Back to resultsPaclitaxel/Carboplatin + Galunisertib for Patients With Carcinosarcoma of the Uterus or Ovary
Primary Purpose
Carcinosarcoma, Ovarian
Status
Unknown status
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
Galunisertib
Paclitaxel
Carboplatin
Sponsored by
About this trial
This is an interventional treatment trial for Carcinosarcoma, Ovarian
Eligibility Criteria
Inclusion Criteria:
- Women ≥ 18 years old with a diagnosis of primary, recurrent or progressive uterine, ovarian, fallopian tube or peritoneal carcinosarcoma, for whom treatment with combination paclitaxel and carboplatin is recommended.
- Written informed consent/assent prior to any study-specific procedures
- Eastern Cooperative Oncology Group (ECOG) performance status 0-2
- Tissue available for translational study (paraffin block or new biopsy) .
- Adequate bone marrow, renal, and hepatic function as defined per protocol.
- No disease-modifying therapy, including investigational treatments, within 28 days prior to initiation of study treatment.
- Ability to swallow tablets
- For Women of child-bearing potential:Willingness to use a highly effective method of contraception during the study and for 6 months following the last dose of galunisertib. Negative beta human chorionic gonadotropin pregnancy test documented within 7 days prior to initiation of study drug.
- Patient must have measurable disease before the treatment
Exclusion Criteria:
- Planned radiotherapy during or after the study chemotherapy prior to disease progression.
- Receipt of chemotherapy or radiation within 28 days of study treatment
- Have had a major surgical procedure or a significant traumatic injury within 28 days prior to study treatment; Minor procedures such as biopsy within 7 days prior to study treatment are allowed.
- Active infection that would preclude receipt of chemotherapy
- Moderate or severe cardiovascular disease per protocol
- Active pregnancy or lactation
- Second primary malignancy for which treatment during the study period would be recommended if this cancer were not also present.
- Prior malignancy requiring treatment within the last 3 years
- Use of another investigational product or device within 4 weeks of study entry or during study participation.
Sites / Locations
- Stephenson Cancer Center, University of Oklahoma Health Sciences Center
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Paclitaxel/Carboplatin + Galunisertib
Arm Description
Outcomes
Primary Outcome Measures
Proportion of patients with completion of 4 cycles of CT + GB
To determine the feasibility of delivering 4 cycles of carboplatin/paclitaxel (CT) in combination with galunisertib (GB) to patients with gynecologic carcinosarcoma
Secondary Outcome Measures
Incidence and severity of adverse events
To determine the frequency and severity of adverse events as assessed by the CTCAE v4
Median progression free survival (months)
To determine the PFS of patients receiving drug combination
Mean (SD) of GB serum concentration levels on day 4, 8 and 29 (cycle 2 day 1)
Galunisertib serum concentration levels will be tested
Median overall survival (months)
To determine the overall survival of patients receiving drug combination
Full Information
NCT ID
NCT03206177
First Posted
June 1, 2017
Last Updated
September 27, 2021
Sponsor
University of Oklahoma
Collaborators
Eli Lilly and Company
1. Study Identification
Unique Protocol Identification Number
NCT03206177
Brief Title
Paclitaxel/Carboplatin + Galunisertib for Patients With Carcinosarcoma of the Uterus or Ovary
Official Title
Feasibility IB Trial of Paclitaxel/Carboplatin + Galunisertib (a Small Molecule Inhibitor of the Kinase Domain of Type 1 TGF-B Receptor) in Patients With Newly Diagnosed, Persistent or Recurrent Carcinosarcoma of the Uterus or Ovary
Study Type
Interventional
2. Study Status
Record Verification Date
September 2021
Overall Recruitment Status
Unknown status
Study Start Date
August 20, 2017 (Actual)
Primary Completion Date
July 28, 2021 (Actual)
Study Completion Date
August 19, 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Oklahoma
Collaborators
Eli Lilly and Company
4. Oversight
Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
This is a Phase 1 B feasibility trial with Galunsertib, a TGFβ inhibitor, in combination with carboplatin/paclitaxel in patients with newly diagnosed, persistent or recurrent carcinosarcoma of the uterus or ovary. The objective of the study is to determine whether this drug combination is safe for this patient population and to see if it is effective in shrinking cancers, keeping them from growing or helping patients live longer.
