LBH589 in Combination With Capecitabine Plus/Minus (±) Lapatinib in Breast Cancer Patients
Study Details
Study Description
Brief Summary
This single center Phase I dose escalation trial will evaluate the safety, tolerability and efficacy of LBH589 when combined with capecitabine and lapatinib in three parts. Part 1 will determine the maximum tolerated doses (MTD) of LBH589 when combined with capecitabine. Parts 2 and 3 will be limited to locally recurrent or metastatic breast cancer patients, ICH 3+ overexpression or FISH amplification documented locally. Part 2 will evaluate the safety of the MTD of LBH589 determined in Part 1 when paired with lapatinib 1000 mg by mouth (PO) daily. Parts 2 and 3 will be limited to locally recurrent or metastatic breast cancer patients, ICH 3+ overexpression or FISH amplification documented locally. Part 3 will evaluate the tolerability and effectiveness of the triplet combination, LBH589, capecitabine and lapatinib in breast cancer patients.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
| Phase 1 |
Detailed Description
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.
The second portion of this study will assess QTc prolongation with the LBH589 and lapatinib combination. A subset of 6 patients will be treated with the LBH589 one dose below the MTD determined during Part I. If tolerated, 6 additional patients will receive LBH589 at the MTD established in Part I with lapatinib (capecitabine will not be administered in this subset of patients).
If there are no clinically significant findings in the LBH589 and lapatinib subset, the study will advance to a third portion which combines the three drugs LBH589, capecitabine, and lapatinib.
The triple combination will initially administer lapatinib 1000 mg orally daily with LBH589 and capecitabine at one dose level below the established MTD. If tolerated, LBH589 and capecitabine doses will be escalated to the MTD.
Toxicity assessments will be ongoing and disease assessments will be repeated every 2 treatment cycles. If all dose level combinations are explored, a total of 45-55 patients will be required to accommodate for the additional patients enrolled in the QTc subset and to establish the recommended phase II dose of the combination regimen.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: LBH589 with Capecitabine MTD, LBH589 with Capecitabine |
Drug: 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.
Other Names:
Drug: Capecitabine
Capecitabine will be administered orally twice daily for 14 days out of every 21 days.
Other Names:
|
| Experimental: LBH589 and Lapatinib LBH589 and Lapatinib |
Drug: 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.
Other Names:
Drug: Lapatinib
Lapatinib, 1000 mg PO daily will be added to this combination.
Other Names:
|
| Experimental: LBH589, Capecitabine and Lapatinib LBH589, Capecitabine and Lapatinib (Breast Cancer Patients) |
Drug: 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.
Other Names:
Drug: Capecitabine
Capecitabine will be administered orally twice daily for 14 days out of every 21 days.
Other Names:
Drug: Lapatinib
Lapatinib, 1000 mg PO daily will be added to this combination.
Other Names:
|
Outcome Measures
Primary Outcome Measures
- 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 [18 months]
MTD for Capecitabine, BID
- 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 [18 months]
MTD for Panobinostat, twice weekly
Secondary Outcome Measures
- To Evaluate the Antitumor Activity of LBH589 in Combination With Capecitabine in Patients With Refractory and Advanced Tumors [18 months]
- 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 [18 months]
Eligibility Criteria
Criteria
Inclusion Criteria:
-
Histologically documented metastatic or locally unresectable, incurable malignancy for which capecitabine is clinically appropriate.
-
Male or female patients aged ≥ 18 years old.
-
Maximum of 3 prior regimens in a metastatic setting allowed and may include other targeted agents, immunotherapy and chemotherapy.
-
Measurable disease by Response Evaluation Criteria in Solid Tumors (RECIST) criteria.
-
Eastern Cooperative Oncology Group performance status (ECOG PS) 0 or 1.
-
Baseline MUGA or ECHO must demonstrate LVEF > than the lower limits of the institutional normal.
-
Laboratory values as follows:
-
ANC > 1500/μL
-
Hgb > 9 g/dL
-
Platelets > 100,000/uL
-
Bilirubin < 1.5 mg/dL
-
AST/SGOT < 2.5 x ULN or < 5.0 x ULN and ALT/SGPT in patients with liver metastases
-
Creatinine < 1.5 mg/dL or calculated creatinine clearance > 50 ml/min
-
Albumin > 3 g/dL
-
Potassium > lower limit of normal (LLN)
-
Phosphorous > LLN
-
Calcium > LLN
-
Magnesium > LLN
-
Women of childbearing potential must have a negative serum or urine pregnancy test performed within 7 days prior to start of treatment and must commit to begin two acceptable methods of birth control, one highly effective method of birth control and one additional effective method at the same time before starting treatment.
