Phase 1
Completed N=15
Study of Dalotuzumab (MK-0646) in Adults With Solid Tumors (MK-0646-009)
Neoplasm
Source: ClinicalTrials.gov NCT00694356 ↗
Enrolled (actual)
15
Serious AEs
6.7%
Results posted
Jun 2017
Primary outcomePrimary: Number of Participants Who Experienced a Dose-limiting Toxicity (DLT) — 0; 0; 0 Participants
Summary
This clinical study evaluates the safety, tolerability, pharmacokinetics, and immunogenicity of dalotuzumab (MK-0646) in participants with relapsed or refractory locally advanced or metastatic solid tumors using once weekly and once every other week dose infusion regimens.
The primary study hypothesis is that administration of dalotuzumab as a once weekly and an every other week infusion will be generally safe and well tolerated
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants Who Experienced a Dose-limiting Toxicity (DLT) |
0; 0; 0 | — |
| PRIMARY Number of Participants Who Experienced an Adverse Event (AE) |
3; 6; 6 | — |
| PRIMARY Number of Participants Who Discontinued Study Treatment Due to an AE |
1; 0; 0 | — |
| SECONDARY Maximum Plasma Concentration (Cmax) of Dalotuzumab |
85.60; 161.78; 244.05 | — |
| SECONDARY Area Under the Concentration-Time Curve From Zero to Infinity (AUC0-∞) of Dalotuzumab |
11.72; 21.71; 38.99 | — |
| SECONDARY Time to Cmax (Tmax) of Dalotuzumab |
1.0; 3.0; 1.0 | — |
| SECONDARY Apparent Terminal Half-life (t1/2) of Dalotuzumab |
129.85; 110.36; 167.09 | — |
| SECONDARY Clearance (CL) of Dalotuzumab |
0.0071; 0.0077; 0.0064 | — |
| SECONDARY Steady State Volume of Distribution (Vss) of Dalotuzumab |
0.0776; 0.0740; 0.0924 | — |
| SECONDARY Number of Participants Who Developed a Human Anti-Humanized Antibody (HAHA) Response to Dalotuzumab |
0; 0; 0 | — |
Eligibility Criteria
Inclusion Criteria
- Has histologically- or cytologically-confirmed metastatic or locally advanced solid tumor(s) that has (have) failed to respond to standard therapy, or for which adequate standard therapy does not exist
- Has tumor(s) associated with insulin-like growth factor 1 receptor (IGF-1R) expression in the literature (e.g. prostate, pancreatic, colon, lung and breast)
- Has Eastern Cooperative Oncology Group (ECOG) Performance Status 0 or 1
- Demonstrates adequate organ function
Exclusion Criteria
- Has had chemotherapy, radiotherapy, or biological therapy within 4 weeks (6 weeks for nitrosoureas or mitomycin C) prior to registration
- Is concurrently using growth hormone (GH), or growth hormone inhibitor
- Has any active central nervous system (CNS) metastases and/or carcinomatous meningitis
- Has any primary CNS tumor - any symptomatic ascites or plural effusion
- Has a history or current evidence of any clinically significant disease that might confound the results of the study, complicate the interpretation of the study results, interfere with the participant's participation, or pose an additional risk to the participant
- Is pregnant or breast-feeding
Data sourced from ClinicalTrials.gov (NCT00694356). 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.