Clinical trial NCT00694356: Study of Dalotuzumab (MK-0646) in Adults With Solid Tumors (MK-0646-009)
Official title: A Phase I Study of MK-0646 in Patients With Relapsed or Refractory Locally Advanced or Metastatic Solid Tumors
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Neoplasm
Lead sponsor: Merck Sharp & Dohme LLC
Sponsor class: INDUSTRY
First posted: 2008-06-10
Enrollment: 15
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief 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


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

Primary outcomes:
measure: Number of Participants Who Experienced a Dose-limiting Toxicity (DLT)
timeFrame: Cycle 1 (Up to 4 weeks)
measure: Number of Participants Who Experienced an Adverse Event (AE)
timeFrame: Up to 30 days after last dose of study treatment (Up to 101 days)
measure: Number of Participants Who Discontinued Study Treatment Due to an AE
timeFrame: Up to 71 days
Secondary outcomes:
measure: Maximum Plasma Concentration (Cmax) of Dalotuzumab
timeFrame: Pre-dose, 0.5 h after start of infusion, end of infusion, 5, 10, 24, 30, 48 and 96 and 168 h post-dose
measure: Area Under the Concentration-Time Curve From Zero to Infinity (AUC0-∞) of Dalotuzumab
timeFrame: Pre-dose, 0.5 h after start of infusion, end of infusion, 5, 10, 24, 30, 48 and 96 and 168 h post-dose
measure: Time to Cmax (Tmax) of Dalotuzumab
timeFrame: Pre-dose, 0.5 h after start of infusion, end of infusion, 5, 10, 24, 30, 48 and 96 and 168 h post-dose
measure: Apparent Terminal Half-life (t1/2) of Dalotuzumab
timeFrame: Pre-dose, 0.5 h after start of infusion, end of infusion, 5, 10, 24, 30, 48 and 96 and 168 h post-dose
measure: Clearance (CL) of Dalotuzumab
timeFrame: Pre-dose, 0.5 h after start of infusion, end of infusion, 5, 10, 24, 30, 48 and 96 and 168 h post-dose
measure: Steady State Volume of Distribution (Vss) of Dalotuzumab
timeFrame: Pre-dose, 0.5 h after start of infusion, end of infusion, 5, 10, 24, 30, 48 and 96 and 168 h post-dose
measure: Number of Participants Who Developed a Human Anti-Humanized Antibody (HAHA) Response to Dalotuzumab
timeFrame: Cycle 1: predose on Days 1, 8, 15, and 22; Cycles 2 and 3: predose on Day 1; 4 weeks after last dose of study drug
Other outcomes:
Locations:
Study officials:
affiliation: Merck Sharp & Dohme LLC
name: Medical Director
role: STUDY_DIRECTOR
References: