Metastatic Breast CancerPhase 2K5-101NCT00988936
Efficacy Study of [F-18]RGD-K5 Positron Emission Tomography (PET) as a Tool to Monitor Response to an Anti-angiogenic Drug
A Phase 2 study testing [F-18]RGD-K5 in people with Metastatic Breast Cancer and Metastatic Colon/Rectum Cancer, run by Siemens Molecular Imaging at 8 sites in United States.
Trial summary
A Pilot Phase II Study The primary objective for this study is: To explore the usefulness of [F-18]RGD-K5 PET/CT to predict efficacy or early response to Avastin® (the anti-angiogenesis drug) plus chemotherapy treatment before the full course of treatment is completed The secondary objectives for this study are: To… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Metastatic Breast Cancer, Metastatic Colon/Rectum Cancer, Non-squamous Non-small Cell Lung Cancer
- What is being tested?
- [F-18]RGD-K5
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 35 participants
- Where
- 8 sitesUnited States
- Study dates
- Sep 2009to May 2012
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patient is >18 years and male or female of any race / ethnicity
- Patient or patient's legally acceptable representative provides written informed consent and willing to comply with protocol requirements
- Patient must be scheduled to receive chemotherapy treatment(s) plus Avastin® for their cancer care; treatment management will be made by the treating medical oncologists (According to the package insert for Avastin®, it is administered as an IV infusion every 3 weeks for nonsquamous non-small cell lung cancer, and every 2 weeks for metastatic breast cancer, colon or rectum cancer)
- Patient will be scheduled to have a clinical [F-18]FDG-PET/CT or diagnostic CT pre-treatment after the fourth but before the fifth Avastin® treatment
Who cannot join
- Patient is not capable of complying with study procedures
- Female patient is pregnant or nursing; exclude the possibility of pregnancy by one of the following:
- Confirming in medical history that the patient is postmenopausal for a minimum of one year, or surgically sterile
- Confirming the patient is using one of the following methods of birth control for a minimum of one month prior to entry into this study: IUD, oral contraceptives, Depo-Provera, or Norplant
- Confirming a negative urine dipstick test taken the morning of receiving the [F-18]RGD-K5
- Patient has a severe hepatic or renal disease as defined by previous medical history or abnormal renal and hepatic functions determined by lab results not within the following ranges, or in the opinion of the Investigator, the values are not acceptable for the patient to be included:
Show all 14Show fewer
- AST (SGOT)/ALT (SGPT) ≤ 2.5 x institutional upper limits of normal
- Serum creatinine ≤ 2x institutional upper limits of normal
- BUN within 2x institutional upper limits of normal
- Patient has known hyper or hypo-coagulation syndromes. (e.g. Protein C, S deficiency, Hemophilia A/B/C, Factor-V Leiden, etc) or lab results are not within the following ranges, or in the opinion of the Investigator, the values are not acceptable for the patient to be included: Platelet counts of < 75 x 103/μL
- Patient has known sensitivity to any components of Avastin® such as recombinant human or humanized antibodies
- Patient has been involved in an investigative, radioactive research procedure within 7 days and during the study participation period
- Patient will participate in experimental therapy procedures while participating in this clinical trial
- Patient has any other condition or personal circumstance that, in the judgment of the investigator, might interfere with the collection of complete data or data quality to achieve study objectives, or complete study and/or post-dose follow-up examinations
Trial locations and contacts
8 sites in 1 country.
8 sites in 1 country
United States8 sites
University of California, Irvine
Irvine, California, 92697-5020
Cedars-Sinai Medical Center
Los Angeles, California, 90048
Beth Israel Medical Center
New York, New York, 10003
Mount Sinai School of Medicine
New York, New York, 10029
UMDNJ
Newark, New Jersey, 07103
Hospital of University of Pennsylvania
Philadelphia, Pennsylvania, 19104
Fox Chase Cancer Center
Philadelphia, Pennsylvania, 19111
Eastern Regional Medical Center
Philadelphia, Pennsylvania, 19124
About this study
Official title: A Phase II, Open Label, Non-randomized, Multi-center, Pilot, Efficacy Study of [F-18]RGD-K5 Positron Emission Tomography (PET) as a Tool to Monitor Response to an Anti-angiogenic Drug
A Pilot Phase II Study
The primary objective for this study is:
Read more
- To explore the usefulness of [F-18]RGD-K5 PET/CT to predict efficacy or early response to Avastin® (the anti-angiogenesis drug) plus chemotherapy treatment before the full course of treatment is completed
The secondary objectives for this study are:
- To continue safety evaluation by collection of safety data from all patients
- To gain experience with [F-18]RGD-K5 PET/CT in order to improve the study design and conduct of future studies
Design: An open label, non-randomized, uncontrolled, single group assignment, pilot efficacy study
Duration: Screening visit (3-4 hrs), pre-treatment imaging visit of [F-18]RGD-K5 PET/CT (~ 3-4 hrs) and the standard [F-18]FDG PET/CT (~ 3-4 hrs) or diagnostic CT, followed by two [F-18]RGD-K5 PET/CT scans, one after the second but before the third Avastin® treatment, and one after the fourth but before the fifth Avastin® treatment, and a follow up standard [F-18]FDG PET (~ 3-4 hrs) or diagnostic CT.
