Clinical trial · Interventional
A Study of BBI608 in Adult Patients With Advanced, Refractory Hematologic Malignancies
A Phase Ib Clinical Study of BBI608 for Adult Patients With Advanced, Refractory Hematologic Malignancies
NCT02352558CI-TRIAL-00071348completedPhase 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 is a multicenter, open label, Phase 1 dose-escalation study of BBI608 administered to patients with relapsed, refractory hematologic malignancies, including multiple myeloma, lymphoma, and others.
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 |
|---|---|---|---|
| Hematologic Malignancy | Hematopoietic and Lymphoid Cell Neoplasm | ALIAS | 0.90 |
Interventions
Interventions (5)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| BBI608 | Drug | — | UNRESOLVED |
| Bortezomib | Drug | Bortezomib | ALIAS |
| Dexamethasone | Drug | Dexamethasone | ALIAS |
| Ibrutinib | Drug | Ibrutinib | ALIAS |
| Imatinib | Drug | Imatinib | ALIAS |
Design
Arms and outcomes
Arms (9)
- type
- EXPERIMENTAL
- label
- Arm 1
- description
- Patients with multiple myeloma treated with BBI608
- interventionNames
- Drug: BBI608
- type
- EXPERIMENTAL
- label
- Arm 2
- description
- Patients with lymphoma treated with BBI608
- interventionNames
- Drug: BBI608
- type
- EXPERIMENTAL
- label
- Arm 3
- description
- Patients with acute myeloid leukemia or myelo-dysplastic syndrome treated with BBI608
- interventionNames
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Major Inclusion Criteria: 1. Signed written informed consent must be obtained and documented according to the International Conference on Harmonisation (ICH) and be in accordance with local regulatory requirements 2. A histologically confirmed hematologic malignancy that is advanced, relapsed, or refractory to standard, currently available anti-cancer treatment options 3. ≥ 18 years of age 4. Eastern Cooperative Oncology Group (ECOG) performance status of ≤ 1 at dose escalation phase and of ≤ 2 at dose expansion phase 5. Male or female patients of child-producing potential must agree to use contraception or avoidance of pregnancy measures during the study and for 30 days after their last dose 6. Females of childbearing potential must have a negative serum pregnancy test 7. Aspartate transaminase (AST) ≤ 2.5 x upper limit of normal (ULN) and alanine transaminase (ALT) ≤ 2.5 × upper limit of normal (ULN). Patients whose disease involves the liver and who have laboratory values of AST ≤ 3.5 ULN, AST ≤ 3.5 ULN, and albumin ≥ 35g/L may be enrolled if agreed upon by the Principal Investigator and Medical Monitor for the Sponsor 8. Total bilirubin \< 1.5 x ULN, except for cases in which elevation of total bilirubin is due to elevated levels of unconjugated bilirubin consistent with a diagnosis of Gilbert's Syndrome 9. Life expectancy ≥ 3 months
References
Publications (0)
Data not yet available
No reference posted for this study.