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Trial Summary

An interventional study to safety, tolerability (how well a substance is tolerated by patients), and Pharmacokinetics (PK, the measure of how the human body processes a substance) of different dosages of Auceliciclib when given to patients with advanced solid tumours as either the only treatment, or in patients with a specific type of cancer, Glioblastoma multiforme (GBM), when given together with a standard of care treatment, Temozolomide (TMZ).

Acronym:

SOC2102

ACTRN/NCT /ethics:

ACTRN12621000479808

Scientific title:

A Phase 1a/b, open-label, dose-exploration, combination/ expansion study to evaluate the safety, tolerability and pharmacokinetics of Auceliciclib in advanced solid tumours and in combination with temozolomide in recurrent or newly diagnosed Glioblastoma multiforme (GBM).

Sponsor / Cooperative group:

Aucentra Therapeutics

Trial & Patient Characteristics

Cancer TypeAll cancers; Brain; Gynaecological
Trial TypeTreatment
PhasePhase I
Age Range18 years and older
SexAll
Tumour Stream -
Cancer StageLocally Recurrent or Locally Advanced; Metastatic or Widespread
Anticipated Start Date2021-06-16
Anticipated End Date2023-06-30

Participating Hospitals

HospitalSouthern Oncology Clinical Research Unit
Clinical Trial CoordinatorMeggan O'Riley
EmailMeggan.ORiley@socru.org.au
Phone0491 679 039
Principal InvestigatorDr Ganessan Kichenadasse
Recruitment StatusRecruiting