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Alkylating agents

Galunisertib for Ovarian Carcinosarcoma

Phase 1
Waitlist Available
Led By Kathleen Moore, MD
Research Sponsored by University of Oklahoma
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up through study completion, an average of 3 years
Awards & highlights

Study Summary

This trial is testing a new cancer drug to see if it is safe and effective for patients with a type of cancer called carcinosarcoma of the uterus or ovary.

Eligible Conditions
  • Ovarian Carcinosarcoma

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~through study completion, an average of 3 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and through study completion, an average of 3 years for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Proportion of patients with completion of 4 cycles of CT + GB
Secondary outcome measures
Incidence and severity of adverse events
Mean (SD) of GB serum concentration levels on day 4, 8 and 29 (cycle 2 day 1)
Median overall survival (months)
+1 more

Trial Design

1Treatment groups
Experimental Treatment
Group I: Paclitaxel/Carboplatin + GalunisertibExperimental Treatment3 Interventions
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Galunisertib
Not yet FDA approved
Carboplatin
FDA approved
Paclitaxel
FDA approved

Find a Location

Who is running the clinical trial?

Eli Lilly and CompanyIndustry Sponsor
2,615 Previous Clinical Trials
3,201,032 Total Patients Enrolled
University of OklahomaLead Sponsor
455 Previous Clinical Trials
97,584 Total Patients Enrolled
1 Trials studying Ovarian Carcinosarcoma
20 Patients Enrolled for Ovarian Carcinosarcoma
Kathleen Moore, MDPrincipal InvestigatorObstetrics and Gynecology
8 Previous Clinical Trials
419 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is this research endeavor restricted to individuals over a certain age?

"The qualifiers for this study are those between the ages of 18 to 99 years old. For minors, there are 79 clinical trials available while elderly patients can access 1155 different studies."

Answered by AI

What diseases does Paclitaxel commonly target?

"Paclitaxel is conventionally used to fight melanoma, yet it can also be prescribed in order to inhibit the metastasis of neoplasms, lymphomas, non-Hodgkin's and advanced sarcoma."

Answered by AI

Is this research now enrolling participants?

"Unfortunately, this clinical trial is currently not accepting patients. Though it was initially posted on August 20th 2017 and has recently been updated in September 2021, there are currently other medical studies involving mixed tumors or paclitaxel recruiting participants - 37 for the former and 1178 for the latter."

Answered by AI

Who are the ideal participants for this clinical experiment?

"This clinical trial is looking for 26 participants aged 18 to 99 who are diagnosed with mullerian mixed tumor and meet the following criteria: access to tissue samples, receptivity towards a combination of paclitaxel and carboplatin treatment, written consent/assent, Eastern Cooperative Oncology Group performance status between 0-2, adequate bone marrow renal and hepatic functioning without prior disease-modifying therapy within 28 days before commencing study drug (galunisertib) , willingness to use effective contraception during study period plus an additional 6 months after last dose of galunisertib. In addition pregnancy tests must be administered"

Answered by AI

What are the objectives of this medical research endeavor?

"The primary outcome of the Eli Lilly and Company-sponsored clinical trial, which spans two years in duration, is measuring the proportion of patients with completion of 4 cycles of CT + GB. Additional secondary outcomes include overall survival, adverse events as assessed by CTCAE v4 standards, and galunisertib serum concentration levels."

Answered by AI

What is the target enrolment for this scientific experiment?

"This medical trial is no longer accepting participants, with the initial posting on August 20th 2017 and most recent update being September 27th 2021. For those looking to take part in another study, there are 37 mixed tumor studies and 1178 Paclitaxel trials that are currently recruiting patients."

Answered by AI

Is there prior research involving Paclitaxel that we should consider?

"Presently, 1178 clinical trials exploring Paclitaxel are running. 332 of these studies have progressed to a Phase 3 status. Shanghai is the most common location for this research; however, there exists 66549 various sites conducting experiments with Paclitaxel."

Answered by AI

Has the Federal Drug Administration authorized Paclitaxel for commercial use?

"Paclitaxel received a score of 1 due to limited evidence on its safety and efficacy, as this is only Phase 1 of the clinical trial process."

Answered by AI
Recent research and studies
clinicaltrials.govStudy
Paclitaxel/Carboplatin + Galunisertib for Patients With Carcinosarcoma of the Uterus or Ovary
2017. "Paclitaxel/Carboplatin + Galunisertib for Patients With Carcinosarcoma of the Uterus or Ovary". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03206177.
~3 spots leftby Apr 2025
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