Breast Cancer Clinical Trial
Official title:
A Phase 1 Study Evaluating the Safety and Pharmacokinetics of ABBV-075 in Subjects With Advanced Cancer
NCT number | NCT02391480 |
Other study ID # | M14-546 |
Secondary ID | |
Status | Completed |
Phase | Phase 1 |
First received | |
Last updated | |
Start date | April 14, 2015 |
Est. completion date | July 5, 2019 |
Verified date | July 2019 |
Source | AbbVie |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
This is a Phase 1, first-in-human, dose escalation study in participants with advanced solid tumors to determine the pharmacokinetics, maximum tolerated dose and the recommended Phase 2 dose of ABBV-075 at different monotherapy dosing schedules. In addition the study will evaluate the safety. tolerability and the pharmacokinetics of ABBV-075 monotherapy or combination therapy in disease specific expansion cohorts.
Status | Completed |
Enrollment | 128 |
Est. completion date | July 5, 2019 |
Est. primary completion date | July 5, 2019 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility |
Inclusion Criteria: 1. Participant in the dose escalation cohorts must have histological confirmation of locally advanced or metastatic solid tumor that is either refractory after standard of care therapy for the disease or for which standard of care therapy or does not exist. 2. Participants in the expansion cohorts must have histological confirmation of AML, Multiple Myeloma, breast cancer, NSCLC, prostate cancer, SCLC, or NHL that is either refractory after standard of care therapy or for which standard of care therapy does not exist. 3. Participant must have an Eastern Cooperative Oncology Group (ECOG) Performance status of: 0 - 1 (dose escalation cohorts) or 0 - 2 (expansion cohorts) 4. Participants in the dose escalation cohort must have a serum albumin of = 3.2 g/dL at screening. 5. Adequate bone marrow, renal, and hepatic function. 6. QTc interval < 480 milliseconds (msec) on the baseline electrocardiogram. Exclusion Criteria: 1. Participant has untreated brain or meningeal metastases. 2. Participant has received anti-cancer therapy including chemotherapy, immunotherapy, biologic or any investigational therapy within a period of 21 days prior to Study Day 1. 3. Participant has active peptic ulcer disease or other hemorrhagic esophagitis/gastritis. 4. Symptoms of gross hematuria or gross hemoptysis. 5. Exhibits symptomatic or persistent, uncontrolled hypertension (BP > or = to 140 and/or diastolic pressure of > or = to 90 mm Hg). 6. History of long QT syndrome. 7. Peripheral neuropathy greater than or equal to grade 2. |
Country | Name | City | State |
---|---|---|---|
United States | University of Chicago /ID# 155453 | Chicago | Illinois |
United States | Mary Crowley Cancer Research /ID# 154059 | Dallas | Texas |
United States | City of Hope /ID# 154053 | Duarte | California |
United States | Duke Univ Med Ctr /ID# 154647 | Durham | North Carolina |
United States | Univ TX, MD Anderson /ID# 132276 | Houston | Texas |
United States | UT MD Anderson Cancer Center /ID# 164122 | Houston | Texas |
United States | Indiana Univ School Medicine /ID# 132946 | Indianapolis | Indiana |
United States | Yale University /ID# 136982 | New Haven | Connecticut |
United States | UC Davis Comp Cancer Ctr /ID# 154644 | Sacramento | California |
United States | Scottsdale Healthcare /ID# 132963 | Scottsdale | Arizona |
Lead Sponsor | Collaborator |
---|---|
AbbVie |
United States,
Piha-Paul SA, Sachdev JC, Barve M, LoRusso P, Szmulewitz R, Patel SP, Lara PN Jr, Chen X, Hu B, Freise KJ, Modi D, Sood A, Hutti JE, Wolff J, O'Neil BH. First-in-Human Study of Mivebresib (ABBV-075), an Oral Pan-Inhibitor of Bromodomain and Extra Terminal — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Maximum Tolerated Dose of ABBV-075 | Maximum tolerated dose is defined as the highest dose level at which less than 2 of 6 participants experience the same dose limiting toxicity. If more than 2 participants experience a different dose limiting toxicity, the maximum tolerated dose may be further evaluated or determined to be exceeded based on discussions with the investigators and medical monitors. | Minimum first cycle of dosing (28 days) up to one year for dose escalation segment. | |
