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First-in-Human Evaluation of GRN-300 in Subjects With Recurrent Ovarian, Primary Peritoneal, and Fallopian Tube Cancers.

NCT04711161 · Status: SUSPENDED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 73

Last updated 2024-01-23

No results posted yet for this study

Summary

The study consists of two parts based on the administration of single-agent GRN-300 or in combination with paclitaxel.

Part 1 (Phase IA) will test the tolerability of continuous twice a day dosing of oral GRN-300, a salt-inducible kinase inhibitor, 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 dose limiting toxicities (DLTs) or adverse events.

Part 2 (Phase IB) will test the tolerability of continuous 28-day cycles of GRN-300 in combination with weekly paclitaxel given 3 of 4 weeks per month (x 3).

Overall duration of the study will be approximately 48 months, depending on the rate of enrollment and number of subjects enrolled.

Conditions

  • Ovarian Tumors

Interventions

DRUG

GRN-300

A salt-inducible kinase (SIK) inhibitor

DRUG

Paclitaxel

Microtubule inhibitor

Sponsors & Collaborators

  • Green3Bio, Inc.

    lead INDUSTRY

Principal Investigators

  • Siqing Fu, MD, PhD · M.D. Anderson Cancer Center

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-12-21
Primary Completion
2024-12-31
Completion
2025-03-31
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04711161 on ClinicalTrials.gov