TumorsPhase 1NCT00345189
Study of Oral CNF2024 (BIIB021) in Advanced Solid Tumors
A Phase 1 study testing CNF2024 in people with Tumors and Lymphoma, run by Biogen at 4 sites in 2 countries.
Trial summary
This is an open-label, multicenter, dose-escalation, safety, pharmacokinetics, and pharmacodynamics study. Read more about this study
- Who is it for?
- Ages 18 years and older
- What is being tested?
- CNF2024
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 70 participants
- Where
- 4 sitesin 2 countries
- Study dates
- Feb 2006to Apr 2009
- 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
- Histologically or cytologically confirmed solid tumor which has failed standard therapies (surgery, radiotherapy, endocrine therapy, chemotherapy) or for which effective therapy is not available
- At least 18 years of age
- Hematology: Absolute neutrophil count (ANC) > 1500 cells/mm3, platelet count > 100,000 cells/mm3 and hemoglobin >= 9 gm/L
- Hepatic: Bilirubin < 1.5 X upper limit of normal (ULN); alanine aminotransferase (ALT) or aspartate aminotransferase (AST) < 2.5 X ULN. Patients with known liver metastases or liver neoplasms: alanine aminotransferase (ALT) or aspartate aminotransferase (AST) < 5.0 X ULN.
- Renal: Serum creatinine levels < 2.0 mg/dL or creatinine clearance > 60 mL/min
- Coagulation: international normalized ratio (INR) < 1.5 times normal
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- Adrenal: Normal plasma cortisol and adrenocorticotropic hormone (ACTH) levels
- Normal electrocardiogram (ECG) with QTc <= 450 msec for men and <= 470 msec for women
- Estimated life expectancy of at least 3 months as determined by the Investigator
- Eastern Cooperative Oncology Group (ECOG) performance status <= 2
- Male and female patients of childbearing potential must practice effective double-barrier contraception during the study and continue contraception for 3 months after their last dose of study drug. Male patients must agree to not have intercourse with pregnant or nursing women during the study and for 3 months after their last dose of study drug, unless using double-barrier contraception. The only exceptions to double-barrier contraception are: Patient or partner is surgically sterile,female patient is postmenopausal for at least 1 year before screening or patient abstains from sexual intercourse, at the discretion of the Investigator
Who cannot join
- Pregnant or nursing women, women of child-bearing age not using reliable means of contraception.
- Radiotherapy or chemotherapy within the previous 28 days. Recovery to Grade 1 or less from chemotherapy-induced toxic effect, except alopecia, is required.
- Participation in any investigational drug study within 28 days prior to CNF2024 administration
- Active infection requiring intravenous antibiotic treatment
- Patients with second malignancy requiring active treatment (except hormonal therapy)
- Concurrent severe or uncontrolled medical disease (i.e., systemic infection, diabetes, hypertension, coronary artery disease, congestive heart failure)
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- Active symptomatic fungal, bacterial and/or viral infection including active HIV or viral (A, B or C) hepatitis
- Problems with swallowing or malabsorption
- Chronic diarrhea (excess of 2-3 stools/day above normal frequency)
- Gastrointestinal diseases including gastritis, ulcerative colitis, Crohn's disease, or hemorrhagic coloproctitis
- Major surgery of the stomach or small intestine
- Adrenal dysfunction > Grade 2
- Patients with diabetes (your doctor will discuss if you are eligible for this study)
Trial locations and contacts
4 sites in 2 countries.
4 sites in 2 countries
United States3 sites
Research site
New Haven, Connecticut, 06520
Research site
San Antonio, Texas, 78245
Research site
Scottsdale, Arizona, 85258
About this study
Official title: A Phase 1, Multicenter, Open-Label, Dose-Escalation, Safety, PK, and PD Study of CNF2024 Administered Orally Twice Weekly for 3 Weeks of a 4 Week Course or Twice Weekly for 4 Weeks of a 4 Week Course to Patients With Advanced Solid Tumors
This is an open-label, multicenter, dose-escalation, safety, pharmacokinetics, and pharmacodynamics study.
