Cancer of the BreastPhase 1/2NCT00217815
Preliminary Study of Mycograb and Docetaxel in Advanced Breast Cancer
A Phase 1/2 study testing Mycograb, Docetaxel in people with Cancer of the Breast, run by NeuTec Pharma at 3 sites in 2 countries.
Trial summary
The study hypothesis is that the addition of Mycograb to docetaxel will improve outcome in advanced carcinoma of the breast. Read more about this study
- Who is it for?
- Ages 18 to 70 years, women only
- Conditions the study is for
- Cancer of the Breast
- What is being tested?
- Mycograb, Docetaxel
- How many people
- 20 participants
- Where
- 3 sitesin 2 countries
- Study dates
- Sep 2005to Oct 2006
- 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 to 70 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients must be female between the ages of 18 to 70 years old.
- Patients must have histologically or clinically confirmed metastatic and/or recurrent breast cancer amenable to treatment with docetaxel.
- Patients must have presence of at least one uni-dimensional measurable lesion with minimal lesion size > 20 mm at the largest diameter.
- Patients may have had one previous chemotherapy regimen and must not have received prior chemotherapy with docetaxel.
- Patients must have been off all hormonal therapy for at least 2 weeks prior to initiation of therapy.
- Patients must have been off all chemotherapy or radiotherapy regimens for at least 4 weeks prior to initiation of chemotherapy.
Show all 12Show fewer
- Patients must have a life expectancy of at least 6 months.
- Patients must have a ECOG status of 0, 1 or 2.
- Patients must be willing to complete all procedures and visits as outlined in the protocol.
- Patients must sign an informed consent form.
- Patients must have negative blood test for HIV and hepatitis B and C.
- Female patients of child bearing potential should use an effective method of contraception.
Who cannot join
- Patients with brain or meningeal metastases.
- Patients whose only measurable lesion is in the bone.
- Patients with clinically significant cardiovascular, pulmonary, renal, endocrine, hepatic, respiratory, neurologic, psychiatric, immunologic, gastrointestinal, hematologic, metabolic or any other condition or laboratory abnormality that in the opinion of the investigator makes the patient unsuitable for participation in the study.
- Patients with history of seizure disorder.
- Patients who have received treatment with any other investigational drug within the preceding one month.
- Patients who are pregnant or breast feeding.
Trial locations and contacts
3 sites in 2 countries.
3 sites in 2 countries
Serbia2 sites
Clinical Hospital Centre Bezanijska Kosa
Bezanijska Kosa Bb, Belgrade, 11000
Institute For Oncology and Radiology of Serbia
Pasterova 14, Belgrade, 11000
Poland1 site
Chemotherapie Clinic of Medical University Lodz
Lodz, Pabianicka, 93-513
About this study
Official title: A Phase Ib, Pharmacokinetic, Multiple Center, Open Label Study Evaluating the Safety and Efficacy of Mycograb Administered IV in Combination With Docetaxel in Metastatic or Recurrent Breast Cancer Patients
The study hypothesis is that the addition of Mycograb to docetaxel will improve outcome in advanced carcinoma of the breast.
Read the detailed description
Combination therapies that incorporate new agents have demonstrated the potential to improve outcome for patients with metastatic breast carcinoma. Docetaxel has been shown to be a very active drug in breast cancer, and anthracycline-based chemotherapy combinations represent the most active form of therapy generating objective response rates of between 40-70%. Mycograb® was most effective in breast carcinoma cell lines in combination with cisplatin, docetaxel and anthracyclines (doxorubicin, daunorubicin).
We propose that Mycograb® binds to hsp90, inhibiting hsp90 chaperone functioning and resulting in the destabilization of key proteins including estrogen/steroid receptors, nitric oxide synthase, ras1, MAP (Mitogen-activated protein) kinase, Src, Erb-B2,(erythroblastic leukemia viral oncogene homolog 2) HER(human estrogen receptor) kinases and EGFR (epidermal grown factor receptor). Over expression of HER2 receptors are observed in malignancies such as breast cancer and reportedly have been associated with resistance to chemotherapeutic agents. Both maturing and fully mature forms of the receptor depend on hsp90 association for stability. Inhibition of hsp90 function down regulates AKT kinase and Src kinase which are non-receptor kinase. Therefore, Mycograb® may be of use in estrogen dependent and hormone independent breast cancers.
Mycograb® has been demonstrated to have anti-tumor activity in cell culture. The 50% cytotoxicity of Mycograb® on its own is 50 Combination therapies that incorporate new agents have demonstrated the potential to improve outcome for patients with metastatic breast carcinoma. Docetaxel has been shown to be a very active drug in breast cancer, and anthracycline-based chemotherapy combinations represent the most active form of therapy generating objective response rates of between 40-70%. Mycograb® was most effective in breast carcinoma cell lines in combination with cisplatin, docetaxel and anthracyclines (doxorubicin, daunorubicin).
We propose that Mycograb® binds to hsp90, inhibiting hsp90 chaperone functioning and resulting in the destabilization of key proteins including estrogen/steroid receptors, nitric oxide synthase, ras1, MAP kinase, Src, Erb-B2, HER kinases and EGFR. Overexpression of HER2 receptors are observed in malignancies such as breast cancer and reportedly have been associated with resistance to chemotherapeutic agents. Both maturing and fully mature forms of the receptor depend on hsp90 association for stability. Inhibition of hsp90 function down regulates AKT kinase and Src kinase which are non-receptor kinase. Therefore, Mycograb® may be of use in estrogen dependent and hormone independent breast cancers.
Mycograb® has been demonstrated to have anti-tumor activity in cell culture. The 50% cytotoxicity of Mycograb® on its own is 50 µg/ml (MCF7 [Breast cancer cell line designation]). Mycograb® in combination with docetaxel, doxorubicin and cisplatin and Herceptin increased the cytotoxicity in breast cancer cells.
It is appropriate to evaluate the apparent tumor response and survivor benefits resulting from the addition of Mycograb® to a docetaxel containing chemotherapy regimen in metastatic or recurrent breast cancer patients.
(MCF7). Mycograb® in combination with docetaxel, doxorubicin and cisplatin and Herceptin increased the cytotoxicity in breast cancer cells.
It is appropriate to evaluate the apparent tumor response and survivor benefits resulting from the addition of Mycograb® to a docetaxel containing chemotherapy regimen in metastatic or recurrent breast cancer patients.
- Conditions
- Cancer of the Breast
- Being tested
- Mycograb, Docetaxel
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mycograb, DocetaxelDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
Impact on tumour size when compared to historical controls
Secondary outcomes (2)
Safety data
Pharmacokinetics data
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Sep 2005 (estimated)
- Study startSep 2005
- Study completionOct 2006
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cancer of the BreastStudies 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
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants
Sponsor and investigators
- Lead sponsor
- NeuTec Pharma
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Anna Pluzanska, MD, Principal investigator, University of Lodz
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00217815
- Sponsor's protocol ID
- NTP/ONC/001
- Status last verified
- Jul 2008
- First submitted
- 15 Sep 2005
- Last updated
- 15 Jul 2008
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Jul 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase Ib, Pharmacokinetic, Multiple Center, Open Label Study Evaluating the Safety and Efficacy of Mycograb Administered IV in Combination With Docetaxel in Metastatic or Recurrent Breast Cancer Patients
- ClinicalTrials.gov ID
- NCT00217815
- Acronym / sponsor ID
- NTP/ONC/001
- Conditions
- Cancer of the Breast
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants
- Lead sponsor
- NeuTec PharmaIndustry (pharma, biotech, devices)
- Study start
- Sep 2005
- Study completion
- Oct 2006
- First posted
- 22 Sep 2005 (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 study hypothesis is that the addition of Mycograb to docetaxel will improve outcome in advanced carcinoma of the breast.
Detailed description
Combination therapies that incorporate new agents have demonstrated the potential to improve outcome for patients with metastatic breast carcinoma. Docetaxel has been shown to be a very active drug in breast cancer, and anthracycline-based chemotherapy combinations represent the most active form of therapy generating objective response rates of between 40-70%. Mycograb® was most effective in breast carcinoma cell lines in combination with cisplatin, docetaxel and anthracyclines (doxorubicin, daunorubicin).
