Endometrial AdenocarcinomaPhase 2NCT01307631
Akt Inhibitor MK2206 in Treating Patients With Recurrent or Advanced Endometrial Cancer
A Phase 2 study testing Akt Inhibitor MK2206 and Laboratory Biomarker Analysis in people with Endometrial Adenocarcinoma and Endometrial Adenosquamous Carcinoma, run by National Cancer Institute (NCI) at 7 sites in United States.
Trial summary
This phase II trial studies how well Akt inhibitor MK2206 works in treating patients with recurrent or advanced endometrial cancer. Akt inhibitor MK2206 may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Endometrial Adenocarcinoma, Endometrial Adenosquamous Carcinoma, Endometrial Clear Cell Adenocarcinoma
- What is being tested?
- Akt Inhibitor MK2206 and Laboratory Biomarker Analysis
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 37 participants
- Where
- 7 sitesUnited States
- Study dates
- Mar 2011to 18 Sep 2015
- Phase
- Phase 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 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Participants must have histologically confirmed recurrent or persistent high grade endometrial carcinoma with a serous component, which is refractory to curative therapy or established treatments; histologic confirmation of the original primary tumor is required
- All patients must have measurable disease as defined by RECIST 1.1; measurable disease is defined as at least one lesion that can be accurately measured in at least one dimension (longest diameter to be recorded); each lesion must be >= 10 mm when measured by computed tomography (CT), magnetic resonance imaging (MRI) or caliper measurement by clinical exam; or >= 20 mm when measured by chest x-ray; lymph nodes must be >= 15 mm in short axis when measured by CT or MRI
- Patients must have had one prior chemotherapeutic regimen for management of endometrial carcinoma initial treatment may include chemotherapy, chemotherapy and radiation therapy, and/or consolidation/maintenance therapy; chemotherapy administered in conjunction with primary radiation as a radio-sensitizer WILL be counted as a systemic chemotherapy regimen
- Patients are allowed to receive, but are not required to receive, one additional prior treatment regimen (including a single chemotherapeutic, a combination of chemotherapeutics, or an anti-angiogenic drug such as bevacizumab) for management of their recurrent or persistent disease; prior hormonal therapy is allowed and does not count towards this prior regimen
- Patients must have NOT received any class of drugs targeted to the PI3K pathway (such has PI3K inhibitors or mTOR inhibitors) for management of recurrent or persistent disease
- Life expectancy of greater than 6 months
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- Eastern Cooperative Oncology Group (ECOG) performance status =< 2 (Karnofsky >= 50%)
- Absolute neutrophil count >= 1,500/mcL
- Platelets >= 100,000/mcL
- Total bilirubin within normal institutional limits
- Aspartate aminotransferase (AST) (serum glutamic oxaloacetic transaminase [SGOT])/alanine aminotransferase (ALT) (serum glutamic pyruvate transaminase [SGPT]) =< 2.5 x institutional upper limit of normal
- Creatinine within normal institutional limits or creatinine clearance >= 60 mL/min/1.73 m^2 for subjects with creatinine levels about institutional normal
- Hemoglobin A1c (HgA1c) =< 7.5% and fasting blood glucose less than 130mg/dL
- Availability of a formalin fixed paraffin embedded (FFPE) block of cancer tissue from the original or most recent biopsy for mutational analysis
- Women of childbearing potential must use two forms of contraception (hormonal or barrier method of birth control; abstinence) prior to study entry and for the duration of study participation; should a patient become pregnant or suspect she is pregnant while she is participating in this study, she should inform the treating physician immediately
- Toxicities of prior therapy (excepting alopecia) should be resolved to =< grade 1 per the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4
- MK-2206 is an oral medication; patients must be able to tolerate oral medications and not have gastrointestinal illnesses that would preclude absorption of MK-2206
- Ability to understand and the willingness to sign a written informed consent document
Who cannot join
- Participants who have had chemotherapy or radiotherapy within 3 weeks (6 weeks for nitrosoureas or mitomycin C) prior to entering the study or those who have not recovered to =< grade 1 (excepting alopecia) from adverse events (as per the revised NCI CTCAE version 4) due to agents administered more than 3 weeks earlier
