Clinical trial · Interventional
Effect of Food and Antacid on BIIB021 With Advanced Solid Tumors
An Assessment of the Effect of Food and Antacid on BIIB021 Pharmacokinetics in Subjects With Advanced Solid Tumors.
NCT01017198CI-TRIAL-00012070completedPhase 1ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
This study is designed to assess the effect of food and antacid use on the pharmacokinetic properties of BIIB021.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Advanced Solid Tumors | Solid Neoplasm | CURATED_BROADER | 0.80 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| BIIB0121 and Antacid | Drug | — | UNRESOLVED |
| BIIB021 and Food | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- BIIB021 and Food
- description
- The food phase will assess the effect of a high fat meal on the pharmacokinetics of BIIB021.
- interventionNames
- Drug: BIIB021 and Food
- type
- EXPERIMENTAL
- label
- BIIB021 and Antacid
- description
- Antacid phase will assess the effect of an antacid on the pharmacokinetics of BIIB021.
- interventionNames
- Drug: BIIB0121 and Antacid
Primary outcomes (1)
- 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.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * 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. Exclusion Criteria: * 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. * 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.
References
Publications (0)
Data not yet available
No reference posted for this study.