Advanced CancerPhase 1NCT00667485
Rapamycin Plus Bevacizumab in Advanced Cancers
A Phase 1 study testing Rapamycin (liquid), Bevacizumab and Rapamycin (Tablets) in people with Advanced Cancer and Metastatic Cancer, run by University of Chicago at 1 site in United States.
Trial summary
The goal of this trial is to determine the toxicity and maximum dose of rapamycin and bevacizumab given together to subjects with advanced cancers. This study will also look at the pharmacokinetics and antitumor activity of the combination. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Advanced Cancer, Metastatic Cancer
- What is being tested?
- Rapamycin (liquid), Bevacizumab and Rapamycin (Tablets)
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 28 participants
- Where
- 1 siteUnited States
- Study dates
- Apr 2008to 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
- Metastatic or unresectable solid tumor for which standard treatments do not exist or are no longer effective
- Performance status of 0-1
- Measurable or non-measurable disease
- Life expectancy of at least 12 weeks
- No anticipated need of other cancer treatments within the next 4 weeks
- 18 years or older
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- Negative pregnancy test for women able to have children, agreement to use a medically accepted birth control method while receiving the study drugs and for at least 2 weeks after stopping, not breast feeding
- Ability to understand and willingness to sign a written informed consent document
- No evidence of bleeding diathesis
- Patients without lung cancer receiving anti-coagulation treatment can participate
- Adequate organ and marrow function:
- ALT and AST less than or equal to 2.5 times the institutional ULN (less than 5 times for patients with liver involvement)
- hemoglobin at least 9g/dL
- absolute neutrophil count at least 1,500/µL
- platelets at least 100,000/µL
- total bilirubin less than or equal to 1.5 times the institutional ULN
- creatinine less than or equal to 1.5 times the institutional ULN
Who cannot join
- Prior treatment with both bevacizumab and an mTOR inhibitor is not allowed. Prior treatment with both bevacizumab OR mTOR inhibitor (including rapamycin) is allowed. Patients who had a grade 3 or greater side effect with either bevacizumab or an mTOR inhibitor cannot take part in this study.
- Chemotherapy or Immunotherapy within the 4 weeks of study start
- Radiotherapy within 14 days of study start
- Cannot be receiving any other investigational drugs or any other cancer treatments while on study (with the exception of androgen ablating agents for patients with prostate cancer).
- Patients with squamous non-small cell lung cancer (NSCLC)
- Patients with lung cancer or lung metastases:
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- on full dose anticoagulation
- taking 325mg aspirin per day
- on non-steroidal anti-inflammatory agents
- HIV positive patients receiving combination anti-retroviral therapy are excluded due to potential for serious infections while taking marrow suppressing agents
- Ongoing illness or medical exclusions, including but not limited to:
- active or ongoing infection
- symptomatic congestive heart failure
- uncontrolled hypertension despite optimal medical management
- cardiac arrhythmia except paroxysmal atrial fibrillation
- psychiatric illness/social situations that would limit compliance with study requirements
- history of organ allograft, bone marrow or peripheral blood stem cell transplant
- known or suspect allergy to bevacizumab or rapamycin
- seizure disorder treated with steroid or anticonvulsant therapy
- thrombotic or embolic events within 6 months of starting study
- pulmonary hemorrhage/bleeding within 12 weeks of starting study (grade 3 event within 4 weeks of first dose of drug). Patients with a history of pulmonary hemorrhage/bleeding cannot be on full dose anticoagulation.
- pulmonary fibrosis or interstitial lung disease
- serious non-healing wound, ulcer or bone fracture
- Major surgery, open biopsy or a traumatic injury within 4 weeks of starting study drug
- anticipated need for major surgery while on-study
- current use of any herbal supplements or rifampin (rifampicin)
- prior history of hypertensive crisis or hypertensive encephalopathy
- history of myocardial infarction or unstable angina within 6 months of starting study
- known CNS disease
- significant vascular disease
- symptomatic peripheral vascular disease
- evidence of bleeding diathesis or coagulopathy
- core biopsy or other minor surgical procedure (except placement of vascular access device) within 7 days of starting study
- history of abdominal fistula, gastrointestinal perforation, or intra-abdominal abscess within 6 months of study start
- proteinuria at screening
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Phase I Study of Rapamycin (Sirolimus) With Bevacizumab in Patients With Advanced Malignancies
The goal of this trial is to determine the toxicity and maximum dose of rapamycin and bevacizumab given together to subjects with advanced cancers. This study will also look at the pharmacokinetics and antitumor activity of the combination.
