Breast CancerPhase 1/2NCT00505271
Safety and Efficacy Study Using Rexin-G for Breast Cancer
A Phase 1/2 study testing Rexin-G in people with Breast Cancer, run by Epeius Biotechnologies at 3 sites in United States.
Trial summary
The goal of the adaptive trial design is to confirm the over-all safety of Rexin-G and to determine the optimal dosing regimen for Rexin-G that would document the significant clinical benefits required to support a Phase II registration protocol for recurrent or metastatic breast cancer. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Breast Cancer
- What is being tested?
- Rexin-G
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 3 sitesUnited States
- Study dates
- Jul 2007to Jun 2011
- Phase
- Phase 1/2
- 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
- Histologically or cytologically confirmed recurrent or metastatic breast cancer that is refractory to standard chemotherapy and that is measurable.
- Adequate hepatic function: Total bilirubin < 2.0 mg/dL (upper limit included); AST/ALT < 2x institutional norm; alkaline phosphatase < 2.5x upper limit of institutional norm unless the patient has extensive bone metastases. Patients with elevated alkaline phosphatase due to extensive liver disease will be excluded from study; albumin > 3.0 mg/dL. There must be no substantial ascites. PT and PTT must be within normal limits.
- Performance status must be < 1 (ECOG 0-1) with a life expectancy of at least 3 months.
- Hemoglobin > 9 gms%
- Absolute granulocyte count > 1000/uL, and platelet count > 100,000/uL.
- Serum creatinine of less than 1.5 mg%.
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- There must be no plans for the patient to receive further cancer therapy from the date of enrollment until the completion of the 6-week follow-up visit.
- Accessibility of peripheral or central IV line
- Age > 18 years
- Patients will be off chemotherapy for a minimum of 4 weeks prior to initiation of therapy and should have recovered to Grade 1 or less toxicity.
- The ability to understand and the willingness to sign a written informed consent document.
Who cannot join
- Prior malignancy, except for non-melanoma skin cancer, stage 1 breast cancer, CIS of cervix from which the patient has been disease-free for 5 years.
- Woman who are pregnant or nursing
- Fertile patients unless they agree to use barrier contraception (condoms and spermicide jelly) during the vector infusion period and for six weeks after infusion. Male patients must agree to use barrier contraception.
- Patients who are transfusion dependent (more than one transfusion per month)
- Patients with medical, psychiatric, or social conditions that would compromise successful adherence to this protocol.
- Patient who do not meet the inclusion criteria.
Trial locations and contacts
3 sites in 1 country.
United States3 sites
Bruckner Oncology
New York, New York, 10003
Epeius Clinical Research Unit
San Marino, California, 91108
Sarcoma Oncology Center
Santa Monica, California, 90403
About this study
Official title: Phase I/II Evaluation of Safety and Efficacy of Pathotropic Nanoparticles Bearing a Dominant Negative Cyclin G1 Construct (Rexin-G) as Intervention for Recurrent or Metastatic Breast Cancer
The goal of the adaptive trial design is to confirm the over-all safety of Rexin-G and to determine the optimal dosing regimen for Rexin-G that would document the significant clinical benefits required to support a Phase II registration protocol for recurrent or metastatic breast cancer.
Read the detailed description
The clinical trial incorporates a Phase II component that will evaluate the efficacy of Rexin-G using an adaptive trial design. Each treatment cycle will be six weeks: four weeks of treatment and two weeks of rest. Unlike a standard Phase I protocol, eligible patients may have repeat cycles after the safety data and objective tumor response/s are recorded. Continued Rexin-G treatment will enable the targeted nanomedicine to catch up with tumor growth, halt disease progression, and reduce tumor burden. The treatment strategy is to achieve tumor control as quickly as safely possible. The goal of the adaptive trial design is to confirm the over-all safety of Rexin-G and to determine the optimal dosing regimen for Rexin-G that would document the significant clinical benefits required to support a Phase II registration protocol for breast cancer.
- Conditions
- Breast Cancer
- Being tested
- Rexin-G
- Keywords
- Breast Cancer, Rexin-G, Gene Therapy
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Rexin-GGenetic
Three patients will receive Rexin-G at Dose Level I. If 1 of 3 patients at Dose Level I develops a grade 3 or 4 adverse event (CTCAE Version 3.0) which appears to be related or possibly related to Rexin-G, then 3 additional patients will be enrolled at the same dose level. If at least 2 of the first 3, or 3 of 6 patients at Dose Level I develop a grade 3 to 4 adverse event which appears to be related or possibly related to Rexin-G, accrual into the study will be held.
At any dose level, up to six patients may be enrolled if there is evidence of biological activity in the first three patients. Dose escalation may stop if there is impressive evidence of biological activity. An amendment would be submitted to allow further expansion of dose level based on impressive biological activity.
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Escalating doses of Rexin-G will be given two or three times a week for four weeks, with a 2 week rest period Receives: Genetic: Rexin-G |
What is being measured
The primary outcome is the main question the study is designed to answer.
Clinical toxicity (DLT and MTD) as defined by patient performance status, toxicity assessment score, hematologic and metabolic profiles.
