Advanced Breast Cancer Clinical Trial
Official title:
A Phase I Study of MK0752, a Notch Inhibitor, in Patients With Metastatic or Locally Advanced Breast Cancer and Other Solid Tumors
Verified date | January 2015 |
Source | Merck Sharp & Dohme Corp. |
Contact | n/a |
Is FDA regulated | No |
Health authority | United States: Food and Drug Administration |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 103 |
Est. completion date | August 2011 |
Est. primary completion date | August 2011 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years and older |
Eligibility |
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 |
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
n/a |
Lead Sponsor | Collaborator |
---|---|
Merck Sharp & Dohme Corp. |
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 pharmac — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Safety and tolerability; MTD will be established | Day 1 to Day 28 | Yes | |
Secondary | Overall tumor/disease response will be evaluated using RECIST criteria, radiographic and clinical evaluations | radigraphic evaluation = every 56 days | No |
Status | Clinical Trial | Phase | |
---|---|---|---|
Recruiting |
NCT04653740 -
Omic Technologies to Track Resistance to Palbociclib in Metastatic Breast Cancer
|
N/A | |
Recruiting |
NCT05156619 -
Health Care Disparities in Culturally Diverse, Special Needs & Disadvantaged Populations - Bridging the Gap
|
||
Recruiting |
NCT05173103 -
Retrospective Study of 2nd-line Therapies After CDK4/6i + Hormonal Therapy in HR+/HER2- Advanced Breast Cancer
|
||
Withdrawn |
NCT05191004 -
Study of NUV-422 in Combination With Fulvestrant in Patients With HR+HER2- aBC
|
Phase 1/Phase 2 | |
Completed |
NCT00754325 -
Randomized Trial of Fulvestrant With or Without Dasatinib in Men and Postmenopausal Women Who Have Hormone Receptor-positive Advanced Breast Cancer Previously Treated With an Aromatase Inhibitor
|
Phase 2 | |
Recruiting |
NCT04953377 -
PFMT Educational Intervention for Patients With Advancer Breast Cancer
|
N/A | |
Completed |
NCT03240224 -
Bioinformation Therapy for Breast Cancer
|
Phase 2/Phase 3 | |
Recruiting |
NCT06193525 -
FUnctional Selection of Advanced Breast Cancer Patients for Talazoparib Treatment Using the REpair Capacity (RECAP) Test
|
Phase 2 | |
Completed |
NCT03312738 -
A Study of Everolimus Plus Exemestane in Chinese Postmenopausal Women With Estrogen Receptor Positive, Locally Advanced, Recurrent, or Metastatic Breast Cancer After Recurrence or Progression on Non-steroidal Aromatase Inhibitor
|
Phase 2 | |
Active, not recruiting |
NCT05063786 -
Trastuzumab + Alpelisib +/- Fulvestrant vs Trastuzumab + CT in Patients With PIK3CA Mutated Previously Treated HER2+ Advanced BrEasT Cancer (ALPHABET)
|
Phase 3 | |
Recruiting |
NCT05655598 -
TAS-116 Plus Palbociclib in Breast and Rb-null Cancer
|
Phase 1 | |
Active, not recruiting |
NCT02499146 -
Palbociclib Pharmacokinetics Study In Postmenopausal Chinese Women With ER (+), HER2 (-) Advanced Breast Cancer
|
Phase 1 | |
Completed |
NCT00445458 -
A Phase 1/2 Study of HKI-272 (Neratinib) in Combination With Paclitaxel (Taxol) in Subjects With Solid Tumors and Breast Cancer
|
Phase 1/Phase 2 | |
Recruiting |
NCT04456855 -
Locoregional Surgery of the Primary Tumor in de Novo Stage IV Breast Cancer Patients
|
||
Completed |
NCT04408118 -
First Line Atezolizumab, Paclitaxel, and Bevacizumab (Avastin®) in mTNBC
|
Phase 2 | |
Recruiting |
NCT04222413 -
Metarrestin (ML-246) in Subjects With Metastatic Solid Tumors
|
Phase 1 | |
Completed |
NCT03205761 -
Analysis of Olaparib Response in Patients With BRCA1 and/or 2 Promoter Methylation Diagnosed of Advanced Breast Cancer
|
Phase 2 | |
Withdrawn |
NCT04316169 -
Hydroxychloroquine, Abemaciclib and Endocrine Therapy in Hormone Receptor Positive (HR+)/Her 2 Negative Breast Cancer
|
Phase 1 | |
Completed |
NCT00546104 -
Phase II Dasatinib Study in Advanced Breast Cancer
|
Phase 2 | |
Completed |
NCT00387907 -
Study of Larotaxel in Combination With Weekly Herceptin® in Patients With HER2 Positive Metastatic Breast Cancer
|
Phase 2 |