- Conditions
- Advanced Cancer, Metastatic Cancer
- Being tested
- Rapamycin (liquid), Bevacizumab, Rapamycin (Tablets)
- Medical subject headings
- Neoplasm Metastasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Rapamycin (liquid)Drug
Also called sirolimus, Rapamune
Weekly Rapamycin (liquid) 90mg (dose will be split 45mg on Day 1 and Day 2 of each week)
BevacizumabDrug
Also called Avastin
Multiple doses (dose depends on time of study entry) given by IV once every 3 weeks
Rapamycin (Tablets)Drug
Also called sirolimus, Rapamune
Daily oral rapamycin (tablets) - 2 doses will be tested 4mg and 6mg
| Study group | Role | What they receive |
|---|---|---|
| Weekly Rapamcyin | Experimental | Rapamycin (liquid) taken weekly and Bevacizumab (IV infusion ) once every 3 weeks Receives: Drug: Rapamycin (liquid); Drug: Bevacizumab |
| Daily Rapamycin | Experimental | Daily oral rapamycin (tablets) and Bevacizumab (IV infusion)once every 3 weeks Receives: Drug: Bevacizumab; Drug: Rapamycin (Tablets) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Toxicity
Measured: 3 weeks
Secondary outcomes (2)
Response
Measured: 6 weeks
Pharmacokinetics
Measured: 3 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Apr 2008 (estimated)
- Study startApr 2008
- Primary completionMay 2012
- Study completionMay 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Advanced CancerStudies 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
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 28 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Chicago
- Sponsor type
- University, hospital or other
- Collaborators
- Genentech, Inc.
- Responsible party
- Sponsor
- Investigators
- Ezra Cohen, MD, Principal investigator, University of Chicago
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00667485
- Sponsor's protocol ID
- 15878B
- Other IDs
- AVF4180s
- Status last verified
- Jan 2014
- First submitted
- 24 Apr 2008
- Last updated
- 17 Jan 2014
- Results posted
- No
- Data monitoring committee
- Yes
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 I Study of Rapamycin (Sirolimus) With Bevacizumab in Patients With Advanced Malignancies
- ClinicalTrials.gov ID
- NCT00667485
- Acronym / sponsor ID
- 15878B
- Conditions
- Advanced Cancer, Metastatic Cancer
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 28 participants (actual)
- Lead sponsor
- University of ChicagoUniversity, hospital or other
- Collaborators
- Genentech, Inc.
- Study start
- Apr 2008
- Primary completion
- May 2012 (actual)
- Study completion
- May 2012 (actual)
- First posted
- 28 Apr 2008 (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 goal of this trial is to determine the toxicity and maximum dose of rapamycin and bevacizumab given together to subjects with advanced cancers. This study will also look at the pharmacokinetics and antitumor activity of the combination.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Weekly Rapamcyin | Experimental | Drug: Rapamycin (liquid), Drug: BevacizumabRapamycin (liquid) taken weekly and Bevacizumab (IV infusion ) once every 3 weeks |
| Daily Rapamycin | Experimental | Drug: Bevacizumab, Drug: Rapamycin (Tablets)Daily oral rapamycin (tablets) and Bevacizumab (IV infusion)once every 3 weeks |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (17 listed)
- Metastatic or unresectable solid tumor for which standard treatments do not exist or are no longer effective
- Performance status of 0-1
- Measurable or non-measurable disease
- Life expectancy of at least 12 weeks
- No anticipated need of other cancer treatments within the next 4 weeks
Key exclusion criteria (35 listed)
- Prior treatment with both bevacizumab and an mTOR inhibitor is not allowed. Prior treatment with both bevacizumab OR mTOR inhibitor (including rapamycin) is allowed. Patients who had a grade 3 or greater side effect with either bevacizumab or an mTOR inhibitor cannot take part in this study.
- Chemotherapy or Immunotherapy within the 4 weeks of study start
- Radiotherapy within 14 days of study start
- Cannot be receiving any other investigational drugs or any other cancer treatments while on study (with the exception of androgen ablating agents for patients with prostate cancer).
- Patients with squamous non-small cell lung cancer (NSCLC)
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 (liquid)Also: sirolimus, RapamuneWeekly Rapamycin (liquid) 90mg (dose will be split 45mg on Day 1 and Day 2 of each week) | Drug | Weekly Rapamcyin |
| BevacizumabAlso: AvastinMultiple doses (dose depends on time of study entry) given by IV once every 3 weeks | Drug | Daily Rapamycin, Weekly Rapamcyin |
| Rapamycin (Tablets)Also: sirolimus, RapamuneDaily oral rapamycin (tablets) - 2 doses will be tested 4mg and 6mg | Drug | Daily Rapamycin |
Primary outcome
Toxicity
Time frame: 3 weeks
2 secondary outcomes
Response
Time frame: 6 weeks
Pharmacokinetics
Time frame: 3 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.
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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 Phase 1 study testing Rapamycin (liquid), Bevacizumab and Rapamycin (Tablets) in people with Advanced Cancer and Metastatic Cancer, 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 17 inclusion and 35 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?
Toxicity (time frame: 3 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 17 Jan 2014.