A safety and efficacy study of the drug BGB-290 in combination with radiation therapy and/or temozolomide (TMZ) in patients with brain cancer.

Phase 1

• Conditions: glioblastoma; Therapeutic area: Diseases [C] - Cancer [C04]

• Registration Number: EUCTR2017-001554-33-NL
• Lead Sponsor: BeiGene USA, Inc.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2017-09-05
• Last Update Posted: 16 December 2019

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: 300

Inclusion Criteria

ALL PATIENTS
1 Age = 18 years old.
2 Confirmed diagnosis of glioblastoma (WHO Grade IV).
3 Ability to undergo serial MRIs.
4 ECOG status = 1.
5 Adequate bone marrow function.
6 Adequate renal and hepatic function.
7 Ability to swallow whole capsules.
Subjects in Arms A and B (not Arm C) must also meet inclusion criteria:
8 No previous treatment for GB except surgery.
9 Able to start radiation therapy = 49 days after surgery but = 14 days
after a biopsy or =28 days after an open biopsy or craniotomy with
adequate wound healing.
10 Documented unmethylated MGMT promoter status.
Subjects in Arm C ESCALATION only must also meet inclusion criteria:
11 Documentation of MGMT promoter status
? It is preferable to determine MGMT status by MS-PCR. Other
acceptable platforms include pyrosequencing methodologies and MSHRM
assays with comparable sensitivity, applied to archival or fresh
tumor tissue.
12 No prior systemic chemotherapy other than TMZ for GB and nd no
prior anti-angiogenic therapy
13 Histologically confirmed secondary glioblastoma
14 Progressive disease > 2 months after completion of first line therapy.
15 Disease that is evaluable or measurable by mRANO
Subjects in Arm C EXPANSION only must also meet inclusion criteria:
16 Histologically confirmed de novo (primary) glioblastoma with
unequivocal first
progressive disease (PD) after RT with concurrent/adjuvant TMZ
chemotherapy as defined
by one or more of the following:
? PD = 3 months after the end of radiotherapy
? PD that is clearly outside the radiation field
? PD that has been unequivocally proven by surgery/biopsy
17 Disease that is measurable as defined by RANO criteria
18 Documentation of MGMT promoter status.
For full list of inclusion criteria refer to the study protocol.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 150
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 150

Exclusion Criteria

ALL PATIENTS:
1. Chemotherapy, biologic therapy, immunotherapy, or investigational
agent = 21 days (or = 5 half-lives, whichever is shorter) prior to Day 1
2. Unresolved acute effects of any prior therapy of Grade = 2, except for
AEs not constituting a safety
risk by investigator judgement
3. Major surgical procedure, open biopsy, or significant traumatic injury
= 28 days prior to Day 1, or anticipation of need for major surgical
procedure during the course of the study.
4. Other diagnosis of malignancy
? - Except for surgically excised non-melanoma skin cancer, adequately
treated carcinoma in situ of the cervix, localized prostate cancer treated
with curative intent, adequately treated low-stage bladder cancer, ductal
carcinoma in situ treated surgically with curative intent, or a malignancy
diagnosed >2 years ago with no current evidence of disease and no
therapy = 2 years prior to Day 1
5. Active infection requiring systemic treatment
6. Active cardiac disease, inflammatory gastrointestinal disease,
bleeding disorder (for details see protocol)
7. Anticoagulation with heparin, warfarin, or other anticoagulants (for
details see protocol)
8. Use = 10 days (or = 5 half-lives, whichever is shorter) prior to Day 1
or anticipated need for food or
drugs known to be strong or moderate CYP3A inhibitors or strong CYP3A
inducers including known enzyme inducing anti-epileptic drugs
FOR PATIENTS IN Arm B and C (NOT applicable to Arm A)
9. Known hypersensitivity to any temozolomide component or to
dacarbazine (DTIC)
10. Have hereditary problems of galactose intolerance, the Lapp lactase
deficiency, or
glucose-galactose malabsorption
For full list of exclusion criteria see protocol.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified