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

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ClinicalTrials.gov Identifier: NCT02262455
Recruitment Status : Completed
First Posted : October 13, 2014
Last Update Posted : February 13, 2017
Sponsor:
Information provided by (Responsible Party):
Santa Maria Biotherapeutics

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.

Condition or disease Intervention/treatment Phase
Ovarian Cancer Fallopian Tube Cancer Endometrial Cancer Solid Tumors Drug: STM 434 Drug: Liposomal doxorubicin Phase 1

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 32 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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
Actual Study Start Date : October 2014
Actual Primary Completion Date : January 13, 2017
Actual Study Completion Date : January 13, 2017


Arm Intervention/treatment
Experimental: STM 434 Drug: STM 434
STM 434 will be administered by IV injection. There are five planned dose levels, from 0.25mg/kg to 4mg/kg, which is dependent on the cohort (group) a participant is assigned to.

Experimental: STM 434 and Liposomal Doxorubicin Drug: STM 434
STM 434 will be administered by IV injection. There are five planned dose levels, from 0.25mg/kg to 4mg/kg, which is dependent on the cohort (group) a participant is assigned to.

Drug: Liposomal doxorubicin
Liposomal doxorubicin (40 mg/m2) will be administered once every 28 days by IV infusion prior to STM 434 for those participants enrolled in Part 3 of the trial. Liposomal doxorubicin will be administered for a maximum of 6 cycles (each cycle being 28 days).




Primary Outcome Measures :
  1. Maximum Tolerated Dose (MTD) [ Time Frame: MTD will be assessed for STM 434 alone in Part 1 and in combination with liposomal doxorubicin in Part 3 once the last subject in each cohort completes 28 days of treatment. ]
    To define the maximum tolerated dose (MTD) of STM 434 administered alone or in combination with liposomal doxorubicin chemotherapy in patients with ovarian cancer or other advanced solid tumors.


Secondary Outcome Measures :
  1. Recommended Phase 2 dose (RP2D) [ Time Frame: RP2D will be assessed in Part 1 once the last subject in each cohort completes 28 days of treatment. ]
    To define the recommended Phase 2 dose (RP2D) in the event that there is no maximum tolerated dose (MTD) reached.

  2. Radiographic response rate [ Time Frame: Efficacy parameters will be assessed at three points in the study: once Part 1 and Part 3 are fully enrolled, and during Part 2 of the study. On average the review is expected to occur once every 8 months, for up to 24 months. ]
    To collect preliminary radiographic response data, including CT, MRI scans, during therapy with STM 434.

  3. Muscle function and body composition [ Time Frame: Efficacy parameters will be assessed at three points in the study: once Part 1 and Part 3 are fully enrolled, and during Part 2 of the study. On average the review is expected to occur once every 8 months for up to 24 months. ]
    To collect preliminary anti-cachexia data, including body composition and laboratory parameters, during therapy with STM 434.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02262455


Locations
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United States, Massachusetts
Dana Farber Cancer Institute
Boston, Massachusetts, United States, 02114
United States, New York
Memorial Sloan Kettering Cancer Center
New York, New York, United States, 10065
United States, Tennessee
Sarah Cannon Research Institute
Nashville, Tennessee, United States, 37203
United States, Texas
South Texas Accelerated Research Therapeutics
San Antonio, Texas, United States, 78229
Sponsors and Collaborators
Santa Maria Biotherapeutics
Investigators
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Study Director: Willis Navarro, MD Santa Maria Biotherapeutics

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Santa Maria Biotherapeutics
ClinicalTrials.gov Identifier: NCT02262455     History of Changes
Other Study ID Numbers: STM-434-001
First Posted: October 13, 2014    Key Record Dates
Last Update Posted: February 13, 2017
Last Verified: February 2017
Keywords provided by Santa Maria Biotherapeutics:
Serous tumor
Granulosa tumor
Clear Cell tumor
Endometrial cancer
Advanced solid tumors
Adenocarcinoma
Prostate cancer
Head and Neck cancer
Lung cancer
Non-small cell lung cancer
Small cell lung cancer
Gastric cancer
Kidney cancer
Pancreatic cancer
Breast cancer
Colorectal cancer
Bladder cancer
Esophagus cancer
Liver cancer
Hepatobiliary cancer
Skin cancer
Additional relevant MeSH terms:
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Doxorubicin
Liposomal doxorubicin
Ovarian Neoplasms
Carcinoma, Ovarian Epithelial
Endometrial Neoplasms
Fallopian Tube Neoplasms
Neoplasms
Endocrine Gland Neoplasms
Neoplasms by Site
Ovarian Diseases
Adnexal Diseases
Genital Diseases, Female
Genital Neoplasms, Female
Urogenital Neoplasms
Endocrine System Diseases
Gonadal Disorders
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Uterine Neoplasms
Uterine Diseases
Fallopian Tube Diseases
Antibiotics, Antineoplastic
Antineoplastic Agents
Topoisomerase II Inhibitors
Topoisomerase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action