ACTRN12618000357257CompletedPhase 2
Single arm, open label, signal seeking, phase IIa trial of the activity of eribulin in patients with advanced CD31 positive angiosarcoma and selected CD31 positive sarcomas.
Conditions
Trial Snapshot
- Phase
- Phase 2
- Status
- Completed
- Sponsor
- The University 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
- •The Cancer Molecular Screening and Therapeutics (MoST) Program - A framework protocol for multiple, parallel, signal-seeking clinical studies of novel molecularly targeted therapies for patients with advanced cancer and unmet clinical need is registered under ACTRN12616000908437.
- •Inclusion Criteria – molecular screening
- •1.Male or female patients, aged 18 years and older, with pathologically confirmed advanced and/or metastatic solid cancer of any histologic type or an earlier diagnosis of a poor prognosis cancer.
- •2.Sufficient and accessible tissue for molecular screening.
- •3.Patients receiving their last line of standard treatment or who have received and failed all standard anticancer therapy (where standard therapy exists) or have documented unsuitability for any further standard anticancer therapy Poor prognosis cancers or cancers with low expected response rate to standard treatment (in the opinion of the investigator and based on available evidence) may be screened on an earlier line of treatment.
- •a.Failure is defined as either progression of disease (clinical or radiological) or intolerance to standard therapy resulting in the discontinuation of the therapy.
- •b.Documented unsuitability for further standard therapy includes known hypersensitivity, organ dysfunction or other patient factors that would make therapy unsuitable in the judgement of the responsible investigator.
- •4.ECOG performance status 0, 1 or 2
- •5.Willing and potentially able to comply with study requirements, including treatment, timing and/or nature of required assessments; It is the intention to screen patients who are in principle wishing to take part in a MoST substudy if they are found to have an appropriate tumour biomarker and are still eligible for enrolment at the time of the treatment phase.
- •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.
- •Inclusion Criteria – substudy
- •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):
- •a.bone marrow function; and haemoglobin greater than or equal to 9g/dL (5.6mmol/L);
- •5.Participants must have normal organ and marrow function as defined below:
- •a.leukocytes greater than or equal to 3.0 x 109 L
- •b.absolute neutrophil countgreater than or equal to 1.0 x 10^9 L
- •c.platelets greater than or equal to 100 x 10^9 L
- •d.AST(SGOT)/ALT(SGPT) less than or equal to 2.5 × institutional upper limit of normal
- •e. creatinine clearance greater than or equal to 50 mL/min (Cockcroft and Gault formula – see section 6 for detail)
- •6.CD31-positive (CD31+) metastatic, unresectable or locally advanced angiosarcoma OR metastatic or locally advanced CD31 positive sarcomas including malignant and progressive epithelioid hemangioendothelioma (EHE).
- •7.Participants must have measurable
Exclusion Criteria
- •The Cancer Molecular Screening and Therapeutics (MoST) Program - A framework protocol for multiple, parallel, signal-seeking clinical studies of novel molecularly targeted therapies for patients with advanced cancer and unmet clinical need is registered under ACTRN12616000908437.
- •Exclusion Criteria – molecular screening
- •1.Suitable for standard therapy or accepted standard care, if the patient has not been previously treated;
- •2.Specific comorbidities or conditions (e.g. psychiatric) or concomitant medications which may contraindicate participation and/or interact with the investigational product(s);
- •3.Other co-morbidities or conditions that may compromise assessment of key outcomes or in the opinion of the clinician, limit the ability of the patient to comply with the protocol;
- •4.For non central nervous system (CNS) cancers, patients with symptomatic CNS involvement of his/her cancer. Subjects with stable neurological function, on stable doses of steroids/anti-epileptics over 4 weeks, and with no evidence of CNS progression within 12 weeks prior to study entry are eligible.
- •5.History of another malignancy within 2 years prior to registration unless adequately treated and determined free of progressive and metastatic disease for at least 6 months. Patients with a past history of adequately treated carcinoma-in-situ, basal cell carcinoma of the skin, squamous cell carcinoma of the skin, or superficial transitional cell carcinoma of the bladder are eligible;
- •6.Pregnancy, lactation, or inadequate contraception. Women must be post-menopausal, infertile, or use a reliable means of contraception. Women of childbearing potential must have a negative pregnancy test done within 7 days prior to registration. Men must have been surgically sterilised or use a barrier method of contraception (double barrier, if required).
- •Exclusion criteria – substudy
- •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:
- •-Radiation 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;
- •-Immunotherapy within 28 days prior to the first dose of study treatment;
- •-Chemotherapy, biologic therapy, or hormonal therapy within 14 days or 5 half-lives of a drug, prior to the first dose of study treatment or until recovery from previous therapy (whichever is longer);
- •5.Administration of any investigational treatment within 30 days or 5 half-lives (whichever is longer) prior to receiving the first dose of study treatment;
- •6.Participants who have had chemotherapy or radiotherapy within 3 weeks (6 weeks for nitrosoureas or mitomycin C), immunotherapy within 3 weeks, targeted therapies (e.g. small molecule inhibitors such as pazopanib) within 2 weeks prior to entering the study or those who have not recovered from adverse events due to agents administered more than 4 weeks earlier. Clinically insignificant or clinically stable adverse events from prior therapy (e.g. immunotherapy related hypothyroidism or insulin-dependent d
Investigators
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