TumorsPhase 1NCT00375245
Rapamycin With Grapefruit Juice for Advanced Malignancies
A Phase 1 study testing Rapamycin (sirolimus) and Grapefruit Juice in people with Tumors and Neoplasm Metastasis, run by University of Chicago at 1 site in United States.
Trial summary
The purpose of this study is to determine the highest safe dose of rapamycin when given with a fixed amount of grapefruit juice. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Tumors, Neoplasm Metastasis
- What is being tested?
- Rapamycin (sirolimus) and Grapefruit Juice
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 41 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2006to May 2012
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
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- 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
- AST (SGOT) and ALT (SGPT) less than or equal to 2.5 times institutional upper limit of normal
- Serum triglycerides less than or equal to 500 mg/dl
- Creatinine within normal institutional limits OR creatinine clearance greater or equal to 60 mL/min for patients with creatinine levels above institutional normal
- Women of childbearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence)
- Ability to understand and the willingness to sign a written informed consent document.
Who cannot join
- 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
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- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Chicago Hospitals
Chicago, Illinois, 60637
About this study
Official title: A Phase Ib Study Administering Rapamycin (Sirolimus) With Grapefruit Juice in Patients With Advanced Malignancies
The purpose of this study is to determine the highest safe dose of rapamycin when given with a fixed amount of grapefruit juice.
- Conditions
- Tumors, Neoplasm Metastasis
- Being tested
- Rapamycin (sirolimus), Grapefruit Juice
- Keywords
- phase I, metastatic, advanced cancer, lung cancer, renal cancer, kidney cancer, head and neck cancer, bladder cancer, breast cancer, colorectal cancer, esophagus, GIST, liver cancer, melanoma, mesothelioma, lymphoma, ovary cancer, ovarian cancer, pancreas cancer, pancreatic cancer
- Medical subject headings
- Neoplasms, Neoplasm Metastasis, Lung Neoplasms, Kidney Neoplasms, Head and Neck Neoplasms, Urinary Bladder Neoplasms, Breast Neoplasms, Colorectal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Rapamycin (sirolimus)Drug
Also called Rapamune
Weekly oral doses, dose is assigned at the time of study entry
Grapefruit JuiceOther
Daily oral doses starting during the second week on study.
| Study group | Role | What they receive |
|---|---|---|
| Rapamycin + Grapefruit juice | Experimental | Not described Receives: Drug: Rapamycin (sirolimus); Other: Grapefruit Juice |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pharmacokinetic interaction
Measured: 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Sep 2006 (estimated)
- Study startSep 2006
- Primary completionMay 2009
- Study completionMay 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for TumorsStudies of the same condition, open and under way.
- More trials run by University of ChicagoThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 41 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Chicago
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Ezra W Cohen, MD, Principal investigator, University of Chicago
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00375245
- Sponsor's protocol ID
- 14435B
- Status last verified
- Jan 2014
- First submitted
- 11 Sep 2006
- Last updated
- 17 Jan 2014
- Results posted
- No
- Data monitoring committee
- Yes
Publications
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.
PubMed 19192962
Study at a glance
From the registry record, last updated by the sponsor on 17 Jan 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase Ib Study Administering Rapamycin (Sirolimus) With Grapefruit Juice in Patients With Advanced Malignancies
- ClinicalTrials.gov ID
- NCT00375245
- Acronym / sponsor ID
- 14435B
- Conditions
- Tumors, Neoplasm Metastasis
- Keywords
- phase I, metastatic, advanced cancer, lung cancer, renal cancer, kidney cancer, head and neck cancer, bladder cancer
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 41 participants (actual)
- Lead sponsor
- University of ChicagoUniversity, hospital or other
- Study start
- Sep 2006
- Primary completion
- May 2009 (actual)
- Study completion
- May 2012 (actual)
- First posted
- 12 Sep 2006 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to determine the highest safe dose of rapamycin when given with a fixed amount of grapefruit juice.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Rapamycin + Grapefruit juice | Experimental | Drug: Rapamycin (sirolimus), Other: Grapefruit Juice |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (20 listed)
- 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
Key exclusion criteria (10 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Rapamycin (sirolimus)Also: RapamuneWeekly oral doses, dose is assigned at the time of study entry | Drug | Rapamycin + Grapefruit juice |
| Grapefruit JuiceDaily oral doses starting during the second week on study. | Other | Rapamycin + Grapefruit juice |
Primary outcome
Pharmacokinetic interaction
Time frame: 4 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Jan 2014.
- Derived from this study: PubMed 19192962Treiber 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ezra W Cohen, MD principal investigator
University of Chicago
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Rapamycin (sirolimus) and Grapefruit Juice in people with Tumors and Neoplasm Metastasis, run by University of Chicago at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 20 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 17 Jan 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pharmacokinetic interaction (time frame: 4 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00375245, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Jan 2014.