Measured: 24 months
Secondary outcomes (1)
To identify an objective tumor response to Rexin-G
Measured: 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jul 2007 (estimated)
- Study startJul 2007
- Primary completionJul 2010
- Study completionJun 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for 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 1/2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Epeius Biotechnologies
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Sant P Chawla, M.D., Principal investigator, Epeius Clinical Research Unit/Sarcoma Oncology CenterHoward W Bruckner, M.D., Principal investigator, Bruckner Oncology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00505271
- Sponsor's protocol ID
- C07-104
- Status last verified
- Jun 2011
- First submitted
- 19 Jul 2007
- Last updated
- 10 Jun 2011
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 10 Jun 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase I/II Evaluation of Safety and Efficacy of Pathotropic Nanoparticles Bearing a Dominant Negative Cyclin G1 Construct (Rexin-G) as Intervention for Recurrent or Metastatic Breast Cancer
- ClinicalTrials.gov ID
- NCT00505271
- Acronym / sponsor ID
- C07-104
- Conditions
- Breast Cancer
- Keywords
- Breast Cancer, Rexin-G, Gene Therapy
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Epeius BiotechnologiesIndustry (pharma, biotech, devices)
- Study start
- Jul 2007
- Primary completion
- Jul 2010 (actual)
- Study completion
- Jun 2011 (actual)
- First posted
- 23 Jul 2007 (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.
The goal of the adaptive trial design is to confirm the over-all safety of Rexin-G and to determine the optimal dosing regimen for Rexin-G that would document the significant clinical benefits required to support a Phase II registration protocol for recurrent or metastatic breast cancer.
Detailed description
The clinical trial incorporates a Phase II component that will evaluate the efficacy of Rexin-G using an adaptive trial design. Each treatment cycle will be six weeks: four weeks of treatment and two weeks of rest. Unlike a standard Phase I protocol, eligible patients may have repeat cycles after the safety data and objective tumor response/s are recorded. Continued Rexin-G treatment will enable the targeted nanomedicine to catch up with tumor growth, halt disease progression, and reduce tumor burden. The treatment strategy is to achieve tumor control as quickly as safely possible. The goal of the adaptive trial design is to confirm the over-all safety of Rexin-G and to determine the optimal dosing regimen for Rexin-G that would document the significant clinical benefits required to support a Phase II registration protocol for breast cancer.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Genetic: Rexin-GEscalating doses of Rexin-G will be given two or three times a week for four weeks, with a 2 week rest period |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- Histologically or cytologically confirmed recurrent or metastatic breast cancer that is refractory to standard chemotherapy and that is measurable.
- Adequate hepatic function: Total bilirubin < 2.0 mg/dL (upper limit included); AST/ALT < 2x institutional norm; alkaline phosphatase < 2.5x upper limit of institutional norm unless the patient has extensive bone metastases. Patients with elevated alkaline phosphatase due to extensive liver disease will be excluded from study; albumin > 3.0 mg/dL. There must be no substantial ascites. PT and PTT must be within normal limits.
- Performance status must be < 1 (ECOG 0-1) with a life expectancy of at least 3 months.
- Hemoglobin > 9 gms%
- Absolute granulocyte count > 1000/uL, and platelet count > 100,000/uL.
Key exclusion criteria (6 listed)
- Prior malignancy, except for non-melanoma skin cancer, stage 1 breast cancer, CIS of cervix from which the patient has been disease-free for 5 years.
- Woman who are pregnant or nursing
- Fertile patients unless they agree to use barrier contraception (condoms and spermicide jelly) during the vector infusion period and for six weeks after infusion. Male patients must agree to use barrier contraception.
- Patients who are transfusion dependent (more than one transfusion per month)
- Patients with medical, psychiatric, or social conditions that would compromise successful adherence to this protocol.
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 |
|---|---|---|
| Rexin-GThree patients will receive Rexin-G at Dose Level I. If 1 of 3 patients at Dose Level I develops a grade 3 or 4 adverse event (CTCAE Version 3.0) which appears to be related or possibly related to Rexin-G, then 3 additional patients will be enrolled at the same dose level. If at least 2 of the first 3, or 3 of 6 patients at Dose Level I develop a grade 3 to 4 adverse event which appears to be related or possibly related to Rexin-G, accrual into the study will be held. At any dose level, up to six patients may be enrolled if there is evidence of biological activity in the first three patients. Dose escalation may stop if there is impressive evidence of biological activity. An amendment would be submitted to allow further expansion of dose level based on impressive biological activity. | Genetic | 1 |
Primary outcome
Clinical toxicity (DLT and MTD) as defined by patient performance status, toxicity assessment score, hematologic and metabolic profiles.
Time frame: 24 months
1 secondary outcome
To identify an objective tumor response to Rexin-G
Time frame: 24 months
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 10 Jun 2011.
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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.
Sant P Chawla, M.D. principal investigator
Epeius Clinical Research Unit/Sarcoma Oncology Center
Howard W Bruckner, M.D. principal investigator
Bruckner Oncology
3 sites 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 Rexin-G in people with Breast Cancer, run by Epeius Biotechnologies at 3 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 11 inclusion and 6 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 10 Jun 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 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 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?
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?
Clinical toxicity (DLT and MTD) as defined by patient performance status, toxicity assessment score, hematologic and metabolic profiles. (time frame: 24 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 10 Jun 2011.