- Participants may not be receiving any other study agents
- Participants with known brain metastases should be excluded from this clinical trial because of their poor prognosis and because they often develop progressive neurologic dysfunction that would confound the evaluation of neurologic and other adverse events; should patients develop brain metastases while on trial and have clinical benefit from MK-2206 otherwise, patients may continue on drug after clinical management of the brain metastases with the permission of the principal investigator. MK-2206 should be restarted between 3 and 6 weeks after the last radiation treatment
- History of allergic reactions attributed to compounds of similar chemical or biologic composition to MK-2206
- Patients requiring any medications or substances that are strong inhibitors or inducers of CYP 450 3A4 are ineligible
- Preclinical studies demonstrated the potential of MK-2206 for induction of hyperglycemia in all preclinical species tested; patients with diabetes or in risk for hyperglycemia should not be excluded from trials with MK-2206, but the hyperglycemia should be well controlled on oral agents before the patient enters the trial. HgbA1c > 7.5% or fasting glucose greater than 130mg/dL will exclude patients from entry on study; patients requiring insulin for control of their hyperglycemia are excluded from entry on this study
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- Preclinical studies indicated transient changes in QTc interval during MK-2206 treatment; prolongation of QTc interval is potentially a safety concern while on MK-2206 therapy; cardiovascular: baseline QTcF > 450 msec (male) or QTcF > 470 msec (female) will exclude patients from entry on study
- Due to a high incidence of bradycardia by Holter monitor, preexisting bundle branch block or baseline bradycardia due to cardiac disease will exclude patients from treatment with MK-2206
- Uncontrolled intercurrent illness including, but not limited to ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia or psychiatric illness/social situations that would limit compliance with study requirements
- Pregnant women are excluded from this study; mother with MK-2206 breastfeeding should be discontinued if the mother is treated with MK-2206; these potential risks may also apply to other agents used in this study
- MK-2206 is an oral medication; patients who are unable to tolerate oral medication are not eligible; patients with signs and symptoms of bowel obstruction or with uncontrolled, persistent diarrhea will be excluded
- Individuals with a history of a different malignancy are ineligible except for the following circumstances. Individuals with a history of other malignancies are eligible if they have been disease-free for at least 5 years and are deemed by the investigator to be at low risk for recurrence of that malignancy. Individuals with the following cancers are eligible if diagnosed and treated within the past 5 years: breast cancer in situ, cervical cancer in situ, and basal cell or squamous cell carcinoma of the skin
- Human immunodeficiency virus (HIV)-positive individuals on combination antiretroviral therapy are ineligible
- Patients may not use natural herbal products or other "folk remedies" while participating in this study
Trial locations and contacts
7 sites in 1 country.
7 sites in 1 country
United States7 sites
Massachusetts General Hospital Cancer Center
Boston, Massachusetts, 02114
Dana-Farber Cancer Institute
Boston, Massachusetts, 02115
Beth Israel Deaconess Medical Center
Boston, Massachusetts, 02215
Massachusetts General Hospital
Charlestown, Massachusetts, 02129
M D Anderson Cancer Center
Houston, Texas, 77030
Memorial Sloan-Kettering Cancer Center
New York, New York, 10065
Newton-Wellesley Hospital
Newton, Massachusetts, 02462
About this study
Official title: A Phase II, 2-Stage, 2-Arm PIK3CA Mutation Stratified Trial of MK-2206 in Recurrent or Advanced Endometrial Cancer
This phase II trial studies how well Akt inhibitor MK2206 works in treating patients with recurrent or advanced endometrial cancer. Akt inhibitor MK2206 may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth.
Read the detailed description
PRIMARY OBJECTIVES:
- To assess the activity of MK-2206 (Akt inhibitor MK2206) in patients with recurrent or persistent endometrial cancer classified by phosphoinositide-3-kinase catalytic alpha (PIK3CA) mutation. Activity will be ascertained by the proportion of patients who survive progression-free for at least 6 months after initiating therapy or who have objective tumor response.
II. To evaluate the efficacy of MK2206 in patients with serous tumors using a composite endpoint of complete and partial response by Response Evaluation Criteria In Solid Tumors (RECIST) and progression-free interval of 6 months or longer.
SECONDARY OBJECTIVES:
- To determine the duration of progression-free survival and overall survival. II. To determine the nature and degree of toxicity of MK-2206 as assessed by version 4 of the National Cancer Institute (NCI) Common Terminology Criteria For Adverse Events (CTCAE) in these cohorts of patients.
III. To explore the associations between select biomarkers and response to MK-2206 such as progression-free survival, objective tumor response, and overall survival as well as patient characteristics such as histological cell type.
IV. To explore the development of feed-back loop activation (post-treatment biopsy biomarker analysis) and target inhibition using MK-2206 via analysis of pre-treatment and post-treatment biopsies in select patients enrolled in the trial.
- To determine the duration of progression-free and overall survival, following initiation of therapy with MK-2206.
VI. To determine the toxicities of MK-2206, as assessed with the revised NCI CTCAE version 4.
VII. To explore the association between select biomarkers and response to MK-2206 such as progression-free survival, objective tumor response.
OUTLINE:
Patients receive Akt inhibitor MK2206 orally (PO) once weekly. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
After completion of study treatment, patients are followed up for 3 years.
- Conditions
- Endometrial Adenocarcinoma, Endometrial Adenosquamous Carcinoma, Endometrial Clear Cell Adenocarcinoma, Endometrial Serous Adenocarcinoma, Recurrent Uterine Corpus Carcinoma
- Being tested
- Akt Inhibitor MK2206, Laboratory Biomarker Analysis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Akt Inhibitor MK2206Drug
Also called MK2206
Given PO
Laboratory Biomarker AnalysisOther
Correlative studies
| Study group | Role | What they receive |
|---|---|---|
| Treatment (Akt inhibitor MK2206 | Experimental | Patients receive Akt inhibitor MK2206 PO once weekly. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. Receives: Drug: Akt Inhibitor MK2206; Other: Laboratory Biomarker Analysis |
What is being measured
The primary outcome is the main question the study is designed to answer.
Objective Tumor Response According to RECIST
Activity will be ascertained by the proportion of patients who survive progression-free for at least 6 months after initiating therapy or who have objective tumor response. Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions. Any pathological lymph node must have reduction in short axis to < 10 mm; Partial Response (PR), at least 30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR
Measured: Up to 6 months
Progression-free Survival According to RECIST
Activity will be ascertained by the proportion of patients who survive progression-free for at least 6 months after initiating therapy or who have objective tumor response. Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions. Any pathological lymph node must have reduction in short axis to < 10 mm; Partial Response (PR), at least 30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR
Measured: From start of treatment to time of objective disease progression, assessed up to 6 months
Secondary outcomes (2)
Duration of Overall Survival
Estimated by using Kaplan-Meier analysis.
Measured: Up to 3 years
Duration of Progression-free Survival
Estimated by using Kaplan-Meier analysis.
Measured: Up to 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Mar 2011 (estimated)
- Study startMar 2011
- Primary completion18 Sep 2015
- Study completion18 Sep 2015
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.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Endometrial AdenocarcinomaStudies of the same condition, open and under way.
- More trials run by National Cancer Institute (NCI)The 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 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 37 participants (actual)
Sponsor and investigators
- Lead sponsor
- National Cancer Institute (NCI)
- Sponsor type
- US National Institutes of Health
- Responsible party
- Sponsor
- Investigators
- Panagiotis Konstantinopoulos, Principal investigator, Dana-Farber Cancer Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01307631
- Sponsor's protocol ID
- NCI-2013-00521
- Other IDs
- NCI-2013-00521, 10.258, 10-258, 8760, P30CA006516, U01CA062490, UM1CA186709
- Status last verified
- Jan 2022
- First submitted
- 1 Mar 2011
- Last updated
- 11 Feb 2022
- Results posted
- Yes, on ClinicalTrials.gov
Publications
Myers AP, Konstantinopoulos PA, Barry WT, Luo W, Broaddus RR, Makker V, Drapkin R, Liu J, Doyle A, Horowitz NS, Meric-Bernstam F, Birrer M, Aghajanian C, Coleman RL, Mills GB, Cantley LC, Matulonis UA, Westin SN. Phase II, 2-stage, 2-arm, PIK3CA mutation stratified trial of MK-2206 in recurrent endometrial cancer. Int J Cancer. 2020 Jul 15;147(2):413-422. doi: 10.1002/ijc.32783. Epub 2019 Dec 13.
