Breast CancerPhase 2NCT00096668
Evaluation of Safety and Efficacy of TOCOSOL(R) Paclitaxel as Initial Treatment for Metastatic Breast Cancer
A Phase 2 study testing TOCOSOL(R) Paclitaxel in people with Breast Cancer, run by Achieve Life Sciences at 7 sites in Russia.
Trial summary
This is an open label study where each patient will receive TOCOSOL(R) Paclitaxel 120mg/m2 every week for first line treatment of metastatic breast cancer. Patients will be followed to determine the efficacy of treatment (as measured by objective response rate), and the safety associated with weekly administration of… Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Breast Cancer
- What is being tested?
- TOCOSOL(R) Paclitaxel
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 47 participants
- Where
- 7 sitesRussia
- Study dates
- Oct 2004to Sep 2007
- 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
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Female patient with histologic diagnosis of breast carcinoma
- Stage IV (M1) disease
- No prior cytotoxic chemotherapy regimen for treatment of metastatic breast cancer
- Adult (18 years of age or older) patients
- Adequate hematologic function (ANC >=1500 cells/mm3 and platelets >100,000/mm3
- Serum creatinine <=2.0 mg/dL
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- Total bilirubin <=1.5 mg/dL
- AST/SGOT and ALT/SGPT <=3 times the upper limit of institutional normal values
- PT and PTT within institutional normal range
- ECOG performance status of 0-2
- At least one unidimensionally measurable lesion as defined by RECIST criteria assessable by radiographic evaluation
- A signed IRB/Ethics Committee approved Informed Consent
- Life expectancy of at least 12 weeks
- Fully recovered from any previous surgery
- A negative pregnancy test prior to study entry if premenopausal
- Agree not to take Vitamin E supplementation while receiving study medication
Who cannot join
- Any prior taxane-containing chemotherapy including Taxol or Taxotere
- Patients who are pregnant or lactating
- Peripheral neuropathy NCI-CTC grade 2 or greater
- Wide-field radiation, hormonal therapy or trastuzumab within 4 weeks of first dose of study drug; cytotoxic chemotherapy within 6 months of first dose of study drug
- Treatment with an investigational agent within 4 weeks of first dose of study drug
- Patients with a history of carcinomas of primary sites which can not be distinguished histologically from metastatic breast carcinoma
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- Bone metastasis, effusions, ascites or elevated tumor markers as the only evidence of metastatic breast carcinoma
- Brain metastases
- Active bowel obstruction
- Active, serious infection or other serious medical problems (other than metastatic breast cancer) likely to impair completion of the study protocol
- Concurrent therapy with known substrates or inhibitors of the cytochrome P450 isoenzymes CYP2C8 or CYP3A4
- Concurrent therapy with warfarin or other coumarin derivatives
Trial locations and contacts
7 sites in 1 country.
7 sites in 1 country
Russia7 sites
Arkhangelsk Regional Oncology Center
Arkhangelsk, 163045
Moscow Oncology Clinical Hospital #62
Krasnogorskiy Region, 143423
Blokhin Russian Oncology Center
Moscow, 115478
Semashko Central Clinical Hospital of the Ministry of Transport
Moscow, 129128
St Petersburg Oncology Center
Saint Petersburg, 197022
Petrov Research Institute of Oncology
Saint Petersburg, 197758
Voronezh Regional Clinical Oncology Center
Voronezh, 3394000
About this study
Official title: A Phase 2 Multicenter Evaluation of the Safety and Efficacy of TOCOSOL(R) Paclitaxel (S-8184 Paclitaxel Injectable Emulsion) as Initial Treatment of Patients With Metastatic Breast Cancer
This is an open label study where each patient will receive TOCOSOL(R) Paclitaxel 120mg/m2 every week for first line treatment of metastatic breast cancer. Patients will be followed to determine the efficacy of treatment (as measured by objective response rate), and the safety associated with weekly administration of TOCOSOL Paclitaxel.
Read the detailed description
This is an open label, non-randomized Phase 2 study of weekly administration of TOCOSOL Paclitaxel at a dose level, 120mg/m2, known to be tolerated based on Phase 2a studies of this investigational agent in patients with other histological diagnoses. This study is a fixed sample size design with no planned early stopping decision. The goals of the study include the determination of the safety of TOCOSOL Paclitaxel, and the objective response rate, defined by RECIST criteria as complete responses plus partial responses.
