Breast CancerPhase 2NCT01679743
GRN1005 for Brain Metastases From Breast or Lung Cancer
A Phase 2 study testing Trastuzumab and GRN 1005 in people with Breast Cancer and Lung Neoplasms, run by National Cancer Institute (NCI).
Trial summary
Background: Brain metastases are cancer cells that have spread to the brain from primary cancers in other organs. These tumors can be removed surgically. However, researchers are trying to find better ways to treat brain metastases. Read more about this study
- Who is it for?
- Ages 18 to 99 years
- Conditions the study is for
- Breast Cancer, Lung Neoplasms, Breast Neoplasms
- What is being tested?
- Trastuzumab and GRN 1005
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- 29 Aug 2012to 11 Aug 2014
- Phase
- Phase 2
- 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 to 99 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adult patients (greater than or equal to 18 years)
- Histologically or cytologically-documented breast cancer (HER2 status must be known) or NSCLC
- Presence of resectable brain metastases with or without prior radiotherapy. Patients must be greater than 28 days from WBRT or SRS
- Presence of resectable brain metastases, as assessed by neurosurgical evaluation. A brain tumor will be considered to be resectable for the purposes of the study if it is located in the cerebrum or the cerebellum. Tumors that are located in deep brain structures, including the medulla, pons, midbrain, thalamus, and basal ganglia will be considered non-resectable. The tumor must be solitary or, if not, accompanied by another tumor on the same side of the brain that is also considered to be resectable by the same criteria.
- At least one radiologically-confirmed and measurable metastatic brain lesion (greater than or equal to 1.0 centimeters in the longest diameter) by Gd-MRI of the brain less than 14 days prior to first dose of GRN1005 (Cycle 1, Day 1). The spatial resolution of the Philips Gemini TOF PET/CT is 4millimeters [FWHM, (full width half maximum)]. One cm is greater than 2 times this FWHM and it is anticipated that greater than 70% of the actual activity in the lesion will be visualized (i.e. recovered). It is expected that all lesions greater than or equal to 1 centimeters will have sufficient FLT uptake. If no lesions on the baseline image are visualized on FLT PET/CT, then post therapy FLT imaging will not be performed. These patients will be replaced.
- Patients must be neurologically stable, defined as being on stable doses of corticosteroids and anticonvulsants (not enzyme-inducing antiepileptic drugs (EIAEDs), including phenytoin, phenobarbitol, carbamazepine, fosphenytoin, primidone, oxcarbazepine) for greater than or equal to 5 days prior to obtaining the baseline Gd-MRI of the brain and greater than or equal to 5 days prior to first dose of GRN1005
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- Karnofsky Performance Score (KPS) greater than or equal to 80% (which is equivalent to Eastern Cooperative Oncology Group [ECOG] Performance Status of 0 or 1)
- Life expectancy greater than 3 months
- Completed cytotoxic chemotherapy greater than or equal to 21 days (for an every 3-week regimen) or greater than or equal to 14 days (for an every 2-week or weekly regimen) prior to first dose of GRN1005 (Cycle 1, Day 1); all clinically significant toxicities (excluding alopecia) must have resolved to less than or equal to CTCAE v4.0 Grade 1.
- Completed treatment with non-cytotoxic systemic drugs (e.g., targeted drugs) greater than or equal to 14 days for small molecules and greater than or equal to 28 days for monoclonal antibodies (e.g., bevacizumab, with the exception of trastuzumab and bisphosphonates) prior to first dose of GRN1005 (Cycle 1, Day 1). All clinically significant toxicities (excluding alopecia) must have resolved to less than or equal to CTCAE v4.0 Grade 1.
- Adequate laboratory test results for organ systems less than equal 14 days prior to first dose of GRN1005, as follows:
- Absolute neutrophil count (ANC) greater than or equal to 1.5 times 10(9)/L
- Hgb greater than or equal to 9.0 grams per deciliter
- Platelets greater than or equal to 100 times 10(9)/L
- Total bilirubin less than 1.6 milligrams per deciliter or less than the upper limit of normal (ULN). Serum bilirubin less than 2 times ULN for patients with Gilbert s syndrome
- Aspartate aminotransferase (AST; SGOT) and alanine aminotransferase (ALT;
- SGPT) less than 2.5 times ULN. AST, ALT less than 5 times ULN for patients with documented liver metastases
- Alkaline phosphatase less than 2.5 times ULN. For patients with documented liver or bone metastases, alkaline phosphatase less than 5 times ULN
- Serum creatinine less than 1.5 milligrams per deciliter or creatinine clearance greater than or equal to 45 millliter per minute
- Negative pregnancy test less than or equal to 72 hours prior to Cycle 1, Day 1 of GRN1005 (for all women of reproductive potential)
- Patients with HER2-positive disease who are on trastuzumab should be willing and able to continue receiving trastuzumab in accordance with standard institutional practice and prescribing information (EF greater than or equal to 50 % and no history of trastuzumab related CHF or greater than or equal 16% absolute decrease in LVEF from pre-treatment values or an LVEF value below institutional limits of normal and greater than or equal 10% absolute decrease in LVEF from pretreatment values). If these criteria are not met, trastuzumab will not be administered during this protocol.
