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LBH589 in Combination With Capecitabine Plus/Minus (±) Lapatinib in Breast Cancer Patients

This study has been completed.
Sponsor:
Collaborator:
Novartis
Information provided by (Responsible Party):
SCRI Development Innovations, LLC
ClinicalTrials.gov Identifier:
NCT00632489
First received: March 3, 2008
Last updated: June 4, 2015
Last verified: June 2015
Results First Received: May 18, 2015  
Study Type: Interventional
Study Design: Allocation: Non-Randomized;   Endpoint Classification: Safety Study;   Intervention Model: Single Group Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Condition: Breast Cancer
Interventions: Drug: LBH589
Drug: Capecitabine
Drug: Lapatinib

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
LBH589 With Capecitabine

MTD, LBH589 with Capecitabine

LBH589: LBH589 will be evaluated when administered twice weekly at the following possible dose levels: 20 mg, 30 mg, 45 mg, and 60 mg. Capecitabine will be paired with LBH589 and will range in dose from 825 mg/m2 to 1250 mg/m2 orally BID 14 of every 21 days. Treatment cycles will be 21 days in length. Once determined safe, 10 additional patients will be treated at the determined MTD to further assess safety.

Capecitabine: Capecitabine will be administered orally twice daily for 14 days out of every 21 days.

LBH589 and Lapatinib

LBH589 and Lapatinib

LBH589: LBH589 will be evaluated when administered twice weekly at the following possible dose levels: 20 mg, 30 mg, 45 mg, and 60 mg. Capecitabine will be paired with LBH589 and will range in dose from 825 mg/m2 to 1250 mg/m2 orally BID 14 of every 21 days. Treatment cycles will be 21 days in length. Once determined safe, 10 additional patients will be treated at the determined MTD to further assess safety.

Lapatinib: Lapatinib, 1000 mg PO daily will be added to this combination.

LBH589, Capecitabine and Lapatinib

LBH589, Capecitabine and Lapatinib (Breast Cancer Patients)

LBH589: LBH589 will be evaluated when administered twice weekly at the following possible dose levels: 20 mg, 30 mg, 45 mg, and 60 mg. Capecitabine will be paired with LBH589 and will range in dose from 825 mg/m2 to 1250 mg/m2 orally BID 14 of every 21 days. Treatment cycles will be 21 days in length. Once determined safe, 10 additional patients will be treated at the determined MTD to further assess safety.

Capecitabine: Capecitabine will be administered orally twice daily for 14 days out of every 21 days.

Lapatinib: Lapatinib, 1000 mg PO daily will be added to this combination.


Participant Flow:   Overall Study
    LBH589 With Capecitabine     LBH589 and Lapatinib     LBH589, Capecitabine and Lapatinib  
STARTED     15     5     0  
COMPLETED     0 [1]   0 [1]   0 [1]
NOT COMPLETED     15     5     0  
[1] Pts remained on study until disease progression, intolerable toxicity or other reason to discontinue



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
LBH589 With Capecitabine

MTD, LBH589 with Capecitabine

LBH589: LBH589 will be evaluated when administered twice weekly at the following possible dose levels: 20 mg, 30 mg, 45 mg, and 60 mg. Capecitabine will be paired with LBH589 and will range in dose from 825 mg/m2 to 1250 mg/m2 orally BID 14 of every 21 days. Treatment cycles will be 21 days in length. Once determined safe, 10 additional patients will be treated at the determined MTD to further assess safety.

Capecitabine: Capecitabine will be administered orally twice daily for 14 days out of every 21 days.

LBH589 and Lapatinib

LBH589 and Lapatinib

LBH589: LBH589 will be evaluated when administered twice weekly at the following possible dose levels: 20 mg, 30 mg, 45 mg, and 60 mg. Capecitabine will be paired with LBH589 and will range in dose from 825 mg/m2 to 1250 mg/m2 orally BID 14 of every 21 days. Treatment cycles will be 21 days in length. Once determined safe, 10 additional patients will be treated at the determined MTD to further assess safety.

Lapatinib: Lapatinib, 1000 mg PO daily will be added to this combination.

LBH589, Capecitabine and Lapatinib

LBH589, Capecitabine and Lapatinib (Breast Cancer Patients)

LBH589: LBH589 will be evaluated when administered twice weekly at the following possible dose levels: 20 mg, 30 mg, 45 mg, and 60 mg. Capecitabine will be paired with LBH589 and will range in dose from 825 mg/m2 to 1250 mg/m2 orally BID 14 of every 21 days. Treatment cycles will be 21 days in length. Once determined safe, 10 additional patients will be treated at the determined MTD to further assess safety.

Capecitabine: Capecitabine will be administered orally twice daily for 14 days out of every 21 days.

Lapatinib: Lapatinib, 1000 mg PO daily will be added to this combination.

Total Total of all reporting groups

Baseline Measures
    LBH589 With Capecitabine     LBH589 and Lapatinib     LBH589, Capecitabine and Lapatinib     Total  
Number of Participants  
[units: participants]
  15     5     0     20  
Age  
[units: years]
Median (Full Range)
  54  
  (45 to 69)  
  66  
  (64 to 68)  
      56  
  (45 to 69)  
Gender  
[units: participants]
       
Female     8     5         13  
Male     7     0         7  
Region of Enrollment  
[units: participants]
       
United States     15     5         20  



  Outcome Measures
  Show All Outcome Measures

1.  Primary:   To Determine the Maximum Tolerated Doses (MTD) and Dose-limiting Toxicities (DLT) of LBH589 in Combination With Capecitabine When Administered to Patients With Refractory and Advanced Tumor Types That Are Sensitive to 5-fluorouracil   [ Time Frame: 18 months ]

2.  Primary:   To Determine the Maximum Tolerated Doses (MTD) and Dose-limiting Toxicities (DLT) of LBH589 in Combination With Capecitabine When Administered to Patients With Refractory and Advanced Tumor Types That Are Sensitive to 5-fluorouracil   [ Time Frame: 18 months ]

3.  Secondary:   To Evaluate the Antitumor Activity of LBH589 in Combination With Capecitabine in Patients With Refractory and Advanced Tumors   [ Time Frame: 18 months ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.   Safety Issue:   No

4.  Secondary:   To Evaluate the Tolerability and Preliminary Efficacy of Established Doses of LBH589 and Capecitabine With Lapatinib in a Limited Number of Patients With HER2+ Breast Cancer   [ Time Frame: 18 months ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.   Safety Issue:   No


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
No text entered.


  More Information
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
The agreement is:
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.


Results Point of Contact:  
Name/Title: John D Hainsworth, MD
Organization: Sarah Cannon Research Institute
phone: 1-877-691-7274
e-mail: asksarah@scresearch.net



Responsible Party: SCRI Development Innovations, LLC
ClinicalTrials.gov Identifier: NCT00632489     History of Changes
Other Study ID Numbers: SCRI REFMAL 119
Study First Received: March 3, 2008
Results First Received: May 18, 2015
Last Updated: June 4, 2015
Health Authority: United States: Food and Drug Administration