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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT03206177
Recruitment Status : Recruiting
First Posted : July 2, 2017
Last Update Posted : March 24, 2021
Eli Lilly and Company
Information provided by (Responsible Party):
University of Oklahoma

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.

Condition or disease Intervention/treatment Phase
Carcinosarcoma, Ovarian Drug: Galunisertib Drug: Paclitaxel Drug: Carboplatin Phase 1

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 25 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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
Actual Study Start Date : August 20, 2017
Estimated Primary Completion Date : December 31, 2021
Estimated Study Completion Date : July 31, 2022

Arm Intervention/treatment
Experimental: Paclitaxel/Carboplatin + Galunisertib Drug: Galunisertib
Galunisertib 150mg po BID day 4-17.)

Drug: Paclitaxel
Paclitaxel 175 mg/m2 over 3 hours

Drug: Carboplatin
IV day 1 Carboplatin AUC 6* over 1 hour (or 5* if no prior radiation therapy)

Primary Outcome Measures :
  1. Number of patients who completed 4 cycles of treatment [ Time Frame: 2 years ]
    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 :
  1. Adverse Events [ Time Frame: 2 years ]
    To determine the frequency and severity of adverse events as assessed by the CTCAE v4

  2. Progression Free Survival [ Time Frame: through study completion, an average of 3 years ]
    To determine the PFS of patients receiving drug combination

  3. Drug Exposure [ Time Frame: 2 months ]
    Galunisertib serum concentration levels will be tested

  4. Overall Survival [ Time Frame: through study completion, an average of 3 years ]
    To determine the overall survival of patients receiving drug combination

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   18 Years to 99 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Gender Based Eligibility:   Yes
Gender Eligibility Description:   The patient population for this study only applies to females.
Accepts Healthy Volunteers:   No

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT03206177

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Contact: Lead Gyn Onc Nurse 405 271-8777

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United States, Oklahoma
Stephenson Cancer Center, University of Oklahoma Health Sciences Center Recruiting
Oklahoma City, Oklahoma, United States, 73104
Contact: Lead Gyn Onc Nurse    405-271-8777   
Sponsors and Collaborators
University of Oklahoma
Eli Lilly and Company
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Principal Investigator: Camille Gunderson, MD Obstetrics and Gynecology
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Responsible Party: University of Oklahoma Identifier: NCT03206177    
Other Study ID Numbers: OU-SCC-EXIST-001
First Posted: July 2, 2017    Key Record Dates
Last Update Posted: March 24, 2021
Last Verified: March 2021

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Mixed Tumor, Mullerian
Neoplasms, Complex and Mixed
Neoplasms by Histologic Type
Neoplasms, Connective and Soft Tissue
Antineoplastic Agents, Phytogenic
Antineoplastic Agents
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action