Phase 1
Completed N=11
APN401 in Treating Patients With Recurrent or Metastatic Pancreatic Cancer, Colorectal Cancer, or Other Solid Tumors That Cannot Be Removed by Surgery
Metastatic Malignant Neoplasm in the Brain · Metastatic Solid Neoplasm · Recurrent Colorectal Carcinoma · Pancreatic Cancer
Source: ClinicalTrials.gov NCT03087591 ↗
Enrolled (actual)
11
Serious AEs
22.2%
Results posted
Oct 2024
Primary outcomePrimary: Number of Adverse Events Common Terminology Criteria for Adverse Events Version 4.0 — 0; 1; 8; 0 Participants
Summary
This phase I trial studies the side effects and best dose of APN401 in treating patients with pancreatic cancer, colorectal cancer, or other solid tumors that have spread to other places in the body or have come back. APN401 may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Adverse Events Common Terminology Criteria for Adverse Events Version 4.0 |
0; 1; 8; 0; 5; 4 | — |
| SECONDARY Clinical Response as Assessed by RECIST |
0; 0; 3; 6 | — |
| SECONDARY Frequency of Immune Cells |
37.1; 40.3; 19.0; 26.4; 15.5; 22.7 | — |
| SECONDARY Immune Response as Measured by Interferon Production |
75.1; 90.7; 226; 674.4 | — |
| SECONDARY Neutrophil to Lymphocyte Ratio |
2.72; 4.98 | — |
| SECONDARY Overall Survival (OS) |
181 | — |
| SECONDARY Progression-free Survival (PFS) |
70 | — |
Eligibility Criteria
Inclusion Criteria
- Patients with histologically confirmed inoperable, recurrent or metastatic malignant solid tumors, deemed incurable, and who have either:
- Failed to respond to standard therapy or
- For whom no standard therapy is available or
- Refuse to receive standard therapies
- The study is intended to enroll patients with pancreatic and colorectal cancer; patients with other types of solid tumors will require approval by the principal investigator
- Measurable disease as defined by Response Evaluation Criteria in Solid Tumors (RECIST)
- Patients with treated, stable, and asymptomatic brain metastases are eligible
- Patients on every 3 or every 4 week systemic therapy programs must be at least 4 weeks since treatment and recovered from any clinically significant toxicity experienced; patients on weekly or daily systemic therapy programs and patients receiving radiation must be at least 1 week since treatment and recovered from any clinically significant toxicity experienced; must be at least 4 weeks and have recovered from major surgery
- Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1
- White blood cells >= 3000/uL
- Platelets >= 100,000/uL
- Hematocrit >= 28%
- Creatinine = = 3.0 g/dL
- International normalized ratio (INR) = = 60% of predicted and a diffusing capacity of the lung for carbon monoxide (DLCO) >= 55% (corrected for hemoglobin)
- Clinically significant cardiovascular abnormalities (e.g., congestive heart failure or symptoms of coronary artery disease), as determined by medical history and physical examination; patients with a history of cardiac disease must have a normal cardiac stress test (treadmill, echocardiogram, or myocardial perfusion scan) within the past 6 months of study entry
- Active infections or oral temperature > 38.2 degrees Celsius (C) within 48 hours of study entry
- Systemic infection requiring chronic maintenance or suppressive therapy
- Patients are excluded for any underlying medical or psychiatric condition, which in the opinion of the investigator, will make treatment hazardous or obscure the interpretation of adverse events, such as a condition associated with frequent rashes or diarrhea
Data sourced from ClinicalTrials.gov (NCT03087591). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.