Advanced Solid TumorsPhase 1NCT00618735
Once or Twice Daily Administration of BIIB021 to Subjects With Advanced Solid Tumors
A Phase 1 study testing BIIB021 in people with Advanced Solid Tumors, run by Biogen at 3 sites in United States.
Trial summary
The purpose of the study is to see if daily and twice daily administration of BIIB021 is tolerated in patients with advanced solid tumors. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Advanced Solid Tumors
- What is being tested?
- BIIB021
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 68 participants
- Where
- 3 sitesUnited States
- Study dates
- Feb 2008to Dec 2010
- 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
- Subjects with histologically or cytologically confirmed solid tumor who have failed or refused standard therapies or for which no approved therapy is available.
- Age greater than or equal to 18 years at the time of informed consent. ECOG performance status of less than or equal to 2. Lab values consistent with adequate renal, hepatic, and bone marrow functions.
Who cannot join
- Prior antitumor therapies, including prior experimental agents or approved antitumor small molecules and biologics within 28 days and all associated toxicities resolved to eligibility levels.
- Subjects with known brain metastases. Concurrent severe or uncontrolled medical disease. Must utilize effective contraception.
Trial locations and contacts
3 sites in 1 country.
United States3 sites
Research Site
Encinitas, California, 92024
Research Site
San Antonio, Texas, 78229
Research Site
Santa Monica, California, 90404
About this study
Official title: A Phase 1, Multicenter, Open-Label, Dose-Escalation, Safety, Pharmacokinetic, and Pharmacodynamic Study of BIIB021 Administered Once or Twice Daily to Subjects With Advanced Solid Tumors
The purpose of the study is to see if daily and twice daily administration of BIIB021 is tolerated in patients with advanced solid tumors.
Read the detailed description
Heat shock protein 90 (HSP90) inhibitors are anticipated to have clinical activity in solid tumors because Hsp90 is required for the folding, activation, and assembly of many proteins involved in cancer cell survival, proliferation, and metastasis. The maximum tolerated dose (MTX) for BIIB021 administered twice weekly in a phase I study in subjects with advanced solid tumors have been defined at 600mg. It is now reasonable from a safety perspective and desirable from a pharmacokinetic perspective to evaluate more frequent dosing intervals in solid tumors with the goal of providing more sustained and completed inhibition of Hsp90.
- Conditions
- Advanced Solid Tumors
- Being tested
- BIIB021
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BIIB021Drug
Also called CNF2024
Dosage, frequency (once daily), and duration as specified in protocol. This dosing arm is currently on hold.
BIIB021Drug
Also called CNF2024
Twice daily dosing
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Subjects in Schedule A will take BIIB021 in the morning at approximately 0800 with at least 6 ounces of water following an overnight fast (Beginning at midnight). Receives: Drug: BIIB021 |
| 2 | Experimental | Subjects in Schedule B will take BIIB021 in the morning at approximately 0800 with at least 6 ounces of water following an overnight fast (beginning at midnight). The second dose will be taken, following at least a 2-hour fast, 12 hours (+/- 2 hours) after the first dose, except on Day 1 of Cycle 1 and Day 1 of Cycle 2. Receives: Drug: BIIB021 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety and tolerability of BIIB021
Measured: As specified in protocol
Secondary outcomes (2)
PK and PD of BIIB021
Measured: As specified in protocol
Antitumor activity
Measured: As specified in protocol
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Feb 2008 (estimated)
- Study startFeb 2008
- Primary completionJul 2010
- Study completionDec 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Advanced Solid 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
- Single group
- Masking
- None (open label)
- Enrolment
- 68 participants (actual)
Sponsor and investigators
- Lead sponsor
- Biogen
- Sponsor type
- Industry (pharma, biotech, devices)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00618735
- Sponsor's protocol ID
- 120ST103
- Status last verified
- Dec 2016
- First submitted
- 8 Feb 2008
- Last updated
- 29 Dec 2016
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Saif MW, Takimoto C, Mita M, Banerji U, Lamanna N, Castro J, O'Brien S, Stogard C, Von Hoff D. A phase 1, dose-escalation, pharmacokinetic and pharmacodynamic study of BIIB021 administered orally in patients with advanced solid tumors. Clin Cancer Res. 2014 Jan 15;20(2):445-55. doi: 10.1158/1078-0432.CCR-13-1257. Epub 2013 Oct 4.