- Ability of subject or Legally Authorized Representative (LAR) (if the patient is deemed by the treating physician to be cognitively impaired or questionably impaired in such a way that the ability of the patient to give informed consent is questionable) to understand and the willingness to sign a written informed consent document indicating that they are aware of the investigational nature of this study.
Who cannot join
- NCI CTCAE v4.0 Grade greater than or equal to 2 neuropathy
- CNS disease requiring immediate neurosurgical intervention (e.g., resection, shunt placement, etc.)
- Known leptomeningeal disease
- Known severe hypersensitivity or allergy to paclitaxel or any of its components
- Treatment with P450 CYP 3A4 or 2C8 enzyme-inducing anticonvulsant drugs less than or equal to 14 days prior to first dose of GRN1005 (Cycle 1, Day 1)
- Patients with the presence of an infection including abscess or fistulae, or infection with hepatitis B or C or HIV
Show all 13Show fewer
- Any evidence of severe or uncontrolled systemic disease, such as clinically significant cardiovascular (including arrhythmias), pulmonary, hepatic, renal, or metabolic disease; wound-healing disorders; ulcers; or bone fractures
- History of interstitial lung disease (e.g., pneumonitis or pulmonary fibrosis) or evidence of clinically significant interstitial lung disease on chest CT scan
- Severe conduction disturbance including clinically significant QTc prolongation defined as a QTc greater than 450 milliseconds in women and QTc greater than 440 milliseconds in men (unless pacemaker in place).
- Women or men of reproductive potential not consenting to use double-barrier contraceptive methods (e.g., diaphragm plus condom) or abstinence during the study, from screening until 3 months after the last GRN1005 administration, and if applicable, for 6 months after the last trastuzumab administration
- Women who are pregnant or breast-feeding
- Prior GRN1005 treatment
- Allergy to gadolinium used in MRI
About this study
Official title: A Pilot Study of GRN1005 for Resectable Brain Metastases in Patients With Breast Cancer and Non-Small Cell Lung Cancer
Background:
- Brain metastases are cancer cells that have spread to the brain from primary cancers in other organs. These tumors can be removed surgically. However, researchers are trying to find better ways to treat brain metastases. A new drug, GRN1005, has been designed to cross into the brain and deliver the cancer treatment drug paclitaxel to treat tumors. Researchers want to see how well GRN1005 works on brain metastases from breast or lung cancer.
Read more
Objectives:
- To test the safety and effectiveness of GRN1005 in treating brain metastases from breast or lung cancer.
Eligibility:
- Individuals at least 18 years of age who have breast or lung cancer that has spread to the brain.
Design:
- Participants will be screened with a physical exam and medical history. Blood and urine samples will be collected. Tumor tissue samples may also be collected. Imaging studies will also be performed.
- Participants who have breast cancer will be divided into two groups. Those whose cancer contains the HER2 protein will be treated with the drug Herceptin as well as GRN1005. Those without HER2 will have only GRN1005.
- Participants who have lung cancer will also have only GRN1005.
- All participants will have two doses of GRN1005, each 3 weeks apart. On the day the second dose of GRN1005 is given, participants will undergo surgery to remove the brain tumors.
- Treatment will be monitored with frequent blood tests and imaging studies.
Read the detailed description
Background:
Brain metastasis is the most common intra-cranial tumor in adults with approximately 170,000 new cases being diagnosed in the United States annually. The incidence of brain metastasis is increasing. Usually brain metastases of breast cancer occur after the diagnosis of systemic metastases; but approximately 10 25% of patients with lung cancer have brain metastases at diagnosis and another 40 50% develop them during the course of their disease. Multiple factors are contributing to this increase: aging population, improved imaging techniques, and improvement in the treatment of tumors leading to prolonged survival, thereby allowing the emergence of brain metastases, with the brain being generally regarded as a sanctuary site because of the blood brain barrier (BBB). Lung cancer and breast cancer are the leading tumor types, accounting for approximately 50% and 15 - 20% of patients with brain metastases. This study will evaluate the ability of 18F-FLT to determine if amount of change in the uptake in the brain metastases from breast and lung cancer after one dose of therapy with GRN1005, correlates with intra-cranial response. FLT-PET utilizes a radiolabeled form of thymidine, which is incorporated into DNA in proliferating cells. 18F-FLT uptake correlates better than 18F-FDG with proliferation, tumor progression, and survival. Because CNS uptake of FLT is low in contrast to FDG, this makes it potentially useful in evaluating CNS metastases. We would like to see which of these imaging modalities is superior in detection of brain metastases, and monitoring response to therapy.
