A Notch Signalling Pathway Inhibitor for Patients With Advanced Breast Cancer (0752-014)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier:
NCT00106145
First received: March 21, 2005
Last updated: February 21, 2014
Last verified: February 2014

March 21, 2005
February 21, 2014
April 2005
August 2011   (final data collection date for primary outcome measure)
Safety and tolerability; MTD will be established [ Time Frame: Day 1 to Day 28 ] [ Designated as safety issue: Yes ]
Not Provided
Complete list of historical versions of study NCT00106145 on ClinicalTrials.gov Archive Site
Overall tumor/disease response will be evaluated using RECIST criteria, radiographic and clinical evaluations [ Time Frame: radigraphic evaluation = every 56 days ] [ Designated as safety issue: No ]
Not Provided
Not Provided
Not Provided
 
A Notch Signalling Pathway Inhibitor for Patients With Advanced Breast Cancer (0752-014)
A Phase I Study of MK0752, a Notch Inhibitor, in Patients With Metastatic or Locally Advanced Breast Cancer and Other Solid Tumors

An investigational study to determine the safety/tolerability, and efficacy of a notch signaling pathway inhibitor in patients with metastatic or locally advanced breast cancer and other advanced solid tumors.

Not Provided
Interventional
Phase 1
Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
  • Advanced Breast Cancer
  • Other Solid Tumors
  • Drug: Comparator: MK0752, Notch Inhibitor
    Dose escalating beginning with rising dose levels of 300, 450, and 600 mg/day in a continuous dosing schedule.
  • Drug: Comparator: MK0752, Notch Inhibitor - 450 mg
    Dose 450 mg capsules daily for 28 day cycles.
  • Drug: Comparator: MK0752, Notch Inhibitor - 3 days on, 4 off
    Dose escalating in a repeating intermittent dosing schedule of 3 days on and 4 days off at rising dose levels of 450, 600, 800, 1000, 1200, and 1400 mg/day.
  • Drug: Comparator: MK0752, Notch Inhibitor - 1 day on, 6 off
    Dose escalating in a repeating intermittent dosing schedule of 1 day on/6 days off at rising dose levels of 600, 900, 1200, 1500, 1800, 2400, 3200 mg/day once weekly and then increase at 33% increments.
  • Drug: Comparator: MK0752, Notch Inhibitor - 3 days on, 4 off 350 mg
    Dose 350 mg capsules daily intermittent 3 days on/4 days off dosing. THIS DOSING SCHEDULE IS NO LONGER UNDER INVESTIGATION
  • Experimental: Part I - Arm 1
    Intervention: Drug: Comparator: MK0752, Notch Inhibitor
  • Experimental: Part II - Arm 1
    Intervention: Drug: Comparator: MK0752, Notch Inhibitor - 450 mg
  • Experimental: Part III - Arm 1
    Intervention: Drug: Comparator: MK0752, Notch Inhibitor - 3 days on, 4 off
  • Experimental: Part IV - Arm 1
    Intervention: Drug: Comparator: MK0752, Notch Inhibitor - 1 day on, 6 off
  • Experimental: Part V - Arm 1
    Intervention: Drug: Comparator: MK0752, Notch Inhibitor - 3 days on, 4 off 350 mg
Krop I, Demuth T, Guthrie T, Wen PY, Mason WP, Chinnaiyan P, Butowski N, Groves MD, Kesari S, Freedman SJ, Blackman S, Watters J, Loboda A, Podtelezhnikov A, Lunceford J, Chen C, Giannotti M, Hing J, Beckman R, Lorusso P. Phase I pharmacologic and pharmacodynamic study of the gamma secretase (Notch) inhibitor MK-0752 in adult patients with advanced solid tumors. J Clin Oncol. 2012 Jul 1;30(19):2307-13. doi: 10.1200/JCO.2011.39.1540. Epub 2012 Apr 30.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
103
August 2011
August 2011   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Women or men greater than or equal to 18 years of age
  • ECOG status less than or equal to 2 (a measurement to determine your ability to perform daily activities)
  • In Parts I, III, and IV, patient must have a histologically confirmed, metastatic or locally advanced solid tumor that has failed to respond to standard therapy, progressed despite standard therapy, or for which standard therapy does not exist. There is no limit on the number of prior treatment regimens
  • In Part II, only breast cancer patients are eligible
  • In Part V, only patients with Numb negative breast cancer (i.e., tumor shows Numb immunoreactivity in less than 10% of the neoplastic cells assessed) are eligible
  • Patient has recovered from and is at least 2 weeks from previous antineoplastic therapy, including chemotherapy, biological therapy (including Herceptin), hormonal therapy, radiotherapy, or surgery

Exclusion Criteria:

  • Patient has had an investigational treatment in the preceding 21 days
  • Uncontrolled congestive heart failure or myocardial infarction (heart attack) within 3 months of study start
  • History of hepatitis B or C or HIV
  • Patient has the presence of clinically apparent central nervous system metastases or carcinomatous meningitis. Patients with CNS metastases who have completed a course of radiotherapy and are clinically stable in the judgment of the investigator are eligible
  • Patients with "currently active" second malignancy, other than non-melanoma skin cancer, should not be enrolled. Patients are not considered to have a "currently active" malignancy if they have completed therapy for prior malignancy and are considered by their physician to be at <30% risk of relapse
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Not Provided
 
NCT00106145
0752-014, 2005_008
Not Provided
Merck Sharp & Dohme Corp.
Merck Sharp & Dohme Corp.
Not Provided
Study Director: Medical Monitor Merck Sharp & Dohme Corp.
Merck Sharp & Dohme Corp.
February 2014

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