NCT03206177CompletedPhase 1
Paclitaxel/Carboplatin + Galunisertib for Patients With Carcinosarcoma of the Uterus or Ovary
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
Source: ClinicalTrials.gov · Last updated 7 Aug 2024
Brief summary (registry, in English)
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.
- Status (registry)
- Completed
- Phase (registry)
- Phase 1
- Study type
- Interventional
- Enrollment
- 26 (actual)
- First submitted
- 1 Jun 2017
- Start date
- 23 Aug 2017
- Primary completion date
- 28 Jul 2021
- Lead sponsor
- University of Oklahoma
- Diseases
- Ovarian cancer, Sarcoma
- NCT number
- NCT03206177
What you commit to
- Study type: Interventional · Phase 1
- Participants enrolled: 26
- From 23 Aug 2017 to the primary completion date, 28 Jul 2021
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 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.
- Use of another investigational product or device within 4 weeks of study entry or during study participation.
Other illness
- Active infection that would preclude receipt of chemotherapy
- Moderate or severe cardiovascular disease per protocol
- 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
Other
- Active pregnancy or lactation
Who the study is looking for
- 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
Age in the registry: 18 years to 99 years · Sex: Female · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Stephenson Cancer Center, University of Oklahoma Health Sciences Center Coordinator of this site? Confirm its status | Oklahoma City | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.