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

NCT03206177 | Completed Phase 1 Results DMC FDA Drug

• 1 other identifier: OU-SCC-EXIST-001
• Study Type: interventional
• Target: 26
• Locations: 1 country
• Sites: 1

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.

Conditions

Carcinosarcoma, Ovarian

Outcome Measures

Primary Outcomes (1)

• Proportion of Patients With Completion of 4 Cycles of CT + GB

  Completion of 4 cycles of CT + GB- completion of a cycle will be defined as receiving both carboplatin/paclitaxel and taking ≥75% of the doses of GB for the cycle.

  2 years

Secondary Outcomes (3)

• Median Progression Free Survival (Months)

  through study completion, an average of 3 years

• Median Overall Survival (Months)

  through study completion, an average of 3 years

• Objective Response

  within three years of study entry

Study Arms (1)

Paclitaxel/Carboplatin + Galunisertib

EXPERIMENTAL

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

Drug: Galunisertib; Drug: Paclitaxel; Drug: Carboplatin

Interventions

Galunisertib DRUG

Galunisertib 150mg po BID day 4-17

Paclitaxel/Carboplatin + Galunisertib

Paclitaxel DRUG

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

Paclitaxel/Carboplatin + Galunisertib

Carboplatin DRUG

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

Paclitaxel/Carboplatin + Galunisertib

Eligibility Criteria

• Age: 18 Years - 99 Years
• Gender Eligibility Details: The patient population for this study only applies to females.
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.
• Written informed consent/assent prior to any study-specific procedures
• Eastern Cooperative Oncology Group (ECOG) performance status 0-2
• Tissue available for translational study (paraffin block or new biopsy) .
• Adequate bone marrow, renal, and hepatic function as defined per protocol.
• No disease-modifying therapy, including investigational treatments, within 28 days prior to initiation of study treatment.
• Ability to swallow tablets
• 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.
• Patient must have measurable disease before the treatment

You may not qualify if:

• Planned radiotherapy during or after the study chemotherapy prior to disease progression.
• Receipt of chemotherapy or radiation within 28 days of study treatment
• 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.
• Active infection that would preclude receipt of chemotherapy
• Moderate or severe cardiovascular disease per protocol
• Active pregnancy or lactation
• Second primary malignancy for which treatment during the study period would be recommended if this cancer were not also present.
• 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.

Sponsors & Collaborators

• University of Oklahoma: lead
• Eli Lilly and Company: collaborator

Study Sites (1)

Stephenson Cancer Center, University of Oklahoma Health Sciences Center

Oklahoma City, Oklahoma, 73104, United States

Location

MeSH Terms

Conditions

Carcinosarcoma

Interventions

LY-2157299; Paclitaxel; Carboplatin

Condition Hierarchy (Ancestors)

Neoplasms, Complex and Mixed; Neoplasms by Histologic Type; Neoplasms; Sarcoma; Neoplasms, Connective and Soft Tissue

Intervention Hierarchy (Ancestors)

Taxoids; Cyclodecanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Diterpenes; Terpenes; Coordination Complexes

Results Point of Contact

• Title: Dr. Kathleen Moore
• Organization: University of Oklahoma Health Sciences Center, Stephenson Cancer Center

Kathleen-Moore@ouhsc.edu

405-271-8777

Study Officials

• Kathleen Moore, MD

  Obstetrics and Gynecology

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 1, 2017
• First Posted: July 2, 2017
• Study Start: August 23, 2017
• Primary Completion: July 28, 2021
• Study Completion: February 13, 2024
• Last Updated: August 7, 2024
• Results First Posted: August 7, 2024

Record last verified: 2024-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)