Advanced CancersPhase 1/2NCT00877773
Phosphatidylinositol 3 Kinase and Mammalian Target of Rapamycin (PI3K-mTOR) in Advanced Cancer Patients
A Phase 1/2 study testing Temsirolimus in people with Advanced Cancers, run by M.D. Anderson Cancer Center at 1 site in United States.
Trial summary
The goal of this clinical research study is to learn if temsirolimus can help to control advanced cancer in patients who also have a PI3K mutation and/or PTEN loss. The safety of this drug will also be tested. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Advanced Cancers
- What is being tested?
- Temsirolimus
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 44 participants
- Where
- 1 siteUnited States
- Study dates
- Apr 2009to Jun 2014
- Phase
- Phase 1/2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Patients with pathologically confirmed advanced or metastatic cancer that is refractory to standard therapy, relapsed after standard therapy, or has no standard therapy that improves survival by at least 3 months (unless temsirolimus is indicated as standard treatment for that disease).
- Patients must have evaluable tumor(s) with documented PIK3 mutation and/or PTEN loss.
- Patients must have creatinine </= 3 X upper limit of normal (ULN); absolute neutrophil count >/= 1,000/mL; platelets >/= 50,000; bilirubin </= 3.0 gm/dL. Except for patients with liver metastases: total bilirubin </= 5 ULN.
- Women of childbearing potential must have a negative baseline blood pregnancy test. Women and men must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) for the duration of study.
- Patients must be off other anti-tumor agents for at least 5 half lives of the agent or 4 wks from the last day of treatment, whichever is shorter. For cytotoxic therapies, patients should be off treatment for 3 or more weeks.
- Patients may not be receiving any other experimental agents that are not FDA approved.
- Ability to understand and willingness to sign a written consent document.
- Treatment on this study may begin within 24 hours after Phase 0 dose of Temsirolimus.
Who cannot join
- Pregnant or lactating women.
- Patients with creatinine clearance <10 mL/min
- Patients with a known hypersensitivity to any of the components or metabolites of the drug products.
- Patients with major surgery within 30 days prior to entering study.
- Patients on inhibitors or inducers of CYP3A4 metabolism will have the inhibitors or inducers stopped unless clinically contraindicated. See section 6 (Concomitant Medications) and Appendix E of the protocol for details.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Histology-Independent Study of the mTOR Inhibitor, Temsirolimus, in Patients With Advanced Cancer
The goal of this clinical research study is to learn if temsirolimus can help to control advanced cancer in patients who also have a PI3K mutation and/or PTEN loss. The safety of this drug will also be tested.
Read the detailed description
The Study Drug:
Temsirolimus is designed to block the growth of cancer cells, which may cause the cancer cells to die.
Study Drug Administration:
If you are found to be eligible to take part in this study, you will receive temsirolimus through a needle in your vein on Days 1, 8, 15, and 22 of each 4-week study cycle. On Day 1 of Cycle 1, the study drug will be given over 60 minutes. If you tolerate the study drug well on Day 1 of Cycle 1, it will be given over 30 minutes at all other scheduled administration dates as long as you still tolerate it well. If the dose is not well tolerated, the dose will be reduced for future study visits.
You will receive Benadryl (diphenhydramine) or a similar drug by vein to help prevent side effects about 30 minutes before you receive the study drug.
Study Visits:
One (1) time each week (on each day that the study drug is being given), the following tests and procedures will be performed:
- Your weight and vital signs will be measured.
- You will be asked about any drugs you may be taking and about any side effects you may be having.
- Blood (about 2 teaspoons each time) will be drawn for pharmacodynamic (PD) testing. PD testing measures how the level of study drug in your body may affect the disease. This blood will be drawn at the following times:
At 8 hours (+/- 3 hours) after the dose At 24 hours (+/- 3 hours) after the dose At 72 hours (+/- 24 hours) after the dose
Every 2 weeks, blood (about 2 teaspoons) will be drawn for routine tests.
Every 4 weeks, you will have a physical exam; women who are able to become pregnant will also have a blood (about 1 teaspoon) pregnancy test.
Every 8 weeks, you will have a CT scan, MRI scan, and/or PET/CT scan to check the status of the disease.
Length of Study:
You will be on study for as long as you are benefiting or the disease is stable. You will be taken off study if the disease gets worse, you have intolerable side effects, or the study doctor thinks it is in your best interest.