Read the detailed description
Heat shock protein 90 (Hsp90) is an ubiquitous molecular chaperone protein that is involved in folding, activation, and assembly of many proteins, including key mediators of signal transduction, cell cycle control, and transcriptional regulation. In cancer cells that are dependent upon Hsp90 client proteins, the degree to which clients are inhibited correlates closely with induction of growth inhibition and apoptosis with Hsp90 inhibitory drugs. The active pharmaceutical ingredient of CNF2024, CF1983 mesylate, is a synthetic, new chemical entity designed to inhibit Hsp90. CF1983 hada strong affinity for tumor derived Hsp90 and weaker affinity for Hsp90 isolated from normal cells or recombinant Hsp90.
- Being tested
- CNF2024
- Keywords
- Hsp90 inhibitor, CNF2024, Advanced Solid Tumors
- Medical subject headings
- Neoplasms, Lymphoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CNF2024Drug
Also called Advanced Solid Tumors
CNF2024 capsules administered orally following 2 schedules:
- starting dose of 25 mg, twice a week for 3 weeks out of a 4-week course (Schedule 1) or
- starting dose of 600 mg twice a week for 4 weeks out of a 4-week course (without drug holidays; Schedule 2).
Treatment repeats every 28 days in the absence of disease progression or unacceptable toxicity. Dose escalation proceeds according to the predetermined scheme until the stopping dose is reached due to a dose limiting toxicity (DLT) occurring during the first 4-week course of treatment.
| Study group | Role | What they receive |
|---|---|---|
| Dosing Schedule 1 | Other | Starting dose of 25 mg, with dosing twice a week for 3 weeks out of a 4-week course (Schedule 1). Dosing for schedule 1 is currently closed. Receives: Drug: CNF2024 |
| Dosing Schedule 2 | Other | Starting dose of 600 mg, with dosing twice a week for 4 weeks out of a 4-week course (without drug holidays; Schedule 2). Receives: Drug: CNF2024 |
What is being measured
The primary outcome is the main question the study is designed to answer.
To determine the maximum tolerated dose (MTD)
Measured: Dose escalation will proceed according to the predetermined scheme until the stopping dose (dose > MTD) is reached due to dose limiting toxicities (DLT) occurring during the first 4-week course of treatment.
To determine the safety profile
Measured: Study duration
pharmacokinetic profile
Measured: Dosing period
effect on pharmacodynamic biomarkers
Measured: Dosing period
antitumor activity
Measured: At screening and after every 2 courses
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jun 2006 (estimated)
- Study startFeb 2006
- Primary completionJul 2008
- Study completionApr 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for TumorsStudies 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
- 70 participants (actual)
Sponsor and investigators
- Lead sponsor
- Biogen
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Biogen Idec Medical Monitor, MD, Study director, Biogen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00345189
- Sponsor's protocol ID
- CNF2024-ST-05003
- Other IDs
- 120ST101
- Status last verified
- Jul 2009
- First submitted
- 23 Jun 2006
- Last updated
- 14 Jul 2009
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 14 Jul 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1, Multicenter, Open-Label, Dose-Escalation, Safety, PK, and PD Study of CNF2024 Administered Orally Twice Weekly for 3 Weeks of a 4 Week Course or Twice Weekly for 4 Weeks of a 4 Week Course to Patients With Advanced Solid Tumors
- ClinicalTrials.gov ID
- NCT00345189
- Acronym / sponsor ID
- CNF2024-ST-05003
- Keywords
- Hsp90 inhibitor, CNF2024, Advanced Solid Tumors
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 70 participants (actual)
- Lead sponsor
- BiogenIndustry (pharma, biotech, devices)
- Study start
- Feb 2006
- Primary completion
- Jul 2008 (actual)
- Study completion
- Apr 2009 (actual)
- First posted
- 27 Jun 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.
This is an open-label, multicenter, dose-escalation, safety, pharmacokinetics, and pharmacodynamics study.
Detailed description
Heat shock protein 90 (Hsp90) is an ubiquitous molecular chaperone protein that is involved in folding, activation, and assembly of many proteins, including key mediators of signal transduction, cell cycle control, and transcriptional regulation. In cancer cells that are dependent upon Hsp90 client proteins, the degree to which clients are inhibited correlates closely with induction of growth inhibition and apoptosis with Hsp90 inhibitory drugs. The active pharmaceutical ingredient of CNF2024, CF1983 mesylate, is a synthetic, new chemical entity designed to inhibit Hsp90. CF1983 hada strong affinity for tumor derived Hsp90 and weaker affinity for Hsp90 isolated from normal cells or recombinant Hsp90.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Dosing Schedule 1 | Other | Drug: CNF2024Starting dose of 25 mg, with dosing twice a week for 3 weeks out of a 4-week course (Schedule 1). Dosing for schedule 1 is currently closed. |
| Dosing Schedule 2 | Other | Drug: CNF2024Starting dose of 600 mg, with dosing twice a week for 4 weeks out of a 4-week course (without drug holidays; Schedule 2). |
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 solid tumor which has failed standard therapies (surgery, radiotherapy, endocrine therapy, chemotherapy) or for which effective therapy is not available
- At least 18 years of age
- Hematology: Absolute neutrophil count (ANC) > 1500 cells/mm3, platelet count > 100,000 cells/mm3 and hemoglobin >= 9 gm/L
- Hepatic: Bilirubin < 1.5 X upper limit of normal (ULN); alanine aminotransferase (ALT) or aspartate aminotransferase (AST) < 2.5 X ULN. Patients with known liver metastases or liver neoplasms: alanine aminotransferase (ALT) or aspartate aminotransferase (AST) < 5.0 X ULN.
- Renal: Serum creatinine levels < 2.0 mg/dL or creatinine clearance > 60 mL/min
Key exclusion criteria (13 listed)
- Pregnant or nursing women, women of child-bearing age not using reliable means of contraception.
- Radiotherapy or chemotherapy within the previous 28 days. Recovery to Grade 1 or less from chemotherapy-induced toxic effect, except alopecia, is required.
- Participation in any investigational drug study within 28 days prior to CNF2024 administration
- Active infection requiring intravenous antibiotic treatment
- Patients with second malignancy requiring active treatment (except hormonal therapy)
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: Advanced Solid TumorsCNF2024 capsules administered orally following 2 schedules: * starting dose of 25 mg, twice a week for 3 weeks out of a 4-week course (Schedule 1) or * starting dose of 600 mg twice a week for 4 weeks out of a 4-week course (without drug holidays; Schedule 2). Treatment repeats every 28 days in the absence of disease progression or unacceptable toxicity. Dose escalation proceeds according to the predetermined scheme until the stopping dose is reached due to a dose limiting toxicity (DLT) occurring during the first 4-week course of treatment. | Drug | Dosing Schedule 1, Dosing Schedule 2 |
Primary outcome
To determine the maximum tolerated dose (MTD)
Time frame: Dose escalation will proceed according to the predetermined scheme until the stopping dose (dose > MTD) is reached due to dose limiting toxicities (DLT) occurring during the first 4-week course of treatment.
To determine the safety profile
Time frame: Study duration
pharmacokinetic profile
Time frame: Dosing period
effect on pharmacodynamic biomarkers
Time frame: Dosing period
antitumor activity
Time frame: At screening and after every 2 courses
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 14 Jul 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.
Biogen Idec Medical Monitor, MD study director
Biogen
4 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing CNF2024 in people with Tumors and Lymphoma, run by Biogen at 4 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 11 inclusion and 13 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 14 Jul 2009. 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, United Kingdom. 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?
To determine the maximum tolerated dose (MTD) (time frame: Dose escalation will proceed according to the predetermined scheme until the stopping dose (dose > MTD) is reached due to dose limiting toxicities (DLT) occurring during the first 4-week course of treatment.). The study lists 5 primary outcomes in all. 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 14 Jul 2009.