Advanced Solid TumorsPhase 1NCT01017198
Effect of Food and Antacid on BIIB021 With Advanced Solid Tumors
A Phase 1 study testing BIIB021 and Food and BIIB0121 and Antacid in people with Advanced Solid Tumors, run by Biogen at 3 sites in United States.
Trial summary
This study is designed to assess the effect of food and antacid use on the pharmacokinetic properties of BIIB021. 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 and Food and BIIB0121 and Antacid
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 3 sitesUnited States
- Study dates
- Nov 2009to Jan 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
- Subjects with histologically or cytologically confirmed solid tumors who have failed or are not candidates for standard therapies or for whom no approved therapy is available.
- Eastern Cooperative Oncology Group (ECOG) performance status of greater or equal to 2.
- Medically able to tolerate a high fat meal and to fast as per protocol.
- Expected survival time of at least 3 months in the opinion of the Investigator.
- Ability to take ranitidine as per protocol.
- Must be able to swallow and retain oral medication.
- Lab values consistent with adequate renal, hepatic, and bone marrow functions.
- Electrocardiogram (ECG) with QTc of ≤450 msec for men or ≤470 msec for women and no clinically significant findings.
Who cannot join
- Pregnant (positive pregnancy test) or nursing women.
- Previous treatment with an Hsp90 inhibitor.
- Use of antacids within 7 days of Study Day 1.
- Prior antitumor therapies, including prior experimental agents or approved antitumor therapies within 28 days of the first dose of BIIB021.
- Major surgery or radiation within 28 days of the first dose of BIIB021.
- Uncontrolled, severe medical illness, which in the opinion of the Investigator and/or Sponsor could compromise protocol objectives.
Show all 15Show fewer
- History of gastrectomy or major surgery to small intestine.
- History of exocrine pancreatic insufficiency.
- Chronic diarrhea (excess of 2 to 3 stools/day above normal frequency).
- Active bacterial or viral infection requiring concurrent treatment.
- History of hepatitis B or C or human immunodeficiency virus.
- History of central nervous system metastasis.
- Any thrombotic event occurred <3 months prior to Day 1.
- Conditions that may predispose subjects to seizures: History of seizure, previous significant head trauma
- Drug or alcohol abuse.
Trial locations and contacts
3 sites in 1 country.
United States3 sites
Reseach Facility
Encinitas, California
Reseach Facility
San Antonio, Texas
Reseach Facility
Scottsdale, Arizona
About this study
Official title: An Assessment of the Effect of Food and Antacid on BIIB021 Pharmacokinetics in Subjects With Advanced Solid Tumors.
This study is designed to assess the effect of food and antacid use on the pharmacokinetic properties of BIIB021.
Read the detailed description
This study has 2 phases (the Food Phase and the Antacid Phase), each consisting of a 2-period, 2-sequence, 2-treatment crossover design. The Food Phase will assess the effect of a high fat meal on the pharmacokinetics of 100 mg BIIB021, and the Antacid Phase will assess the effect of an antacid (ranitidine) on the pharmacokinetics of 450 mg BIIB021 in the same subjects. Ranitidine 150 mg will be taken the evening before and the morning of the antacid dosing day.
- Conditions
- Advanced Solid Tumors
- Being tested
- BIIB021 and Food, BIIB0121 and Antacid
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BIIB021 and FoodDrug
Assessing the effect of food use on BIIB021
BIIB0121 and AntacidDrug
Assessing the effect of antacid use on BIIB021
| Study group | Role | What they receive |
|---|---|---|
| BIIB021 and Food | Experimental | The food phase will assess the effect of a high fat meal on the pharmacokinetics of BIIB021. Receives: Drug: BIIB021 and Food |
| BIIB021 and Antacid | Experimental | Antacid phase will assess the effect of an antacid on the pharmacokinetics of BIIB021. Receives: Drug: BIIB0121 and Antacid |
What is being measured
The primary outcome is the main question the study is designed to answer.
The primary objective of the study is to assess the pharmacokinetics of BIIB021 taken under fed conditions compared to BIIB021 taken under fasting conditions in subjects with advanced solid tumors.
Measured: Cycle 1, Day 3
Secondary outcomes (4)
To assess the pharmacokinetics of BIIB021 taken with an antacid (ranitidine) compared to BIIB021 taken with no antacid, both under fasting conditions
Measured: Cycle 1, Day 8 and Day 10
To evaluate the safety and tolerability of BIIB021
Measured: 6 months
To evaluate the antitumor activity of BIIB021
Measured: 6 months
To evaluate the effect of BIIB021 on pharmacodynamic biomarkers.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Nov 2009 (estimated)
- Study startNov 2009
- Primary completionAug 2010
- Study completionJan 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Biogen
- Sponsor type
- Industry (pharma, biotech, devices)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01017198
- Sponsor's protocol ID
- 120ST104
- Status last verified
- Jan 2011
- First submitted
- 18 Nov 2009
- Last updated
- 16 Sep 2013
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 16 Sep 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Assessment of the Effect of Food and Antacid on BIIB021 Pharmacokinetics in Subjects With Advanced Solid Tumors.
- ClinicalTrials.gov ID
- NCT01017198
- Acronym / sponsor ID
- 120ST104
- Conditions
- Advanced Solid Tumors
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- BiogenIndustry (pharma, biotech, devices)
- Study start
- Nov 2009
- Primary completion
- Aug 2010 (actual)
- Study completion
- Jan 2011 (actual)
- First posted
- 20 Nov 2009 (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 study is designed to assess the effect of food and antacid use on the pharmacokinetic properties of BIIB021.
Detailed description
This study has 2 phases (the Food Phase and the Antacid Phase), each consisting of a 2-period, 2-sequence, 2-treatment crossover design. The Food Phase will assess the effect of a high fat meal on the pharmacokinetics of 100 mg BIIB021, and the Antacid Phase will assess the effect of an antacid (ranitidine) on the pharmacokinetics of 450 mg BIIB021 in the same subjects. Ranitidine 150 mg will be taken the evening before and the morning of the antacid dosing day.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| BIIB021 and Food | Experimental | Drug: BIIB021 and FoodThe food phase will assess the effect of a high fat meal on the pharmacokinetics of BIIB021. |
| BIIB021 and Antacid | Experimental | Drug: BIIB0121 and AntacidAntacid phase will assess the effect of an antacid on the pharmacokinetics of BIIB021. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Subjects with histologically or cytologically confirmed solid tumors who have failed or are not candidates for standard therapies or for whom no approved therapy is available.
- Eastern Cooperative Oncology Group (ECOG) performance status of greater or equal to 2.
- Medically able to tolerate a high fat meal and to fast as per protocol.
- Expected survival time of at least 3 months in the opinion of the Investigator.
- Ability to take ranitidine as per protocol.
Key exclusion criteria (15 listed)
- Pregnant (positive pregnancy test) or nursing women.
- Previous treatment with an Hsp90 inhibitor.
- Use of antacids within 7 days of Study Day 1.
- Prior antitumor therapies, including prior experimental agents or approved antitumor therapies within 28 days of the first dose of BIIB021.
- Major surgery or radiation within 28 days of the first dose of BIIB021.
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 |
|---|---|---|
| BIIB021 and FoodAssessing the effect of food use on BIIB021 | Drug | BIIB021 and Food |
| BIIB0121 and AntacidAssessing the effect of antacid use on BIIB021 | Drug | BIIB021 and Antacid |
Primary outcome
The primary objective of the study is to assess the pharmacokinetics of BIIB021 taken under fed conditions compared to BIIB021 taken under fasting conditions in subjects with advanced solid tumors.
Time frame: Cycle 1, Day 3
4 secondary outcomes
To assess the pharmacokinetics of BIIB021 taken with an antacid (ranitidine) compared to BIIB021 taken with no antacid, both under fasting conditions
Time frame: Cycle 1, Day 8 and Day 10
To evaluate the safety and tolerability of BIIB021
Time frame: 6 months
To evaluate the antitumor activity of BIIB021
Time frame: 6 months
To evaluate the effect of BIIB021 on pharmacodynamic biomarkers.
Time frame: 6 months
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 16 Sep 2013.
Related trials for Advanced Solid Tumors
RecruitingPhase 1/2
Study of INBRX-106 and INBRX-106 in Combination With Pembrolizumab (Keytruda®) in Subjects With Locally Advanced or Metastatic Solid Tumors (Hexavalent OX40 Agonist)
Solid Tumor, Non-Small Cell Lung Cancer
Active, not recruitingPhase 1
A Study to Assess Safety, Tolerability, and Pharmacokinetics of ABSK043 in Patients With Advanced Solid Tumor
Neoplasms
RecruitingPhase 1/2
A Study of Neladalkib (NVL-655) in Patients With Advanced NSCLC and Other Solid Tumors Harboring ALK Rearrangement or Activating ALK Mutation (ALKOVE-1)
Locally Advanced Solid Tumor, Metastatic Solid Tumor
Active, not recruitingPhase 2
Testing AZD5363 as a Potential Targeted Treatment in Cancers With AKT Genetic Changes (MATCH-Subprotocol Y)
Advanced Lymphoma, Advanced Malignant Solid Neoplasm
RecruitingPhase 1/2
Docetaxel and SX-682 in Recurrent/Metastatic Head and Neck Squamous Cell Carcinoma, Salivary Gland Carcinoma, and Advanced Prostate Cancer
Head and Neck Cancer, Head and Neck Squamous Cell Carcinoma
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 and Food and BIIB0121 and Antacid 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 8 inclusion and 15 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 16 Sep 2013. 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?
The primary objective of the study is to assess the pharmacokinetics of BIIB021 taken under fed conditions compared to BIIB021 taken under fasting conditions in subjects with advanced solid tumors. (time frame: Cycle 1, Day 3). 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 16 Sep 2013.