Study of Robatumumab (SCH 717454, MK-7454) in Combination With Different Treatment Regimens in Participants With Advanced Solid Tumors (P04722, MK-7454-004)

Neoplasms Clinical Trial

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)

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00954512
• Other study ID #: P04722
• Secondary ID: MK-7454-0042009-
• Status: Terminated
• Phase: Phase 1/Phase 2
• Start date: September 25, 2009
• Est. completion date: June 7, 2011

Study information

• Verified date: July 2018
• Source: Merck Sharp & Dohme Corp.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 15
• Est. completion date: June 7, 2011
• Est. primary completion date: June 7, 2011
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Neoplasms

Intervention

Drug:
• Carboplatin

• Epirubicin

Biological:
• Trastuzumab

Drug:
• Everolimus

• Gemcitabine

Biological:
• Robatumumab
In Part 1, robatumumab was to be administered at 10 mg/kg, 15 mg/kg (for Regimens B and C), or 20 mg/kg together with the assigned standard treatment. For Part 2, robatumumab was to be administered at the dose selected during Part 1, based upon the maximum tolerated dose (MTD) or maximum administered dose (MAD), pharmacokinetic (PK) and pharmacodynamic (PD) data.
• Cetuximab

Drug:
• Paclitaxel

• Cisplatin

• 5-FU

• Erlotinib

• Irinotecan

• Folinic Acid

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Merck Sharp & Dohme Corp.

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Part 2: Number of Participants With Each Type of Response Evaluation Criteria in Solid Tumors (RECIST)-Determined Overall Best Response	Overall best response was determined by RECIST criteria. Types of overall response could be: Complete Response (CR), Partial Response (PR), Stable Disease (SD), Progressive Disease (PD), Not Assessable (NA) or Incomplete Response/Stable Disease (IR/SD).	Up to ~30 days after the final dose of robatumumab (Up to ~14 months)
Primary	Part 1: Number of Participants Who Experienced One or More Adverse Events (AEs)	An AE is any unfavorable and unintended sign, symptom, or disease temporally associated with the use of study drug, whether or not considered related to this study drug. AEs may include the onset of new illness and the exacerbation of pre-existing conditions.	Up to ~30 days after the final dose of robatumumab (Up to ~14 months)