Advanced Solid TumorPhase 1NCT00449280
Drug Interaction Study of Sorafenib and Rapamycin in Advanced Malignancies
A Phase 1 study testing Sorafenib and Rapamycin in people with Advanced Solid Tumor, run by University of Chicago at 1 site in United States.
Trial summary
The goal of this study is to determine whether a significant pharmacokinetic interaction exists between rapamycin and sorafenib. This study will also look at the toxicity of the combination of rapamycin and sorafenib and the antitumor activity of the combination in subjects with advanced cancers. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Advanced Solid Tumor
- What is being tested?
- Sorafenib and Rapamycin
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 34 participants
- Where
- 1 siteUnited States
- Study dates
- Nov 2006to Sep 2009
- 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
- Solid cancer for which curative measures have failed or for which there is no known superior treatment
- ECOG performance status 0-2
- Measurable or non-measurable disease
- Life expectancy of greater than 12 weeks and no anticipated need for other antineoplastic therapy in the next 4 weeks
- Age 18 years or older
- Patients must have adequate organ and marrow function as defined below:
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- ALT and AST less than or equal to 2.5 x the ULN (< 5 x ULN for patients with liver involvement).
- hemoglobin greater than or equal to 9 g/dL
- absolute neutrophil count greater than or equal to 1,500/μL
- platelets greater than or equal to 100,000/μL (greater than or equal to 35,000/μL without transfusion for patients with CLL/SLL or follicular lymphoma)
- total bilirubin less than or equal to 1.5 x ULN
- creatinine less than or equal to 1.5 x ULN
- Women of childbearing potential must have a negative pregnancy test within 7 days of the start of treatment.
- Ability to understand and the willingness to sign a written informed consent document
- Must not have any evidence of bleeding diathesis.
Who cannot join
- Patients who have had chemotherapy or immunotherapy within 3 weeks or radiotherapy within 14 days prior to entering the study
- Patients may not be receiving any other investigational agents or any concomitant antineoplastic therapy
- Patients with uncontrolled brain metastases.
- Concurrent illness or medication exclusions
- HIV-positive patients receiving combination anti-retroviral therapy are excluded from the study because of possible pharmacokinetic interactions with sorafenib or rapamycin.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Drug Interaction Study of Sorafenib (BAY 43-9006 Tosylate) and Rapamycin in Patients With Advanced Malignancies
The goal of this study is to determine whether a significant pharmacokinetic interaction exists between rapamycin and sorafenib.
This study will also look at the toxicity of the combination of rapamycin and sorafenib and the antitumor activity of the combination in subjects with advanced cancers.
- Conditions
- Advanced Solid Tumor
- Being tested
- Sorafenib, Rapamycin
- Keywords
- metastatic, advanced disease, phase I
- Medical subject headings
- Neoplasm Metastasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SorafenibDrug
Also called Nexavar
400mg BID (200 mg twice daily)
RapamycinDrug
Also called Rapamune
30mg once weekly
RapamycinDrug
Also called Rapamune
3mg once daily
| Study group | Role | What they receive |
|---|---|---|
| A | Experimental | Sorafenib two times a day every day for 28 days. Beginning on Day 15 (Week 2), rapamycin will be taken once a week until the end of the cycle (Day 28). After Day 28, weekly rapamycin and daily sorafenib will continue until disease progression or serious side effects are experienced. Receives: Drug: Sorafenib; Drug: Rapamycin |
| B | Experimental | Sorafenib two times a day every day for 28 days. Beginning on Day 15 (Week 2), rapamycin will be taken every day until the end of the cycle (Day 28). After Day 28, rapamycin and sorafenib can continue to be taken daily until the cancer gets worse or serious side effects are experienced. Receives: Drug: Sorafenib; Drug: Rapamycin |
| C | Experimental | Rapamycin once a week starting on Day 1. Beginning on Day 15 (Week 2), sorafenib will be taken twice a day every day until the end of the cycle (Day 28). After Day 28, weekly rapamycin and daily sorafenib will continue until disease progression or serious side effects are experienced. Receives: Drug: Sorafenib; Drug: Rapamycin |
| D | Experimental | Rapamycin every day beginning on Day 1. Starting on Day 15 (Week 2), sorafenib will be taken twice a day every day until the end of the cycle (Day 28). After Day 28, rapamycin and sorafenib can continue to be taken daily until the cancer gets worse or serious side effects are experienced. Receives: Drug: Sorafenib; 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 (1)
