Cancer Clinical Trial
— APX3330Official title:
A Phase 1 Study of APX3330 in Patients With Advanced Solid Tumors
Verified date | September 2020 |
Source | Apexian Pharmaceuticals, Inc. |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
This is a Phase 1, multi-center, open-label, dose-escalation oncology study of APX3330 in patients with advanced solid tumors.
Status | Completed |
Enrollment | 19 |
Est. completion date | January 9, 2019 |
Est. primary completion date | August 18, 2018 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility |
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. |
Country | Name | City | State |
---|---|---|---|
United States | START Midwest | Grand Rapids | Michigan |
United States | Indiana University Simon Cancer Center | Indianapolis | Indiana |
United States | START San Antonio | San Antonio | Texas |
Lead Sponsor | Collaborator |
---|---|
Apexian Pharmaceuticals, Inc. |
United States,
Jiang A, Gao H, Kelley MR, Qiao X. Inhibition of APE1/Ref-1 redox activity with APX3330 blocks retinal angiogenesis in vitro and in vivo. Vision Res. 2011 Jan;51(1):93-100. doi: 10.1016/j.visres.2010.10.008. Epub 2010 Oct 14. — View Citation
Safi Shahda, Nehal J. Lakhani, Bert O'Neil, Drew W. Rasco, Jun Wan, Amber L Mosley, Hao Liu, Mark R. Kelley, Richard Adam Messmann. A phase I study of the APE1 protein inhibitor APX3330 in patients with advanced solid tumors. Journal of Clinical Oncology.
Shah F, Logsdon D, Messmann RA, Fehrenbacher JC, Fishel ML, Kelley MR. Exploiting the Ref-1-APE1 node in cancer signaling and other diseases: from bench to clinic. NPJ Precis Oncol. 2017;1. pii: 19. doi: 10.1038/s41698-017-0023-0. Epub 2017 Jun 8. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Number of Participants With Treatment-Related Adverse Events as Assessed by CTCAE v4.0 | Identification of the safety and tolerability of APX3330 | 12 months | |
Secondary | Any anti-tumor activity that may occur in patients receiving APX3330 using RECIST criteria | Using RECIST criteria | 18 months |
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