End-of-Study Visit:
After you have finished taking the study drug, the following tests and procedures will be performed:
- You will have a physical exam, including measurement of your weight and vital signs.
- You will be asked about any drugs you may be taking and about any side effects you may be having.
This is an investigational study. Temsirolimus is FDA-approved and commercially available for the treatment of advanced renal cancer. Its use in other types of cancer is investigational.
Up to 65 patients will take part in this study. All will be enrolled at MD Anderson.
- Conditions
- Advanced Cancers
- Being tested
- Temsirolimus
- Keywords
- Advanced cancer, Advanced Cancer with genetic mutation, Phosphoinositides 3-kinase, PI3K, PIK3 mutations, Temsirolimus, CCI-779, Torisel, mTOR inhibitor
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TemsirolimusDrug
Also called CCI-779, Torisel
25 mg by vein over 60 minutes on Days 1, 8, 15, and 22 of each 4-week study cycle.
| Study group | Role | What they receive |
|---|---|---|
| Temsirolimus | Experimental | Temsirolimus 25 mg by vein over 60 minutes on Days 1, 8, 15, and 22 of each 4-week study cycle. Receives: Drug: Temsirolimus |
What is being measured
The primary outcome is the main question the study is designed to answer.
Tumor Response
For solid tumors, initial responses defined by Response Evaluation Criteria in Solid (RECIST) criteria in the evaluable lesion(s) per Complete Response (CR): Disappearance of all target lesions; confirmed at 4 weeks; Partial Response (PR): At least 30% decrease; confirmed at 4 weeks; Stable Disease (SD): Neither PR nor PD criteria met; Progressive Disease (PD): 20% increase; no CR, PR or SD documented before increased disease, or new lesion(s).
Measured: Baseline to Disease Progression (restaged at 8 weeks and at 4 months)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Apr 2009 (estimated)
- Study startApr 2009
- Primary completionJun 2014
- Study completionJun 2014
Why it stopped: Slow Accrual
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Advanced CancersStudies of the same condition, open and under way.
- More trials run by M.D. Anderson Cancer CenterThe 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 1/2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 44 participants (actual)
Sponsor and investigators
- Lead sponsor
- M.D. Anderson Cancer Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Daniel Karp, MD, Principal investigator, UT MD Anderson Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00877773
- Sponsor's protocol ID
- 2008-0827
- Other IDs
- NCI-2012-01265
- Status last verified
- Jul 2016
- First submitted
- 7 Apr 2009
- Last updated
- 25 Aug 2016
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Aug 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Histology-Independent Study of the mTOR Inhibitor, Temsirolimus, in Patients With Advanced Cancer
- ClinicalTrials.gov ID
- NCT00877773
- Acronym / sponsor ID
- 2008-0827
- Conditions
- Advanced Cancers
- Keywords
- Advanced cancer, Advanced Cancer with genetic mutation, Phosphoinositides 3-kinase, PI3K, PIK3 mutations, Temsirolimus, CCI-779, Torisel
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Slow Accrual
- Enrolment
- 44 participants (actual)
- Lead sponsor
- M.D. Anderson Cancer CenterUniversity, hospital or other
- Study start
- Apr 2009
- Primary completion
- Jun 2014 (actual)
- Study completion
- Jun 2014 (actual)
- First posted
- 8 Apr 2009 (estimated)
- Results
- Posted 25 Aug 2016
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 clinical research study is to learn if temsirolimus can help to control advanced cancer in patients who also have a PI3K mutation and/or PTEN loss. The safety of this drug will also be tested.
Detailed description
The Study Drug:
Temsirolimus is designed to block the growth of cancer cells, which may cause the cancer cells to die.
Study Drug Administration:
If you are found to be eligible to take part in this study, you will receive temsirolimus through a needle in your vein on Days 1, 8, 15, and 22 of each 4-week study cycle. On Day 1 of Cycle 1, the study drug will be given over 60 minutes. If you tolerate the study drug well on Day 1 of Cycle 1, it will be given over 30 minutes at all other scheduled administration dates as long as you still tolerate it well. If the dose is not well tolerated, the dose will be reduced for future study visits.
You will receive Benadryl (diphenhydramine) or a similar drug by vein to help prevent side effects about 30 minutes before you receive the study drug.
Study Visits:
One (1) time each week (on each day that the study drug is being given), the following tests and procedures will be performed:
- Your weight and vital signs will be measured.
