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Trial record 2 of 2 for:    CJ-023,423

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

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ClinicalTrials.gov Identifier: NCT02538432
Recruitment Status : Withdrawn (PI No Longer at University of Maryland. Now at Fox Chase)
First Posted : September 2, 2015
Last Update Posted : June 6, 2017
Sponsor:
Information provided by (Responsible Party):
University of Maryland

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

Condition or disease Intervention/treatment Phase
Prostate Cancer Non-Small Cell Lung Cancer Breast Cancer Drug: RQ-00000007 Drug: Gemcitabine Phase 2

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.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 0 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: 15xxGCC: PHASE II TRIAL OF THE EP4 RECEPTOR ANTAGONIST, AAT-007 (RQ-07; CJ-023,423) IN ADVANCED SOLID TUMORS
Estimated Study Start Date : June 2017
Estimated Primary Completion Date : December 2019
Estimated Study Completion Date : December 2021

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: RQ-00000007 Alone
RQ-0000007 250 mg will be self-administered orally, with or without food, each morning and evening, approximately 12 hours apart.
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.
Other Names:
  • AAT-007
  • RQ-07
  • CJ-023,423

Active Comparator: 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.
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.
Other Names:
  • AAT-007
  • RQ-07
  • CJ-023,423

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.
Other Name: Gemzar




Primary Outcome Measures :
  1. Circulating Tumor Cells (CTC) [ Time Frame: 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 :
  1. Myeloid Derived Suppressor Cell (MDSC) [ Time Frame: 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



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02538432


Sponsors and Collaborators
University of Maryland
Investigators
Principal Investigator: Martin Edelman, M.D., FACP University of Maryland Greenebaum Cancer Center

Responsible Party: University of Maryland
ClinicalTrials.gov Identifier: NCT02538432     History of Changes
Other Study ID Numbers: 15XXGCC
First Posted: September 2, 2015    Key Record Dates
Last Update Posted: June 6, 2017
Last Verified: June 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by University of Maryland:
Disease Progression
Non-Responsive Disease
Advanced Disease

Additional relevant MeSH terms:
Carcinoma, Non-Small-Cell Lung
Carcinoma, Bronchogenic
Bronchial Neoplasms
Lung Neoplasms
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Neoplasms
Lung Diseases
Respiratory Tract Diseases
Gemcitabine
Antimetabolites, Antineoplastic
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Antiviral Agents
Anti-Infective Agents
Enzyme Inhibitors
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs