NCT00375245

Brief Summary

The purpose of this study is to determine the highest safe dose of rapamycin when given with a fixed amount of grapefruit juice.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
41

participants targeted

Target at P50-P75 for phase_1

Timeline
Completed

Started Sep 2006

Longer than P75 for phase_1

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2006

Completed
10 days until next milestone

First Submitted

Initial submission to the registry

September 11, 2006

Completed
1 day until next milestone

First Posted

Study publicly available on registry

September 12, 2006

Completed
2.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2009

Completed
3 years until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2012

Completed
Last Updated

January 17, 2014

Status Verified

January 1, 2014

Enrollment Period

2.7 years

First QC Date

September 11, 2006

Last Update Submit

January 16, 2014

Conditions

TumorsNeoplasm Metastasis

Keywords

phase Imetastaticadvanced cancerlung cancerrenal cancerkidney cancerhead and neck cancerbladder cancerbreast cancercolorectal canceresophagusGISTliver cancermelanomamesotheliomalymphomaovary cancerovarian cancerpancreas cancerpancreatic cancerprostate cancerstomach cancerthyroid cancerMetastatic solid tumor

Outcome Measures

Primary Outcomes (1)

  • Pharmacokinetic interaction

    4 weeks

Study Arms (1)

Rapamycin + Grapefruit juice

EXPERIMENTAL
Drug: Rapamycin (sirolimus)Other: Grapefruit Juice

Interventions

Rapamycin (sirolimus)DRUG

Weekly oral doses, dose is assigned at the time of study entry

Also known as: Rapamune
Rapamycin + Grapefruit juice
Grapefruit JuiceOTHER

Daily oral doses starting during the second week on study.

Rapamycin + Grapefruit juice

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Histologically confirmed malignancy that is metastatic or unresectable and for which standard curative or palliative measures do not exist or are no longer effective.
  • Patients with hematologic malignancies (lymphoma, multiple myeloma and chronic lymphocytic leukemia (CLL) only) are eligible to participate in the phase IB portion of the trial only.
  • At least 4 weeks since prior chemotherapy or radiation therapy
  • Aged 18 years or older
  • ECOG performance status 0-2
  • Life expectancy of greater than 3 months.
  • Normal organ and marrow function:
  • No transfusions of packed red blood cells within 1 week of starting treatment
  • Leukocytes greater or equal to 3,000/μL
  • \*\* White blood cell (WBC) greater or equal to 1,500/μL for patients with hematologic malignancies
  • Absolute neutrophil count (ANC) greater or equal to 1,500/μL
  • \*\* ANC greater or equal to 1,000/μL for patients with hematologic malignancies
  • Platelets (PLT) greater or equal to 100,000/μL
  • \*\* PLT greater or equal to 50,000/μL for patients with hematologic malignancies
  • Total bilirubin within normal institutional limits
  • +5 more criteria

You may not qualify if:

  • Chemotherapy or radiotherapy within 4 weeks (6 weeks for nitrosoureas or mitomycin C) prior to entering the study or those who have not recovered from adverse events due to agents administered more than 4 weeks earlier.
  • May not be receiving any other investigational agents.
  • Uncontrolled brain metastases or malignancy. Cannot be receiving enzyme-inducing anticonvulsants.
  • History of allergic reactions attributed to compounds of similar chemical or biologic composition to rapamycin
  • Gastrointestinal malabsorption syndromes, partial small bowel obstruction, or any illness that would interfere with the ability to absorb oral medications.
  • Uncontrolled intercurrent illness
  • Severe immunodeficient states (as judged by the treating physician)
  • Pregnant women are excluded from this study; breastfeeding should be discontinued.
  • HIV-positive patients receiving combination antiretroviral therapy are excluded.
  • Concurrent use of ketoconazole, cyclosporine, tacrolimus, diltiazem, and rifampin with rapamycin is not permissible. The concurrent use of calcium channel blockers, terfenadine, astemizole, cisapride, propafenone, cyclosporine, midazolam, triazolam, quinidine, or theophylline with grapefruit juice is not permissible.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Chicago Hospitals

Chicago, Illinois, 60637, United States

Location

Related Publications (1)

  • Treiber G. mTOR inhibitors for hepatocellular cancer: a forward-moving target. Expert Rev Anticancer Ther. 2009 Feb;9(2):247-61. doi: 10.1586/14737140.9.2.247.

    PMID: 19192962DERIVED

MeSH Terms

Conditions

NeoplasmsNeoplasm MetastasisLung NeoplasmsKidney NeoplasmsHead and Neck NeoplasmsUrinary Bladder NeoplasmsBreast NeoplasmsColorectal NeoplasmsLiver NeoplasmsMelanomaMesotheliomaLymphomaOvarian NeoplasmsPancreatic NeoplasmsProstatic NeoplasmsStomach NeoplasmsThyroid Neoplasms

Interventions

Sirolimus

Condition Hierarchy (Ancestors)

Neoplastic ProcessesPathologic ProcessesPathological Conditions, Signs and SymptomsRespiratory Tract NeoplasmsThoracic NeoplasmsNeoplasms by SiteLung DiseasesRespiratory Tract DiseasesUrologic NeoplasmsUrogenital NeoplasmsFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesKidney DiseasesUrologic DiseasesMale Urogenital DiseasesUrinary Bladder DiseasesBreast DiseasesSkin DiseasesSkin and Connective Tissue DiseasesIntestinal NeoplasmsGastrointestinal NeoplasmsDigestive System NeoplasmsDigestive System DiseasesGastrointestinal DiseasesColonic DiseasesIntestinal DiseasesRectal DiseasesLiver DiseasesNeuroendocrine TumorsNeuroectodermal TumorsNeoplasms, Germ Cell and EmbryonalNeoplasms by Histologic TypeNeoplasms, Nerve TissueNevi and MelanomasSkin NeoplasmsAdenomaNeoplasms, Glandular and EpithelialNeoplasms, MesothelialLymphoproliferative DisordersLymphatic DiseasesHemic and Lymphatic DiseasesImmunoproliferative DisordersImmune System DiseasesEndocrine Gland NeoplasmsOvarian DiseasesAdnexal DiseasesGenital Diseases, FemaleGenital Neoplasms, FemaleGenital DiseasesEndocrine System DiseasesGonadal DisordersPancreatic DiseasesGenital Neoplasms, MaleGenital Diseases, MaleProstatic DiseasesStomach DiseasesThyroid Diseases

Intervention Hierarchy (Ancestors)

MacrolidesLactonesOrganic Chemicals

Study Officials

  • Ezra W Cohen, MD

    University of Chicago

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 11, 2006

First Posted

September 12, 2006

Study Start

September 1, 2006

Primary Completion

May 1, 2009

Study Completion

May 1, 2012

Last Updated

January 17, 2014

Record last verified: 2014-01

Locations

US(1)