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GRN-300 + Paclitaxel for Ovarian Cancer
Study Summary
This trial will test the safety and tolerability of GRN-300, a new salt-inducible kinase inhibitor, given in two different ways: alone and in combination with another cancer drug, paclitaxel. The study will last for about two years, and the number of patients enrolled will depend on how well the drug is tolerated.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowTimeline
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Side effects data
From 2014 Phase 4 trial • 32 Patients • NCT01301729Trial Design
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Who is running the clinical trial?
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- You have advanced ovarian, primary peritoneal, or fallopian tube cancer that has come back or has spread, or you have advanced solid tumors of a different type that have not responded to standard treatment and no other effective treatment is available.You should be recommended to receive paclitaxel treatment for your tumor.You need to have a pathology test to confirm the type of tumor you have.You have a history of HIV infection or chronic hepatitis B or C, and need to take antiviral medication.You have cancer that has spread to your brain or the tissues surrounding your brain.If your heart's electrical activity is too slow or irregular, you cannot join the study.You must have a specific, measurable lesion that can be accurately measured according to a certain standard.You have to have tried at least one treatment before for your advanced disease, but it's okay if you've tried more than one.You are able to perform everyday activities without any issue or with only a little restriction.Your bone marrow, liver, and kidneys are working properly.You have a stomach or intestine problem that could make it hard for the study drug to work properly when taken by mouth.You've had a stroke, blood clot, or other serious blood vessel problem in the last six months.
- Group 1: Part 2 (Phase 1b): Single Arm, Open Label (GRN-300 plus paclitaxel)
- Group 2: Part 1 (Phase 1a): Single Arm, Open Label (GRN-300 single-agent)
- Approved for 10 Other Conditions - This treatment demonstrated efficacy for 10 other conditions.
- All Individual Drugs Already Approved - Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.
- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
Are there any vacancies for participants in this trial?
"According to clinicaltrials.gov, this is an ongoing study which was initiated on December 21st 2020 and was last updated January 12th 2021."
Has the Drug and Food Administration granted authorization for GRN-300?
"GRN-300's safety is rated a 1, as this trial only has limited evidence of efficacy and safety."
What insights have been gleaned from research with GRN-300?
"As of now, 832 clinical trials have been conducted on GRN-300. Of these live studies, 227 are in the final phase 3 stage. From Adelaide to South Australia and beyond, over 45681 locations worldwide are running tests for this medication."
How many people are involved in this medical experiment?
"Affirmative. According to clinicaltrials.gov, this medical study is currently recruiting patients who meet the eligibility criteria. The trial was first posted on December 21st 2020 and its details were most recently updated on January 12th 2021; 64 participants are being accepted at one location."
What key objectives are investigators seeking to address with this research?
"According to the details released by Green3Bio, Inc., this clinical trial will assess treatment-related adverse events over a 24 month period as its primary outcome. Secondary outcomes include an examination into GRN-300's immunomodulatory effects on PBMCs (pHDAC5), Maximum plasma concentration (Cmax) of the drug, and Time to Cmax (tmax)."
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