-
Life expectancy > 12 weeks.
-
Accessible for treatment and follow-up.
-
All patients must be able to understand the nature of the study and give written informed consent prior to study entry.
Additional Breast Cancer Patient Subset (Part 2 and Part 3) Inclusion Criteria:
-
Incurable carcinoma of the breast, with measurable locally recurrent or metastatic disease.
-
ICH 3+ overexpression or FISH amplification documented by a local laboratory in primary or metastatic tumor tissue.
-
Prior treatment with an anthracycline, taxane, and trastuzumab or not a candidate for such treatment. Patient may have received these drugs in combination or in sequence for the treatment of locally advanced or metastatic disease and/or adjuvant therapy.
Exclusion Criteria:
-
Prior treatment with an HDAC inhibitor or current treatment with valproic acid.
-
Previous treatment with capecitabine.
-
Impaired cardiac function including any of the following:
-
Screening ECG with a QTc > 450 msec.
-
Congenital long QT syndrome.
-
History of sustained ventricular tachycardia.
-
Any history of ventricular fibrillation or torsades de pointes.
-
Bradycardia defined as heart rate < 50 beats per minute. Patients with a pacemaker and heart rate > 50 beats per minute are eligible.
-
Myocardial infarction or unstable angina within 6 months of study entry.
-
Congestive heart failure (NY Heart Association class III or IV).
-
Right bundle branch block and left anterior hemiblock (bifascicular block).
-
Atrial fibrillation or flutter.
-
Ongoing therapy with antiarrhythmics or other medications associated with QTc prolongation.
-
Uncorrected hypokalemia or hypomagnesaemia.
-
Uncontrolled hypertension (systolic blood pressure [BP] 180 or diastolic BP > 100 mm Hg) or uncontrolled cardiac arrhythmias.
-
Active CNS disease, including meningeal metastases.
-
Known diagnosis of human immunodeficiency virus (HIV) infection.
-
Unresolved diarrhea > CTCAE grade 1.
-
Concomitant requirement for medication classified as CYP3A4 inducers or inhibitors.
-
Patients with a history of allergic reactions attributed to compounds of similar chemical or biologic composition to lapatinib.
-
Patients with known hypersensitivity to 5-fluorouracil chemotherapy, investigational drug therapy, major surgery < 4 weeks prior to starting study drug or patients that have not recovered from side effects of previous therapy.
-
Patient is < 5 years free of another primary malignancy except if the other primary malignancy is not currently clinically significant or requiring active intervention, or if other primary malignancy is a basal cell skin cancer or a cervical carcinoma in situ. Existence of any other malignant disease is not allowed.
-
Concomitant use of any anti-cancer therapy or radiation therapy.
-
Pregnant or breast feeding or female of reproductive potential not using two effective methods of birth control.
-
Male patients whose sexual partners are women of childbearing potential not using effective birth control.
-
Patients with gastrointestinal (GI) tract disease, causing the inability to take oral medication, malabsorption syndrome, a requirement for intravenous (IV) alimentation, prior surgical procedures affecting absorption, uncontrolled inflammatory GI disease (e.g., Crohn's disease, ulcerative colitis).
-
Other concurrent severe, uncontrolled infection or intercurrent illness, including but not limited to ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements.
-
Patients taking any medications listed in "Prohibited Medications" for both capecitabine and lapatinib .
-
Patients with uncontrolled coagulopathy (PT and/or PTT > 1.2 x ULN; patient must also be on stable dose of anticoagulant for a defined medical indication).
-
Abnormal thyroid function (TSH or free T4) detected at screening. Patients with known hypothyroidism who are stable on thyroid replacement are eligible.
