SarcomaPhase 1NCT00927966
RAD001 in Combination With CP-751,871 in Patients Wtih Advanced Sarcomas and Other Malignant Neoplasms
A Phase 1 study testing RAD001 and CP-751,871 in people with Sarcoma and Solid Tumor, run by Suzanne George, MD at 1 site in United States.
Trial summary
The purpose of this research study is to determine the safety of the combination of RAD001 and CP-751,871, as well as the highest dose of this combination that can be given to people safely. RAD001 is a newly discovered drug that may stop cancer cells from growing abnormally. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Sarcoma, Solid Tumor
- What is being tested?
- RAD001 and CP-751,871
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 21 participants
- Where
- 1 siteUnited States
- Study dates
- Jul 2009to Jan 2011
- 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 advanced sarcoma or other advanced malignant solid tumor for which no known curative therapy exists. Patients must have had prior progression on, intolerance or refused approved standard therapies proven to prolong life.
- Measurable disease per RECIST. A lesion in a previously irradiated area is eligible to be considered as measurable disease as long as there is objective evidence of progression of the lesion prior to study enrollment
- 18 years of age or older
- ECOG Performance Status 0-1
- Participants must have normal organ and marrow function as outlined in the protocol
- Fully recovered from the acute effects of prior cancer therapy before initiation of study drug
- Negative urine or serum pregnancy test within 7 days prior to initiation of study drug for women of child-bearing potential
- Women of child-bearing potential and men must agree to use adequate contraception prior to study entry and for up to 6 months after the last dose of study drug
Who cannot join
- Participants with gastrointestinal tumors (GIST) on approved tyrosine kinase inhibitors within 2 weeks prior to study entry
- All other participants who have had systemic anti-cancer therapy within 3 weeks (8 weeks for nitrosoureas or mitomycin C) prior to study entry
- Participants who have had radiotherapy and/or major surgery within 2 weeks prior to study entry
- Concurrent use of any other anti-cancer therapies, study agents, growth hormones, growth hormone inhibitors or aminoglycoside antibiotics
- Participants who have had chronic high dose immunosuppressive steroid therapy within 2 weeks prior to enrollment. Previous high dose steroid treatment > 2 weeks prior to study entry, topical and inhaled corticosteroids are allowed
- Presence of symptomatic or uncontrolled brain or central nervous system metastases
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- History of allergic reactions attributed to compounds of similar chemical or biologic composition to RAD001 and/or CP-751,871
- Participants receiving any medications or substances that are inhibitors or inducers of CYP3A
- Uncontrolled diabetes
- Bleeding diathesis or requirement for therapeutic anticoagulation
- Uncontrolled intercurrent illness
- Pregnant or nursing women
- HIV positive individuals on combination anti-retroviral therapy
Trial locations and contacts
1 site in 1 country.
United States1 site
Dana-Farber Cancer Institute
Boston, Massachusetts, 02115
About this study
Official title: Phase I Clinical Trial of RAD001 in Combination With CP-751,871 in Patients With Advanced Sarcomas and Other Malignant Neoplasms
The purpose of this research study is to determine the safety of the combination of RAD001 and CP-751,871, as well as the highest dose of this combination that can be given to people safely. RAD001 is a newly discovered drug that may stop cancer cells from growing abnormally. This drug has been extensively studied in many cancers. In particular, it has shown to be effective in slowing down the growth of kidney cancer. CP-751,871 is another newly discovered drug that may stop tumor growth. It is currently being studied in a wide variety of cancers, and information from those other research studies suggests that these two drugs in combination may help to stop cancer growth.
Read the detailed description
- In this research study, each "cycle" of study drug dosing lasts 21 days. In the first cycle, participants will come to the clinic on Days 1, 8, and 15. During cycles 2 through 4, participants will come to the clinic on Days 1 and 8. The rest of the clinic visits will occur on Day 1 of every cycle thereafter.
- During each cycle, participants will take RAD001 orally, once a day in the morning. In addition, participants will receive CP-751,871 intravenously once every cycle on the first day of each cycle.
- Since we are looking for the highest dose of the study drug that can be administered safely without severe or unmanageable side effects, not everyone who participates in this research study will receive the same dose of the study drug. The dose will depend on the number of participants enrolled in the study and how well they tolerated their doses.
- Participants may remain on this research study as long as they do not have serious side effects or their diseae does not get worse.
- Conditions
- Sarcoma, Solid Tumor
- Being tested
- RAD001, CP-751,871
- Keywords
- RAD001, CP-751,871, advanced sarcoma, advanced malignant solid tumor
- Medical subject headings
- Sarcoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RAD001Drug
Taken orally once a day.
CP-751,871Drug
Given intravenously on Day 1 of a 21-day cycle
| Study group | Role | What they receive |
|---|---|---|
| RAD001 in combination with figitumumab | Experimental | Not described Receives: Drug: RAD001; Drug: CP-751,871 |
What is being measured
The primary outcome is the main question the study is designed to answer.
To assess the safety and tolerability of daily oral RAD001, administered in combination with CP-751,871 given as an intravenous infusion in patients with advanced sarcomas and other advanced solid tumors that are incurable with any current modality.
Measured: 3 years
Secondary outcomes (2)
To assess the pharmacokinetics of this combination regimen.
Measured: 3 years
To allow a preliminary assessment of the anti-tumor effects of this novel drug combination.
