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

NCT ID: NCT03206177

Last Updated: 2024-08-07

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 26 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-08-23
• Study Completion Date: 2024-02-13

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.

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.

Conditions

Carcinosarcoma, Ovarian

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Paclitaxel/Carboplatin + Galunisertib

Patients will receive the following in every cycle (1 cycle=28days).

• Paclitaxel - 175 mg/m2 over 3 hours via IV on Day 1
• Carboplatin - AUC 6* (or AUC 5*) over 1 hour via IV on Day 1
• Galunisertib - 150mg orally twice a day on Days 4-17

Group Type: EXPERIMENTAL

Galunisertib

Intervention Type: DRUG

Galunisertib 150mg po BID day 4-17

Paclitaxel

Intervention Type: DRUG

IV Day 1: Paclitaxel 175 mg/m2 over 3 hours

Carboplatin

Intervention Type: DRUG

IV Day 1: Carboplatin AUC 6\* over 1 hour (or 5\* if prior radiation therapy)

Interventions

Galunisertib

Galunisertib 150mg po BID day 4-17

Intervention Type: DRUG

Paclitaxel

IV Day 1: Paclitaxel 175 mg/m2 over 3 hours

Intervention Type: DRUG

Carboplatin

IV Day 1: Carboplatin AUC 6\* over 1 hour (or 5\* if prior radiation therapy)

Intervention Type: DRUG

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 99 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Eli Lilly and Company

INDUSTRY

Sponsor Role: collaborator

University of Oklahoma

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Kathleen Moore, MD

Role: PRINCIPAL_INVESTIGATOR

Obstetrics and Gynecology

Locations

Stephenson Cancer Center, University of Oklahoma Health Sciences Center

Oklahoma City, Oklahoma, United States

Countries

United States

Provided Documents

Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Document Type: Informed Consent Form

View Document

Other Identifiers

OU-SCC-EXIST-001

Identifier Type: -

Identifier Source: org_study_id