PSHCI 09-095
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief Summary

Observe the safety/tolerability and effectiveness in terms of response rate and duration of response of the combination pasireotide + everolimus in the treatment of patients with relapsed/refractory multiple melanoma.

Conditions

Multiple Myeloma

Keywords

multiple myeloma

Outcome Measures

Primary Outcomes (1)

• Primary objective

  Initially 12 patients will be enrolled. If there are no responses among these patients with the combination pasireotide + everolimus in the treatment the study will be terminated.

  12 patients enrolled

Secondary Outcomes (1)

• Secondary objective

  25 to 37 patients enrolled

Study Arms (1)

Pasireotide

EXPERIMENTAL

Pasireotide 60 mg day 1 every 28 days

Drug: Pasireotide; Drug: Everolimus

Interventions

Pasireotide DRUG

Given as an intramuscular injection on day 1 every 28 days, 60 mg per dose

Also known as: Pasireotide s.c., Pasireotide LAR, SOM230

Pasireotide

Everolimus DRUG

given as an oral tablet every day on days 1-28, 10 mg per day

Also known as: RAD001

Pasireotide

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Histologically documented multiple myeloma
• Multiple myeloma relapsing or refractory to at least 2 of the currently accepted therapies for multiple myeloma
• Age \> 18 years
• Minimum of 4 weeks since any major surgery, radiation or 5 half life since prior systemic anticancer therapy
• ECOG performance status ≤ 2
• Anticipated life expectancy of 12 weeks or more
• Adequate bone marrow function
• Adequate liver function
• Calculated creatinine
• INR ≤ 1.5
• Fasting serum cholesterol ≤ 300 mg/dL or ≤ 7.75 mmol/L and fasting triglycerides ≤ 2.5 x ULN
• Women of childbearing potential must have a negative serum pregnancy test. Women must not be lactating. Both men and women of childbearing potential must be advised of the importance of using effective birth control during the course of the study.

You may not qualify if:

• Patients should not receive immunization with attenuated live vaccines within one week of study entry or during study period.
• Patients should not receive immunization with attenuated live vaccines during study period or within 1 week of study entry.
• Patients with prior or concurrent malignancy
• Patients with uncontrolled diabetes mellitus
• Patients who have congestive heart failure, unstable angina, sustained ventricular tachycardia, ventricular fibrillation, clinically significant bradycardia, advanced heart block or history of acute myocardial infarction within the 6 months preceding enrollment.
• Liver disease
• Patients who have any severe and/or uncontrolled medical condition or other conditions that could affect their participation in the study.
• Female patients who are pregnant or breast feeding, adults of reproductive potential who are not using effective birth control methods.
• Male patients whose sexual partner(s) are women of child bering potential and who are not willing to use adequate contraception during the study and for 8 weeks after the end of treatment.
• Patients with a known hypersensitivity to everolimus or other rapamycin or to its excipients.
• 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
• Patients taking medication know to inhibit, induce or be a substrate to isoenzyme CYP3A
• 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 points, concomitant disease that could prolong QT intervals, use of concomitant medications know to prolong the QT interval.

Sponsors & Collaborators

• Milton S. Hershey Medical Center: lead

Study Sites (1)

Penn State Milton S. Hershey Medical Center

Hershey, Pennsylvania, 17033, United States

Location

MeSH Terms

Conditions

Multiple Myeloma

Interventions

pasireotide; Everolimus

Condition Hierarchy (Ancestors)

Neoplasms, Plasma Cell; Neoplasms by Histologic Type; Neoplasms; Hemostatic Disorders; Vascular Diseases; Cardiovascular Diseases; Paraproteinemias; Blood Protein Disorders; Hematologic Diseases; Hemic and Lymphatic Diseases; Hemorrhagic Disorders; Lymphoproliferative Disorders; Immunoproliferative Disorders; Immune System Diseases

Intervention Hierarchy (Ancestors)

Sirolimus; Macrolides; Lactones; Organic Chemicals

Study Officials

• Giampaolo Talamo, MD

  Milton S. Hershey Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor of Medicine

Study Record Dates

• First Submitted: August 24, 2010
• First Posted: November 4, 2010
• Study Start: December 1, 2010
• Primary Completion: December 1, 2012
• Study Completion: December 1, 2013
• Last Updated: January 10, 2013

Record last verified: 2013-01

Locations

US (1)