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

NCT ID: NCT02538432

Last Updated: 2019-11-04

Basic Information

• Recruitment Status: WITHDRAWN
• Clinical Phase: PHASE2
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-06-30
• Study Completion Date: 2021-12-31

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.

Conditions

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

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

RQ-00000007 Alone

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

Group Type: EXPERIMENTAL

RQ-00000007

Intervention Type: 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.

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.

Group Type: ACTIVE_COMPARATOR

RQ-00000007

Intervention Type: 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.

Gemcitabine

Intervention Type: 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.

Interventions

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.

Intervention Type: 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.

Intervention Type: DRUG

Other Intervention Names

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

Eligibility Criteria

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

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Maryland, Baltimore

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Martin Edelman, M.D., FACP

Role: PRINCIPAL_INVESTIGATOR

University of Maryland Greenebaum Cancer Center

Other Identifiers

15XXGCC

Identifier Type: -

Identifier Source: org_study_id