Maximum Tolerated Dose (MTD) of Liposomal Doxorubicin in Combination With Seliciclib for Patients With Metastatic Triple Negative Breast Cancer (TNBC)
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|ClinicalTrials.gov Identifier: NCT01333423|
Recruitment Status : Withdrawn
First Posted : April 12, 2011
Last Update Posted : June 26, 2012
|Condition or disease||Intervention/treatment||Phase|
|Breast Cancer||Drug: Liposomal Doxorubicin Drug: Seliciclib||Phase 1|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||0 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||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|
|Study Start Date :||September 2012|
|Estimated Primary Completion Date :||September 2015|
Experimental: Doxil + Seliciclib
Doxil (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
Drug: Liposomal Doxorubicin
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.
- Number of Participants with a Dose Limiting Toxicity(DLT) [ Time Frame: Cycle 1 of therapy (28 days) ]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.
- Number of Participants with Clinical Response [ Time Frame: 6 months ]Disease response assessed using standard imaging techniques every two cycles. Response measured and defined using modified RECIST criterias of CR, PR or SD at 6 months where Complete Response (CR): Disappearance of all target lesions; Partial Response (PR): At least a 30% decrease in sum of longest diameter of target lesions, taking as reference baseline sum longest diameter; and Stable Disease (SD): Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for Progressive Disease (PD), taking as reference smallest sum of longest diameter since treatment started.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01333423
|Principal Investigator:||Stacy Moulder, MD||UT MD Anderson Cancer Center|