Additional Breast Cancer Patient Subset (Part 2 and Part 3) Exclusion Criteria:
- Prior treatment with lapatinib
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Tennessee Oncology, PLLC | Nashville | Tennessee | United States | 37023 |
Sponsors and Collaborators
- SCRI Development Innovations, LLC
- Novartis
Investigators
- Study Chair: Howard A Burris, III, M.D., SCRI Development Innovations, LLC
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- SCRI REFMAL 119
Study Results
Participant Flow
| Recruitment Details | |
|---|---|
| Pre-assignment Detail |
| Arm/Group Title | LBH589 With Capecitabine | LBH589 and Lapatinib | LBH589, Capecitabine and Lapatinib |
|---|---|---|---|
| Arm/Group Description | 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: 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 (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. |
| Period Title: Overall Study | |||
| STARTED | 15 | 5 | 0 |
| COMPLETED | 0 | 0 | 0 |
| NOT COMPLETED | 15 | 5 | 0 |
Baseline Characteristics
| Arm/Group Title | LBH589 With Capecitabine | LBH589 and Lapatinib | LBH589, Capecitabine and Lapatinib | Total |
|---|---|---|---|---|
| Arm/Group Description | 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: 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 (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 of all reporting groups |
| Overall Participants | 15 | 5 | 0 | 20 |
| Age (years) [Median (Full Range) ] | ||||
| Median (Full Range) [years] |
54
|
66
|
56
|
|
| Gender (participants) [Number] | ||||
| Female |
8
53.3%
|
5
100%
|
13
Infinity
|
|
| Male |
7
46.7%
|
0
0%
|
7
Infinity
|
|
| Region of Enrollment (participants) [Number] | ||||
| United States |
15
100%
|
5
100%
|
20
Infinity
|
|
Outcome Measures
| Title | 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 |
|---|---|
| Description | MTD for Capecitabine, BID |
| Time Frame | 18 months |
Outcome Measure Data
| Analysis Population Description |
|---|
| MTD Determination only for part I patients (per protocol) |
| Arm/Group Title | LBH589 With Capecitabine | LBH589 and Lapatinib | LBH589, Capecitabine and Lapatinib |
|---|---|---|---|
| Arm/Group Description | 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: 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 (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. |
| Measure Participants | 15 | 0 | 0 |
| Number [mg/m2] |
100
|
| Title | To Evaluate the Antitumor Activity of LBH589 in Combination With Capecitabine in Patients With Refractory and Advanced Tumors |
|---|---|
| Description | |
| Time Frame | 18 months |
Outcome Measure Data
| Analysis Population Description |
|---|
| [Not Specified] |
| Arm/Group Title |
|---|
| Arm/Group Description |
| Title | 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 |
|---|---|
| Description | |
| Time Frame | 18 months |
Outcome Measure Data
| Analysis Population Description |
|---|
| [Not Specified] |
| Arm/Group Title |
|---|
| Arm/Group Description |
| Title | 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 |
|---|---|
| Description | MTD for Panobinostat, twice weekly |
| Time Frame | 18 months |
Outcome Measure Data
| Analysis Population Description |
|---|
| [Not Specified] |
| Arm/Group Title | LBH589 With Capecitabine | LBH589 and Lapatinib | LBH589, Capecitabine and Lapatinib |
|---|---|---|---|
| Arm/Group Description | 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: 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 (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. |
| Measure Participants | 15 | 0 | 0 |
| Number [mg] |
30
|
Adverse Events
| Time Frame | 18 Months | |||||
|---|---|---|---|---|---|---|
| Adverse Event Reporting Description | ||||||
| Arm/Group Title | LBH589 With Capecitabine | LBH589 and Lapatinib | LBH589, Capecitabine and Lapatinib | |||
| Arm/Group Description | 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: 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 (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. | |||
All Cause Mortality |
||||||
