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



Status:Recruiting
Conditions:Ovarian Cancer, Cervical Cancer, Cancer, Cancer, Cancer, Cancer, Cancer, Endometrial Cancer
Therapuetic Areas:Oncology
Healthy:No
Age Range:18 - Any
Updated:4/21/2016
Start Date:October 2014
End Date:July 2016
Contact:Esther Welkowsky
Email:ewelkowsky@atarabio.com

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An Open-Label Multiple Ascending Dose Phase 1/1B Pharmacokinetic and Pharmacodynamic Study of STM 434, an Activin Type 2B Receptor Fc Fusion, Alone and 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.

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 does to the body), and anti-tumor activities of STM 434 (an inhibitor of activin
A) in patients with ovarian cancer and other advanced solid tumors. The study will be
conducted in 3 phases (Part 1, Part 2 and Part 3). In the first part of the study (Part 1),
which will enroll patients with multiple solid tumor types, the maximum tolerated dose (MTD)
of STM 434 will be determined for use in the second and third parts of the study (Parts 2
and 3). In the second part (Part 2), which will enroll patients with ovarian cancer, STM 434
will be administered alone, and in the third part (Part 3), which will enroll patients with
ovarian cancer, STM 434 will be given together with a chemotherapy called liposomal
doxorubicin. Doses of STM 434 (starting at 0.25 mg/kg up to a maximum of 4 mg/kg) will be
taken on one of three dosing schedules to determine the MTD. Patients will continue taking
STM 434 until their tumor progresses. Serial blood samples will be collected for
pharmacokinetic and pharmacodynamic testing and safety will be monitored throughout the
study.

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)
We found this trial at
4
sites
3322 West End Avenue
Nashville, Tennessee 37203
(615)329-SCRI (7274)
Principal Investigator: Infante, MD
Phone: 615-339-4214
Sarah Cannon Research Institute Sarah Cannon Research Institute (SCRI) is a global strategic research organization...
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450 Brookline Ave
Boston, Massachusetts 2215
617-632-3000
Principal Investigator: Liu, MD
Dana-Farber Cancer Institute Since it’s founding in 1947, Dana-Farber has been committed to providing adults...
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1275 York Ave
New York, New York 10021
(212) 639-2000
Principal Investigator: Hyman, MD
Memorial Sloan Kettering Cancer Center Memorial Sloan Kettering Cancer Center — the world's oldest and...
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New York, NY
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San Antonio, Texas 78229
Principal Investigator: Rasco, MD
Phone: 210-593-5265
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San Antonio, TX
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