Phase 2
Completed N=30
A Study of Axitinib in Advanced Carcinoid Tumors
Carcinoid Tumor
Source: ClinicalTrials.gov NCT01435122 ↗
Enrolled (actual)
30
Serious AEs
40.0%
Results posted
May 2017
Primary outcomePrimary: Rate of Progression Free Survival (PFS) — 74.5 percentage of participants
Summary
The main purpose of this study is to see whether Axitinib will help prolong the time that the patient's carcinoid tumors remain stable, and to examine their treatment response through testing. Researchers also want to find out if Axitinib is safe and tolerable.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Rate of Progression Free Survival (PFS) |
74.5 | — |
| PRIMARY Median Progression Free Survival |
26.7 | — |
| SECONDARY Tumor Response Rate |
1; 21 | — |
| SECONDARY 24 Month Overall Survival (OS) Rate |
74.3 | — |
| SECONDARY Time to Treatment Failure |
9.6 | — |
| SECONDARY Occurrence of Possibly Related Adverse Events (AEs) |
87; 17; 17; 13; 7; 3 | — |
Eligibility Criteria
Inclusion Criteria
- Locally unresectable or metastatic well-and moderately-differentiated (low- or intermediate- grade) neuroendocrine tumors of the aerodigestive tract (e.g. foregut, midgut, and hindgut) and unknown primary site as well as rare primary sites (renal, ovarian, thymic, hepatic); Otherwise known as typical or atypical carcinoid tumors
- Measurable disease by Response Evaluation Criteria In Solid Tumors (RECIST) Criteria
- Functional or nonfunctional tumors allowed
- Evidence of progressive disease within 12 months of study entry
- Adequate hepatic function: total bilirubin ≤1.5 x upper limit of normal (ULN)mg/dl; aspartic transaminase (AST) ≤2.5 x ULN (≤5 x ULN if attributable to liver metastases)
- Adequate renal function: serum creatinine ≤ 1.5 x ULN
- Adequate bone marrow function: absolute neutrophil count ≥ 1,500/mm³; platelets ≥75,000/mm³
- Prothrombin time (PT) and activated partial thromboplastin time (aPTT) levels ≤1.5 x ULN (unless patients receiving coumadin anticoagulation in which case a stable international normalization ration (INR) of 2-3 is required).
- Urine protein 140/90). Patient with baseline hypertension may be eligible after initiation of antihypertensive therapy.
Data sourced from ClinicalTrials.gov (NCT01435122). 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.