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

NCT02538432 | Withdrawn Phase 2 DMC FDA Drug

• 1 other identifier: 15XXGCC
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

Brief Summary

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

Conditions

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

Keywords

Disease Progression; Non-Responsive Disease; Advanced Disease

Outcome Measures

Primary Outcomes (1)

• Circulating Tumor Cells (CTC)

  The efficacy of the treatment drug will be assessed by the reduction of the number of CTCs. Blood sample collection will be done to assess CTCs.

  Day 21

Secondary Outcomes (1)

• Myeloid Derived Suppressor Cell (MDSC)

  Day 21

Study Arms (2)

RQ-00000007 Alone

EXPERIMENTAL

RQ-0000007 250 mg will be self-administered orally, with or without food, each morning and evening, approximately 12 hours apart.

Drug: RQ-00000007

Gemcitabine

ACTIVE COMPARATOR

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 given as an IV.

Drug: RQ-00000007; Drug: Gemcitabine

Interventions

RQ-00000007 DRUG

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.

Also known as: AAT-007, RQ-07, CJ-023,423

Gemcitabine; RQ-00000007 Alone

Gemcitabine DRUG

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.

Also known as: Gemzar

Gemcitabine

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Histologically or cytologically confirmed breast, prostate or non-small cell lung cancer or other A tissue block, 10 unstained slides or fresh tissue biopsy is required.
• At least 2 weeks should have elapsed since the last treatment and patients should have recovered from previous significant toxicity (i.e. to grade 1 or less).
• ECOG Performance Status \<2.
• Patient at least 18 years of age or older.
• Adequate hematological function as defined by the protocol, section 4.1.5.
• Patients must have a serum creatinine within normal limits, or an estimated or measured creatinine clearance \> 35 mg/ml/min.
• Normal serum electrolytes (no \>grade 2 abnormalities), magnesium and phosphorus on the day of therapy. Correction of abnormalities is permitted.
• All patients must be informed of the investigational nature of this study and must sign and give written informed consent.
• Serum calcium, magnesium and potassium must be within normal limits. Supplementation to achieve normal values is permitted.
• Patients who are potentially fertile and sexually active must be willing to utilize effective birth control.
• Patients with CNS metastases which are/were symptomatic must have completed therapy (surgery, gamma knife, XRT) and be neurologically stable.
• Patients must have \> or = 4 circulating tumor cells

You may not qualify if:

• Patients must not have serious infection or other serious underlying medical condition which would impair the ability of the patient to receive protocol treatment.
• Current uncontrolled cardiac disease
• Acute bacterial or fungal infection requiring intravenous antibiotics at the time of registration
• Chronic Obstructive Pulmonary Disease exacerbation or other respiratory illness requiring hospitalization or precluding study therapy within 4 weeks of registration.
• Patients with acquired Immune Deficiency Syndrome (AIDS) based upon current CDC definition or patients known to be HIV positive
• Pregnancy or women of childbearing potential and men who are sexually active and not willing/able to use medically acceptable forms of contraception

Sponsors & Collaborators

• University of Maryland, Baltimore: lead

MeSH Terms

Conditions

Prostatic Neoplasms; Carcinoma, Non-Small-Cell Lung; Breast Neoplasms; Disease Progression

Interventions

grapiprant; Gemcitabine

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases; Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Lung Diseases; Respiratory Tract Diseases; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Heterocyclic Compounds; Deoxycytidine; Cytidine; Pyrimidine Nucleosides; Pyrimidines; Heterocyclic Compounds, 1-Ring

Study Officials

• Martin Edelman, M.D., FACP

  University of Maryland Greenebaum Cancer Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 31, 2015
• First Posted: September 2, 2015
• Study Start: June 1, 2017
• Primary Completion: December 1, 2019
• Study Completion: December 1, 2021
• Last Updated: November 4, 2019

Record last verified: 2017-06

Data Sharing

• IPD Sharing: Will not share