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An open-label, dose escalation, phase I study to evaluate the tolerability, safety and pharmacokinetics of afuresertib monotherapy and in combination with bortezomib and dexamethasone in Japanese relapsed multiple myeloma patients.

An open-label, dose escalation, phase I study to evaluate the tolerability, safety and pharmacokinetics of afuresertib monotherapy and in combination with bortezomib and dexamethasone in Japanese relapsed multiple myeloma patients.

Status
Active, not recruiting
Phases
Phase 1
Study type
Interventional
Source
JPRN
Registry ID
JPRN-jRCT2080222524
Enrollment
18
Registered
2014-06-17
Start date
2014-08-13
Completion date
Unknown
Last updated
2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Multiple Myeloma

Interventions

investigational material(s) Generic name etc : GSK2110183 INN of investigational material : Afuresertib Therapeutic category code : 429 Other antitumor agents Dosage and Administration for Investigati

Sponsors

Novartis
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: Japanese Relapsed Multiple Myeloma Patients

Exclusion criteria

Exclusion criteria: Chemotherapy, radiotherapy, immunotherapy or other anti-myeloma therapy within 28 days prior to enrolment. In addition, any toxicity (except alopecia) should be recovered to <=Grade 1 by National Cancer Institute - Common Terminology Criteria for Adverse Events (NCI-CTCAE), version 4.0.

Design outcomes

Primary

MeasureTime frame
safety Number of subjects with Dose-limiting toxicities (DLTs) when afuresertib is given as monotherapy—

Secondary

MeasureTime frame
safety efficacy Safety and Pharmacokinetics of Afuresertib Monotherapy in Japanese Relapsed Multiple Myeloma Patients—

Countries

Japan

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026