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

Brief Title

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

Official Title

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

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 tumors.

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 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.

Study Phase

Phase 1

Study Type

Interventional

Primary Outcome

Maximum Tolerated Dose (MTD)

Secondary Outcome

 Recommended Phase 2 dose (RP2D)

Condition

Ovarian Cancer

Intervention

STM 434

Study Arms / Comparison Groups

 STM 434

Description:

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status

Drug

Estimated Enrollment

Start Date

October 2014

Completion Date

January 13, 2017

Primary Completion Date

January 13, 2017

Eligibility 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)

Gender

All

Ages

18 Years - N/A

Accepts Healthy Volunteers

No

Contacts

Willis Navarro, MD, ,

Location Countries

United States

Location Countries

United States

Administrative Informations

NCT ID

NCT02262455

Organization ID

STM-434-001

Responsible Party

Sponsor

Study Sponsor

Santa Maria Biotherapeutics

Study Sponsor

Willis Navarro, MD, Study Director, Santa Maria Biotherapeutics

Verification Date

February 2017