Objectives:
-Determine whether one cycle of therapy GRN1005 is associated with a change in FLTPET uptake.
Eligibility:
- Adult patients (greater than or equal to 18 years)
- Histologically or cytologically-documented breast cancer (HER2 status must be known) or NSCLC
- Presence of resectable brain metastases based on evaluation by neurosurgery.
- At least one radiologically-confirmed and measurable metastatic brain lesion.
Design:
- Pilot non-randomized trial with or without trastuzumab
- Ten patients with resectable brain metastases from breast cancer and ten patients with resectable brain metastases from NSCLC will be studied.
- Baseline imaging (brain tumor protocol MRI and DSC-PWI MRI, FLT-PET) 1-14 days prior to first dose of GRN1005.
- Patients will receive 1 dose of GRN1005 on day 1 of study.
- Repeat FLT-PET imaging and MRIs will be done after 1 cycle of therapy and prior to surgery, on day 21.
- On the day of surgery, patients will receive a second dose of GRN1005 3 to 6 hours prior to brain surgery.
- PK studies will be done after each dose of GRN1005.
- Optional extra-cranial tumor biopsies will be performed before and after GRN1005 administration.
- Following surgery radiation therapy will be offered to patients as clinically indicated per radiation oncologist s recommendation.
- Conditions
- Breast Cancer, Lung Neoplasms, Breast Neoplasms, Lung Cancer
- Being tested
- Trastuzumab, GRN 1005
- Keywords
- Metastatic Breast Cancer, Metastatic Lung Cancer, Monoclonal Antibody, 18FLT, Surgery
- Medical subject headings
- Breast Neoplasms, Lung Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TrastuzumabDrug
Trastuzumab will be administered after GRN1005 in patients with HER2+ metastatic breast cancer.
GRN 1005Drug
GRN1005 will be administered at a dose of 550 mg/m2 as an IV infusion at a rate of 8.0 - 8.5 mL/minute on Day 1 of 21-day cycle ( 3 days) and a second dose will be given on the day of surgery (day 21) 3-6 h prior to surgery.
| Study group | Role | What they receive |
|---|---|---|
| A | Experimental | Breast Cancer Cohort Receives: Drug: Trastuzumab; Drug: GRN 1005 |
| B | Experimental | Non-Small Cell Lung Cancer Cohort Receives: Drug: GRN 1005 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Effect of GRN therapy on PET uptake after treatment cycle 1
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Sep 2012 (estimated)
- Study start29 Aug 2012
- Primary completion11 Aug 2014 (estimated)
- Study completion11 Aug 2014 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Breast CancerStudies 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
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- National Cancer Institute (NCI)
- Sponsor type
- US National Institutes of Health
- Responsible party
- Sponsor
- Investigators
- Susan E Bates, M.D., Principal investigator, National Cancer Institute (NCI)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01679743
- Sponsor's protocol ID
- 120199
- Other IDs
- 12-C-0199
- Status last verified
- 11 Aug 2014
- First submitted
- 1 Sep 2012
- Last updated
- 15 Nov 2019
- Results posted
- No
Publications
Platta CS, Khuntia D, Mehta MP, Suh JH. Current treatment strategies for brain metastasis and complications from therapeutic techniques: a review of current literature. Am J Clin Oncol. 2010 Aug;33(4):398-407. doi: 10.1097/COC.0b013e318194f744.
PubMed 19675447Steeg PS, Camphausen KA, Smith QR. Brain metastases as preventive and therapeutic targets. Nat Rev Cancer. 2011 May;11(5):352-63. doi: 10.1038/nrc3053. Epub 2011 Apr 7.
PubMed 21472002Lagerwaard FJ, Levendag PC, Nowak PJ, Eijkenboom WM, Hanssens PE, Schmitz PI. Identification of prognostic factors in patients with brain metastases: a review of 1292 patients. Int J Radiat Oncol Biol Phys. 1999 Mar 1;43(4):795-803. doi: 10.1016/s0360-3016(98)00442-8.