- You will be asked about any drugs you may be taking and about any side effects you may be having.
- Blood (about 2 teaspoons each time) will be drawn for pharmacodynamic (PD) testing. PD testing measures how the level of study drug in your body may affect the disease. This blood will be drawn at the following times:
At 8 hours (+/- 3 hours) after the dose At 24 hours (+/- 3 hours) after the dose At 72 hours (+/- 24 hours) after the dose
Every 2 weeks, blood (about 2 teaspoons) will be drawn for routine tests.
Every 4 weeks, you will have a physical exam; women who are able to become pregnant will also have a blood (about 1 teaspoon) pregnancy test.
Every 8 weeks, you will have a CT scan, MRI scan, and/or PET/CT scan to check the status of the disease.
Length of Study:
You will be on study for as long as you are benefiting or the disease is stable. You will be taken off study if the disease gets worse, you have intolerable side effects, or the study doctor thinks it is in your best interest.
End-of-Study Visit:
After you have finished taking the study drug, the following tests and procedures will be performed:
- You will have a physical exam, including measurement of your weight and vital signs.
- You will be asked about any drugs you may be taking and about any side effects you may be having.
This is an investigational study. Temsirolimus is FDA-approved and commercially available for the treatment of advanced renal cancer. Its use in other types of cancer is investigational.
Up to 65 patients will take part in this study. All will be enrolled at MD Anderson.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Temsirolimus | Experimental | Drug: TemsirolimusTemsirolimus 25 mg by vein over 60 minutes on Days 1, 8, 15, and 22 of each 4-week study cycle. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (8 listed)
- Patients with pathologically confirmed advanced or metastatic cancer that is refractory to standard therapy, relapsed after standard therapy, or has no standard therapy that improves survival by at least 3 months (unless temsirolimus is indicated as standard treatment for that disease).
- Patients must have evaluable tumor(s) with documented PIK3 mutation and/or PTEN loss.
- Patients must have creatinine </= 3 X upper limit of normal (ULN); absolute neutrophil count >/= 1,000/mL; platelets >/= 50,000; bilirubin </= 3.0 gm/dL. Except for patients with liver metastases: total bilirubin </= 5 ULN.
- Women of childbearing potential must have a negative baseline blood pregnancy test. Women and men must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) for the duration of study.
- Patients must be off other anti-tumor agents for at least 5 half lives of the agent or 4 wks from the last day of treatment, whichever is shorter. For cytotoxic therapies, patients should be off treatment for 3 or more weeks.
Key exclusion criteria (5 listed)
- Pregnant or lactating women.
- Patients with creatinine clearance <10 mL/min
- Patients with a known hypersensitivity to any of the components or metabolites of the drug products.
- Patients with major surgery within 30 days prior to entering study.
- Patients on inhibitors or inducers of CYP3A4 metabolism will have the inhibitors or inducers stopped unless clinically contraindicated. See section 6 (Concomitant Medications) and Appendix E of the protocol for details.
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 |
|---|---|---|
| TemsirolimusAlso: CCI-779, Torisel25 mg by vein over 60 minutes on Days 1, 8, 15, and 22 of each 4-week study cycle. | Drug | Temsirolimus |
Primary outcome
Tumor Response
Time frame: Baseline to Disease Progression (restaged at 8 weeks and at 4 months)
For solid tumors, initial responses defined by Response Evaluation Criteria in Solid (RECIST) criteria in the evaluable lesion(s) per Complete Response (CR): Disappearance of all target lesions; confirmed at 4 weeks; Partial Response (PR): At least 30% decrease; confirmed at 4 weeks; Stable Disease (SD): Neither PR nor PD criteria met; Progressive Disease (PD): 20% increase; no CR, PR or SD documented before increased disease, or new lesion(s).
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Aug 2016.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- University of Texas MD Anderson Cancer Center WebsiteLink provided by the sponsor.
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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.
Daniel Karp, MD principal investigator
UT MD Anderson Cancer Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Temsirolimus in people with Advanced Cancers, run by M.D. Anderson Cancer Center 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 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: stopped early, as of the sponsor's last update on 25 Aug 2016. 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 combined 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.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 25 Aug 2016). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Tumor Response (time frame: Baseline to Disease Progression (restaged at 8 weeks and at 4 months)). 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 25 Aug 2016.