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

Phase 2

Withdrawn

• Conditions: Prostate Cancer; Non-Small Cell Lung Cancer; Breast Cancer
• Interventions: Drug: RQ-00000007; Drug: Gemcitabine

• Registration Number: NCT02538432
• Lead Sponsor: University of Maryland, Baltimore

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.

Basic Information
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Recruitment & Eligibility
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Study & Design

Study Timeline

• Study First Submitted: 2015-08-31
• Study First Submitted QC: 2015-08-31
• Study First Posted: 2015-09-02
• Status Verified: 2017-06
• Study Start: 2017-06
• Last Update Submitted: 2019-10-31
• Last Update Posted: 2019-11-04
• Primary Completion: 2019-12
• Study Completion: 2021-12

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

1. 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.

2. 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).

3. ECOG Performance Status <2.

4. Patient at least 18 years of age or older.

5. Adequate hematological function as defined by the protocol, section 4.1.5.

6. Patients must have a serum creatinine within normal limits, or an estimated or measured creatinine clearance > 35 mg/ml/min.

7. 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).

8. All patients must be informed of the investigational nature of this study and must sign and give written informed consent.

9. Serum calcium, magnesium and potassium must be within normal limits. Supplementation to achieve normal values is permitted.

10. Patients who are potentially fertile and sexually active must be willing to utilize effective birth control.

11. Patients with CNS metastases which are/were symptomatic must have completed therapy (surgery, gamma knife, XRT) and be neurologically stable.

12. Patients must have > or = 4 circulating tumor cells

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Exclusion Criteria

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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
RQ-00000007 Alone	RQ-00000007	RQ-0000007 250 mg will be self-administered orally, with or without food, each morning and evening, approximately 12 hours apart.
Gemcitabine	RQ-00000007	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.
Gemcitabine	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 given as an IV.

Primary Outcome Measures

Name	Time	Method
Circulating Tumor Cells (CTC)	Day 21	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

Name	Time	Method
Myeloid Derived Suppressor Cell (MDSC)	Day 21	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