A Study of SCH 717454 in Combination With Different Treatment Regimens in Subjects With Advanced Solid Tumors (P04722)

This study has been terminated.
Sponsor:
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier:
NCT00954512
First received: July 23, 2009
Last updated: September 4, 2014
Last verified: September 2014

July 23, 2009
September 4, 2014
September 2009
June 2011   (final data collection date for primary outcome measure)
  • For Part 2: The Primary Efficacy Endpoint for the current trial is the RECIST-determined response rate. [ Time Frame: Approximately 30 days after the final dose of SCH 717454 or the standard treatment assigned (whichever is last). ] [ Designated as safety issue: No ]
  • For Part 1: Summaries of dose limiting toxicities, all adverse events, and laboratory results will be provided for the MAD. Adverse events and laboratory results will be tabulated by dose level for each regimen. Electrocardiograms will be summarized. [ Time Frame: Approximately 30 days after the final dose of SCH 717454 or the standard treatment assigned (whichever is last). ] [ Designated as safety issue: Yes ]
Same as current
Complete list of historical versions of study NCT00954512 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
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A Study of SCH 717454 in Combination With Different Treatment Regimens in Subjects With Advanced Solid Tumors (P04722)
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)

This is a Phase 1B/2, non-randomized, dose-escalation, multicenter, open-label trial designed to evaluate the safety and tolerability of SCH 717454 in combination with standard treatment in subjects with advanced solid tumors to be conducted in conformance with Good Clinical Practices.

Six different treatment regimens will be investigated in combination with SCH 717454.

The study will be divided into two parts. Part 1 will consist of initial safety evaluation and dose-finding of SCH 717454 in combination with each treatment regimen. Part 2 will consist of an expansion of each SCH 717454 regimen at a newly established dose level, to better define safety, tolerability, and initial efficacy in specific target populations.

Not Provided
Interventional
Phase 2
Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Neoplasms
  • Drug: Regimen A: FOLFIRI (± Cetuximab), and SCH 717454
    FOLFIRI (Irinotecan, Folinic Acid and 5-fluorouracil [5-FU]) will be administered in a 14-day cycle with SCH 717454 (± Cetuximab)
  • Drug: Regimen B: Carboplatin, Paclitaxel, and SCH 717454

    On Day 1 of treatment, carboplatin will be administered with paclitaxel and with SCH 717454.

    One cycle will be defined as 3 weeks.

  • Drug: Regimen C: Epirubicin, Cisplatin, 5-FU, and SCH 717454

    Epirubicin, cisplatin, and SCH 717454 will be administered on Day 1, and 5-FU will be administered via a 21-week continuous IV infusion.

    One cycle will be defined as 3 weeks.

  • Drug: Regimen D: Trastuzumab and SCH 717454

    Trastuzumab will be given on Day 1, Day 8, Day 15, and Day 22 with SCH 717454.

    One cycle will be defined as 4 weeks.

  • Drug: Regimen E: mTor Inhibitor (Everolimus) and SCH 717454

    Everolimus orally once per day, starting on Day 1 of Cycle 1 with SCH 717454.

    One cycle will be defined as 4 weeks.

  • Drug: Regimen F: Gemcitabine (± Erlotinib), and SCH 717454

    Gemcitabine will be administered on Days 1, 8, 15, 22, 29, 36, and 43 followed by a 1-week rest in Cycle 1 (8 weeks).

    For subsequent cycles, gemcitabine will be administered on Days 1, 8, and 15 in subsequent 4 week cycles.

    SCH 717454 will be administered with the regimen.

  • Experimental: Regimen A: FOLFIRI (± Cetuximab), and SCH 717454
    Intervention: Drug: Regimen A: FOLFIRI (± Cetuximab), and SCH 717454
  • Experimental: Regimen B: Carboplatin, Paclitaxel, and SCH 717454
    Intervention: Drug: Regimen B: Carboplatin, Paclitaxel, and SCH 717454
  • Experimental: Regimen C: Epirubicin, Cisplatin, 5-FU, and SCH 717454
    Intervention: Drug: Regimen C: Epirubicin, Cisplatin, 5-FU, and SCH 717454
  • Experimental: Regimen D: Trastuzumab and SCH 717454
    Intervention: Drug: Regimen D: Trastuzumab and SCH 717454
  • Experimental: Regimen E: mTor Inhibitor (Everolimus) and SCH 717454
    Intervention: Drug: Regimen E: mTor Inhibitor (Everolimus) and SCH 717454
  • Experimental: Regimen F: Gemcitabine (± Erlotinib), and SCH 717454
    Intervention: Drug: Regimen F: Gemcitabine (± Erlotinib), and SCH 717454
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Terminated
15
June 2011
June 2011   (final data collection date for primary outcome measure)

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.
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Not Provided
 
NCT00954512
P04722
No
Merck Sharp & Dohme Corp.
Merck Sharp & Dohme Corp.
Not Provided
Not Provided
Merck Sharp & Dohme Corp.
September 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP