Breast CancerPhase 1NCT00412412
CNF2024 (BIIB021) HER2- (QD) HER2+ (BIW w/Herceptin) PK/PD Study
A Phase 1 study testing CNF2024 and CNF2024 + trastuzumab in people with Breast Cancer, run by Biogen at 3 sites in United States.
Trial summary
The goal of this clinical research study is to study the drug CNF2024 as a single agent or in combination with trastuzumab in patients with advanced breast cancer and to: find the highest dose of the drug CNF2024 as a single agent or in combination with trastuzumab that can be given safely measure levels of CNF2024 as… 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?
- CNF2024 and CNF2024 + trastuzumab
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 34 participants
- Where
- 3 sitesUnited States
- Study dates
- Dec 2007to Apr 2011
- Phase
- Phase 1
- 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
- Age ≥18 years at the time of informed consent.
- Male and female subjects with confirmed HER2 adenocarcinoma of the breast with advanced disease (advanced disease will be defined as metastatic disease or locally advanced disease that is surgically unresectable and considered unmanageable with standard therapies such as radiation or systemic therapies) who have had disease progression on at least one standard hormonal or chemotherapy regimen for advanced breast cancer or who have refused standard therapies.
- Evaluable disease either by measurable disease (RECIST) or nonmeasurable disease.
- ECOG ≤2.
- Required Laboratory Values:ANC ≥1500 cells/mm3,platelet count ≥100,000 cells/mm3,hemoglobin ≥9 gm/L; Glucose >3.3 mmol/L, sodium >130 mmol/L, calcium >2.0 mmol/L.
- Plasma cortisol and ACTH levels that are not suggestive of adrenal insufficiency.
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- Normal electrocardiogram (ECG) with QTc ≤450 msec for men and ≤470 msec for women.
- Female subjects of childbearing potential must have a negative pregnancy test within 7 days prior to first study drug administration.
- Age ≥18 years at the time of informed consent.
- Male and female subjects with confirmed HER2+ (IHC 3+ or IHC 2+/FISH+) adenocarcinoma of the breast with advanced disease that have had disease progression on at least 1 standard hormonal or chemotherapy regimen for advanced metastatic breast cancer. Advanced disease will be defined as metastatic disease or locally advanced disease that is surgically unresectable and considered unmanageable with standard therapies such as radiation or systemic therapies.
- Subjects must have progressed either within 3 months following last dose of adjuvant trastuzumab treatment or progressed following trastuzumab based therapies for metastatic disease.
- Measurable disease by RECIST or evaluable nonmeasurable disease
- ECOG ≤2.
- Required Laboratory Values: ANC ≥1500 cells/mm3,platelet count ≥100,000 cells/mm3,hemoglobin ≥9 gm/L; Glucose >3.3 mmol/L, sodium >130 mmol/L, calcium >2.0 mmol/L.
- Plasma cortisol and ACTH levels that are not suggestive of adrenal insufficiency.
- Normal ECG with QTc ≤450 msec for men and ≤470 msec for women.
- Female subjects of childbearing potential must have a negative pregnancy test within 7 days prior to first study drug administration.
Who cannot join
- Prior antitumor therapies including prior experimental agents or approved antitumor therapies, within 1 month.
- Active infection requiring intravenous (IV) antibiotic treatment.
- History of prior malignancies within the past 5 years with the exception of curatively treated basal or squamous cell carcinomas of the skin or carcinoma in situ of the cervix.
- Concurrent severe or uncontrolled diabetes and/or other medical disease
- Problems with swallowing or malabsorption.
- History of major surgery to small intestine.
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- Prior treatment with Hsp90 inhibitors.
- History of central nervous system (CNS) metastasis.
- Prior antitumor therapies, including prior experimental agents or approved antitumor therapies, within 1 month.
- Active infection requiring intravenous (IV) antibiotic treatment.
- History of prior malignancies within the past 5 years with the exception of curatively treated basal or squamous cell carcinomas of the skin or carcinoma in situ of the cervix.
- Concurrent severe or uncontrolled diabetes and/or other medical disease
- Problems with swallowing or malabsorption.
- History of major surgery to small intestine.
- Cardiac left ventricular function with resting ejection fraction <50%, assessed by either ECHO or MUGA.
- Prior treatment with Hsp90 inhibitors.
- Diabetes treated with insulin.
- History of CNS metastasis.
Trial locations and contacts
3 sites in 1 country.
United States3 sites
Research site
Houston, Texas, 77030
Research Site
New York, New York, 10021
Research Site
Tampa, Florida, 33612
About this study
Official title: A Ph1 Open-Label,Dose-Escalation,Safety,PK & PD Study of CNF2024 as a Single-Agent Treatment in Subjects w/HER2- Adv Breast Cancer or in Combo w/Trastuzumab in Subjects w/HER2+ Advanced Breast Cancer
The goal of this clinical research study is to study the drug CNF2024 as a single agent or in combination with trastuzumab in patients with advanced breast cancer and to:
- find the highest dose of the drug CNF2024 as a single agent or in combination with trastuzumab that can be given safely
- measure levels of CNF2024 as a single agent or in combination with trastuzumab in blood
- determine if CNF2024 as a single agent or in combination with trastuzumab can stop breast cancer cells from growing
Read the detailed description
A Phase 1 Open-Label, Dose-Escalation, Safety, Pharmacokinetic, and Pharmacodynamic Study of CNF2024 as a Single-Agent Treatment in Subjects with HER2- Advanced Breast Cancer or in Combination with Trastuzumab in Subjects with HER2+ Advanced Breast Cancer
- Conditions
- Breast Cancer
- Being tested
- CNF2024, CNF2024 + trastuzumab
- Keywords
- Cancer of Breast, Cancer of the Breast
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CNF2024Drug
Also called BIIB021
Oral doses of CNF2024 as specified in the protocol.
