CancerPhase 1NCT01529138
Study of Axitinib and Temsirolimus in Solid Tumors
A Phase 1 study testing Axitinib and Temsirolimus in people with Cancer, run by Emory University at 1 site in United States.
Trial summary
This study is being done to determine the highest safe dose of the combination of temsirolimus and axitinib; to learn the side effects when these drugs are given together; and to determine how the patient's disease responds to treatment. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cancer
- What is being tested?
- Axitinib and Temsirolimus
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 13 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 2011to Mar 2014
- 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
- Patients must have histologically confirmed non-hematologic malignancy for which standard curative or palliative measures do not exist or are no longer effective
- Patients with hepatocellular carcinoma do not need histologic confirmation of malignancy if the following criteria were met at diagnosis:
- Liver lesions 1 - 2 cm with arterial enhancement and washout in venous phase of CT/MRI
- Liver lesions ≥ 2 cm with arterial enhancement and washout in venous phase of CT/MRI or serum alpha-feto protein ≥ 200 ng/mL
- Eastern Cooperative Oncology Group (ECOG) Performance Status 0 or 1
- Marrow and Organ function requirements:
Show all 25Show fewer
- Absolute Neutrophil Count ≥ 1000/mm³
- Platelets ≥ 75,000/mm³
- Hemoglobin ≥ 9.0 g/dL
- Total bilirubin ≤ 1.5 x upper limit of normal (ULN)
- Alkaline phosphatase ≤ 2.5 x ULN (≤ 5 x ULN if liver metastasis present)
- Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤ 2.5 x ULN (≤ 5 x ULN if liver metastasis present or patient has diagnosis of hepatocellular carcinoma or cholangiocarcinoma)
- Creatinine ≤ 1.5 x ULN
- Urinalysis ≤ 1+ protein on dipstick or Urine creatinine:protein ratio < 1.0 If urine protein >1 1+ or urine creatinine:protein ratio > 1, then 24 hour urine protein should be obtained and the level should be < 1000 mg for patient enrollment.
- Fasting serum cholesterol ≤ 350 mg/dL
- Triglycerides ≤1.5 x ULN
- Life expectancy ≥ 12 weeks
- At least 2 weeks since end of prior systemic treatment (4 weeks for bevacizumab containing regimens), radiotherapy, or surgical procedure with resolution of all treatment related toxicity
- No evidence of uncontrolled hypertension as evidenced by 2 readings of < 140/90 measured 1 hour apart. Preexisting hypertension controlled with medication is allowed
- No gastrointestinal disorders including active peptic ulcer disease (within 6 months); active bleeding unrelated to malignancy; or melena, hematemesis, or hematochezia in the past 3 months without endoscopically-proven resolution
- No cardiovascular history within 12 months including: myocardial infarction (MI), uncontrolled angina, coronary artery bypass graft (CABG), or symptomatic congestive heart failure (CHF)
- Women of child bearing potential must have negative pregnancy test
- Willingness and ability to comply with scheduled visits
- Able to ingest oral medications
- No concurrent use or anticipated need for potent cytochrome P450 3A4 (CYP3A4) inhibitors or CYP3A4 or cytochrome P450 1A2 (CYP1A2) inducers
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
United States1 site
Emory University Winship Cancer Institute
Atlanta, Georgia, 30322
About this study
Official title: Phase I Study of Axitinib and Temsirolimus in Solid Tumors
This study is being done to determine the highest safe dose of the combination of temsirolimus and axitinib; to learn the side effects when these drugs are given together; and to determine how the patient's disease responds to treatment.
The combination of the drugs temsirolimus and axitinib has not been studied before so it is unknown whether this treatment will have any benefit in the patient's cancer.
Read more
Temsirolimus is commercially available and approved for treatment of some types of kidney cancer.
Axitinib has been tested in several diseases but it is not yet commercially available for the treatment of any cancer in the United States.
The combination of temsirolimus and axitinib is not approved for treatment of any cancer outside of a clinical trial.
- Conditions
- Cancer
- Being tested
- Axitinib, Temsirolimus
- Keywords
- Cancer
- Medical subject headings
- Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AxitinibDrug
Also called Inlyta, AG013736
Combination treatment with temsirolimus and axitinib
TemsirolimusDrug
Also called Torisel, CCI-779
Combination treatment with temsirolimus and axitinib
| Study group | Role | What they receive |
|---|---|---|
| Temsirolimus | Experimental | An ester of the macrocyclic immunosuppressive agent sirolimus. Receives: Drug: Temsirolimus |
| Axitinib | Experimental | An oral, selective inhibitor of vascular endothelial growth factor (VEGF) receptors 1, 2, 3. Receives: Drug: Axitinib |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in the largest diameter (unidimensional measurement) of the tumor lesions and the shortest diameter in the case of malignant lymph nodes are used in the Response Evaluation Criteria in Solid Tumors (RECIST) criteria for evaluation.