Response Rate
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 posted20 Mar 2007 (estimated)
- Study startNov 2006
- Primary completionJun 2009
- Study completionSep 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Advanced Solid TumorStudies 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 34 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Chicago
- Sponsor type
- University, hospital or other
- Collaborators
- Bayer
- Responsible party
- Sponsor
- Investigators
- Ezra Cohen, MD, Principal investigator, University of Chicago
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00449280
- Sponsor's protocol ID
- 14908B
- Status last verified
- Jun 2013
- First submitted
- 16 Mar 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 Drug Interaction Study of Sorafenib (BAY 43-9006 Tosylate) and Rapamycin in Patients With Advanced Malignancies
- ClinicalTrials.gov ID
- NCT00449280
- Acronym / sponsor ID
- 14908B
- Conditions
- Advanced Solid Tumor
- Keywords
- metastatic, advanced disease, phase I
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 34 participants (actual)
- Lead sponsor
- University of ChicagoUniversity, hospital or other
- Collaborators
- Bayer
- Study start
- Nov 2006
- Primary completion
- Jun 2009 (actual)
- Study completion
- Sep 2009 (actual)
- First posted
- 20 Mar 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.
The goal of this study is to determine whether a significant pharmacokinetic interaction exists between rapamycin and sorafenib.
This study will also look at the toxicity of the combination of rapamycin and sorafenib and the antitumor activity of the combination in subjects with advanced cancers.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| A | Experimental | Drug: Sorafenib, Drug: RapamycinSorafenib two times a day every day for 28 days. Beginning on Day 15 (Week 2), rapamycin will be taken once a week until the end of the cycle (Day 28). After Day 28, weekly rapamycin and daily sorafenib will continue until disease progression or serious side effects are experienced. |
| B | Experimental | Drug: Sorafenib, Drug: RapamycinSorafenib two times a day every day for 28 days. Beginning on Day 15 (Week 2), rapamycin will be taken every day until the end of the cycle (Day 28). After Day 28, rapamycin and sorafenib can continue to be taken daily until the cancer gets worse or serious side effects are experienced. |
| C | Experimental | Drug: Sorafenib, Drug: RapamycinRapamycin once a week starting on Day 1. Beginning on Day 15 (Week 2), sorafenib will be taken twice a day every day until the end of the cycle (Day 28). After Day 28, weekly rapamycin and daily sorafenib will continue until disease progression or serious side effects are experienced. |
| D | Experimental | Drug: Sorafenib, Drug: RapamycinRapamycin every day beginning on Day 1. Starting on Day 15 (Week 2), sorafenib will be taken twice a day every day until the end of the cycle (Day 28). After Day 28, rapamycin and sorafenib can continue to be taken daily until the cancer gets worse or serious side effects are experienced. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (15 listed)
- Solid cancer for which curative measures have failed or for which there is no known superior treatment
- ECOG performance status 0-2
- Measurable or non-measurable disease
- Life expectancy of greater than 12 weeks and no anticipated need for other antineoplastic therapy in the next 4 weeks
- Age 18 years or older
Key exclusion criteria (5 listed)
- Patients who have had chemotherapy or immunotherapy within 3 weeks or radiotherapy within 14 days prior to entering the study
- Patients may not be receiving any other investigational agents or any concomitant antineoplastic therapy
- Patients with uncontrolled brain metastases.
- Concurrent illness or medication exclusions
- HIV-positive patients receiving combination anti-retroviral therapy are excluded from the study because of possible pharmacokinetic interactions with sorafenib or rapamycin.
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 |
|---|---|---|
| SorafenibAlso: Nexavar400mg BID (200 mg twice daily) | Drug | A, B, C, D |
| RapamycinAlso: Rapamune30mg once weekly | Drug | A, C |
| RapamycinAlso: Rapamune3mg once daily | Drug | B, D |
Primary outcome
Pharmacokinetic interactions
Time frame: 4 weeks
1 secondary outcome
Response Rate
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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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 Sorafenib and Rapamycin in people with Advanced Solid Tumor, 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 15 inclusion and 5 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?
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 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.