Measured: 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jun 2009 (estimated)
- Study startJul 2009
- Primary completionJan 2011
- Study completionJan 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SarcomaStudies of the same condition, open and under way.
- 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
- 21 participants (actual)
Sponsor and investigators
- Lead sponsor
- Suzanne George, MD
- Sponsor type
- University, hospital or other
- Collaborators
- Brigham and Women's Hospital, Novartis, Pfizer
- Responsible party
- Sponsor-investigator, Suzanne George, MD, Dana-Farber Cancer Institute
- Investigators
- Suzanne George, MD, Principal investigator, Dana-Farber Cancer Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00927966
- Sponsor's protocol ID
- 09-091
- Status last verified
- Nov 2013
- First submitted
- 24 Jun 2009
- Last updated
- 14 Nov 2013
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 14 Nov 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase I Clinical Trial of RAD001 in Combination With CP-751,871 in Patients With Advanced Sarcomas and Other Malignant Neoplasms
- ClinicalTrials.gov ID
- NCT00927966
- Acronym / sponsor ID
- 09-091
- Conditions
- Sarcoma, Solid Tumor
- Keywords
- RAD001, CP-751,871, advanced sarcoma, advanced malignant solid tumor
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 21 participants (actual)
- Lead sponsor
- Suzanne George, MDUniversity, hospital or other
- Collaborators
- Brigham and Women's Hospital, Novartis, Pfizer
- Study start
- Jul 2009
- Primary completion
- Jan 2011 (actual)
- Study completion
- Jan 2011 (actual)
- First posted
- 25 Jun 2009 (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 research study is to determine the safety of the combination of RAD001 and CP-751,871, as well as the highest dose of this combination that can be given to people safely. RAD001 is a newly discovered drug that may stop cancer cells from growing abnormally. This drug has been extensively studied in many cancers. In particular, it has shown to be effective in slowing down the growth of kidney cancer. CP-751,871 is another newly discovered drug that may stop tumor growth. It is currently being studied in a wide variety of cancers, and information from those other research studies suggests that these two drugs in combination may help to stop cancer growth.
Detailed description
- In this research study, each "cycle" of study drug dosing lasts 21 days. In the first cycle, participants will come to the clinic on Days 1, 8, and 15. During cycles 2 through 4, participants will come to the clinic on Days 1 and 8. The rest of the clinic visits will occur on Day 1 of every cycle thereafter.
- During each cycle, participants will take RAD001 orally, once a day in the morning. In addition, participants will receive CP-751,871 intravenously once every cycle on the first day of each cycle.
- Since we are looking for the highest dose of the study drug that can be administered safely without severe or unmanageable side effects, not everyone who participates in this research study will receive the same dose of the study drug. The dose will depend on the number of participants enrolled in the study and how well they tolerated their doses.
- Participants may remain on this research study as long as they do not have serious side effects or their diseae does not get worse.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| RAD001 in combination with figitumumab | Experimental | Drug: RAD001, Drug: CP-751,871 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Histologically confirmed advanced sarcoma or other advanced malignant solid tumor for which no known curative therapy exists. Patients must have had prior progression on, intolerance or refused approved standard therapies proven to prolong life.
- Measurable disease per RECIST. A lesion in a previously irradiated area is eligible to be considered as measurable disease as long as there is objective evidence of progression of the lesion prior to study enrollment
- 18 years of age or older
- ECOG Performance Status 0-1
- Participants must have normal organ and marrow function as outlined in the protocol
Key exclusion criteria (13 listed)
- Participants with gastrointestinal tumors (GIST) on approved tyrosine kinase inhibitors within 2 weeks prior to study entry
- All other participants who have had systemic anti-cancer therapy within 3 weeks (8 weeks for nitrosoureas or mitomycin C) prior to study entry
- Participants who have had radiotherapy and/or major surgery within 2 weeks prior to study entry
- Concurrent use of any other anti-cancer therapies, study agents, growth hormones, growth hormone inhibitors or aminoglycoside antibiotics
- Participants who have had chronic high dose immunosuppressive steroid therapy within 2 weeks prior to enrollment. Previous high dose steroid treatment > 2 weeks prior to study entry, topical and inhaled corticosteroids are allowed
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 |
|---|---|---|
| RAD001Taken orally once a day. | Drug | RAD001 in combination with figitumumab |
| CP-751,871Given intravenously on Day 1 of a 21-day cycle | Drug | RAD001 in combination with figitumumab |
Primary outcome
To assess the safety and tolerability of daily oral RAD001, administered in combination with CP-751,871 given as an intravenous infusion in patients with advanced sarcomas and other advanced solid tumors that are incurable with any current modality.
Time frame: 3 years
2 secondary outcomes
To assess the pharmacokinetics of this combination regimen.
Time frame: 3 years
To allow a preliminary assessment of the anti-tumor effects of this novel drug combination.
Time frame: 3 years
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 14 Nov 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.
Suzanne George, MD principal investigator
Dana-Farber Cancer Institute
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 RAD001 and CP-751,871 in people with Sarcoma and Solid Tumor, run by Suzanne George, MD 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 8 inclusion and 13 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 14 Nov 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?
To assess the safety and tolerability of daily oral RAD001, administered in combination with CP-751,871 given as an intravenous infusion in patients with advanced sarcomas and other advanced solid tumors that are incurable with any current modality. (time frame: 3 years). 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 14 Nov 2013.