Status:
COMPLETED
Effects of STM 434 Alone or in Combination With Liposomal Doxorubicin in Patients With Ovarian Cancer or Other Advanced Solid Tumors
Lead Sponsor:
Santa Maria Biotherapeutics
Conditions:
Ovarian Cancer
Fallopian Tube Cancer
Eligibility:
All Genders
18+ years
Phase:
PHASE1
Brief 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 t...
Detailed Description
This is an open-label (identity of assigned study drug will be known) study to evaluate the safety, pharmacokinetics (study of what the body does to a drug), pharmacodynamics (study of what a drug doe...
Eligibility Criteria
Inclusion
- 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
- 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 agents (ticlopidine or clopidogrel)
- History of hereditary hemorrhagic telangiectasia (HHT, Osler-Weber-Rendu syndrome)
- Myocardial infarction, unstable angina within the past 6 months, or congestive heart failure New York Heart Association Class II or greater
- Chemotherapy, hormonal therapy or radiation therapy within the past 3 weeks, antibody/biologic therapy within 5 half-lives or within the past 4 weeks (whichever is longer)
- Current bowel obstruction
- Brain metastasis
- Known HIV infection and/or active Hepatitis B or C infection
- Prior treatment with any investigational product within the past 4 weeks
- Not willing to use contraception (inclusive of abstinence)
Key Trial Info
Start Date :
October 1 2014
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 13 2017
Estimated Enrollment :
32 Patients enrolled
Trial Details
Trial ID
NCT02262455
Start Date
October 1 2014
End Date
January 13 2017
Last Update
February 13 2017
Active Locations (4)
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1
Dana Farber Cancer Institute
Boston, Massachusetts, United States, 02114
2
Memorial Sloan Kettering Cancer Center
New York, New York, United States, 10065
3
Sarah Cannon Research Institute
Nashville, Tennessee, United States, 37203
4
South Texas Accelerated Research Therapeutics
San Antonio, Texas, United States, 78229