Detailed Description
Patients who consent to this study will receive treatment for four 28 day cycles unless they are unable to continue study treatment due to toxicity or disease progression. Paclitaxel and carboplatin will be given intravenously on day 1 of each cycle and galunisertib in pill form on days 4-17. No medicine will be given on days 17-28 of each cycle. Patients may have the option of continuing treatment with the study drug if they complete the 4 cycles the study requires. Subjects will receive tests and procedures that are part of regular cancer care as well as those required for the purposes of the study. Blood samples will be taken to monitor the level of study drug in the blood. Patients will have the option of allowing blood and tumor samples to be used for future research.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Carcinosarcoma, Ovarian
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
26 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Paclitaxel/Carboplatin + Galunisertib
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
Galunisertib
Intervention Description
Galunisertib 150mg po BID day 4-17.)
Intervention Type
Drug
Intervention Name(s)
Paclitaxel
Intervention Description
Paclitaxel 175 mg/m2 over 3 hours
Intervention Type
Drug
Intervention Name(s)
Carboplatin
Intervention Description
IV day 1 Carboplatin AUC 6* over 1 hour (or 5* if no prior radiation therapy)
Primary Outcome Measure Information:
Title
Proportion of patients with completion of 4 cycles of CT + GB
Description
To determine the feasibility of delivering 4 cycles of carboplatin/paclitaxel (CT) in combination with galunisertib (GB) to patients with gynecologic carcinosarcoma
Time Frame
2 years
Secondary Outcome Measure Information:
Title
Incidence and severity of adverse events
Description
To determine the frequency and severity of adverse events as assessed by the CTCAE v4
Time Frame
2 years
Title
Median progression free survival (months)
Description
To determine the PFS of patients receiving drug combination
Time Frame
through study completion, an average of 3 years
Title
Mean (SD) of GB serum concentration levels on day 4, 8 and 29 (cycle 2 day 1)
Description
Galunisertib serum concentration levels will be tested
Time Frame
2 months
Title
Median overall survival (months)
Description
To determine the overall survival of patients receiving drug combination
Time Frame
through study completion, an average of 3 years
10. Eligibility
Sex
Female
Gender Based
Yes
Gender Eligibility Description
The patient population for this study only applies to females.
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
99 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Women ≥ 18 years old with a diagnosis of primary, recurrent or progressive uterine, ovarian, fallopian tube or peritoneal carcinosarcoma, for whom treatment with combination paclitaxel and carboplatin is recommended.
Written informed consent/assent prior to any study-specific procedures
Eastern Cooperative Oncology Group (ECOG) performance status 0-2
Tissue available for translational study (paraffin block or new biopsy) .
Adequate bone marrow, renal, and hepatic function as defined per protocol.
No disease-modifying therapy, including investigational treatments, within 28 days prior to initiation of study treatment.
Ability to swallow tablets
For Women of child-bearing potential:Willingness to use a highly effective method of contraception during the study and for 6 months following the last dose of galunisertib. Negative beta human chorionic gonadotropin pregnancy test documented within 7 days prior to initiation of study drug.
Patient must have measurable disease before the treatment
Exclusion Criteria:
Planned radiotherapy during or after the study chemotherapy prior to disease progression.
Receipt of chemotherapy or radiation within 28 days of study treatment
Have had a major surgical procedure or a significant traumatic injury within 28 days prior to study treatment; Minor procedures such as biopsy within 7 days prior to study treatment are allowed.
Active infection that would preclude receipt of chemotherapy
Moderate or severe cardiovascular disease per protocol
Active pregnancy or lactation
Second primary malignancy for which treatment during the study period would be recommended if this cancer were not also present.
Prior malignancy requiring treatment within the last 3 years
Use of another investigational product or device within 4 weeks of study entry or during study participation.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Kathleen Moore, MD
Organizational Affiliation
Obstetrics and Gynecology
Official's Role
Principal Investigator
Facility Information:
Facility Name
Stephenson Cancer Center, University of Oklahoma Health Sciences Center
City
Oklahoma City
State/Province
Oklahoma
ZIP/Postal Code
73104
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Paclitaxel/Carboplatin + Galunisertib for Patients With Carcinosarcoma of the Uterus or Ovary
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