Effects of STM 434 Alone or in Combination With Liposomal Doxorubicin in Patients With Ovarian Ca… (NCT02262455) | Clinical Trial Compass
CompletedPhase 1
Effects of STM 434 Alone or in Combination With Liposomal Doxorubicin in Patients With Ovarian Cancer or Other Advanced Solid Tumors
United States32 participantsStarted 2014-10
Plain-language summary
This is a Phase I study to test the safety, pharmacokinetics and effectiveness of STM 434 alone, or in combination with liposomal doxorubicin, in patients with ovarian cancer or other advanced solid tumors.
Who can participate
Age range18 Years
SexALL
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Inclusion Criteria:
* Males and postmenopausal females, 18 years or older
* Advanced solid tumors with histologic diagnosis confirming cancer
* Patients with recurrent metastatic or locally advanced disease considered refractory or intolerant to all standard treatment available for their tumor, or those tumors for which no standard treatment is available
* Subjects with serous ovarian/fallopian tube/primary peritoneal, granulosa cell tumors or clear cell tumors considered platinum refractory/resistant, defined as having at least one prior platinum-based chemotherapeutic regimen with a subsequent platinum-free interval of \< 12 months, having progression during platinum-based therapy, or having persistent disease after a platinum-based therapy, are eligible. Intolerant subjects, defined as unable to receive further platinum due to toxicity, are eligible.
* Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
* Informed consent
Exclusion Criteria:
* History of gastrointestinal bleeding within the past 6 months
* History of epistaxis requiring medical/surgical intervention (such as nasal packing) within the past 6 months
* History of central nervous system hemorrhage
* History of bleeding diathesis or known qualitative platelet defect (including von Willebrand disease)
* Ongoing need for therapeutic anticoagulants (full dose heparin, warfarin, factor Xa or direct thrombin inhibitors; rivaroxaban, apixaban, dabigatran) chronic use of aspirin or anti-platelet …
What they're measuring
1
Maximum Tolerated Dose (MTD)
Timeframe: MTD will be assessed for STM 434 alone in Part 1 and in combination with liposomal doxorubicin in Part 3 once the last subject in each cohort completes 28 days of treatment.