| LBH589 With Capecitabine | LBH589 and Lapatinib | LBH589, Capecitabine and Lapatinib | ||||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | / (NaN) | / (NaN) | / (NaN) | |||
Serious Adverse Events |
||||||
| LBH589 With Capecitabine | LBH589 and Lapatinib | LBH589, Capecitabine and Lapatinib | ||||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 6/15 (40%) | 3/5 (60%) | 0/0 (NaN) | |||
| Gastrointestinal disorders | ||||||
| Constipation | 1/15 (6.7%) | 0/5 (0%) | 0/0 (NaN) | |||
| General disorders | ||||||
| General disorders and administration site conditions - Other, disease progression | 2/15 (13.3%) | 1/5 (20%) | 0/0 (NaN) | |||
| General disorders and administration site conditions - Other, failure to thrive | 0/15 (0%) | 1/5 (20%) | 0/0 (NaN) | |||
| Infections and infestations | ||||||
| Infections and infestations - Other, unspecified | 1/15 (6.7%) | 0/5 (0%) | 0/0 (NaN) | |||
| Investigations | ||||||
| Platelet count decreased | 1/15 (6.7%) | 0/5 (0%) | 0/0 (NaN) | |||
| Metabolism and nutrition disorders | ||||||
| Dehydration | 0/15 (0%) | 1/5 (20%) | 0/0 (NaN) | |||
| Nervous system disorders | ||||||
| Dysarthria | 1/15 (6.7%) | 0/5 (0%) | 0/0 (NaN) | |||
| Peripheral sensory neuropathy | 0/15 (0%) | 1/5 (20%) | 0/0 (NaN) | |||
| Psychiatric disorders | ||||||
| Psychiatric disorders - Other, change in mental status | 1/15 (6.7%) | 0/5 (0%) | 0/0 (NaN) | |||
Other (Not Including Serious) Adverse Events |
||||||
| LBH589 With Capecitabine | LBH589 and Lapatinib | LBH589, Capecitabine and Lapatinib | ||||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 11/15 (73.3%) | 5/5 (100%) | 0/0 (NaN) | |||
| Blood and lymphatic system disorders | ||||||
| THROMBOCYTOPENIA | 4/15 (26.7%) | 2/5 (40%) | 0/0 (NaN) | |||
| ANAEMIA | 1/15 (6.7%) | 1/5 (20%) | 0/0 (NaN) | |||
| Gastrointestinal disorders | ||||||
| VOMITING | 7/15 (46.7%) | 5/5 (100%) | 0/0 (NaN) | |||
| DIARRHOEA | 5/15 (33.3%) | 3/5 (60%) | 0/0 (NaN) | |||
| NAUSEA | 3/15 (20%) | 5/5 (100%) | 0/0 (NaN) | |||
| CONSTIPATION | 4/15 (26.7%) | 3/5 (60%) | 0/0 (NaN) | |||
| DRY MOUTH | 0/15 (0%) | 3/5 (60%) | 0/0 (NaN) | |||
| DYSPEPSIA | 3/15 (20%) | 0/5 (0%) | 0/0 (NaN) | |||
| General disorders | ||||||
| FATIGUE | 5/15 (33.3%) | 4/5 (80%) | 0/0 (NaN) | |||
| MUCOSAL INFLAMMATION | 3/15 (20%) | 2/5 (40%) | 0/0 (NaN) | |||
| ASTHENIA | 2/15 (13.3%) | 1/5 (20%) | 0/0 (NaN) | |||
| Investigations | ||||||
| WEIGHT DECREASED | 2/15 (13.3%) | 1/5 (20%) | 0/0 (NaN) | |||
| Metabolism and nutrition disorders | ||||||
| ANOREXIA | 3/15 (20%) | 5/5 (100%) | 0/0 (NaN) | |||
| DEHYDRATION | 1/15 (6.7%) | 1/5 (20%) | 0/0 (NaN) | |||
| Nervous system disorders | ||||||
| DIZZINESS | 1/15 (6.7%) | 3/5 (60%) | 0/0 (NaN) | |||
| HEADACHE | 1/15 (6.7%) | 1/5 (20%) | 0/0 (NaN) | |||
| NEUROPATHY PERIPHERAL | 2/15 (13.3%) | 0/5 (0%) | 0/0 (NaN) | |||
| SOMNOLENCE | 1/15 (6.7%) | 1/5 (20%) | 0/0 (NaN) | |||
| DYSGEUSIA | 0/15 (0%) | 2/5 (40%) | 0/0 (NaN) | |||
| Psychiatric disorders | ||||||
| ANXIETY | 0/15 (0%) | 2/5 (40%) | 0/0 (NaN) | |||
| Respiratory, thoracic and mediastinal disorders | ||||||
| COUGH | 0/15 (0%) | 2/5 (40%) | 0/0 (NaN) | |||
| DYSPNOEA | 1/15 (6.7%) | 1/5 (20%) | 0/0 (NaN) | |||
| Skin and subcutaneous tissue disorders | ||||||
| PALMAR-PLANTAR ERYTHRODYSAESTHESIA SYNDROME | 2/15 (13.3%) | 0/5 (0%) | 0/0 (NaN) | |||
| RASH | 1/15 (6.7%) | 1/5 (20%) | 0/0 (NaN) | |||
Limitations/Caveats
More Information
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
The sponsor can review/embargo results communications prior to public release for a period that is >60 but =180 days from date submitted to sponsor, who may require changes to the communication in order to remove specifically identified confidential information (other than study data) and/or delay the proposed publication to enable the sponsor to seek patent protection for inventions. The PI may not publish its results until 18 mos. after the trial has been completed at all sites
Results Point of Contact
| Name/Title | John D Hainsworth, MD |
|---|---|
| Organization | Sarah Cannon Research Institute |
| Phone | 1-877-691-7274 |
| asksarah@scresearch.net |
- SCRI REFMAL 119