Phase 1
Completed N=80
Dose Escalation Trial of Dalotuzumab (MK-0646) in Advanced Solid Tumors and Multiple Myeloma (MK-0646-001)
Source: ClinicalTrials.gov NCT00701103 ↗Enrolled (actual)
80
Serious AEs
22.5%
Results posted
Mar 2017
Primary outcomePrimary: Percentage of Participants Who Experienced One or More Dose-limiting Toxicities (DLTs) — 0; 0; 13; 0 Percentage of Participants
Summary
This study will look for the highest tolerated dose of dalotuzumab (MK-0646) given as weekly, every other week. or a every three week infusion.
The hypothesis of this study is that administration of dalotuzumab as a one- to two-hour weekly, every other week, or every three week infusion in participants with advanced cancer will be generally safe and tolerated at a dose which achieves a trough concentration ≥3 μg/mL.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Participants Who Experienced One or More Dose-limiting Toxicities (DLTs) |
0; 0; 13; 0; 0; 0 | — |
| PRIMARY Mean Terminal Half-life (t1/2) of Dalotuzumab |
67; 79; 83; 169; 100; 95 | — |
| PRIMARY Area Under the Time-concentration Curve From 0 to Infinity Hours (AUC0-∞) of Dalotuzumab |
1.6; 3.7; 12.9; 28.9; 18.4; 39.4 | — |
| PRIMARY Mean Serum Clearance of Dalotuzumab |
0.013; 0.012; 0.007; 0.006; 0.009; 0.007 | — |
| PRIMARY Mean Trough Serum Concentration (Ctrough) of Dalotuzumab |
2.4; 7.2; 21.2; 54.8; 45.2; 81.2 | — |
| SECONDARY Change From Baseline in Insulin-like Growth Factor Receptor Type 1 (IGF-1R) Protein Expression Level H-score in Skin Samples |
186.7; 203.3; 218.6; 171.8; 182.0; 146.3 | — |
| SECONDARY Change From Baseline in IGF-1R Protein Expression Level H-score in Tumor Samples |
145.0; 84.0; 110.0; 134.3; 152.5; -80.0 | — |
| SECONDARY Percentage of Participants Who Developed a Serum Human-anti-humanized-antibody (HAHA) Response to Dalotuzumab |
40; 0; 0; 0; 0; 0 | — |
| SECONDARY Percentage of Participants Who Experienced a Complete Response (CR) or Partial Response (PR) |
0; 0; 0; 0; 0; 0 | — |
Eligibility Criteria
Inclusion Criteria
- Participant has metastatic or locally advanced solid tumor or multiple myeloma
- Tumor specimen has IGF-1R expression
- Participant agrees to use birth control throughout study
Exclusion Criteria
- Participant must not be recovering from antineoplastic therapy in the last 4 weeks
- Participant has participated in a clinical trial in the last 4 weeks
- Participant has a history of heart problems such as congestive heart failure, angina, heart attack or stroke in the last 3 months
- Participant is taking growth hormone or growth hormone inhibitors
- If female, participant is pregnant or breastfeeding
- Participant is human immunodeficiency virus (HIV) positive
- Participant has a history of hepatitis B or C
Data sourced from ClinicalTrials.gov (NCT00701103). 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.