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Kinase Inhibitor

GRN-300 + Paclitaxel for Ovarian Cancer

Phase 1
Waitlist Available
Led By Siqing Fu, MD, PhD
Research Sponsored by Green3Bio, Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Diagnosis of persistent or recurrent, locally non-resectable or metastatic ovarian, primary peritoneal or fallopian tube epithelial cancer, or advanced solid tumors of any other histology who have progressed on standard therapy and for whom no further effective therapy is available
Paclitaxel treatment for the tumor should be indicated
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 48 months
Awards & highlights

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.

Who is the study for?
This trial is for adults over 18 with recurrent ovarian, primary peritoneal, or fallopian tube cancers that are not removable by surgery or have metastasized. Participants must have progressed after standard therapy and should be suitable for paclitaxel treatment. They need measurable disease, at least one prior second-line treatment, stable minor toxicities from past treatments if any, an expected survival of three months post-study drug initiation, good performance status (ECOG PS 0-1), and proper organ function.Check my eligibility
What is being tested?
The study evaluates GRN-300 alone or with paclitaxel in two parts: Phase IA tests oral GRN-300's tolerability across continuous 28-day cycles; Phase IB combines GRN-300 with weekly paclitaxel dosing (3 weeks on/1 week off). The focus is on dose tolerance and side effects over approximately four years depending on enrollment rates.See study design
What are the potential side effects?
Potential side effects include those typical of cancer therapies such as fatigue, nausea, allergic reactions to medication components (specifically noted for paclitaxel), blood disorders like low counts leading to increased infection risk or bleeding problems. Organ-specific inflammation may occur due to the novel inhibitor.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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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.
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You should be recommended to receive paclitaxel treatment for your tumor.
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You need to have a pathology test to confirm the type of tumor you have.
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You must have a specific, measurable lesion that can be accurately measured according to a certain standard.
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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.
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You are able to perform everyday activities without any issue or with only a little restriction.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~48 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and 48 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Part 1 (Phase 1A) - Determination of the MTD and the RP2D of GRN-300 single-agent based on evaluation of the DLT in the study population.
Part 1 (Phase 1A) - Number of participants with treatment-related adverse events as assessed by CTCAE v5.0.
Part 2 (Phase 1B) - Determination of the MTD and the RP2D of GRN-300 with paclitaxel based on evaluation of the DLT in the study population
+1 more
Secondary outcome measures
Part 1 (Phase 1A) - Determination of GRN-300 monotherapy PK profile (AUC0-Inf).
Part 1 (Phase 1A) - Determination of GRN-300 monotherapy PK profile (AUC0-t).
Part 1 (Phase 1A) - Determination of GRN-300 monotherapy PK profile (CL/F).
+15 more
Other outcome measures
Part 1 and 2: progression free survival (PFS)

Side effects data

From 2014 Phase 4 trial • 32 Patients • NCT01301729
59%
Leukopenia
56%
Neutropenia
34%
Hypoaesthesia
31%
Agranulocytosis
22%
Alopecia
22%
Asthenia
19%
Pyrexia
16%
Nail disorder
16%
Oedema peripheral
16%
Diarrhoea
16%
Hypophagia
13%
Neurotoxicity
13%
Alanine aminotransferase increased
13%
Cough
13%
Vomting
9%
Headache
9%
Aspartate aminotransferase increased
9%
Musculoskeletal pain
9%
Chest discomfort
9%
Rash
9%
Pigmentation disorder
9%
Nausea
9%
Bone marrow failure
9%
Anaemia
6%
Insomnia
6%
Transaminases increased
6%
Constipation
6%
Mouth ulceration
6%
Nasopharyngitis
6%
Paronychia
6%
Flushing
6%
Face oedema
6%
Thrombocytopenia
3%
Infection
3%
Upper respiratory tract infection
3%
Completed suicide
3%
Cataract
100%
80%
60%
40%
20%
0%
Study treatment Arm
Trastuzumab

Trial Design

2Treatment groups
Experimental Treatment
Group I: Part 2 (Phase 1b): Single Arm, Open Label (GRN-300 plus paclitaxel)Experimental Treatment2 Interventions
The study will determine the safety of continuous twice a day oral dosing of GRN-300, with each cycle consisting of 28 days of treatment, in combination with intravenously administered paclitaxel weekly x 3 during each 28-day cycle. The number of administered cycles will depend on the tolerability of each dose level and the severity and occurrence of side effects and DLTs. The maximal tolerated dose (MTD) and recommended Phase 2 dose (RP2D) of GRN-300 in combination with paclitaxel will be determined. The overall duration of Part 2 will be approximately 12-18 months, depending on the rate of enrollment and the number of subjects enrolled. Part 2 will commence following determination of the MTD and RP2D of single-agent GRN-300 in Part 1. Overall duration of the study will be approximately 36-48 months, depending on the rate of enrollment and number of subjects enrolled.
Group II: Part 1 (Phase 1a): Single Arm, Open Label (GRN-300 single-agent)Experimental Treatment1 Intervention
Part 1 of the study will determine the safety of continuous twice a day oral dosing of GRN-300, with each cycle consisting of 28 days of treatment. The number of administered cycles will depend on the tolerability of each dose level and the severity and occurrence of side effects and DLTs. The maximal tolerated dose (MTD) and recommended Phase 2 dose (RP2D) of GRN-300 as a single agent will be determined. The overall duration of Part 1 will be approximately 24-36 months, depending on the rate of enrollment and the number of subjects enrolled.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Paclitaxel
FDA approved

Find a Location

Who is running the clinical trial?

Green3Bio, Inc.Lead Sponsor
Siqing Fu, MD, PhDPrincipal InvestigatorM.D. Anderson Cancer Center
2 Previous Clinical Trials
74 Total Patients Enrolled

Media Library

GRN-300 (Kinase Inhibitor) Clinical Trial Eligibility Overview. Trial Name: NCT04711161 — Phase 1
Ovarian Tumors Research Study Groups: Part 2 (Phase 1b): Single Arm, Open Label (GRN-300 plus paclitaxel), Part 1 (Phase 1a): Single Arm, Open Label (GRN-300 single-agent)
Ovarian Tumors Clinical Trial 2023: GRN-300 Highlights & Side Effects. Trial Name: NCT04711161 — Phase 1
GRN-300 (Kinase Inhibitor) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04711161 — Phase 1

Frequently Asked Questions

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

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."

Answered by AI

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."

Answered by AI

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."

Answered by AI

What conditions is GRN-300 typically prescribed for?

"GRN-300 is commonly prescribed to treat neoplasm metastasis, as well as more rare conditions like kaposi sarcoma, advance directives, and fallopian tubes cancer."

Answered by AI

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."

Answered by AI

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)."

Answered by AI
~12 spots leftby Dec 2024