PubMed 10098435
Study at a glance
From the registry record, last updated by the sponsor on 15 Nov 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Pilot Study of GRN1005 for Resectable Brain Metastases in Patients With Breast Cancer and Non-Small Cell Lung Cancer
- ClinicalTrials.gov ID
- NCT01679743
- Acronym / sponsor ID
- 120199
- Conditions
- Breast Cancer, Lung Neoplasms, Breast Neoplasms, Lung Cancer
- Keywords
- Metastatic Breast Cancer, Metastatic Lung Cancer, Monoclonal Antibody, 18FLT, Surgery
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Withdrawn
- Enrolment
- 0 participants (actual)
- Lead sponsor
- National Cancer Institute (NCI)US National Institutes of Health
- Study start
- 29 Aug 2012
- Primary completion
- 11 Aug 2014 (estimated)
- Study completion
- 11 Aug 2014 (estimated)
- First posted
- 6 Sep 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.
Background:
- Brain metastases are cancer cells that have spread to the brain from primary cancers in other organs. These tumors can be removed surgically. However, researchers are trying to find better ways to treat brain metastases. A new drug, GRN1005, has been designed to cross into the brain and deliver the cancer treatment drug paclitaxel to treat tumors. Researchers want to see how well GRN1005 works on brain metastases from breast or lung cancer.
Objectives:
- To test the safety and effectiveness of GRN1005 in treating brain metastases from breast or lung cancer.
Eligibility:
- Individuals at least 18 years of age who have breast or lung cancer that has spread to the brain.
Design:
- Participants will be screened with a physical exam and medical history. Blood and urine samples will be collected. Tumor tissue samples may also be collected. Imaging studies will also be performed.
- Participants who have breast cancer will be divided into two groups. Those whose cancer contains the HER2 protein will be treated with the drug Herceptin as well as GRN1005. Those without HER2 will have only GRN1005.
- Participants who have lung cancer will also have only GRN1005.
- All participants will have two doses of GRN1005, each 3 weeks apart. On the day the second dose of GRN1005 is given, participants will undergo surgery to remove the brain tumors.
- Treatment will be monitored with frequent blood tests and imaging studies.
Detailed description
Background:
Brain metastasis is the most common intra-cranial tumor in adults with approximately 170,000 new cases being diagnosed in the United States annually. The incidence of brain metastasis is increasing. Usually brain metastases of breast cancer occur after the diagnosis of systemic metastases; but approximately 10 25% of patients with lung cancer have brain metastases at diagnosis and another 40 50% develop them during the course of their disease. Multiple factors are contributing to this increase: aging population, improved imaging techniques, and improvement in the treatment of tumors leading to prolonged survival, thereby allowing the emergence of brain metastases, with the brain being generally regarded as a sanctuary site because of the blood brain barrier (BBB). Lung cancer and breast cancer are the leading tumor types, accounting for approximately 50% and 15 - 20% of patients with brain metastases. This study will evaluate the ability of 18F-FLT to determine if amount of change in the uptake in the brain metastases from breast and lung cancer after one dose of therapy with GRN1005, correlates with intra-cranial response. FLT-PET utilizes a radiolabeled form of thymidine, which is incorporated into DNA in proliferating cells. 18F-FLT uptake correlates better than 18F-FDG with proliferation, tumor progression, and survival. Because CNS uptake of FLT is low in contrast to FDG, this makes it potentially useful in evaluating CNS metastases. We would like to see which of these imaging modalities is superior in detection of brain metastases, and monitoring response to therapy.
Objectives:
-Determine whether one cycle of therapy GRN1005 is associated with a change in FLTPET uptake.
Eligibility:
- Adult patients (greater than or equal to 18 years)
- Histologically or cytologically-documented breast cancer (HER2 status must be known) or NSCLC
- Presence of resectable brain metastases based on evaluation by neurosurgery.
- At least one radiologically-confirmed and measurable metastatic brain lesion.
Design:
- Pilot non-randomized trial with or without trastuzumab
- Ten patients with resectable brain metastases from breast cancer and ten patients with resectable brain metastases from NSCLC will be studied.
- Baseline imaging (brain tumor protocol MRI and DSC-PWI MRI, FLT-PET) 1-14 days prior to first dose of GRN1005.
- Patients will receive 1 dose of GRN1005 on day 1 of study.
- Repeat FLT-PET imaging and MRIs will be done after 1 cycle of therapy and prior to surgery, on day 21.
- On the day of surgery, patients will receive a second dose of GRN1005 3 to 6 hours prior to brain surgery.
- PK studies will be done after each dose of GRN1005.