Procedures: Informed consent, collection of demographic information, medical history, blood labs, physical examination, vital signs, ECGs, three sets of [F-18]RGD-K5 dosing and imaging scans including pretreatment, early mid-treatment, and later mid-treatment, concomitant medication collection, adverse event monitoring, and assessment of tumor response to treatment
Patients: Approximately forty (40) patients with non-squamous non-small cell lung cancer, metastatic breast cancer, metastatic colon or rectum cancer who will receive chemotherapy plus Avastin®. This allows for approximately 30 evaluable patients to complete this study at approximately four to eight sites internationally
Read the detailed description
The aim of this pilot study is to examine the utility of a new molecular imaging tracer, [F-18]RGD-K5 to monitor treatment responses in patients scheduled to undergo treatment with Avastin® (Bevacizumab) plus standard chemotherapy. The changes of [F-18]RGD-K5 PET/CT image scans between before treatment and after both mid-treatment cycles of Avastin® (Bevacizumab) will be evaluated. The hypothesis for this study is that changes in the uptake of [F-18]RGD-K5 PET in tumors may reflect changes in the level of integrin expression and/or angiogenesis. This pilot study will help to define if changes in uptake of [F-18]RGD-K5 are an early indicator of treatment efficacy to Avastin®.
- Conditions
- Metastatic Breast Cancer, Metastatic Colon/Rectum Cancer, Non-squamous Non-small Cell Lung Cancer
- Being tested
- [F-18]RGD-K5
- Keywords
- [F-18]RGD-K5, RGD-K5, K5-101, Avastin, angiogenesis, anti-angiogenesis, chemotherapy, breast cancer, colon cancer, rectal cancer, lung cancer, non-squamous, non small cell
- Medical subject headings
- Breast Neoplasms, Rectal Neoplasms, Colonic Neoplasms, Lung Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
[F-18]RGD-K5Drug
Approximately forty (40) patients with non-squamous non-small cell lung cancer, metastatic breast cancer, metastatic colon or rectum cancer will receive chemotherapy plus Avastin® and will be imaged under PET/CT with [F-18]RGD-K5
| Study group | Role | What they receive |
|---|---|---|
| [F-18]RDG-K5 | Experimental | Not described Receives: Drug: [F-18]RGD-K5 |
What is being measured
The primary outcome is the main question the study is designed to answer.
To explore the usefulness of [F-18]RGD-K5 PET/CT to predict efficacy or early response to Avastin® (the anti-angiogenesis drug) plus chemotherapy treatment before the full course of treatment is completed.
Measured: (5) visits over a period of approximately 5 cycles of Avastin
Secondary outcomes (2)
To continue safety evaluation by collection of safety data from all patients.
Measured: (5) visits over a period of approximately 5 cycles of Avastin
To gain experience with [F-18]RGD-K5 PET/CT in order to improve the study design and conduct of future studies.
Measured: (5) visits over a period of approximately 5 cycles of Avastin
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Oct 2009 (estimated)
- Study startSep 2009
- Primary completionMar 2012
- Study completionMay 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Metastatic Breast CancerStudies 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 2
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 35 participants (actual)
Sponsor and investigators
- Lead sponsor
- Siemens Molecular Imaging
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Edward Aten, MD, Study director, President, Certus International
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00988936
- Sponsor's protocol ID
- K5-101
- Acronym
- K5-101
- Status last verified
- Aug 2012
- First submitted
- 1 Oct 2009
- Last updated
- 22 Aug 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Aug 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase II, Open Label, Non-randomized, Multi-center, Pilot, Efficacy Study of [F-18]RGD-K5 Positron Emission Tomography (PET) as a Tool to Monitor Response to an Anti-angiogenic Drug
- ClinicalTrials.gov ID
- NCT00988936
- Acronym / sponsor ID
- K5-101 / K5-101
- Conditions
- Metastatic Breast Cancer, Metastatic Colon/Rectum Cancer, Non-squamous Non-small Cell Lung Cancer
- Keywords
- [F-18]RGD-K5, RGD-K5, K5-101, Avastin, angiogenesis, anti-angiogenesis, chemotherapy, breast cancer
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 35 participants (actual)
- Lead sponsor
- Siemens Molecular ImagingIndustry (pharma, biotech, devices)
- Study start
- Sep 2009
- Primary completion
- Mar 2012 (actual)
- Study completion
- May 2012 (actual)
- First posted
- 2 Oct 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.
