Maximum Tolerated Dose (MTD) of Liposomal Doxorubicin in Combination With Seliciclib for Patients With Metastatic Triple Negative Breast Cancer (TNBC)
A Phase I With Dose Expansion to Determine the Maximum Tolerated Dose of Liposomal Doxorubicin in Combination With Seliciclib for the Treatment of Patients With Metastatic Triple Negative Breast Cancer
2 other identifiers
interventional
N/A
0 countries
N/A
Brief Summary
The goal of this clinical research study is to find the highest tolerable dose of seliciclib that can be given in combination with liposomal doxorubicin to patients with metastatic breast cancer.
Trial Health
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Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
April 8, 2011
CompletedFirst Posted
Study publicly available on registry
April 12, 2011
CompletedStudy Start
First participant enrolled
September 1, 2012
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 1, 2015
CompletedJune 26, 2012
June 1, 2012
3 years
April 8, 2011
June 22, 2012
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Number of Participants with a Dose Limiting Toxicity(DLT)
Dose-limiting toxicity (DLT) defined as NCI Common Toxicity Criteria (version 4.0): Grade 3 or 4 thrombocytopenia lasting \> 2 weeks; Grade 3 or 4 neutropenia lasting \>2 weeks; Febrile neutropenia; Grade 3 or 4 non-hematologic toxicity that lasts \> 72 hours despite appropriate medical management (excluding grade 3 fatigue); or Delay in administration of cycle 2 of therapy for \>2 weeks due to myelosuppression. DLT must be considered treatment related and occur during cycle 1 of therapy.
Cycle 1 of therapy (28 days)
Secondary Outcomes (1)
Number of Participants with Clinical Response
6 months
Study Arms (1)
Doxil + Seliciclib
EXPERIMENTALDoxil (Liposomal doxorubicin) 40 mg/m2 intravenous (IV) over 2 -3 hours on Day 4 and Seliciclib starting dose 200 mg orally twice a day on Days 1 - 3 of 28 day cycle
Interventions
40 mg by vein administered over 2 -3 hours on Day 4 of a 28 day cycle.
Starting dose 200 mg by mouth twice daily on Days 1 - 3 of a 28 day cycle.
Eligibility Criteria
You may qualify if:
- Both male and female patients with invasive cancer that is confirmed ER/PR/HER2 negative carcinoma of the breast with locally advanced or stage IV disease that is not amenable to curative therapy. For purposes of this study, triple negative disease will be tumors that have ER/PR \<10% and HER2 \</=1+ by IHC or HER2 FISH non-amplified (ratio \<2.0).
- Patients must have an ECOG performance status of 0, 1 or 2
- Age \>/= 18 years
- Women must not be pregnant or lactating because of the teratogenic potential of these drugs. All females of childbearing potential (i.e. A female not free from menses \> 1 year or not surgically sterilized) must have a blood test or urine study within 2 weeks prior to start of therapy to rule out pregnancy.
- Women of childbearing potential (i.e. A female not free from menses \> 1 year or not surgically sterilized) and are strongly advised to use an accepted and effective non-hormonal method of contraception.
- Must have at least one site of objective measurable or evaluable disease. Baseline measurements and evaluations must be obtained within 4 weeks of start of therapy.
- Patients must be disease free of prior malignancy for \>/= 5 years with the exception of curatively treated squamous cell carcinomas of the skin or carcinoma in situ of the cervix or breast.
- Patients must have no serious medical illness, other that treated by this study, which would limit survival to less than 1 month or psychiatric illness which would limit informed consent.
- Patients must not have peripheral neuropathy \> grade 2.
- Required Cardiac Parameters: Patients must not have had a history of New York Heart Association class 3 or 4 heart failure, or history of myocardial infarction, unstable angina or CVA within 6 months of protocol registration. LVEF \> 50% by MUGA or ECHO.
- Patients must not have history of PR prolongation or AV block
- Required laboratory parameters: Patients must have serum creatinine \< 1.5 mg/dl.
- Patients must have adequate hematologic functions: granulocytes \> 1500/mm\^3 and platelets \> 100,000/mm\^3
- Patients must have adequate hepatocellular function: SGOT (AST) and SGPT (ALT) \< 1.5 x upper limit of normal (unless liver is involved by tumor, in which case SGOT (AST) and SGPT (ALT) can be \< 2.0 x upper limit of normal)
- Patients must have no history of prior therapy with seliciclib.
- +5 more criteria
You may not qualify if:
- \) None.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- M.D. Anderson Cancer Centerlead
- National Institutes of Health (NIH)collaborator
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Stacy Moulder, MD
UT MD Anderson Cancer Center
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
April 8, 2011
First Posted
April 12, 2011
Study Start
September 1, 2012
Primary Completion
September 1, 2015
Last Updated
June 26, 2012
Record last verified: 2012-06