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

• Status: Completed
• Trial end date: 2017-01-13
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Santa Maria Biotherapeutics
• Treatments: Doxorubicin; Liposomal doxorubicin

Criteria

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 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)