NL-OMON50797
Withdrawn
Phase 2
Phase 1/2 Study to Investigate the Safety, Pharmacokinetics and Efficacy of Tinostamustine, a First-in-Class Alkylating Histone Deacetylase Inhibition (HDACi) Fusion Molecule, in Patients with Advanced Solid Tumors - Phase * study with tinostamustine in pat. with advanced solid tumors
Overview
- Phase
- Phase 2
- Intervention
- Not specified
- Conditions
- Not specified
- Sponsor
- Mundipharma
- Enrollment
- 15
- Status
- Withdrawn
- Last Updated
- 2 years ago
Overview
Brief Summary
Trial never started
Investigators
Eligibility Criteria
Inclusion Criteria
- •General Inclusion Criteria:
- •Signed informed consent.
- •Patients age \>\=18 years at signing of the informed consent.
- •Life expectancy \> 3 months
- •Histologically confirmed diagnosis of advanced or metastatic solid
- •tumors, disease should have progressed following at least 1 line of therapy and
- •no other standard therapy with proven clinical benefit is available or
- •recommended based on the investigator\*s individual risk\- benefit assessment for
- •the patient.
- •Patients with secondary metastasis to the central nervous system
Exclusion Criteria
- •To be eligible to participate in the trial, a patient cannot meet any of the
- •following exclusion criteria:
- •Patients with primary CNS cancer.
- •Patients with QTc interval (Fridericia\*s formula) \>450 ms.
- •Patients who are on treatment with drugs known to prolong the QT/QTc
- •interval. Refer to CredibleMeds list of drugs with known risk of Torsade des
- •pointes (TdP): http://crediblemeds.org/new\-drug\-list.
- •Patients who are being treated with valproic acid for any of its indication
- •(epilepsy, mood disorder)
- •Any serious medical condition that interferes with adherence to trial
Outcomes
Primary Outcomes
Not specified
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