A Pilot Phase II Study
The primary objective for this study is:
- To explore the usefulness of [F-18]RGD-K5 PET/CT to predict efficacy or early response to Avastin® (the anti-angiogenesis drug) plus chemotherapy treatment before the full course of treatment is completed
The secondary objectives for this study are:
- To continue safety evaluation by collection of safety data from all patients
- To gain experience with [F-18]RGD-K5 PET/CT in order to improve the study design and conduct of future studies
Design: An open label, non-randomized, uncontrolled, single group assignment, pilot efficacy study
Duration: Screening visit (3-4 hrs), pre-treatment imaging visit of [F-18]RGD-K5 PET/CT (~ 3-4 hrs) and the standard [F-18]FDG PET/CT (~ 3-4 hrs) or diagnostic CT, followed by two [F-18]RGD-K5 PET/CT scans, one after the second but before the third Avastin® treatment, and one after the fourth but before the fifth Avastin® treatment, and a follow up standard [F-18]FDG PET (~ 3-4 hrs) or diagnostic CT.
Procedures: Informed consent, collection of demographic information, medical history, blood labs, physical examination, vital signs, ECGs, three sets of [F-18]RGD-K5 dosing and imaging scans including pretreatment, early mid-treatment, and later mid-treatment, concomitant medication collection, adverse event monitoring, and assessment of tumor response to treatment
Patients: Approximately forty (40) patients with non-squamous non-small cell lung cancer, metastatic breast cancer, metastatic colon or rectum cancer who will receive chemotherapy plus Avastin®. This allows for approximately 30 evaluable patients to complete this study at approximately four to eight sites internationally
Detailed description
The aim of this pilot study is to examine the utility of a new molecular imaging tracer, [F-18]RGD-K5 to monitor treatment responses in patients scheduled to undergo treatment with Avastin® (Bevacizumab) plus standard chemotherapy. The changes of [F-18]RGD-K5 PET/CT image scans between before treatment and after both mid-treatment cycles of Avastin® (Bevacizumab) will be evaluated. The hypothesis for this study is that changes in the uptake of [F-18]RGD-K5 PET in tumors may reflect changes in the level of integrin expression and/or angiogenesis. This pilot study will help to define if changes in uptake of [F-18]RGD-K5 are an early indicator of treatment efficacy to Avastin®.
Study design
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| [F-18]RDG-K5 | Experimental | Drug: [F-18]RGD-K5 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Patient is >18 years and male or female of any race / ethnicity
- Patient or patient's legally acceptable representative provides written informed consent and willing to comply with protocol requirements
- Patient must be scheduled to receive chemotherapy treatment(s) plus Avastin® for their cancer care; treatment management will be made by the treating medical oncologists (According to the package insert for Avastin®, it is administered as an IV infusion every 3 weeks for nonsquamous non-small cell lung cancer, and every 2 weeks for metastatic breast cancer, colon or rectum cancer)
- Patient will be scheduled to have a clinical [F-18]FDG-PET/CT or diagnostic CT pre-treatment after the fourth but before the fifth Avastin® treatment
Key exclusion criteria (14 listed)
- Patient is not capable of complying with study procedures
- Female patient is pregnant or nursing; exclude the possibility of pregnancy by one of the following:
- Patient has a severe hepatic or renal disease as defined by previous medical history or abnormal renal and hepatic functions determined by lab results not within the following ranges, or in the opinion of the Investigator, the values are not acceptable for the patient to be included:
- Patient has known sensitivity to any components of Avastin® such as recombinant human or humanized antibodies
- Patient has been involved in an investigative, radioactive research procedure within 7 days and during the study participation period
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 |
|---|---|---|
| [F-18]RGD-K5Approximately forty (40) patients with non-squamous non-small cell lung cancer, metastatic breast cancer, metastatic colon or rectum cancer will receive chemotherapy plus Avastin® and will be imaged under PET/CT with [F-18]RGD-K5 | Drug | [F-18]RDG-K5 |
Primary outcome
To explore the usefulness of [F-18]RGD-K5 PET/CT to predict efficacy or early response to Avastin® (the anti-angiogenesis drug) plus chemotherapy treatment before the full course of treatment is completed.
Time frame: (5) visits over a period of approximately 5 cycles of Avastin
2 secondary outcomes
To continue safety evaluation by collection of safety data from all patients.
Time frame: (5) visits over a period of approximately 5 cycles of Avastin
To gain experience with [F-18]RGD-K5 PET/CT in order to improve the study design and conduct of future studies.
Time frame: (5) visits over a period of approximately 5 cycles of Avastin
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 22 Aug 2012.
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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.
Edward Aten, MD study director
President, Certus International
8 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 [F-18]RGD-K5 in people with Metastatic Breast Cancer and Metastatic Colon/Rectum Cancer, run by Siemens Molecular Imaging at 8 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 4 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 22 Aug 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 8 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?
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 explore the usefulness of [F-18]RGD-K5 PET/CT to predict efficacy or early response to Avastin® (the anti-angiogenesis drug) plus chemotherapy treatment before the full course of treatment is completed. (time frame: (5) visits over a period of approximately 5 cycles of Avastin). 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 22 Aug 2012.