Clinical trial NCT00954512: Study of Robatumumab (SCH 717454, MK-7454) in Combination With Different Treatment Regimens in Participants With Advanced Solid Tumors (P04722, MK-7454-004)
Official title: A Dose-Escalation Study to Evaluate the Safety and Tolerability of SCH 717454 in Combination With Different Treatment Regimens in Subjects With Advanced Solid Tumors (Phase 1B/2; Protocol No. P04722)
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE1
PHASE2
Conditions: Neoplasms
Keywords: Antibodies, neoplasm
Lead sponsor: Merck Sharp & Dohme LLC
Sponsor class: INDUSTRY
First posted: 2009-08-07
Enrollment: 15
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This is a Phase 1B/2, non-randomized, dose-escalation, multicenter, open-label study designed to evaluate the safety and tolerability of robatumumab (SCH 717454, MK-7454) in combination with standard treatment in participants with advanced solid tumors to be conducted in conformance with Good Clinical Practices.

Six different treatment regimens will be investigated in combination with robatumumab.

The study will be divided into two parts. Part 1 will consist of initial safety evaluation and dose-finding of robatumumab in combination with each treatment regimen. Part 2 will consist of an expansion of each robatumumab regimen at a newly established dose level, to better define safety, tolerability, and initial efficacy in specific target populations.


Eligibility criteria: Inclusion Criteria:

* Be willing and able to provide written informed consent for the study.
* Be ±18 years of age of either sex and of any race/ethnicity;
* Part 1: Have a histologically or cytologically confirmed advanced malignant solid tumor;
* Part 2: Have a histologically or cytologically confirmed, with measurable disease (as defined by Response Evaluation Criteria in Solid Tumors \[RECIST\]), advanced, malignant solid tumor.
* Have an Eastern Cooperative Oncology Group (ECOG) performance status of \<=2.
* Have adequate organ function within 3 weeks prior to first study drug administration.

Exclusion Criteria:

* Not have known treated or untreated leptomeningeal metastasis or a metastatic central nervous system lesion.
* Not have a history of another malignancy
* Not have received prior therapy with any anti-insulin-like growth factor receptor 1 (anti-IGF-1R) monoclonal antibody.
* Not have received radiation therapy within 2 weeks prior to first study drug administration.
* Not have received radiation therapy to \>25% of his/her total bone marrow during his/her lifetime.
* Not have undergone major surgery within 3 weeks prior to first study drug administration.
* Not have known human immunodeficiency virus (HIV) infection or a known HIV-related malignancy.
* Not have known active hepatitis B or C.
* Not have any serious or uncontrolled infection.
* Not have uncontrolled diabetes mellitus.
* Not have had any of the following within 6 months prior to first study drug administration: myocardial infarction, severe/unstable angina pectoris, coronary/peripheral artery bypass graft, symptomatic congestive heart failure, clinically significant cardiac dysrhythmia or clinically significant electrocardiogram (ECG) abnormality, cerebrovascular accident or transient ischemic attack, or seizure disorder.

Primary outcomes:
measure: Part 2: Number of Participants With Each Type of Response Evaluation Criteria in Solid Tumors (RECIST)-Determined Overall Best Response
timeFrame: Up to ~30 days after the final dose of robatumumab (Up to ~14 months)
measure: Part 1: Number of Participants Who Experienced One or More Adverse Events (AEs)
timeFrame: Up to ~30 days after the final dose of robatumumab (Up to ~14 months)
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Merck Sharp & Dohme LLC
name: Medical Director
role: STUDY_DIRECTOR
References: