Effects of STM 434 Alone or in Combination With Liposomal Doxorubicin in Patients With Ovarian Cancer or Other Advanced Solid Tumors
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.
Ask AI to explain this studyKey things to know
This describes the study’s primary purpose.
The study team can explain what participation involves.
These are broad labels—not an eligibility decision.
Checked against the public recordLast updated Feb 13, 2017 · Source: ClinicalTrials.gov
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Interventional
Locations may change over time.
Study sponsor
What this study is about
- Purpose
- Treatment
- Study type
- Interventional
- Phase
- Phase 1
- Sponsor
- Santa Maria Biotherapeutics
- Interventions being studied
- Drug: STM 434; Drug: Liposomal doxorubicin
How this study is categorized
These labels come from structured fields and exact terms in the public record.
Who may be able to participate
The sponsor separates these requirements into two groups. You do not need to interpret them alone—use them to guide a conversation with the study team.
- 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
- 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)
Important: This is the sponsor’s public criteria, not a determination of eligibility. The study team must review your individual situation.
U.S. locations
- Dana Farber Cancer InstituteBoston, Massachusetts
- Memorial Sloan Kettering Cancer CenterNew York, New York
- Sarah Cannon Research InstituteNashville, Tennessee
- South Texas Accelerated Research TherapeuticsSan Antonio, Texas
Source and freshness
Processed from ClinicalTrials.gov. Last public update: Feb 13, 2017. Always confirm current availability with the study team.