Trial Outcomes & Findings for LBH589 in Combination With Capecitabine Plus/Minus (±) Lapatinib in Breast Cancer Patients (NCT NCT00632489)
NCT ID: NCT00632489
Last Updated: 2015-06-08
Results Overview
MTD for Capecitabine, BID
Recruitment status
COMPLETED
Study phase
PHASE1
Target enrollment
20 participants
Primary outcome timeframe
18 months
Results posted on
2015-06-08
Participant Flow
Participant milestones
| Measure |
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.
|
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.
|
|---|---|---|---|
|
Overall Study
STARTED
|
0
|
15
|
5
|
|
Overall Study
COMPLETED
|
0
|
0
|
0
|
|
Overall Study
NOT COMPLETED
|
0
|
15
|
5
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
LBH589 in Combination With Capecitabine Plus/Minus (±) Lapatinib in Breast Cancer Patients
Baseline characteristics by cohort
| Measure |
LBH589 With Capecitabine
n=15 Participants
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
n=5 Participants
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
n=20 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
54 years
n=99 Participants
|
66 years
n=107 Participants
|
—
|
56 years
n=7 Participants
|
|
Gender
Female
|
8 participants
n=99 Participants
|
5 participants
n=107 Participants
|
—
|
13 participants
n=7 Participants
|
|
Gender
Male
|
7 participants
n=99 Participants
|
0 participants
n=107 Participants
|
—
|
7 participants
n=7 Participants
|
|
Region of Enrollment
United States
|
15 participants
n=99 Participants
|
5 participants
n=107 Participants
|
—
|
20 participants
n=7 Participants
|
PRIMARY outcome
Timeframe: 18 monthsPopulation: MTD Determination only for part I patients (per protocol)
MTD for Capecitabine, BID
Outcome measures
| Measure |
LBH589 With Capecitabine
n=15 Participants
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.
|
|---|---|---|---|
|
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
|
100 mg/m2
|
—
|
—
|
PRIMARY outcome
Timeframe: 18 monthsMTD for Panobinostat, twice weekly
Outcome measures
| Measure |
LBH589 With Capecitabine
n=15 Participants
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.
|
|---|---|---|---|
|
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
|
30 mg
|
—
|
—
|
SECONDARY outcome
Timeframe: 18 monthsOutcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 18 monthsOutcome measures
Outcome data not reported
Adverse Events
LBH589, Capecitabine and Lapatinib
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
LBH589 With Capecitabine
Serious events: 6 serious events
Other events: 11 other events
Deaths: 0 deaths
LBH589 and Lapatinib
Serious events: 3 serious events
Other events: 5 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
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.
|
LBH589 With Capecitabine
n=15 participants at risk
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
n=5 participants at risk
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.
|
|---|---|---|---|
|
Gastrointestinal disorders
Constipation
|
—
0/0 • 18 Months
|
6.7%
1/15 • 18 Months
|
0.00%
0/5 • 18 Months
|
|
Metabolism and nutrition disorders
Dehydration
|
—
0/0 • 18 Months
|
0.00%
0/15 • 18 Months
|
20.0%
1/5 • 18 Months
|
|
Nervous system disorders
Dysarthria
|
—
0/0 • 18 Months
|
6.7%
1/15 • 18 Months
|
0.00%
0/5 • 18 Months
|
|
General disorders
General disorders and administration site conditions - Other, disease progression
|
—
0/0 • 18 Months
|
13.3%
2/15 • 18 Months
|
20.0%
1/5 • 18 Months
|
|
General disorders
General disorders and administration site conditions - Other, failure to thrive
|
—
0/0 • 18 Months
|
0.00%
0/15 • 18 Months
|
20.0%
1/5 • 18 Months
|
|
Infections and infestations
Infections and infestations - Other, unspecified
|
—
0/0 • 18 Months
|
6.7%
1/15 • 18 Months
|
0.00%
0/5 • 18 Months
|
|
Nervous system disorders
Peripheral sensory neuropathy
|
—
0/0 • 18 Months
|
0.00%
0/15 • 18 Months
|
20.0%
1/5 • 18 Months
|
|
Investigations
Platelet count decreased
|
—
0/0 • 18 Months
|
6.7%
1/15 • 18 Months
|
0.00%
0/5 • 18 Months
|
|
Psychiatric disorders
Psychiatric disorders - Other, change in mental status
|
—
0/0 • 18 Months
|
6.7%
1/15 • 18 Months
|
0.00%
0/5 • 18 Months
|
Other adverse events
| Measure |
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.
|
LBH589 With Capecitabine
n=15 participants at risk
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
n=5 participants at risk
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.
