Solid TumorsEarly Phase 1NCT00583063
Interaction Study of Rapamycin and Sunitinib in Patients With Advanced Cancers
A Early Phase 1 study testing sunitinib and rapamycin in people with Solid Tumors, run by University of Chicago at 1 site in United States.
Trial summary
Determine the pharmacokinetic interactions between rapamycin and sunitinib in patients with advanced solid tumors. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Solid Tumors
- What is being tested?
- sunitinib and rapamycin
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 23 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 2007to Apr 2008
- Phase
- Early 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
- Metastatic or unresectable cancer for which standard treatments do not exist or are no longer effective or cancers where evidence of efficacy of single agent sunitinib or single agent mTOR inhibitor has been demonstrated
- Measurable or non-measurable disease.
- No prior treatments for 4 weeks before starting study
- No ongoing toxicities from previous treatments
- 18 years or older
- Performance status 2 or better
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- Life expectancy of at least 3 months.
- Normal organ and marrow function as defined below:
- No transfusions of packed red blood cells within 1 week of starting treatment. A hemoglobin of 9.0 g/dL or greater is recommended. Patients should not be transfused for protocol participation.
- Leukocytes greater than or equal to 3,000/μL
- Absolute neutrophil count greater than or equal to 1,500/μL
- Platelets greater than or equal to 100,000/μL
- Total bilirubin less than or equal to 1.5 x ULN
- AST and ALT less than or equal to 2.5x ULN (less than or equal to 5x ULN if liver function abnormalities are due to underlying disease)
- Creatinine within normal institutional limits OR
- Creatinine clearance > 60 mL/min/1.73 m2
- PT or INR within normal institutional limits
- Serum calcium within normal institutional limits
- QTc < 500 msec.
- Patients with prior anthracycline exposure or that have received central thoracic radiation must have NYHA class I cardiac function
- Must agree to use adequate birth control
- Ability to understand and the willingness to sign a written informed consent document.
Who cannot join
- Prior treatments within 4 weeks (6 weeks for nitrosoureas or mitomycin C) of entering the study or those who have not recovered from adverse events due prior treatments
- Current treatment with other investigational agents.
- Prior therapy with a VEGFR or mTOR inhibitor
- History of allergic reactions attributed to compounds of similar chemical or biologic composition to rapamycin or sunitinib.
- QTc prolongation (QTc interval equal to or greater than 500 msec) or other significant ECG abnormalities
- Uncontrolled intercurrent illness or psychiatric illness/social situations that would limit compliance with study requirements.
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- Patients with any of the following conditions are excluded:
- Serious or non-healing wound, ulcer, or bone fracture.
- History of abdominal fistula, gastrointestinal perforation, or intra-abdominal abscess within 28 days of treatment.
- Known active infection
- Major surgery or radiation therapy within 4 weeks of starting the study treatment.
- NCI CTCAE Version 3.0 grade 3 hemorrhage within 4 weeks of starting the study treatment.
- History of CVA or transient ischemic attack within 12 months prior to study entry.
- History of myocardial infarction, cardiac arrhythmia, stable/unstable angina, symptomatic congestive heart failure, or coronary/peripheral artery bypass graft or stenting within 12 months prior to study entry.
- History of pulmonary embolism within the past 12 months.
- Class III or IV heart failure as defined by the NYHA functional classification system
- Ongoing cardiac dysrhythmias
- Poorly controlled hypertension (systolic blood pressure of 140 mmHg or higher or diastolic blood pressure of 90 mmHg or higher)
- Pre-existing thyroid abnormality with thyroid function that cannot be maintained in the normal range with medication
- History of interstitial lung disease
- Patients with severe immunodeficient states (as judged by the treating physician)
- Pregnancy or breastfeeding.
- HIV-positive patients on combination antiretroviral therapy are ineligible because of the potential for interactions with the study drugs
- Use of certain medications (as determined by the investigator)
- Other severe acute or chronic medical or psychiatric condition or laboratory abnormality that may increase the risk or interfere with the study
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Pharmacokinetic Interaction Study of Rapamycin (Sirolimus) and SU11248 (Sunitinib) in Patients With Advanced Solid Tumors
Determine the pharmacokinetic interactions between rapamycin and sunitinib in patients with advanced solid tumors.
