ClinicalTrials.gov
ClinicalTrials.gov Menu

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.
ClinicalTrials.gov Identifier: NCT03206177
Recruitment Status : Recruiting
First Posted : July 2, 2017
Last Update Posted : September 26, 2017
Sponsor:
Collaborator:
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.

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 20 participants
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 : June 1, 2019
Estimated Study Completion Date : June 1, 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 ]

Other Outcome Measures:
  1. Immunohistochemistry (IHC) levels [ Time Frame: 2 years ]
    To determine if H-score criteria (% of cells and intensity) of IHC nuclear phospho-smad levels after cycle 1 are associated with response to galunisertib therapy



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.


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
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.

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 ClinicalTrials.gov identifier (NCT number): NCT03206177


Contacts
Contact: Ingrid Block, RN 405 271-8777 ingrid-block@ouhsc.edu

Locations
United States, Oklahoma
University of Oklahoma Health Sciences Center Recruiting
Oklahoma City, Oklahoma, United States, 73104
Contact: Kathleen Moore, MD         
Sponsors and Collaborators
University of Oklahoma
Eli Lilly and Company
Investigators
Study Chair: Kathleen Moore, MDF= University of Oklahoma

Responsible Party: University of Oklahoma
ClinicalTrials.gov Identifier: NCT03206177     History of Changes
Other Study ID Numbers: 7934
First Posted: July 2, 2017    Key Record Dates
Last Update Posted: September 26, 2017
Last Verified: September 2017

Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
Carcinosarcoma
Mixed Tumor, Mullerian
Uterine Neoplasms
Ovarian Neoplasms
Neoplasms, Complex and Mixed
Neoplasms by Histologic Type
Neoplasms
Sarcoma
Neoplasms, Connective and Soft Tissue
Genital Neoplasms, Female
Urogenital Neoplasms
Neoplasms by Site
Uterine Diseases
Genital Diseases, Female
Endocrine Gland Neoplasms
Ovarian Diseases
Adnexal Diseases
Endocrine System Diseases
Gonadal Disorders
Paclitaxel
Albumin-Bound Paclitaxel
Carboplatin
Antineoplastic Agents, Phytogenic
Antineoplastic Agents
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action