Description:
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.
Title
- 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
Clinical Trial IDs
- ORG STUDY ID:
OU-SCC-EXIST-001
- NCT ID:
NCT03206177
Conditions
Interventions
Drug | Synonyms | Arms |
---|
Galunisertib | | Paclitaxel/Carboplatin + Galunisertib |
Paclitaxel | | Paclitaxel/Carboplatin + Galunisertib |
Carboplatin | | Paclitaxel/Carboplatin + Galunisertib |
Purpose
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.
Trial Arms
Name | Type | Description | Interventions |
---|
Paclitaxel/Carboplatin + Galunisertib | Experimental | | - Galunisertib
- Paclitaxel
- Carboplatin
|
Eligibility Criteria
Inclusion Criteria:
1. 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.
2. Written informed consent/assent prior to any study-specific procedures
3. Eastern Cooperative Oncology Group (ECOG) performance status 0-2
4. Tissue available for translational study (paraffin block or new biopsy) .
5. Adequate bone marrow, renal, and hepatic function as defined per protocol.
6. No disease-modifying therapy, including investigational treatments, within 28 days
prior to initiation of study treatment.
7. Ability to swallow tablets
8. 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.
9. Patient must have measurable disease before the treatment
Exclusion Criteria:
1. Planned radiotherapy during or after the study chemotherapy prior to disease
progression.
2. Receipt of chemotherapy or radiation within 28 days of study treatment
3. 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.
4. Active infection that would preclude receipt of chemotherapy
5. Moderate or severe cardiovascular disease per protocol
6. Active pregnancy or lactation
7. Second primary malignancy for which treatment during the study period would be
recommended if this cancer were not also present.
8. Prior malignancy requiring treatment within the last 3 years
9. Use of another investigational product or device within 4 weeks of study entry or
during study participation.
Maximum Eligible Age: | 99 Years |
Minimum Eligible Age: | 18 Years |
Eligible Gender: | Female |
Healthy Volunteers: | No |
Primary Outcome Measures
Measure: | Number of patients who completed 4 cycles of treatment |
Time Frame: | 2 years |
Safety Issue: | |
Description: | 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
Measure: | Adverse Events |
Time Frame: | 2 years |
Safety Issue: | |
Description: | To determine the frequency and severity of adverse events as assessed by the CTCAE v4 |
Measure: | Progression Free Survival |
Time Frame: | through study completion, an average of 3 years |
Safety Issue: | |
Description: | To determine the PFS of patients receiving drug combination |
Measure: | Drug Exposure |
Time Frame: | 2 months |
Safety Issue: | |
Description: | Galunisertib serum concentration levels will be tested |
Measure: | Overall Survival |
Time Frame: | through study completion, an average of 3 years |
Safety Issue: | |
Description: | To determine the overall survival of patients receiving drug combination |
Details
Phase: | Phase 1 |
Primary Purpose: | Interventional |
Overall Status: | Active, not recruiting |
Lead Sponsor: | University of Oklahoma |
Last Updated
June 7, 2021