ClinTrial Refer

Trial Acronym
M16-109

Registration Number
NCT03222609

Scientific Title
A Phase 2 Open-Label Study Evaluating Tolerability and Efficacy of Navitoclax Alone or in Combination With Ruxolitinib in Subjects With Myelofibrosis

This is a Phase 2 open-label, multicenter study evaluating tolerability and efficacy of
navitoclax alone or when added to ruxolitinib in participants with myelofibrosis.

-  Participants with documented diagnosis of intermediate or high-risk primary Myelofibrosis, post polycythemia Vera Myelofibrosis or post-essential thrombocythemia myelofibrosis

    -  Participant must be ineligible or unwilling to undergo stem cell transplantation at time of study entry

    -  ECOG of 0,1, or 2.

    -  Participant must have either received prior treatment with ruxolitinib OR another JAK-2 inhibitor therapy OR must not have received any prior treatment with JAK-2 inhibitor.

    -  Participant has splenomegaly as defined in the protocol.

    -  Participant must meet the laboratory parameters (adequate bone marrow, renal and hepatic function) as defined in the protocol.

-  Splenic irradiation within 6 months prior to screening, or prior splenectomy.

    -  Leukemic transformation (> 10% blasts in peripheral blood or bone marrow biopsy).

    -  Participant is currently on medications that interfere with coagulation (including warfarin) or platelet function with the exception of low dose aspirin (up to 100 mg) and Low-molecular-weight heparin.

    -  Prior therapy with a BH3 mimetic compound.

    -  Participant has received strong or moderate CYP3A inhibitors within 14 days prior to the administration of the first dose of navitoclax.

Trial Location Name

Address

Status

Alfred Health (Haematology)

The Alfred, Commercial Road, Melbourne VIC, Australia

Closed

Primary Contact : John Nguyen, john.nguyen@alfred.org.au , 03 9076 7135

Fiona Stanley Hospital (Haematology)

11 Robin Warren Dr, Murdoch WA 6150, Australia

Closed

Primary Contact : Wendy Angelatos, wendy.angelatos@health.wa.gov.au , 08 6152 6540

Peter MacCallum - Parkville Cancer Clinical Trials Unit (PCCTU) (Haematology)

Peter MacCallum Cancer Centre, Grattan Street, Melbourne VIC, Australia

Closed

Primary Contact : Enquiry Line Coordinator, clinicaltrials.enquiries@petermac.org , +613 8559 7456

St Vincents Hospital Sydney (Haematology)

St Vincent's Hospital Sydney, Victoria Street, Darlinghurst NSW, Australia

Closed

Primary Contact : Georgia McCaughan, georgia.mccaughan@svha.org.au , 02 9355 5656

AbbVie

Website URL

Link Name

Link URL

ANZCTR

http://www.anzctr.org.au/TrialSearch.aspx?searchTxt=NCT03222609

Clinicaltrials.gov

https://clinicaltrials.gov/ct2/show/NCT03222609

Secondary IDs
2017-001398-17M16-109

Study Type
Interventional

Intervention Code
Treatment - Drugs

Phase
Phase 2

Minimum Age
18

Maximum Age
100

Date Registered
04/06/2020

Date Closed
N/A

Status
Closed

Enrolment Type
By Specialist and/or Surgeon Referral

Mutation Status and Biomarker
Any or not stated

Is it a Cohort Trial?
No

Is this a Tele-Trial?
No

Can healthy volunteer participate?
No

Discipline

Health Condition

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