Phase 1
Completed N=48
A Study of Dalotuzumab (MK-0646) in Breast Cancer Patients (MK-0646-013)
Source: ClinicalTrials.gov NCT00759785 ↗Enrolled (actual)
48
Serious AEs
4.4%
Results posted
Apr 2017
Primary outcomePrimary: Percentage of Participants Demonstrating a Decrease in the Growth Factor Signature (GFS) — 28.6; 17.6 Percentage of participants
Summary
A study to evaluate the response of growth factor signatures (GFS) to a single dose of dalotuzumab in participants with triple negative (TN) or estrogen receptor (ER)-positive luminal B breast cancer. The primary hypothesis is that dalotuzumab will induce a decrease in the GFS in at least 40% of participants.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Participants Demonstrating a Decrease in the Growth Factor Signature (GFS) |
28.6; 17.6 | — |
| SECONDARY Percentage of IGF1R Positive Participants With a Decrease in GFS by Cohort |
25.0; 11.1 | — |
| SECONDARY Percentage of IGF1R Negative Participants With a Decrease in GFS by Cohort |
0.0; 20.0 | — |
| SECONDARY Change From Baseline in IGF1R Membrane H-Score After a Single Dose of Dalotuzumab |
-104.5; -11.5 | — |
Eligibility Criteria
Inclusion Criteria
- Participant has operable stage I-IIIa breast cancer of the following subtypes: (1) estrogen receptor (ER)-negative, progesterone receptor (PR)-negative, and human epidermal growth factor receptor 2 (HER2)-negative breast cancer; (2) ER-positive tumor meeting one of the following criteria: histologic grade 3; histologic grade 2 and PR-negative; histologic grade 2 and Ki67 antigen ≥10%. Tumor is at least 2 cm in diameter as assessed by physical or radiographic exam
- Participant is female and ≥18 years of age
Exclusion Criteria
- Participant is pregnant, breastfeeding or planning to become pregnant while in the study
- Participant has received prior chemotherapy, biological therapy or radiation
- Participant has participated in a clinical trial in the last 30 days
- Participant has a history of drug or alcohol abuse in the last year
- Participant is human immunodeficiency virus (HIV) positive. Patient has a history of Hepatitis B or C
- Participant has poorly controlled diabetes mellitus
Data sourced from ClinicalTrials.gov (NCT00759785). 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.