Clinical Trials /

A Study of APX3330 in Patients With Advanced Solid Tumors

NCT03375086

Description:

This is a Phase 1, multi-center, open-label, dose-escalation oncology study of APX3330 in patients with advanced solid tumors.

Related Conditions:
  • Malignant Solid Tumor
Recruiting Status:

Recruiting

Phase:

Phase 1

Trial Eligibility

Document

Title

  • Brief Title: A Study of APX3330 in Patients With Advanced Solid Tumors
  • Official Title: A Phase 1 Study of APX3330 in Patients With Advanced Solid Tumors

Clinical Trial IDs

  • ORG STUDY ID: APX_CLN_0011
  • NCT ID: NCT03375086

Conditions

  • Cancer

Interventions

DrugSynonymsArms
APX3330E3330Single arm

Purpose

This is a Phase 1, multi-center, open-label, dose-escalation oncology study of APX3330 in patients with advanced solid tumors.

Detailed Description

      Apurinic/apyrimidinic endonuclease 1/redox factor-1 (APE1/Ref-1) is a protein that regulates
      multiple transcription factors involved in cancer cell signaling and APX3330 is a highly
      selective inhibitor of APE1/Ref-1 redox function.

      The anti-tumor effect of APX330 has been demonstrated in a variety of preclinical models and
      the human safety profile of APX3330 was established in prior clinical studies. Apexian
      Pharmaceuticals is developing APX3330 as an orally administered anti-cancer agent targeting
      the APE1/Ref-1 protein.

      APX_CLN_0011 is a Phase 1, multi-center, open-label, dose-escalation oncology study in
      patients with advanced solid tumors. The study primary objective is to determine the
      recommended Phase 2 study dose of APX3330. Secondary objectives include assessment of APX3330
      safety, anti-tumor activity, pharmacokinetic and pharmacodynamic profile.
    

Trial Arms

NameTypeDescriptionInterventions
Single armExperimentalPatients will receive APX3330 orally, twice per day until disease progression
  • APX3330

Eligibility Criteria

        Inclusion Criteria:

          1. Written informed consent must be obtained from the patient.

          2. Patient must be > 18 years of age.

          3. Patient must have recurrent or advanced cancer (i.e., solid tumors) for whom standard
             therapy offers no curative potential.

          4. Evaluable disease by RECIST v1.1.

          5. Performance status (PS) of 0-2 on the Eastern Cooperative Oncology Group (ECOG) scale.
             Note: PS 2 patients can only participate if, in the assessment of the clinical
             investigator, and with the consent of the medical monitor, the patient has the ability
             to participate in the clinical study for a minimum of at least 2 cycles.

          6. > 21 days from therapeutic radiation or chemotherapy (>6 weeks from nitrosoureas and
             mitomycin C) and recovery to (NCI CTCAE v4.03) Grade ≤ 1 from all clinically
             significant toxicities related to prior therapies.

          7. Must have adequate organ function defined as:

               1. Absolute neutrophil count (ANC) ≥ 1.5 x 10^9/L.

               2. Platelet ≥ 100 x 10^9/L.

               3. Hemoglobin ≥ 9 g/dL.

               4. Activated partial thromboplastin time/ partial thromboplastin time (aPTT/PTT) ≤
                  1.5 x ULN

               5. Aspartate aminotransferase (AST) or alanine aminotransferase (ALT) ≤ 2.5 × upper
                  limit of normal (ULN). In the case of known (i.e., radiological or biopsy
                  documented) liver metastasis, serum transaminase levels must be < 5 x ULN.

               6. Total serum bilirubin ≤ 1.5 x ULN, (except for patients with known Gilbert's
                  Syndrome ≤ 3 x ULN is permitted)

               7. Renal: Serum creatinine < 2.0 x ULN or creatinine clearance ≥ 50 mL/min/1.73m^2
                  for patients with serum creatinine levels above 2 x ULN.

          8. Agreement to use acceptable methods of contraception during the study and for at least
             120 days after the last dose of APX3330 if sexually active and able to bear or beget
             children.

        Exclusion Criteria:

          1. Diagnosed with another malignancy within the past 2 years (excluding a history of
             carcinoma in situ of the cervix, superficial non-melanoma skin cancer, superficial
             bladder cancer, or endometrial cancer that has been adequately treated, or stage 1
             prostate cancer that does not require treatment).

          2. History of a major surgical procedure or a significant traumatic injury within 14 days
             prior to commencing treatment, or the anticipation of the need for a major surgical
             procedure during the course of the study.

          3. Patients who have been treated with an investigational agent within 21 days prior to
             the first dose of study drug.

          4. Concurrent serious (as determined by the Principal Investigator) medical conditions,
             including, but not limited to, New York Heart Association (NYHA) class III or IV
             congestive heart failure, history of congenital prolonged QT syndrome, uncontrolled
             infection, active hepatitis B, C or HIV, or other significant co-morbid conditions
             that in the opinion of the investigator would impair study participation or
             cooperation.

          5. Impaired liver function Child-Pugh class B or C (score 7-15).

          6. Women who are pregnant or lactating.

          7. Patients with evidence of symptomatic brain metastases. Patients with treated
             (surgically excised or irradiated) and stable brain metastases are eligible assuming
             the patient has adequately recovered from treatment, the treatment was at least 28
             days prior to initiation of study drug, and baseline brain computed tomography (CT)
             with contrast, or magnetic resonance imaging (MRI) within 14 days of initiation of
             study drug, is negative for new or worsening brain metastases

          8. Other concurrent chemotherapy, immunotherapy, radiotherapy or investigational therapy
             except for hormonal therapy (e.g., tamoxifen, etc.).

          9. Patients requiring palliative radiotherapy to lesions that are defined as target
             lesions by RECIST criteria at the time of study entry.
      
Maximum Eligible Age:N/A
Minimum Eligible Age:18 Years
Eligible Gender:All
Healthy Volunteers:No

Primary Outcome Measures

Measure:Number of Participants With Treatment-Related Adverse Events as Assessed by CTCAE v4.0
Time Frame:12 months
Safety Issue:
Description:Identification of the safety and tolerability of APX3330

Secondary Outcome Measures

Measure:Any anti-tumor activity that may occur in patients receiving APX3330 using RECIST criteria
Time Frame:18 months
Safety Issue:
Description:Using RECIST criteria

Details

Phase:Phase 1
Primary Purpose:Interventional
Overall Status:Recruiting
Lead Sponsor:Apexian Pharmaceuticals, Inc.

Last Updated

February 7, 2018