NCT02538432

Phase II Trial of EP4 Receptor Antagonist, AAT-007 (RQ-07; CJ-023,423) in Advanced Solid Tumors

15xxGCC: PHASE II TRIAL OF THE EP4 RECEPTOR ANTAGONIST, AAT-007 (RQ-07; CJ-023,423) IN ADVANCED SOLID TUMORS

• Status: Withdrawn
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: University of Maryland, Baltimore · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This is a phase II trial of (RQ-07) in advanced solid tumors in prostate, breast or non-small cell lung cancer.

Detailed description

This is a phase II trial of (RQ-07) in advanced solid tumors in advanced prostate, breast or lung cancer. The purpose of this trial is to determine whether the administration of the study drug RQ-07 can decrease circulating tumor cells in advanced prostate, breast or lung cancer. Additionally, the study will evaluate whether the study drug may improve outcome in advanced prostate, breast or lungs cancer either by itself or when combined with gemcitabine, a standard chemotherapy drug. The combination of with gemcitabine will only be investigated after disease has worsened with the study drug RQ-07 by itself and only in patients with prostate or lung cancer.

Conditions

• Prostate Cancer
• Non-Small Cell Lung Cancer
• Breast Cancer

Interventions

Type	Name	Description
DRUG	RQ-00000007	RQ-07 250 mg will taken orally, with or without food, each morning and evening, approximately 12 hours apart. Drug administration will be continuous. Every 21 day period will be considered one cycle of treatment.
DRUG	Gemcitabine	For patients with breast or lung cancer who have not previously received gemcitabine as part of their therapy or who may benefit from re-challenge with gemcitabine, gemcitabine will be administered at 1000 mg/m2 IV over 30 minutes for 3 out of 4 weeks after appropriate pre-medications. Every 4 week period (28 days) will be considered one cycle.

Timeline

• Start date: 2017-06-01
• Primary completion: 2019-12-01
• Completion: 2021-12-01
• First posted: 2015-09-02
• Last updated: 2019-11-04

Regulatory

• FDA-regulated drug study