CNF2024 + trastuzumabDrug
Also called BIIB021 (CNF2024), Herceptin (trastuzumab)
Oral doses of CNF2024 as specified in the protocol Intravenous doses of trastuzumab as specified in the package insert.
| Study group | Role | What they receive |
|---|---|---|
| A | Experimental | Patients with HER2- Breast Cancer Receives: Drug: CNF2024 |
| B | Experimental | Patients with HER2+ Breast Cancer Receives: Drug: CNF2024 + trastuzumab |
What is being measured
The primary outcome is the main question the study is designed to answer.
Clinical and laboratory safety assessments
Measured: 30 days after discontinuation of CNF2024 or until drug-related toxicites have returned to less than Grade 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Dec 2006 (estimated)
- Study startDec 2007
- Primary completionApr 2011
- Study completionApr 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.
- More trials run by BiogenThe sponsor's other registered studies.
- 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
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 34 participants (actual)
Sponsor and investigators
- Lead sponsor
- Biogen
- Sponsor type
- Industry (pharma, biotech, devices)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00412412
- Sponsor's protocol ID
- 120BC101
- Status last verified
- Dec 2011
- First submitted
- 15 Dec 2006
- Last updated
- 8 Jun 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Jun 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Ph1 Open-Label,Dose-Escalation,Safety,PK & PD Study of CNF2024 as a Single-Agent Treatment in Subjects w/HER2- Adv Breast Cancer or in Combo w/Trastuzumab in Subjects w/HER2+ Advanced Breast Cancer
- ClinicalTrials.gov ID
- NCT00412412
- Acronym / sponsor ID
- 120BC101
- Conditions
- Breast Cancer
- Keywords
- Cancer of Breast, Cancer of the Breast
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 34 participants (actual)
- Lead sponsor
- BiogenIndustry (pharma, biotech, devices)
- Study start
- Dec 2007
- Primary completion
- Apr 2011 (actual)
- Study completion
- Apr 2011 (actual)
- First posted
- 18 Dec 2006 (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 this clinical research study is to study the drug CNF2024 as a single agent or in combination with trastuzumab in patients with advanced breast cancer and to:
- find the highest dose of the drug CNF2024 as a single agent or in combination with trastuzumab that can be given safely
- measure levels of CNF2024 as a single agent or in combination with trastuzumab in blood
- determine if CNF2024 as a single agent or in combination with trastuzumab can stop breast cancer cells from growing
Detailed description
A Phase 1 Open-Label, Dose-Escalation, Safety, Pharmacokinetic, and Pharmacodynamic Study of CNF2024 as a Single-Agent Treatment in Subjects with HER2- Advanced Breast Cancer or in Combination with Trastuzumab in Subjects with HER2+ Advanced Breast Cancer
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| A | Experimental | Drug: CNF2024Patients with HER2- Breast Cancer |
| B | Experimental | Drug: CNF2024 + trastuzumabPatients with HER2+ Breast Cancer |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (17 listed)
- Age ≥18 years at the time of informed consent.
- Male and female subjects with confirmed HER2 adenocarcinoma of the breast with advanced disease (advanced disease will be defined as metastatic disease or locally advanced disease that is surgically unresectable and considered unmanageable with standard therapies such as radiation or systemic therapies) who have had disease progression on at least one standard hormonal or chemotherapy regimen for advanced breast cancer or who have refused standard therapies.
- Evaluable disease either by measurable disease (RECIST) or nonmeasurable disease.
- ECOG ≤2.
- Required Laboratory Values:ANC ≥1500 cells/mm3,platelet count ≥100,000 cells/mm3,hemoglobin ≥9 gm/L; Glucose >3.3 mmol/L, sodium >130 mmol/L, calcium >2.0 mmol/L.
Key exclusion criteria (18 listed)
- Prior antitumor therapies including prior experimental agents or approved antitumor therapies, within 1 month.
- Active infection requiring intravenous (IV) antibiotic treatment.
- History of prior malignancies within the past 5 years with the exception of curatively treated basal or squamous cell carcinomas of the skin or carcinoma in situ of the cervix.
- Concurrent severe or uncontrolled diabetes and/or other medical disease
- Problems with swallowing or malabsorption.
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 |
|---|---|---|
| CNF2024Also: BIIB021Oral doses of CNF2024 as specified in the protocol. | Drug | A |
| CNF2024 + trastuzumabAlso: BIIB021 (CNF2024), Herceptin (trastuzumab)Oral doses of CNF2024 as specified in the protocol Intravenous doses of trastuzumab as specified in the package insert. | Drug | B |
Primary outcome
Clinical and laboratory safety assessments
Time frame: 30 days after discontinuation of CNF2024 or until drug-related toxicites have returned to less than Grade 1
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 8 Jun 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.
The record lists no contact. Use the official record to reach the sponsor.
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing CNF2024 and CNF2024 + trastuzumab in people with Breast Cancer, run by Biogen 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 17 inclusion and 18 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 8 Jun 2012. 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 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.
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 and laboratory safety assessments (time frame: 30 days after discontinuation of CNF2024 or until drug-related toxicites have returned to less than Grade 1). 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 8 Jun 2012.