Breast NeoplasmsPhase 2NCT00048633
Phase II Study to Evaluate Tariquidar (XR9576), a Selective MDR-1 Inhibitor, in Chemotherapy Resistant Advanced Breast Cancer
A Phase 2 study testing Chemotherapy in people with Breast Neoplasms, run by QLT Inc. at 4 sites in United States.
Trial summary
The primary objective of this phase II study is to assess if XR9576, a selective MDR-1 inhibitor, is able to reverse primary doxorubicin or taxane resistance in advanced breast cancer. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Breast Neoplasms
- What is being tested?
- Chemotherapy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 4 sitesUnited States
- Study dates
- Nov 2001to Jun 2003
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Histologically proven breast cancer with primary resistance to anthracyclines (doxorubicin, epirubicin) or taxane (paclitaxel, docetaxel) or both. Primary chemotherapy resistance is defined for the purpose of this protocol as any of the following:
- Progression after a minimum of 1 cycles of therapy, or
- Stable disease after a minimum of 2 cycles of therapy or,
- Relapse within 6 months after completion of an anthracycline or/and taxane containing chemotherapy regimen.
- Patients with anthracycline/taxane resistance INOPERABLE, locally advanced breast cancer are eligible.
- Patients must have measurable disease as defined by the RECIST criteria in their breast/nodal regions or at a distant organ site(s).
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- There is no limit on prior hormonal therapies but only one prior chemotherapy for metastatic breast cancer is allowed.
- Patients may receive concomitant bisphosphonate therapy for bone metastasis.
- Patients may continue Herceptin if it has previously been started. Herceptin cannot be added to the chemotherapy regimen as a new agent at the same time when XR9576 is initiated.
- Patients much have recovered from acute toxic effects of any prior therapy.
- Zubrod performance status less than or equal to 2.
- Adequate bone marrow function: platelets greater than or equal to 100,000/mm3, ANC greater than or equal to 1500 cells/mm3, hemoglobin greater than or equal to 8g/dl.
- Normal renal function: creatinine less than or equal to 2.0 mg/dl. Adequate liver function: bilirubin less than or equal to 1.5 mg/dl. Transaminase (SGOT) and alkaline phosphatase must be less than or equal to 1.5 x of the upper limit of normal in the absence of bone or liver metastasis, or less than or equal to 2.5 x of the upper limit of normal in the presence of radiologically apparent liver metastasis or bone metastasis, respectively.
- Female patients must be of non-lactating and using adequate contraception if premenopausal. Beta-HCG will be checked in premenopausal patients if clinically indicated.
- Patients with brain metastases whose disease remained stable for more than 3 months after completing therapy to the brain are eligible.
- Written informed consent.
Who cannot join
- More than 1 chemotherapy regimen for metastatic breast cancer.
- Patients who relapsed more than 6 months after completion of anthracycline or taxane therapy.
- Current treatment with a non-taxane, non-anthracycline based chemotherapy.
- Uncontrolled psychiatric, or social (addictive) disorders that would preclude obtaining informed consent or patient participation in the study.
- Clinical contraindication of continued anthracycline or taxane therapy. For patients who show primary resistance to anthracyclines this includes greater than 300 mg/m2 maximum life-time cumulative dose of doxorubicin, symptomatic heart failure, history of heart failure, recent myocardial infarction (less than 6 months) or left ventricular ejection fraction below normal range. For patients with primary resistance to taxanes, persistent grade 2 or greater neuropathy (neuropathy that interferes with function).
- Patients with operable primary breast cancer are not eligible.
- Patients who have developed primary resistance to the chemotherapy combination of doxorubicin/docetaxel.
Trial locations and contacts
4 sites in 1 country.
United States4 sites
Arlington Cancer Center
Arlington, Texas, 76012
MD Anderson Cancer Center
Houston, Texas, 77030-4009
Florida Oncology Associates
Jacksonville, Florida, 32207-5905
Medical Center of Vincennes
Vincennes, Indiana, 47591
About this study
The primary objective of this phase II study is to assess if XR9576, a selective MDR-1 inhibitor, is able to reverse primary doxorubicin or taxane resistance in advanced breast cancer. Clinical activity will be measured by objective tumor response rates observed after treatment with XR9576 in combination with taxane or anthracycline containing chemotherapy in patients previously resistant to the same agent(s).
