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 Carcinoma
  • Primary Peritoneal Carcinosarcoma
  • Uterine Carcinosarcoma
Recruiting Status:

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: 7934
  • 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:

          -  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. Eastern Cooperative Oncology
             Group (ECOG) performance status 0-2. Tissue available for translational study
             (paraffin block or new biopsy). 5. Adequate bone marrow, renal, and hepatic function
             per study requirements. Women of childbearing potential must be willing to use a
             highly effective form of birth control during the study and for 6 months after the
             last dose of galunsertib.

        Exclusion Criteria:

          -  Planned radiotherapy during or after the study chemotherapy prior to disease
             progression. Chemotherapy or radiation within 28 days of study treatment. Major
             surgical procedure or a significant traumatic injury within 28 days prior to study
             treatment. Active infection that would preclude receipt of chemotherapy. Moderate or
             severe cardiovascular disease. Active pregnancy or lactation. 7. Second primary
             malignancy for which treatment during the study period would be recommended. 8. 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.
      
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:

Details

Phase:Phase 1
Primary Purpose:Interventional
Overall Status:Recruiting
Lead Sponsor:University of Oklahoma

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