|
|---|---|---|---|
|
Gastrointestinal disorders
VOMITING
|
—
0/0 • 18 Months
|
46.7%
7/15 • 18 Months
|
100.0%
5/5 • 18 Months
|
|
General disorders
FATIGUE
|
—
0/0 • 18 Months
|
33.3%
5/15 • 18 Months
|
80.0%
4/5 • 18 Months
|
|
Metabolism and nutrition disorders
ANOREXIA
|
—
0/0 • 18 Months
|
20.0%
3/15 • 18 Months
|
100.0%
5/5 • 18 Months
|
|
Gastrointestinal disorders
DIARRHOEA
|
—
0/0 • 18 Months
|
33.3%
5/15 • 18 Months
|
60.0%
3/5 • 18 Months
|
|
Gastrointestinal disorders
NAUSEA
|
—
0/0 • 18 Months
|
20.0%
3/15 • 18 Months
|
100.0%
5/5 • 18 Months
|
|
Gastrointestinal disorders
CONSTIPATION
|
—
0/0 • 18 Months
|
26.7%
4/15 • 18 Months
|
60.0%
3/5 • 18 Months
|
|
Blood and lymphatic system disorders
THROMBOCYTOPENIA
|
—
0/0 • 18 Months
|
26.7%
4/15 • 18 Months
|
40.0%
2/5 • 18 Months
|
|
General disorders
MUCOSAL INFLAMMATION
|
—
0/0 • 18 Months
|
20.0%
3/15 • 18 Months
|
40.0%
2/5 • 18 Months
|
|
Nervous system disorders
DIZZINESS
|
—
0/0 • 18 Months
|
6.7%
1/15 • 18 Months
|
60.0%
3/5 • 18 Months
|
|
Gastrointestinal disorders
DRY MOUTH
|
—
0/0 • 18 Months
|
0.00%
0/15 • 18 Months
|
60.0%
3/5 • 18 Months
|
|
Gastrointestinal disorders
DYSPEPSIA
|
—
0/0 • 18 Months
|
20.0%
3/15 • 18 Months
|
0.00%
0/5 • 18 Months
|
|
General disorders
ASTHENIA
|
—
0/0 • 18 Months
|
13.3%
2/15 • 18 Months
|
20.0%
1/5 • 18 Months
|
|
Investigations
WEIGHT DECREASED
|
—
0/0 • 18 Months
|
13.3%
2/15 • 18 Months
|
20.0%
1/5 • 18 Months
|
|
Blood and lymphatic system disorders
ANAEMIA
|
—
0/0 • 18 Months
|
6.7%
1/15 • 18 Months
|
20.0%
1/5 • 18 Months
|
|
Psychiatric disorders
ANXIETY
|
—
0/0 • 18 Months
|
0.00%
0/15 • 18 Months
|
40.0%
2/5 • 18 Months
|
|
Respiratory, thoracic and mediastinal disorders
COUGH
|
—
0/0 • 18 Months
|
0.00%
0/15 • 18 Months
|
40.0%
2/5 • 18 Months
|
|
Metabolism and nutrition disorders
DEHYDRATION
|
—
0/0 • 18 Months
|
6.7%
1/15 • 18 Months
|
20.0%
1/5 • 18 Months
|
|
Skin and subcutaneous tissue disorders
PALMAR-PLANTAR ERYTHRODYSAESTHESIA SYNDROME
|
—
0/0 • 18 Months
|
13.3%
2/15 • 18 Months
|
0.00%
0/5 • 18 Months
|
|
Nervous system disorders
HEADACHE
|
—
0/0 • 18 Months
|
6.7%
1/15 • 18 Months
|
20.0%
1/5 • 18 Months
|
|
Nervous system disorders
NEUROPATHY PERIPHERAL
|
—
0/0 • 18 Months
|
13.3%
2/15 • 18 Months
|
0.00%
0/5 • 18 Months
|
|
Skin and subcutaneous tissue disorders
RASH
|
—
0/0 • 18 Months
|
6.7%
1/15 • 18 Months
|
20.0%
1/5 • 18 Months
|
|
Respiratory, thoracic and mediastinal disorders
DYSPNOEA
|
—
0/0 • 18 Months
|
6.7%
1/15 • 18 Months
|
20.0%
1/5 • 18 Months
|
|
Nervous system disorders
SOMNOLENCE
|
—
0/0 • 18 Months
|
6.7%
1/15 • 18 Months
|
20.0%
1/5 • 18 Months
|
|
Nervous system disorders
DYSGEUSIA
|
—
0/0 • 18 Months
|
0.00%
0/15 • 18 Months
|
40.0%
2/5 • 18 Months
|
Additional Information
John D Hainsworth, MD
Sarah Cannon Research Institute
Phone: 1-877-691-7274
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee 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
- Publication restrictions are in place
Restriction type: OTHER