Carcinosarcoma, OvarianPhase 1NCT03206177
Paclitaxel/Carboplatin + Galunisertib for Patients With Carcinosarcoma of the Uterus or Ovary
A Phase 1 study testing Galunisertib, Paclitaxel and Carboplatin in people with Carcinosarcoma, Ovarian, run by University of Oklahoma at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 99 years, women only
- Conditions the study is for
- Carcinosarcoma, Ovarian
- What is being tested?
- Galunisertib, Paclitaxel and Carboplatin
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 26 participants
- Where
- 1 siteUnited States
- Study dates
- 23 Aug 2017to 13 Feb 2024
- Phase
- Phase 1
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 99 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
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- 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
Who cannot join
- 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
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- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
Stephenson Cancer Center, University of Oklahoma Health Sciences Center
Oklahoma City, Oklahoma, 73104
About this study
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
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.
Read the 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
- Being tested
- Galunisertib, Paclitaxel, Carboplatin
- Medical subject headings
- Carcinosarcoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GalunisertibDrug
Galunisertib 150mg po BID day 4-17
PaclitaxelDrug
IV Day 1: Paclitaxel 175 mg/m2 over 3 hours
CarboplatinDrug
IV Day 1: Carboplatin AUC 6* over 1 hour (or 5* if prior radiation therapy)
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Drug: Galunisertib; Drug: Paclitaxel; Drug: Carboplatin |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 2 years
Secondary outcomes (3)
Median Progression Free Survival (Months)
Progression free survival is defined as time from when the patient is registered on the study until RECIST v1.1 documented disease progression as per the protocol or death.
Measured: through study completion, an average of 3 years
Median Overall Survival (Months)
Overall survival defined as time from study entry to death
Measured: through study completion, an average of 3 years
Objective Response
Proportion of patients who had RECIST documented partial or complete response. Measurable disease is defined as at least one lesion that can be accurately measured in at least one dimension (longest dimension to be recorded). Each lesion must be ≥ 10 mm when measured by CT and MRI; or ≥ 20 mm when measured by conventional techniques, including plain x-ray. Response was documented per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1) for target lesions.
Measured: within three years of study entry
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jul 2017
- Study start23 Aug 2017
- Primary completion28 Jul 2021
- Study completion13 Feb 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Carcinosarcoma, OvarianStudies of the same condition, open and under way.
- More trials run by University of OklahomaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 26 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Oklahoma
- Sponsor type
- University, hospital or other
- Collaborators
- Eli Lilly and Company
- Responsible party
- Sponsor
- Investigators
- Kathleen Moore, MD, Principal investigator, Obstetrics and Gynecology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03206177
- Sponsor's protocol ID
- OU-SCC-EXIST-001
- Status last verified
- Mar 2024
- First submitted
- 1 Jun 2017
- Last updated
- 7 Aug 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT03206177
- Acronym / sponsor ID
- OU-SCC-EXIST-001
- Conditions
- Carcinosarcoma, Ovarian
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 26 participants (actual)
- Lead sponsor
- University of OklahomaUniversity, hospital or other
- Collaborators
- Eli Lilly and Company
- Study start
- 23 Aug 2017 (actual)
- Primary completion
- 28 Jul 2021 (actual)
- Study completion
- 13 Feb 2024 (actual)
- First posted
- 2 Jul 2017 (actual)
- Results
- Posted 7 Aug 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Paclitaxel/Carboplatin + Galunisertib | Experimental | Drug: Galunisertib, Drug: Paclitaxel, Drug: CarboplatinPatients 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 |
Who may qualify
- Ages
- 18 to 99 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- 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.
Key exclusion criteria (9 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| GalunisertibGalunisertib 150mg po BID day 4-17 | Drug | Paclitaxel/Carboplatin + Galunisertib |
| PaclitaxelIV Day 1: Paclitaxel 175 mg/m2 over 3 hours | Drug | Paclitaxel/Carboplatin + Galunisertib |
| CarboplatinIV Day 1: Carboplatin AUC 6* over 1 hour (or 5* if prior radiation therapy) | Drug | Paclitaxel/Carboplatin + Galunisertib |
Primary outcome
Proportion of Patients With Completion of 4 Cycles of CT + GB
Time frame: 2 years
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.
3 secondary outcomes
Median Progression Free Survival (Months)
Time frame: through study completion, an average of 3 years
Median Overall Survival (Months)
Time frame: through study completion, an average of 3 years
Objective Response
Time frame: within three years of study entry
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Aug 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Kathleen Moore, MD principal investigator
Obstetrics and Gynecology
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Galunisertib, Paclitaxel and Carboplatin in people with Carcinosarcoma, Ovarian, run by University of Oklahoma at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 7 Aug 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 7 Aug 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Proportion of Patients With Completion of 4 Cycles of CT + GB (time frame: 2 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Aug 2024.