Primary | Time to Cmax (peak time, Tmax) for ABBV-075 | Approximately 24 hours following a single dose of ABBV-075 up to approximately 2 years. | ||
Primary | Number of participants with adverse events | Screening, Cycle 1 Day 1, 8 and 15, then Day 1 of each cycle up to approximately 2 years. | ||
Primary | Maximum observed plasma concentration (Cmax) of ABBV-075 | Approximately 24 hours following a single dose of ABBV-075 up to approximately 2 years. | ||
Primary | Area under the curve (AUC) | Area under the plasma concentration versus time curve from time 0 (pre-dose) to the time of the last measurable concentration (AUC 0-t). | Cycle 1 Day 1 Pre-dose, 1, 2, 3, 4, 6, 8 and 24 hours post ABBV-075 dosing, and on Cycle 1 Day 15 at 14, 17, 20 hours post dose. | |
Secondary | Duration of overall response (DOR) | DOR is defined as the time from the participant's initial CR or PR to the time of disease progression | At screening, every 8 weeks from Cycle 1 Day 1, and at the Final visit up to approximately 2 years. | |
Secondary | Objective Response Rate (ORR) | ORR is defined as the proportion of participants who have a complete response (CR) or partial response (PR). | At screening, every 8 weeks from Cycle 1 Day 1, and at the Final visit up to approximately 2 years. | |
Secondary | Progression Free Survival (PFS) | PFS is defined as the time from the first dose of ABBV-075 to either disease progression or death, whichever occurs first. | Screening, every 8 weeks from Cycle 1 Day 1, and at the Final visit up to approximately 2 years. |
Status | Clinical Trial | Phase | |
---|---|---|---|
Recruiting |
NCT04681911 -
Inetetamab Combined With Pyrotinib and Chemotherapy in the Treatment of HER2 Positive Metastatic Breast Cancer
|
Phase 2 | |
Completed |
NCT04890327 -
Web-based Family History Tool
|
N/A | |
Terminated |
NCT04066790 -
Pyrotinib or Trastuzumab Plus Nab-paclitaxel as Neoadjuvant Therapy in HER2-positive Breast Cancer
|
Phase 2 | |
Completed |
NCT03591848 -
Pilot Study of a Web-based Decision Aid for Young Women With Breast Cancer, During the Proposal for Preservation of Fertility
|
N/A | |
Recruiting |
NCT03954197 -
Evaluation of Priming Before in Vitro Maturation for Fertility Preservation in Breast Cancer Patients
|
N/A | |
Terminated |
NCT02202746 -
A Study to Assess the Safety and Efficacy of the VEGFR-FGFR-PDGFR Inhibitor, Lucitanib, Given to Patients With Metastatic Breast Cancer
|
Phase 2 | |
Active, not recruiting |
NCT01472094 -
The Hurria Older PatiEnts (HOPE) With Breast Cancer Study
|
||
Completed |
NCT06049446 -
Combining CEM and Magnetic Seed Localization of Non-Palpable Breast Tumors
|
||
Withdrawn |
NCT06057636 -
Hypnosis for Pain in Black Women With Advanced Breast Cancer: A Feasibility Study
|
N/A | |
Recruiting |
NCT05560334 -
A Single-Arm, Open, Exploratory Clinical Study of Pemigatinib in the Treatment of HER2-negative Advanced Breast Cancer Patients With FGFR Alterations
|
Phase 2 | |
Active, not recruiting |
NCT05501769 -
ARV-471 in Combination With Everolimus for the Treatment of Advanced or Metastatic ER+, HER2- Breast Cancer
|
Phase 1 | |
Recruiting |
NCT04631835 -
Phase I Study of the HS-10352 in Patients With Advanced Breast Cancer
|
Phase 1 | |
Completed |
NCT04307407 -
Exercise in Breast Cancer Survivors
|
N/A | |
Recruiting |
NCT03544762 -
Correlation of 16α-[18F]Fluoro-17β-estradiol PET Imaging With ESR1 Mutation
|
Phase 3 | |
Terminated |
NCT02482389 -
Study of Preoperative Boost Radiotherapy
|
N/A | |
Enrolling by invitation |
NCT00068003 -
Harvesting Cells for Experimental Cancer Treatments
|
||
Completed |
NCT00226967 -
Stress, Diurnal Cortisol, and Breast Cancer Survival
|
||
Recruiting |
NCT06037954 -
A Study of Mental Health Care in People With Cancer
|
N/A | |
Recruiting |
NCT06006390 -
CEA Targeting Chimeric Antigen Receptor T Lymphocytes (CAR-T) in the Treatment of CEA Positive Advanced Solid Tumors
|
Phase 1/Phase 2 | |
Recruiting |
NCT06019325 -
Rhomboid Intercostal Plane Block on Chronic Pain Incidence and Acute Pain Scores After Mastectomy
|
N/A |