Clinical Trials /

Paclitaxel/Carboplatin + Galunisertib for Patients With Carcinosarcoma of the Uterus or Ovary

NCT03206177

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.

Related Conditions:
  • Fallopian Tube Carcinosarcoma
  • Ovarian Carcinosarcoma
  • Primary Peritoneal Carcinosarcoma
  • Uterine Carcinosarcoma
Recruiting Status:

Active, not recruiting

Phase:

Phase 1

Trial Eligibility

Document

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

  • Carcinosarcoma, Ovarian

Interventions

DrugSynonymsArms
GalunisertibPaclitaxel/Carboplatin + Galunisertib
PaclitaxelPaclitaxel/Carboplatin + Galunisertib
CarboplatinPaclitaxel/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

NameTypeDescriptionInterventions
Paclitaxel/Carboplatin + GalunisertibExperimental
  • 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