ACTRN12616000931471CompletedPhase 1
MoST Substudy 1: Single arm, open label, signal seeking, phase Ib/IIa trial of the CDK4/6 inhibitor palbociclib in patients with tumours with amplified D-type cyclins or CDK4 or inactivation of CDKN2A.
Conditions
Trial Snapshot
- Phase
- Phase 1
- Status
- Completed
- Sponsor
- niversity of Sydney
- Enrollment
- 16
Study Overview
Brief Summary
No summary available.
Study Design
- Study Type
- Interventional
- Allocation
- Non-randomised trial
- Primary Purpose
- Treatment
- Masking
- Open (masking not used)
Eligibility Criteria
- Ages
- 18 Years to o limit (—)
- Sex
- All
Inclusion Criteria
- •To be eligible for treatment in a substudy, patients must continue to meet all of the inclusion criteria and none of the exclusion criteria specified for entry into molecular screening at the time of registration to a treatment substudy. In addition, they must meet all the inclusion criteria and none of the exclusion criteria in the substudy addendum at the time of registration.
- •1.Confirmation of molecular eligibility by the molecular tumour board;
- •2.Received and failed all standard anticancer therapy or have documented unsuitability for any further standard therapy, if standard therapy exists;
- •3.Clinical or radiological progression on or following last anticancer therapy;
- •4.Adequate organ system function as assessed by the following minimal laboratory requirements (within 7 days prior to first administration of study drug):
- •5.Meet any additional inclusion criteria specified in the relevant substudy addendum;
- •6.Signed, written informed consent to participation in the specific treatment substudy.
- •Inclusion Criteria specific to this sub-study :
- •1.Subjects with tumours carrying somatic mutations in the Rb-pathway including amplification or activating mutations in CCND1, CCND2, CCND3 or CDK4, or loss of function mutations in CDKN2A;
- •2.Able to swallow capsules.
Exclusion Criteria
- •Exclusion criteria will include those relevant for screening but also include:
- •1.Contraindications to investigational product, as listed in the substudy addendum and outlined in the Investigator Brochure appended to each substudy module;
- •2.Known history of hypersensitivity to active or inactive components of investigational product;
- •3.Previous treatment with the same agent or same class of agent;
- •4.Treatment with any of the following anti-cancer therapies prior to the first dose of study treatment:
- •oRadiation therapy, surgery or tumour embolization within 14 days prior to the first dose of study treatment. Palliative radiotherapy (for analgesia) is acceptable only if the irradiated field does not include target lesions;
- •oImmunotherapy within 28 days prior to the first dose of study treatment;
- •oChemotherapy, biologic therapy, investigation therapy or hormonal therapy within 30 days or 5 half-lives of a drug (whichever is longer), prior to the first dose of study treatment;
- •5. Administration of any non-oncologic investigational treatment within 30 days or 5 half-lives (whichever is longer) prior to receiving the first dose of study treatment;
- •6. Any additional exclusion criteria specified in the relevant substudy addendum.
- •Exclusion Criteria specific to this sub-study:
- •1.Subjects with breast cancer, mantle cell lymphoma, myeloma, or germ cell tumours;
- •2.Patients with steroid-responsive tumours must be on a stable dose of dexamethasone for a minimum of 14 days prior to registration
- •3.Contraindications to palbociclib, including known hypersensitivity to any of the components of palbociclib;
- •4.Prior treatment with a CDK inhibitor.
Investigators
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