We propose that Mycograb® binds to hsp90, inhibiting hsp90 chaperone functioning and resulting in the destabilization of key proteins including estrogen/steroid receptors, nitric oxide synthase, ras1, MAP (Mitogen-activated protein) kinase, Src, Erb-B2,(erythroblastic leukemia viral oncogene homolog 2) HER(human estrogen receptor) kinases and EGFR (epidermal grown factor receptor). Over expression of HER2 receptors are observed in malignancies such as breast cancer and reportedly have been associated with resistance to chemotherapeutic agents. Both maturing and fully mature forms of the receptor depend on hsp90 association for stability. Inhibition of hsp90 function down regulates AKT kinase and Src kinase which are non-receptor kinase. Therefore, Mycograb® may be of use in estrogen dependent and hormone independent breast cancers.
Mycograb® has been demonstrated to have anti-tumor activity in cell culture. The 50% cytotoxicity of Mycograb® on its own is 50 Combination therapies that incorporate new agents have demonstrated the potential to improve outcome for patients with metastatic breast carcinoma. Docetaxel has been shown to be a very active drug in breast cancer, and anthracycline-based chemotherapy combinations represent the most active form of therapy generating objective response rates of between 40-70%. Mycograb® was most effective in breast carcinoma cell lines in combination with cisplatin, docetaxel and anthracyclines (doxorubicin, daunorubicin).
We propose that Mycograb® binds to hsp90, inhibiting hsp90 chaperone functioning and resulting in the destabilization of key proteins including estrogen/steroid receptors, nitric oxide synthase, ras1, MAP kinase, Src, Erb-B2, HER kinases and EGFR. Overexpression of HER2 receptors are observed in malignancies such as breast cancer and reportedly have been associated with resistance to chemotherapeutic agents. Both maturing and fully mature forms of the receptor depend on hsp90 association for stability. Inhibition of hsp90 function down regulates AKT kinase and Src kinase which are non-receptor kinase. Therefore, Mycograb® may be of use in estrogen dependent and hormone independent breast cancers.
Mycograb® has been demonstrated to have anti-tumor activity in cell culture. The 50% cytotoxicity of Mycograb® on its own is 50 µg/ml (MCF7 [Breast cancer cell line designation]). Mycograb® in combination with docetaxel, doxorubicin and cisplatin and Herceptin increased the cytotoxicity in breast cancer cells.
It is appropriate to evaluate the apparent tumor response and survivor benefits resulting from the addition of Mycograb® to a docetaxel containing chemotherapy regimen in metastatic or recurrent breast cancer patients.
(MCF7). Mycograb® in combination with docetaxel, doxorubicin and cisplatin and Herceptin increased the cytotoxicity in breast cancer cells.
It is appropriate to evaluate the apparent tumor response and survivor benefits resulting from the addition of Mycograb® to a docetaxel containing chemotherapy regimen in metastatic or recurrent breast cancer patients.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 18 to 70 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- Patients must be female between the ages of 18 to 70 years old.
- Patients must have histologically or clinically confirmed metastatic and/or recurrent breast cancer amenable to treatment with docetaxel.
- Patients must have presence of at least one uni-dimensional measurable lesion with minimal lesion size > 20 mm at the largest diameter.
- Patients may have had one previous chemotherapy regimen and must not have received prior chemotherapy with docetaxel.
- Patients must have been off all hormonal therapy for at least 2 weeks prior to initiation of therapy.
Key exclusion criteria (6 listed)
- Patients with brain or meningeal metastases.
- Patients whose only measurable lesion is in the bone.
- Patients with clinically significant cardiovascular, pulmonary, renal, endocrine, hepatic, respiratory, neurologic, psychiatric, immunologic, gastrointestinal, hematologic, metabolic or any other condition or laboratory abnormality that in the opinion of the investigator makes the patient unsuitable for participation in the study.
- Patients with history of seizure disorder.
- Patients who have received treatment with any other investigational drug within the preceding one month.
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 |
|---|---|---|
| Mycograb, Docetaxel | Drug | – |
Primary outcome
Impact on tumour size when compared to historical controls
2 secondary outcomes
Safety data
Pharmacokinetics data
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 15 Jul 2008.
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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.
Anna Pluzanska, MD principal investigator
University of Lodz
3 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Mycograb, Docetaxel in people with Cancer of the Breast, run by NeuTec Pharma at 3 sites in 2 countries.
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 12 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 15 Jul 2008. 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 Serbia, Poland. 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?
Impact on tumour size when compared to historical controls. 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 15 Jul 2008.