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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

Primary Purpose

Ovarian Cancer, Fallopian Tube Cancer, Endometrial Cancer

Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
STM 434
Liposomal doxorubicin
Sponsored by
Santa Maria Biotherapeutics
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Ovarian Cancer focused on measuring 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

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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)

Sites / Locations

  • Dana Farber Cancer Institute
  • Memorial Sloan Kettering Cancer Center
  • Sarah Cannon Research Institute
  • South Texas Accelerated Research Therapeutics

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

STM 434

STM 434 and Liposomal Doxorubicin

Arm Description

Outcomes

Primary Outcome Measures

Maximum Tolerated Dose (MTD)
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

Recommended Phase 2 dose (RP2D)
To define the recommended Phase 2 dose (RP2D) in the event that there is no maximum tolerated dose (MTD) reached.
Radiographic response rate
To collect preliminary radiographic response data, including CT, MRI scans, during therapy with STM 434.
Muscle function and body composition
To collect preliminary anti-cachexia data, including body composition and laboratory parameters, during therapy with STM 434.

Full Information

First Posted
September 29, 2014
Last Updated
February 10, 2017
Sponsor
Santa Maria Biotherapeutics
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1. Study Identification

Unique Protocol Identification Number
NCT02262455
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
Study Type
Interventional

2. Study Status

Record Verification Date
February 2017
Overall Recruitment Status
Completed
Study Start Date
October 2014 (Actual)
Primary Completion Date
January 13, 2017 (Actual)
Study Completion Date
January 13, 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Santa Maria Biotherapeutics

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Ovarian Cancer, Fallopian Tube Cancer, Endometrial Cancer, Solid Tumors
Keywords
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

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
32 (Actual)

8. Arms, Groups, and Interventions

Arm Title
STM 434
Arm Type
Experimental
Arm Title
STM 434 and Liposomal Doxorubicin
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
STM 434
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
Liposomal doxorubicin
Intervention Description
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 Measure Information:
Title
Maximum Tolerated Dose (MTD)
Description
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.
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.
Secondary Outcome Measure Information:
Title
Recommended Phase 2 dose (RP2D)
Description
To define the recommended Phase 2 dose (RP2D) in the event that there is no maximum tolerated dose (MTD) reached.
Time Frame
RP2D will be assessed in Part 1 once the last subject in each cohort completes 28 days of treatment.
Title
Radiographic response rate
Description
To collect preliminary radiographic response data, including CT, MRI scans, during therapy with STM 434.
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.
Title
Muscle function and body composition
Description
To collect preliminary anti-cachexia data, including body composition and laboratory parameters, during therapy with STM 434.
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.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Willis Navarro, MD
Organizational Affiliation
Santa Maria Biotherapeutics
Official's Role
Study Director
Facility Information:
Facility Name
Dana Farber Cancer Institute
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02114
Country
United States
Facility Name
Memorial Sloan Kettering Cancer Center
City
New York
State/Province
New York
ZIP/Postal Code
10065
Country
United States
Facility Name
Sarah Cannon Research Institute
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37203
Country
United States
Facility Name
South Texas Accelerated Research Therapeutics
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78229
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
31068369
Citation
Tao JJ, Cangemi NA, Makker V, Cadoo KA, Liu JF, Rasco DW, Navarro WH, Haqq CM, Hyman DM. First-in-Human Phase I Study of the Activin A Inhibitor, STM 434, in Patients with Granulosa Cell Ovarian Cancer and Other Advanced Solid Tumors. Clin Cancer Res. 2019 Sep 15;25(18):5458-5465. doi: 10.1158/1078-0432.CCR-19-1065. Epub 2019 May 8.
Results Reference
derived

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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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