PubMed 24097863
Study at a glance
From the registry record, last updated by the sponsor on 29 Dec 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1, Multicenter, Open-Label, Dose-Escalation, Safety, Pharmacokinetic, and Pharmacodynamic Study of BIIB021 Administered Once or Twice Daily to Subjects With Advanced Solid Tumors
- ClinicalTrials.gov ID
- NCT00618735
- Acronym / sponsor ID
- 120ST103
- Conditions
- Advanced Solid Tumors
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 68 participants (actual)
- Lead sponsor
- BiogenIndustry (pharma, biotech, devices)
- Study start
- Feb 2008
- Primary completion
- Jul 2010 (actual)
- Study completion
- Dec 2010 (actual)
- First posted
- 20 Feb 2008 (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 purpose of the study is to see if daily and twice daily administration of BIIB021 is tolerated in patients with advanced solid tumors.
Detailed description
Heat shock protein 90 (HSP90) inhibitors are anticipated to have clinical activity in solid tumors because Hsp90 is required for the folding, activation, and assembly of many proteins involved in cancer cell survival, proliferation, and metastasis. The maximum tolerated dose (MTX) for BIIB021 administered twice weekly in a phase I study in subjects with advanced solid tumors have been defined at 600mg. It is now reasonable from a safety perspective and desirable from a pharmacokinetic perspective to evaluate more frequent dosing intervals in solid tumors with the goal of providing more sustained and completed inhibition of Hsp90.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Drug: BIIB021Subjects in Schedule A will take BIIB021 in the morning at approximately 0800 with at least 6 ounces of water following an overnight fast (Beginning at midnight). |
| 2 | Experimental | Drug: BIIB021Subjects in Schedule B will take BIIB021 in the morning at approximately 0800 with at least 6 ounces of water following an overnight fast (beginning at midnight). The second dose will be taken, following at least a 2-hour fast, 12 hours (+/- 2 hours) after the first dose, except on Day 1 of Cycle 1 and Day 1 of Cycle 2. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Subjects with histologically or cytologically confirmed solid tumor who have failed or refused standard therapies or for which no approved therapy is available.
- Age greater than or equal to 18 years at the time of informed consent. ECOG performance status of less than or equal to 2. Lab values consistent with adequate renal, hepatic, and bone marrow functions.
Key exclusion criteria (2 listed)
- Prior antitumor therapies, including prior experimental agents or approved antitumor small molecules and biologics within 28 days and all associated toxicities resolved to eligibility levels.
- Subjects with known brain metastases. Concurrent severe or uncontrolled medical disease. Must utilize effective contraception.
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 |
|---|---|---|
| BIIB021Also: CNF2024Dosage, frequency (once daily), and duration as specified in protocol. This dosing arm is currently on hold. | Drug | 1 |
| BIIB021Also: CNF2024Twice daily dosing | Drug | 2 |
Primary outcome
Safety and tolerability of BIIB021
Time frame: As specified in protocol
2 secondary outcomes
PK and PD of BIIB021
Time frame: As specified in protocol
Antitumor activity
Time frame: As specified in protocol
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 29 Dec 2016.
- Background: PubMed 24097863Saif MW, Takimoto C, Mita M, Banerji U, Lamanna N, Castro J, O'Brien S, Stogard C, Von Hoff D. A phase 1, dose-escalation, pharmacokinetic and pharmacodynamic study of BIIB021 administered orally in patients with advanced solid tumors. Clin Cancer Res. 2014 Jan 15;20(2):445-55. doi: 10.1158/1078-0432.CCR-13-1257. Epub 2013 Oct 4.
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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 BIIB021 in people with Advanced Solid Tumors, 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 2 inclusion and 2 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 29 Dec 2016. 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?
Safety and tolerability of BIIB021 (time frame: As specified in protocol). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00618735, which also lists 1 linked publication.
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 29 Dec 2016.