Complete Response: Disappearance of all target lesions.Any pathological lymph nodes must have reduction in short axis to <10 mm.
Partial Response (PR): At least a 30% decrease in the sum of the diameters of target lesions Progressive Disease (PD): At least a 20% increase in the sum of the diameters of target lesions.Note: the appearance of one or more new lesions is also considered progressions).
Stable Disease: Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD.
Measured: Approximately re-evaluated every 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Feb 2012 (estimated)
- Study startOct 2011
- Primary completionMar 2014
- Study completionMar 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CancerStudies of the same condition, open and under way.
- More trials run by Emory UniversityThe 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
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 13 participants (actual)
Sponsor and investigators
- Lead sponsor
- Emory University
- Sponsor type
- University, hospital or other
- Collaborators
- Pfizer
- Responsible party
- Principal investigator, Bradley Carthon MD, PhD, Emory University
- Investigators
- Bradley Carthon, MD, PhD, Principal investigator, Emory University Winship Cancer Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01529138
- Sponsor's protocol ID
- IRB00048705
- Other IDs
- WCI1939-10
- Status last verified
- Apr 2015
- First submitted
- 14 Nov 2011
- Last updated
- 13 Apr 2015
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 13 Apr 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase I Study of Axitinib and Temsirolimus in Solid Tumors
- ClinicalTrials.gov ID
- NCT01529138
- Acronym / sponsor ID
- IRB00048705
- Conditions
- Cancer
- Keywords
- Cancer
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 13 participants (actual)
- Lead sponsor
- Emory UniversityUniversity, hospital or other
- Collaborators
- Pfizer
- Study start
- Oct 2011
- Primary completion
- Mar 2014 (actual)
- Study completion
- Mar 2014 (actual)
- First posted
- 8 Feb 2012 (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.
This study is being done to determine the highest safe dose of the combination of temsirolimus and axitinib; to learn the side effects when these drugs are given together; and to determine how the patient's disease responds to treatment.
The combination of the drugs temsirolimus and axitinib has not been studied before so it is unknown whether this treatment will have any benefit in the patient's cancer.
Temsirolimus is commercially available and approved for treatment of some types of kidney cancer.
Axitinib has been tested in several diseases but it is not yet commercially available for the treatment of any cancer in the United States.
The combination of temsirolimus and axitinib is not approved for treatment of any cancer outside of a clinical trial.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Temsirolimus | Experimental | Drug: TemsirolimusAn ester of the macrocyclic immunosuppressive agent sirolimus. |
| Axitinib | Experimental | Drug: AxitinibAn oral, selective inhibitor of vascular endothelial growth factor (VEGF) receptors 1, 2, 3. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (25 listed)
- Patients must have histologically confirmed non-hematologic malignancy for which standard curative or palliative measures do not exist or are no longer effective
- Patients with hepatocellular carcinoma do not need histologic confirmation of malignancy if the following criteria were met at diagnosis:
- Eastern Cooperative Oncology Group (ECOG) Performance Status 0 or 1
- Marrow and Organ function requirements:
- Life expectancy ≥ 12 weeks
Key exclusion criteria (0 listed)
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 |
|---|---|---|
| AxitinibAlso: Inlyta, AG013736Combination treatment with temsirolimus and axitinib | Drug | Axitinib |
| TemsirolimusAlso: Torisel, CCI-779Combination treatment with temsirolimus and axitinib | Drug | Temsirolimus |
Primary outcome
Changes in the largest diameter (unidimensional measurement) of the tumor lesions and the shortest diameter in the case of malignant lymph nodes are used in the Response Evaluation Criteria in Solid Tumors (RECIST) criteria for evaluation.
Time frame: Approximately re-evaluated every 8 weeks
Complete Response: Disappearance of all target lesions.Any pathological lymph nodes must have reduction in short axis to <10 mm. Partial Response (PR): At least a 30% decrease in the sum of the diameters of target lesions Progressive Disease (PD): At least a 20% increase in the sum of the diameters of target lesions.Note: the appearance of one or more new lesions is also considered progressions). Stable Disease: Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD.
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 13 Apr 2015.
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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.
Bradley Carthon, MD, PhD principal investigator
Emory University Winship 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 Axitinib and Temsirolimus in people with Cancer, run by Emory University 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 25 inclusion and 0 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 13 Apr 2015. 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?
Changes in the largest diameter (unidimensional measurement) of the tumor lesions and the shortest diameter in the case of malignant lymph nodes are used in the Response Evaluation Criteria in Solid Tumors (RECIST) criteria for evaluation. (time frame: Approximately re-evaluated every 8 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 13 Apr 2015.