A Study of BBI608 in Adult Patients With Advanced, Refractory Hematologic Malignancies

Sumitomo Pharma

Status and phase: Completed; Phase 1

Conditions: Hematologic Malignancy

Treatments: Drug: Ibrutinib; Drug: Imatinib; Drug: Bortezomib; Drug: BBI608; Drug: Dexamethasone

Study type: Interventional

Funder types: Industry

Identifiers

NCT02352558

BBI608-103HEME

BBI608-103HEM (Other Identifier)

Details and patient eligibility

About

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.

Enrollment: 15 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

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

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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15 participants in 9 patient groups

Arm 1

Experimental group

Description:

Patients with multiple myeloma treated with BBI608

Treatment:

Drug: BBI608

Arm 2

Experimental group

Description:

Patients with lymphoma treated with BBI608

Treatment:

Drug: BBI608

Arm 3

Experimental group

Description:

Patients with acute myeloid leukemia or myelo-dysplastic syndrome treated with BBI608

Treatment:

Drug: BBI608

Arm 4

Experimental group

Description:

Patients with chronic myeloid leukemia treated with BBI608

Treatment:

Drug: BBI608

Arm 5

Experimental group

Description:

Patients with multiple myeloma treated with BBI608 and dexamethasone

Treatment:

Drug: BBI608

Drug: Dexamethasone

Arm 6

Experimental group

Description:

Patients with multiple myeloma treated with BBI608 and bortezomib

Treatment:

Drug: BBI608

Drug: Bortezomib

Arm 7

Experimental group

Description:

Patients with chronic myeloid leukemia treated with BBI608 and imatinib

Treatment:

Drug: BBI608

Drug: Imatinib

Arm 8

Experimental group

Description:

Patients with chronic lymphocytic leukemia treated with BBI608

Treatment:

Drug: BBI608

Arm 9

Experimental group

Description:

Patients with chronic lymphocytic leukemia treated with BBI608 and ibrutinib

Treatment:

Drug: BBI608

Drug: Ibrutinib