- Conditions
- Breast Cancer
- Being tested
- TOCOSOL(R) Paclitaxel
- Keywords
- Breast cancer, TOCOSOL Paclitaxel
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TOCOSOL(R) PaclitaxelDrug
| Study group | Role | What they receive |
|---|---|---|
| TOCOSOL Paclitaxel | Experimental | TOCOSOL Paclitaxel administered weekly at 120mg/mm2 Receives: Drug: TOCOSOL(R) Paclitaxel |
What is being measured
The primary outcome is the main question the study is designed to answer.
Tolerability
Measured: After all patients complete treatment
Secondary outcomes (1)
Objective Response Rate
Measured: After alll patients complete treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Nov 2004 (estimated)
- Study startOct 2004
- Primary completionSep 2007
- Study completionSep 2007
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 2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 47 participants (actual)
Sponsor and investigators
- Lead sponsor
- Achieve Life Sciences
- Sponsor type
- Industry (pharma, biotech, devices)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00096668
- Sponsor's protocol ID
- SON-8184-1074
- Status last verified
- Jun 2009
- First submitted
- 12 Nov 2004
- Last updated
- 4 Jun 2009
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Jun 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 2 Multicenter Evaluation of the Safety and Efficacy of TOCOSOL(R) Paclitaxel (S-8184 Paclitaxel Injectable Emulsion) as Initial Treatment of Patients With Metastatic Breast Cancer
- ClinicalTrials.gov ID
- NCT00096668
- Acronym / sponsor ID
- SON-8184-1074
- Conditions
- Breast Cancer
- Keywords
- Breast cancer, TOCOSOL Paclitaxel
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 47 participants (actual)
- Lead sponsor
- Achieve Life SciencesIndustry (pharma, biotech, devices)
- Study start
- Oct 2004
- Primary completion
- Sep 2007 (actual)
- Study completion
- Sep 2007 (actual)
- First posted
- 15 Nov 2004 (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.
This is an open label study where each patient will receive TOCOSOL(R) Paclitaxel 120mg/m2 every week for first line treatment of metastatic breast cancer. Patients will be followed to determine the efficacy of treatment (as measured by objective response rate), and the safety associated with weekly administration of TOCOSOL Paclitaxel.
Detailed description
This is an open label, non-randomized Phase 2 study of weekly administration of TOCOSOL Paclitaxel at a dose level, 120mg/m2, known to be tolerated based on Phase 2a studies of this investigational agent in patients with other histological diagnoses. This study is a fixed sample size design with no planned early stopping decision. The goals of the study include the determination of the safety of TOCOSOL Paclitaxel, and the objective response rate, defined by RECIST criteria as complete responses plus partial responses.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| TOCOSOL Paclitaxel | Experimental | Drug: TOCOSOL(R) PaclitaxelTOCOSOL Paclitaxel administered weekly at 120mg/mm2 |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (16 listed)
- Female patient with histologic diagnosis of breast carcinoma
- Stage IV (M1) disease
- No prior cytotoxic chemotherapy regimen for treatment of metastatic breast cancer
- Adult (18 years of age or older) patients
- Adequate hematologic function (ANC >=1500 cells/mm3 and platelets >100,000/mm3
Key exclusion criteria (12 listed)
- Any prior taxane-containing chemotherapy including Taxol or Taxotere
- Patients who are pregnant or lactating
- Peripheral neuropathy NCI-CTC grade 2 or greater
- Wide-field radiation, hormonal therapy or trastuzumab within 4 weeks of first dose of study drug; cytotoxic chemotherapy within 6 months of first dose of study drug
- Treatment with an investigational agent within 4 weeks of first dose of study drug
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 |
|---|---|---|
| TOCOSOL(R) Paclitaxel | Drug | TOCOSOL Paclitaxel |
Primary outcome
Tolerability
Time frame: After all patients complete treatment
1 secondary outcome
Objective Response Rate
Time frame: After alll patients complete treatment
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 4 Jun 2009.
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 TOCOSOL(R) Paclitaxel in people with Breast Cancer, run by Achieve Life Sciences at 7 sites in Russia.
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 12 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 4 Jun 2009. 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 Russia. 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?
Tolerability (time frame: After all patients complete treatment). 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 4 Jun 2009.