- Conditions
- Solid Tumors
- Being tested
- sunitinib, rapamycin
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
sunitinibDrug
Also called Sutent
25 mg daily (oral dosing)
rapamycinDrug
Also called Rapamune
4 mg daily (oral dosing)
| Study group | Role | What they receive |
|---|---|---|
| A | Experimental | Sunitinib taken by mouth every day. Rapamycin (taken by mouth) will be started on Day 15 and then taken every day. Drugs can be taken until disease progression. Receives: Drug: sunitinib; Drug: rapamycin |
| B | Experimental | Rapamycin taken by mouth every day. Sunitinib (taken by mouth) will be started on Day 15 and then taken every day. Drugs can be taken until disease progression. Receives: Drug: sunitinib; Drug: rapamycin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pharmacokinetic interactions
Measured: 4 weeks
Secondary outcomes (2)
Toxicity of the combined drug regimen
Measured: 4 weeks
Response to drug regimen
Measured: 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Dec 2007 (estimated)
- Study startOct 2007
- Primary completionApr 2008
- Study completionApr 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Solid 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
- Early Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 23 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Chicago
- Sponsor type
- University, hospital or other
- Collaborators
- Pfizer
- Responsible party
- Sponsor
- Investigators
- Ezra Cohen, MD, Principal investigator, University of Chicago
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00583063
- Sponsor's protocol ID
- 15328B
- Status last verified
- Mar 2011
- First submitted
- 20 Dec 2007
- Last updated
- 12 Jun 2013
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 12 Jun 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Pharmacokinetic Interaction Study of Rapamycin (Sirolimus) and SU11248 (Sunitinib) in Patients With Advanced Solid Tumors
- ClinicalTrials.gov ID
- NCT00583063
- Acronym / sponsor ID
- 15328B
- Conditions
- Solid Tumors
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 23 participants (actual)
- Lead sponsor
- University of ChicagoUniversity, hospital or other
- Collaborators
- Pfizer
- Study start
- Oct 2007
- Primary completion
- Apr 2008 (actual)
- Study completion
- Apr 2008 (actual)
- First posted
- 31 Dec 2007 (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.
Determine the pharmacokinetic interactions between rapamycin and sunitinib in patients with advanced solid tumors.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| A | Experimental | Drug: sunitinib, Drug: rapamycinSunitinib taken by mouth every day. Rapamycin (taken by mouth) will be started on Day 15 and then taken every day. Drugs can be taken until disease progression. |
| B | Experimental | Drug: sunitinib, Drug: rapamycinRapamycin taken by mouth every day. Sunitinib (taken by mouth) will be started on Day 15 and then taken every day. Drugs can be taken until disease progression. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (22 listed)
- Metastatic or unresectable cancer for which standard treatments do not exist or are no longer effective or cancers where evidence of efficacy of single agent sunitinib or single agent mTOR inhibitor has been demonstrated
- Measurable or non-measurable disease.
- No prior treatments for 4 weeks before starting study
- No ongoing toxicities from previous treatments
- 18 years or older
Key exclusion criteria (25 listed)
- Prior treatments within 4 weeks (6 weeks for nitrosoureas or mitomycin C) of entering the study or those who have not recovered from adverse events due prior treatments
- Current treatment with other investigational agents.
- Prior therapy with a VEGFR or mTOR inhibitor
- History of allergic reactions attributed to compounds of similar chemical or biologic composition to rapamycin or sunitinib.
- QTc prolongation (QTc interval equal to or greater than 500 msec) or other significant ECG abnormalities
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 |
|---|---|---|
| sunitinibAlso: Sutent25 mg daily (oral dosing) | Drug | A, B |
| rapamycinAlso: Rapamune4 mg daily (oral dosing) | Drug | A, B |
Primary outcome
Pharmacokinetic interactions
Time frame: 4 weeks
2 secondary outcomes
Toxicity of the combined drug regimen
Time frame: 4 weeks
Response to drug regimen
Time frame: 8 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 12 Jun 2013.
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A Study to Assess Safety, Tolerability, and Pharmacokinetics of ABSK043 in Patients With Advanced Solid Tumor
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A Safety and Efficacy Extension Study of Pertuzumab in Patients With Solid Tumors Previously Enrolled in a Hoffmann-La Roche-Sponsored Pertuzumab Clinical Trial
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IL-12 Genetically Engineered Myeloid Cells in Participants With Relapsed, Refractory Solid Tumors
Relapsed Solid Tumor Malignancies, Refractory Solid Tumor Malignancies
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Immune Checkpoint Inhibitor Toxicity Risk Prediction in Solid Tumors
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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 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 Early Phase 1 study testing sunitinib and rapamycin in people with Solid Tumors, 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 22 inclusion and 25 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 12 Jun 2013. 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?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
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 interactions (time frame: 4 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 12 Jun 2013.