The secondary objectives of the study are to assess the biological activity of XR9576 and evaluate MDR-1 expression in these tumors. The MDR-1 inhibitory activity of XR9576 will be evaluated by serial sestamibi scans of the tumor. MDR-1 expression will be detected by immunohistochemistry.
- Conditions
- Breast Neoplasms
- Being tested
- Chemotherapy
- Keywords
- Chemotherapy resistance advanced breast cancer
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ChemotherapyDrug
| Study group | Role | What they receive |
|---|---|---|
| Tariquidar | Experimental | Not described Receives: Drug: Chemotherapy |
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Nov 2002 (estimated)
- Study startNov 2001
- Primary completionJun 2003
- Study completionJun 2003
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast NeoplasmsStudies 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
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 30 participants
Sponsor and investigators
- Lead sponsor
- QLT Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Graeme R Boniface, Study director, Sponsor GmbH
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00048633
- Sponsor's protocol ID
- TQD BRST 001
- Status last verified
- May 2012
- First submitted
- 4 Nov 2002
- Last updated
- 23 May 2012
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 May 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase II Study to Evaluate Tariquidar (XR9576), a Selective MDR-1 Inhibitor, in Chemotherapy Resistant Advanced Breast Cancer
- ClinicalTrials.gov ID
- NCT00048633
- Acronym / sponsor ID
- TQD BRST 001
- Conditions
- Breast Neoplasms
- Keywords
- Chemotherapy resistance advanced breast cancer
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants
- Lead sponsor
- QLT Inc.Industry (pharma, biotech, devices)
- Study start
- Nov 2001
- Primary completion
- Jun 2003 (actual)
- Study completion
- Jun 2003 (actual)
- First posted
- 6 Nov 2002 (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 primary objective of this phase II study is to assess if XR9576, a selective MDR-1 inhibitor, is able to reverse primary doxorubicin or taxane resistance in advanced breast cancer. Clinical activity will be measured by objective tumor response rates observed after treatment with XR9576 in combination with taxane or anthracycline containing chemotherapy in patients previously resistant to the same agent(s).
The secondary objectives of the study are to assess the biological activity of XR9576 and evaluate MDR-1 expression in these tumors. The MDR-1 inhibitory activity of XR9576 will be evaluated by serial sestamibi scans of the tumor. MDR-1 expression will be detected by immunohistochemistry.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Tariquidar | Experimental | Drug: Chemotherapy |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (16 listed)
- Histologically proven breast cancer with primary resistance to anthracyclines (doxorubicin, epirubicin) or taxane (paclitaxel, docetaxel) or both. Primary chemotherapy resistance is defined for the purpose of this protocol as any of the following:
- Patients with anthracycline/taxane resistance INOPERABLE, locally advanced breast cancer are eligible.
- Patients must have measurable disease as defined by the RECIST criteria in their breast/nodal regions or at a distant organ site(s).
- There is no limit on prior hormonal therapies but only one prior chemotherapy for metastatic breast cancer is allowed.
- Patients may receive concomitant bisphosphonate therapy for bone metastasis.
Key exclusion criteria (7 listed)
- More than 1 chemotherapy regimen for metastatic breast cancer.
- Patients who relapsed more than 6 months after completion of anthracycline or taxane therapy.
- Current treatment with a non-taxane, non-anthracycline based chemotherapy.
- Uncontrolled psychiatric, or social (addictive) disorders that would preclude obtaining informed consent or patient participation in the study.
- Clinical contraindication of continued anthracycline or taxane therapy. For patients who show primary resistance to anthracyclines this includes greater than 300 mg/m2 maximum life-time cumulative dose of doxorubicin, symptomatic heart failure, history of heart failure, recent myocardial infarction (less than 6 months) or left ventricular ejection fraction below normal range. For patients with primary resistance to taxanes, persistent grade 2 or greater neuropathy (neuropathy that interferes with function).
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 |
|---|---|---|
| Chemotherapy | Drug | Tariquidar |
Primary outcome
Not reported in the source record.
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 23 May 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.
Graeme R Boniface study director
Sponsor GmbH
4 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 Chemotherapy in people with Breast Neoplasms, run by QLT Inc. at 4 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 16 inclusion and 7 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 23 May 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 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.
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 23 May 2012.