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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)


Phase 2
18 Years
N/A
Not Enrolling
Both
Neoplasms

Thank you

Trial Information

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)


Inclusion Criteria:



- Each subject must be willing and able to provide written informed consent for the
trial.

- Each subject must be ±18 years of age. A subject may be of either sex and of any
race/ethnicity;

- Part 1: Each subject must have a histologically or cytologically confirmed advanced
malignant solid tumor;

- Part 2: Each subject must have a histologically or cytologically confirmed, with
measurable disease (as defined by RECIST), advanced, malignant solid tumor.

- Each subject must have an Eastern Cooperative Oncology Group (ECOG) performance
status (PS) of <=2.

- Each subject must have adequate organ function within 3 weeks prior to first study
drug administration.

Exclusion Criteria:

- A subject must not have known treated or untreated leptomeningeal metastasis or a
metastatic central nervous system lesion.

- A subject must not have a history of another malignancy

- A subject must not have received prior therapy with any anti-IGF-1R monoclonal
antibody.

- A subject must not have received radiation therapy within 2 weeks prior to first
study drug administration.

- A subject must not have received radiation therapy to >25% of his/her total bone
marrow during his/her lifetime.

- A subject must not have undergone major surgery within 3 weeks prior to first study
drug administration.

- A subject must not have known human immunodeficiency virus (HIV) infection or a known
HIV-related malignancy.

- A subject must not have known active hepatitis B or C.

- A subject must not have any serious or uncontrolled infection.

- A subject must not have uncontrolled diabetes mellitus.

- A subject must 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.

Type of Study:

Interventional

Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

For Part 2: The Primary Efficacy Endpoint for the current trial is the RECIST-determined response rate.

Outcome Time Frame:

Approximately 30 days after the final dose of SCH 717454 or the standard treatment assigned (whichever is last).

Safety Issue:

No

Authority:

United States: Food and Drug Administration

Study ID:

P04722

NCT ID:

NCT00954512

Start Date:

September 2009

Completion Date:

June 2011

Related Keywords:

  • Neoplasms
  • Antibodies, neoplasm
  • Neoplasms

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