B-Cell Chronic Lymphocytic LeukemiaPhase 1NCT00344786
Phase 1, Dose-Escalation Study of Oral CNF2024(BIIB021) in CLL
A Phase 1 study testing CNF2024 (BIIB021) in people with B-Cell Chronic Lymphocytic Leukemia, run by Biogen at 3 sites in United States.
Trial summary
CLL dosing escalating study; daily dosing schedule; PK/PD safety Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- B-Cell Chronic Lymphocytic Leukemia
- What is being tested?
- CNF2024 (BIIB021)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15 participants
- Where
- 3 sitesUnited States
- Study dates
- Feb 2006to Sep 2008
- 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
- Patients with CLL who relapsed following or are intolerant to purine analog -based therapy
- Hemoglobin >=9 gm/dL (may be post-transfusion)
- Total bilirubin <2 X ULN, and ALT and AST <2 x ULN
- Creatinine <=2 X ULN
- Normal plasma cortisol and ACTH concentrations
- ECOG Performance Status <=2
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- Anticipated survival >=3 months
- For men and women of child-producing potential, use of effective contraceptive methods during the study and for one month after treatment
- Ability to understand the requirements of the study, provide written informed consent and authorization of use and disclosure of protected health information, and agree to abide by the study restrictions and return for the required assessments
Who cannot join
- Pregnant or nursing women
- Treatment with chemotherapy, monoclonal antibody, or radiotherapy within 28 days before entering the study
- Participation in any investigational drug study within 28 days before CNF2024 administration
- Patients with secondary malignancy requiring active treatment (except hormonal therapy)
- Active symptomatic bacterial, fungal, or viral infection including active HIV or viral (A, B, or C) hepatitis
- Problems with swallowing or malabsorption
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- Diarrhea (excess of 2-3 stools/day above normal frequency in the past month)
- Gastrointestinal diseases including gastritis, ulcerative colitis, Crohn's disease, or hemorrhagic coloproctitis
- Major surgery of the stomach or small intestine
- Adrenal dysfunction
- Patients with life- or function-threatening CLL complications (e.g., cord compression, hemolytic crisis, urinary tract obstruction)
- Any illness or condition that in the opinion of the investigator may affect safety of treatment or evaluation of any the study's endpoints
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
San Diego, California, 92093
About this study
Official title: A Phase 1, Dose-Escalation Study of CNF2024 Administered Orally to Patients With B Cell Chronic Lymphocytic Leukemia (CLL)
CLL dosing escalating study; daily dosing schedule; PK/PD safety
Read the detailed description
Phase 1, open-label, accelerated-titration study designed to evaluate the effects of increasing doses of CNF2024 on safety, pharmacokinetics, pharmacodynamic markers, and hematological response
- Conditions
- B-Cell Chronic Lymphocytic Leukemia
- Being tested
- CNF2024 (BIIB021)
- Keywords
- CLL, CNF2024, Hsp90 inhibitor
- Medical subject headings
- Leukemia, Lymphocytic, Chronic, B-Cell
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CNF2024 (BIIB021)Drug
Also called Single arm trial; no comparator
Dose starting at 12.5 mg/d, p.o. as a once-daily dose for 21 days followed by a 1-week rest period.
Dose escalation will proceed according to the predetermined scheme until the maximum tolerated dose (MTD) is reached due to dose limiting toxicities (DLT) during the first course of treatment.
| Study group | Role | What they receive |
|---|---|---|
| CNF2024 | Experimental | Not described Receives: Drug: CNF2024 (BIIB021) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety and toxicity (maximum tolerated dose (MTD))
Measured: 4 week periods until MTD is reached
Pharmacokinetics
Measured: Dosing period
Pharmacodynamics
Measured: Dosing period
Secondary outcomes (2)
To determine clinical and hematological response
Measured: Study Duration
To determine the recommended Phase 2 dose
Measured: Study duration
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 completionSep 2008
Why it stopped: Sponsor's decision
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for B-Cell Chronic Lymphocytic LeukemiaStudies 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
- Single group
- Masking
- None (open label)
- Enrolment
- 15 participants (actual)
Sponsor and investigators
- Lead sponsor
- Biogen
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Chris Storgard, MD, Study chair, Biogen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00344786
- Sponsor's protocol ID
- CNF2024-CLL-05002
- Other IDs
- 120CL101
- Status last verified
- Jun 2009
- First submitted
- 23 Jun 2006
- Last updated
- 5 Jun 2009
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Jun 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1, Dose-Escalation Study of CNF2024 Administered Orally to Patients With B Cell Chronic Lymphocytic Leukemia (CLL)
- ClinicalTrials.gov ID
- NCT00344786
- Acronym / sponsor ID
- CNF2024-CLL-05002
- Conditions
- B-Cell Chronic Lymphocytic Leukemia
- Keywords
- CLL, CNF2024, Hsp90 inhibitor
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Sponsor's decision
- Enrolment
- 15 participants (actual)
- Lead sponsor
- BiogenIndustry (pharma, biotech, devices)
- Study start
- Feb 2006
- Primary completion
- Jul 2008 (actual)
- Study completion
- Sep 2008 (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.
CLL dosing escalating study; daily dosing schedule; PK/PD safety
Detailed description
Phase 1, open-label, accelerated-titration study designed to evaluate the effects of increasing doses of CNF2024 on safety, pharmacokinetics, pharmacodynamic markers, and hematological response
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| CNF2024 | Experimental | Drug: CNF2024 (BIIB021) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Patients with CLL who relapsed following or are intolerant to purine analog -based therapy
- Hemoglobin >=9 gm/dL (may be post-transfusion)
- Total bilirubin <2 X ULN, and ALT and AST <2 x ULN
- Creatinine <=2 X ULN
- Normal plasma cortisol and ACTH concentrations
Key exclusion criteria (12 listed)
- Pregnant or nursing women
- Treatment with chemotherapy, monoclonal antibody, or radiotherapy within 28 days before entering the study
- Participation in any investigational drug study within 28 days before CNF2024 administration
- Patients with secondary malignancy requiring active treatment (except hormonal therapy)
- Active symptomatic bacterial, fungal, or viral infection including active HIV or viral (A, B, or C) hepatitis
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 |
|---|---|---|
| CNF2024 (BIIB021)Also: Single arm trial; no comparatorDose starting at 12.5 mg/d, p.o. as a once-daily dose for 21 days followed by a 1-week rest period. Dose escalation will proceed according to the predetermined scheme until the maximum tolerated dose (MTD) is reached due to dose limiting toxicities (DLT) during the first course of treatment. | Drug | CNF2024 |
Primary outcome
Safety and toxicity (maximum tolerated dose (MTD))
Time frame: 4 week periods until MTD is reached
Pharmacokinetics
Time frame: Dosing period
Pharmacodynamics
Time frame: Dosing period
2 secondary outcomes
To determine clinical and hematological response
Time frame: Study Duration
To determine the recommended Phase 2 dose
Time frame: Study duration
Results and safety
The study was stopped early (reason given: Sponsor's decision). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Jun 2009.
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HPC Offered for PRESERVE Expansion
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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.
Chris Storgard, MD study chair
Biogen
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 (BIIB021) in people with B-Cell Chronic Lymphocytic Leukemia, 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 9 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: stopped early, as of the sponsor's last update on 5 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 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 was stopped early (reason given: Sponsor's decision). Results are not available in the source record.
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?
Safety and toxicity (maximum tolerated dose (MTD)) (time frame: 4 week periods until MTD is reached). The study lists 3 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 5 Jun 2009.