- Optional extra-cranial tumor biopsies will be performed before and after GRN1005 administration.
- Following surgery radiation therapy will be offered to patients as clinically indicated per radiation oncologist s recommendation.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| A | Experimental | Drug: Trastuzumab, Drug: GRN 1005Breast Cancer Cohort |
| B | Experimental | Drug: GRN 1005Non-Small Cell Lung Cancer Cohort |
Who may qualify
- Ages
- 18 to 99 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (22 listed)
- Adult patients (greater than or equal to 18 years)
- Histologically or cytologically-documented breast cancer (HER2 status must be known) or NSCLC
- Presence of resectable brain metastases with or without prior radiotherapy. Patients must be greater than 28 days from WBRT or SRS
- Presence of resectable brain metastases, as assessed by neurosurgical evaluation. A brain tumor will be considered to be resectable for the purposes of the study if it is located in the cerebrum or the cerebellum. Tumors that are located in deep brain structures, including the medulla, pons, midbrain, thalamus, and basal ganglia will be considered non-resectable. The tumor must be solitary or, if not, accompanied by another tumor on the same side of the brain that is also considered to be resectable by the same criteria.
- At least one radiologically-confirmed and measurable metastatic brain lesion (greater than or equal to 1.0 centimeters in the longest diameter) by Gd-MRI of the brain less than 14 days prior to first dose of GRN1005 (Cycle 1, Day 1). The spatial resolution of the Philips Gemini TOF PET/CT is 4millimeters [FWHM, (full width half maximum)]. One cm is greater than 2 times this FWHM and it is anticipated that greater than 70% of the actual activity in the lesion will be visualized (i.e. recovered). It is expected that all lesions greater than or equal to 1 centimeters will have sufficient FLT uptake. If no lesions on the baseline image are visualized on FLT PET/CT, then post therapy FLT imaging will not be performed. These patients will be replaced.
Key exclusion criteria (13 listed)
- NCI CTCAE v4.0 Grade greater than or equal to 2 neuropathy
- CNS disease requiring immediate neurosurgical intervention (e.g., resection, shunt placement, etc.)
- Known leptomeningeal disease
- Known severe hypersensitivity or allergy to paclitaxel or any of its components
- Treatment with P450 CYP 3A4 or 2C8 enzyme-inducing anticonvulsant drugs less than or equal to 14 days prior to first dose of GRN1005 (Cycle 1, Day 1)
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 |
|---|---|---|
| TrastuzumabTrastuzumab will be administered after GRN1005 in patients with HER2+ metastatic breast cancer. | Drug | A |
| GRN 1005GRN1005 will be administered at a dose of 550 mg/m2 as an IV infusion at a rate of 8.0 - 8.5 mL/minute on Day 1 of 21-day cycle ( 3 days) and a second dose will be given on the day of surgery (day 21) 3-6 h prior to surgery. | Drug | A, B |
Primary outcome
Effect of GRN therapy on PET uptake after treatment cycle 1
Time frame: 2 years
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Nov 2019.
- Background: PubMed 19675447Platta CS, Khuntia D, Mehta MP, Suh JH. Current treatment strategies for brain metastasis and complications from therapeutic techniques: a review of current literature. Am J Clin Oncol. 2010 Aug;33(4):398-407. doi: 10.1097/COC.0b013e318194f744.
- Background: PubMed 21472002Steeg PS, Camphausen KA, Smith QR. Brain metastases as preventive and therapeutic targets. Nat Rev Cancer. 2011 May;11(5):352-63. doi: 10.1038/nrc3053. Epub 2011 Apr 7.
- Background: PubMed 10098435Lagerwaard FJ, Levendag PC, Nowak PJ, Eijkenboom WM, Hanssens PE, Schmitz PI. Identification of prognostic factors in patients with brain metastases: a review of 1292 patients. Int J Radiat Oncol Biol Phys. 1999 Mar 1;43(4):795-803. doi: 10.1016/s0360-3016(98)00442-8.
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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.
Susan E Bates, M.D. principal investigator
National Cancer Institute (NCI)
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Trastuzumab and GRN 1005 in people with Breast Cancer and Lung Neoplasms, run by National Cancer Institute (NCI).
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 22 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: withdrawn, as of the sponsor's last update on 15 Nov 2019. Status can change between updates, so confirm with the study contact before making plans.
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?
The study was withdrawn before enrolling participants, so there are no results.
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?
Effect of GRN therapy on PET uptake after treatment cycle 1 (time frame: 2 years). 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 NCT01679743, which also lists 3 linked publications.
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 15 Nov 2019.