Phase 1
Completed N=21
Safety And PK Study Of CVX-060 In Patients With Advanced Solid Tumors
Solid Tumors · Neoplasms · Carcinoma · Cancer
Source: ClinicalTrials.gov NCT00879684 ↗
Enrolled (actual)
21
Serious AEs
26.5%
Results posted
Jan 2015
Primary outcomePrimary: Number of Participants With Treatment Emergent Treatment-Related Adverse Events (AEs) — 2; 3; 1; 2 participants
Summary
The purpose of this study is to determine the safety and tolerability of CVX-060 in patients with advanced solid tumors.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants With Treatment Emergent Treatment-Related Adverse Events (AEs) |
2; 3; 1; 2; 2; 1 | — |
| SECONDARY Maximum Observed Serum Concentration (Cmax) |
10550; 22660; 68280; 140300; 249600; 318600 | — |
| SECONDARY Serum Decay Half-Life (t1/2) |
138.1; 92.23; 86.83; 115.2; 124.7; 129.9 | — |
| SECONDARY Area Under the Curve From Time Zero to 168 Hours [AUC (0-168)] |
1030000; 1644000; 5259000; 11990000; 23700000; 26410000 | — |
| SECONDARY Apparent Volume of Distribution (Vss) |
32.34; 54.15; 50.70; 51.07; 54.58; 59.67 | — |
| SECONDARY Apparent Clearance (CL) |
0.1684; 0.4399; 0.4225; 0.3222; 0.3078; 0.3483 | — |
| SECONDARY Time to Reach Maximum Observed Serum Concentration (Tmax) |
2.35; 1.50; 2.62; 2.54; 2.42; 2.50 | — |
| SECONDARY Recommended Phase 2 Dose (RP2D): Stage 1 |
15 | — |
| SECONDARY Number of Participants With Anti-CVX-060 Antibodies |
20 | — |
| SECONDARY Number of Samples From Participants With Anti-CVX-060 Antibodies |
45 | — |
| SECONDARY Number of Participants With Best Overall Response (BOR) |
0; 0; 0; 0; 0; 0 | — |
Eligibility Criteria
Inclusion Criteria
- Confirmed advanced solid tumors unresponsive to currently available therapies or for which there is no standard therapy.
- Adequate coagulation, liver, and renal function.
- Candidate for DCE-MRI evaluations.
- ECOG (Eastern Cooperative Oncology Group) performance status of 0 or 1.
Exclusion Criteria
- Evidence of significant bleeding problems.
- History of certain gastrointestinal problems including fistula and abscess.
- Chronic, uncontrolled hypertension.
- Patients with any history of primary or metastatic tumor involvement of the brain or with tumors that encase great vessels.
Data sourced from ClinicalTrials.gov (NCT00879684). 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.