PubMed 31714586
Study at a glance
From the registry record, last updated by the sponsor on 11 Feb 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase II, 2-Stage, 2-Arm PIK3CA Mutation Stratified Trial of MK-2206 in Recurrent or Advanced Endometrial Cancer
- ClinicalTrials.gov ID
- NCT01307631
- Acronym / sponsor ID
- NCI-2013-00521
- Conditions
- Endometrial Adenocarcinoma, Endometrial Adenosquamous Carcinoma, Endometrial Clear Cell Adenocarcinoma, Endometrial Serous Adenocarcinoma, Recurrent Uterine Corpus Carcinoma
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 37 participants (actual)
- Lead sponsor
- National Cancer Institute (NCI)US National Institutes of Health
- Study start
- Mar 2011 (actual)
- Primary completion
- 18 Sep 2015 (actual)
- Study completion
- 18 Sep 2015 (actual)
- First posted
- 3 Mar 2011 (estimated)
- Results
- Posted 5 Sep 2017
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This phase II trial studies how well Akt inhibitor MK2206 works in treating patients with recurrent or advanced endometrial cancer. Akt inhibitor MK2206 may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth.
Detailed description
PRIMARY OBJECTIVES:
- To assess the activity of MK-2206 (Akt inhibitor MK2206) in patients with recurrent or persistent endometrial cancer classified by phosphoinositide-3-kinase catalytic alpha (PIK3CA) mutation. Activity will be ascertained by the proportion of patients who survive progression-free for at least 6 months after initiating therapy or who have objective tumor response.
II. To evaluate the efficacy of MK2206 in patients with serous tumors using a composite endpoint of complete and partial response by Response Evaluation Criteria In Solid Tumors (RECIST) and progression-free interval of 6 months or longer.
SECONDARY OBJECTIVES:
- To determine the duration of progression-free survival and overall survival. II. To determine the nature and degree of toxicity of MK-2206 as assessed by version 4 of the National Cancer Institute (NCI) Common Terminology Criteria For Adverse Events (CTCAE) in these cohorts of patients.
III. To explore the associations between select biomarkers and response to MK-2206 such as progression-free survival, objective tumor response, and overall survival as well as patient characteristics such as histological cell type.
IV. To explore the development of feed-back loop activation (post-treatment biopsy biomarker analysis) and target inhibition using MK-2206 via analysis of pre-treatment and post-treatment biopsies in select patients enrolled in the trial.
- To determine the duration of progression-free and overall survival, following initiation of therapy with MK-2206.
VI. To determine the toxicities of MK-2206, as assessed with the revised NCI CTCAE version 4.
VII. To explore the association between select biomarkers and response to MK-2206 such as progression-free survival, objective tumor response.
OUTLINE:
Patients receive Akt inhibitor MK2206 orally (PO) once weekly. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
After completion of study treatment, patients are followed up for 3 years.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Treatment (Akt inhibitor MK2206 | Experimental | Drug: Akt Inhibitor MK2206, Other: Laboratory Biomarker AnalysisPatients receive Akt inhibitor MK2206 PO once weekly. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (18 listed)
- Participants must have histologically confirmed recurrent or persistent high grade endometrial carcinoma with a serous component, which is refractory to curative therapy or established treatments; histologic confirmation of the original primary tumor is required
- All patients must have measurable disease as defined by RECIST 1.1; measurable disease is defined as at least one lesion that can be accurately measured in at least one dimension (longest diameter to be recorded); each lesion must be >= 10 mm when measured by computed tomography (CT), magnetic resonance imaging (MRI) or caliper measurement by clinical exam; or >= 20 mm when measured by chest x-ray; lymph nodes must be >= 15 mm in short axis when measured by CT or MRI
- Patients must have had one prior chemotherapeutic regimen for management of endometrial carcinoma initial treatment may include chemotherapy, chemotherapy and radiation therapy, and/or consolidation/maintenance therapy; chemotherapy administered in conjunction with primary radiation as a radio-sensitizer WILL be counted as a systemic chemotherapy regimen
- Patients are allowed to receive, but are not required to receive, one additional prior treatment regimen (including a single chemotherapeutic, a combination of chemotherapeutics, or an anti-angiogenic drug such as bevacizumab) for management of their recurrent or persistent disease; prior hormonal therapy is allowed and does not count towards this prior regimen
- Patients must have NOT received any class of drugs targeted to the PI3K pathway (such has PI3K inhibitors or mTOR inhibitors) for management of recurrent or persistent disease
Key exclusion criteria (14 listed)
- Participants who have had chemotherapy or radiotherapy within 3 weeks (6 weeks for nitrosoureas or mitomycin C) prior to entering the study or those who have not recovered to =< grade 1 (excepting alopecia) from adverse events (as per the revised NCI CTCAE version 4) due to agents administered more than 3 weeks earlier
- Participants may not be receiving any other study agents
- Participants with known brain metastases should be excluded from this clinical trial because of their poor prognosis and because they often develop progressive neurologic dysfunction that would confound the evaluation of neurologic and other adverse events; should patients develop brain metastases while on trial and have clinical benefit from MK-2206 otherwise, patients may continue on drug after clinical management of the brain metastases with the permission of the principal investigator. MK-2206 should be restarted between 3 and 6 weeks after the last radiation treatment
- History of allergic reactions attributed to compounds of similar chemical or biologic composition to MK-2206
- Patients requiring any medications or substances that are strong inhibitors or inducers of CYP 450 3A4 are ineligible
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 |
|---|---|---|
| Akt Inhibitor MK2206Also: MK2206Given PO | Drug | Treatment (Akt inhibitor MK2206 |
| Laboratory Biomarker AnalysisCorrelative studies | Other | Treatment (Akt inhibitor MK2206 |
Primary outcome
Objective Tumor Response According to RECIST
Time frame: Up to 6 months
Activity will be ascertained by the proportion of patients who survive progression-free for at least 6 months after initiating therapy or who have objective tumor response. Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions. Any pathological lymph node must have reduction in short axis to < 10 mm; Partial Response (PR), at least 30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR
Progression-free Survival According to RECIST
Time frame: From start of treatment to time of objective disease progression, assessed up to 6 months
Activity will be ascertained by the proportion of patients who survive progression-free for at least 6 months after initiating therapy or who have objective tumor response. Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions. Any pathological lymph node must have reduction in short axis to < 10 mm; Partial Response (PR), at least 30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR
2 secondary outcomes
Duration of Overall Survival
Time frame: Up to 3 years
Duration of Progression-free Survival
Time frame: Up to 3 years
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Feb 2022.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 31714586Myers AP, Konstantinopoulos PA, Barry WT, Luo W, Broaddus RR, Makker V, Drapkin R, Liu J, Doyle A, Horowitz NS, Meric-Bernstam F, Birrer M, Aghajanian C, Coleman RL, Mills GB, Cantley LC, Matulonis UA, Westin SN. Phase II, 2-stage, 2-arm, PIK3CA mutation stratified trial of MK-2206 in recurrent endometrial cancer. Int J Cancer. 2020 Jul 15;147(2):413-422. doi: 10.1002/ijc.32783. Epub 2019 Dec 13.
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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.
Panagiotis Konstantinopoulos principal investigator
Dana-Farber Cancer Institute
7 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Akt Inhibitor MK2206 and Laboratory Biomarker Analysis in people with Endometrial Adenocarcinoma and Endometrial Adenosquamous Carcinoma, run by National Cancer Institute (NCI) at 7 sites 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 18 inclusion and 14 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 11 Feb 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 sites 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 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 5 Sep 2017). 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?
Objective Tumor Response According to RECIST (time frame: Up to 6 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01307631, which also lists 1 linked publication.
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 11 Feb 2022.