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

Primary Purpose

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

Status

Withdrawn

Phase

Phase 2

Locations

Study Type

Interventional

Intervention

RQ-00000007

Gemcitabine

About this trial

This is an interventional treatment trial for Prostate Cancer focused on measuring Disease Progression, Non-Responsive Disease, Advanced Disease

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

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.
Adequate hepatic function per institutional standards (see exclusion).
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

Exclusion Criteria:

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

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

RQ-00000007 Alone

Gemcitabine

Arm Description

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

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Myeloid Derived Suppressor Cell (MDSC)

The efficacy of the treatment drug RQ-07 will be assessed as a single agent and in combination with gemcitabine in breast cancer and lung cancer patients only. MDSC evaluation will be done via a blood sample collection

Full Information

NCT ID

NCT02538432

First Posted

August 31, 2015

Last Updated

October 31, 2019

Sponsor

University of Maryland, Baltimore

1. Study Identification

Unique Protocol Identification Number

NCT02538432

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

June 2017

Overall Recruitment Status

Withdrawn

Why Stopped

PI No Longer at University of Maryland. Now at Fox Chase

Study Start Date

June 2017 (Anticipated)

Primary Completion Date

December 2019 (Anticipated)

Study Completion Date

December 2021 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

University of Maryland, Baltimore

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Yes

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

Yes

5. Study Description

Brief 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

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

Keywords

Disease Progression, Non-Responsive Disease, Advanced Disease

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

Non-Randomized

Enrollment

0 (Actual)

8. Arms, Groups, and Interventions

Arm Title

RQ-00000007 Alone

Arm Type

Experimental

Arm Description

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

Arm Title

Gemcitabine

Arm Type

Active Comparator

Arm Description

Intervention Type

Drug

Intervention Name(s)

RQ-00000007

Other Intervention Name(s)

AAT-007, RQ-07, CJ-023,423

Intervention Description

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.

Intervention Type

Drug

Intervention Name(s)

Gemcitabine

Other Intervention Name(s)

Gemzar

Intervention Description

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.

Primary Outcome Measure Information:

Title

Circulating Tumor Cells (CTC)

Description

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.

Time Frame

Day 21

Secondary Outcome Measure Information:

Title

Myeloid Derived Suppressor Cell (MDSC)

Description

Time Frame

Day 21

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: 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. Adequate hepatic function per institutional standards (see exclusion). 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 Exclusion Criteria: 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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Martin Edelman, M.D., FACP

Organizational Affiliation

University of Maryland Greenebaum Cancer Center

Official's Role

Principal Investigator

12. IPD Sharing Statement

Plan to Share IPD

Learn more about this trial

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

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