Effects of STM 434 Alone or in Combination With Liposomal Doxorubicin in Patients With Ovarian Cancer or Other Advanced Solid Tumors

Completed · Phase 1

Conditions studied: Ovarian Cancer, Fallopian Tube Cancer, Endometrial Cancer, Solid Tumors

In brief

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.

Key facts

Study ID

NCT02262455

Run by

Santa Maria Biotherapeutics

People needed

32

Starts

2014-10-01

Expected to finish

2017-01-13

Last updated by the study team

2017-02-13

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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)

Where it is running

• Dana Farber Cancer Institute — Boston, Massachusetts, United States
• Memorial Sloan Kettering Cancer Center — New York, New York, United States
• Sarah Cannon Research Institute — Nashville, Tennessee, United States
• South Texas Accelerated Research Therapeutics — San Antonio, Texas, United States

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.