Trial Outcomes & Findings for GCC 0845:Vorinostat and Lapatinib in Advanced Solid Tumors and Advanced Breast Cancer to Evaluate Response and Biomarkers (NCT NCT01118975)
NCT ID: NCT01118975
Last Updated: 2019-11-13
Results Overview
Safety and tolerability were assessed. Adverse events and dose limiting toxicities were recorded during an escalting dose pilot phase.
Recruitment status
TERMINATED
Study phase
PHASE1/PHASE2
Target enrollment
12 participants
Primary outcome timeframe
6 weeks
Results posted on
2019-11-13
Participant Flow
Participant milestones
| Measure |
Pilot Phase - Vornistat 200 to 400mg + Lapatinib
lapatinib 1,250 mg continuous daily and escalating doses of vorinistat (200mg run-up, 300mg, and 400mg 4 days on 3 days off)
|
Phase II - Vorinistat 400mg + Lapatinib
lapatinib 1,250 mg continuous daily and vorinostat 400 mg 4 days on 3 days
|
|---|---|---|
|
Overall Study
STARTED
|
9
|
3
|
|
Overall Study
COMPLETED
|
9
|
2
|
|
Overall Study
NOT COMPLETED
|
0
|
1
|
Reasons for withdrawal
| Measure |
Pilot Phase - Vornistat 200 to 400mg + Lapatinib
lapatinib 1,250 mg continuous daily and escalating doses of vorinistat (200mg run-up, 300mg, and 400mg 4 days on 3 days off)
|
Phase II - Vorinistat 400mg + Lapatinib
lapatinib 1,250 mg continuous daily and vorinostat 400 mg 4 days on 3 days
|
|---|---|---|
|
Overall Study
Adverse Event
|
0
|
1
|
Baseline Characteristics
GCC 0845:Vorinostat and Lapatinib in Advanced Solid Tumors and Advanced Breast Cancer to Evaluate Response and Biomarkers
Baseline characteristics by cohort
| Measure |
Pilot Phase - Vornistat 200 to 400mg + Lapatinib
n=9 Participants
lapatinib 1,250 mg continuous daily and escalating doses of vorinistat (200mg run-up, 300mg, and 400mg 4 days on 3 days off)
|
Phase II - Vorinistat 400mg + Lapatinib
n=3 Participants
lapatinib 1,250 mg continuous daily and vorinostat 400 mg 4 days on 3 days
|
Total
n=12 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Customized
|
52 years
n=5 Participants
|
51 years
n=7 Participants
|
52 years
n=5 Participants
|
|
Sex: Female, Male
Female
|
9 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
12 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 6 weeksSafety and tolerability were assessed. Adverse events and dose limiting toxicities were recorded during an escalting dose pilot phase.
Outcome measures
| Measure |
Pilot Phase
n=9 Participants
The pilot phase consisted of an escalating dose design. Three patients received lapatinib 1,250 mg daily plus 300 mg vorinistat 4 days on then 3 days off. This dose was tolerated so six more patients recieved lapatinib 1,250 mg daily plus 400 mg vorinistat 4 days on 3 days off.
|
|---|---|
|
Dose Limiting Toxicities
|
0 Dose limiting toxicities
|
PRIMARY outcome
Timeframe: Radiological evaluations are performed every 12 weeks to determine disease statusThe Clinical Benefit Rate is the number of patients with either Complete Response (CR), Partial Response (PR), or Stable Disease (SD) for ≥ 6 months
Outcome measures
| Measure |
Pilot Phase
n=3 Participants
The pilot phase consisted of an escalating dose design. Three patients received lapatinib 1,250 mg daily plus 300 mg vorinistat 4 days on then 3 days off. This dose was tolerated so six more patients recieved lapatinib 1,250 mg daily plus 400 mg vorinistat 4 days on 3 days off.
|
|---|---|
|
Clinical Benefit Rate
|
1 participants
|
Adverse Events
Pilot Phase - Vornistat 200 to 400mg + Lapatinib
Serious events: 1 serious events
Other events: 9 other events
Deaths: 0 deaths
Phase II - Vorinistat 400mg + Lapatinib
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Pilot Phase - Vornistat 200 to 400mg + Lapatinib
n=9 participants at risk
lapatinib 1,250 mg continuous daily and escalating doses of vorinistat (200mg run-up, 300mg, and 400mg 4 days on 3 days off)
|
Phase II - Vorinistat 400mg + Lapatinib
n=3 participants at risk
lapatinib 1,250 mg continuous daily and vorinostat 400 mg 4 days on 3 days
|
|---|---|---|
|
Respiratory, thoracic and mediastinal disorders
Upper Respiratory Infection
|
11.1%
1/9 • Number of events 1
|
0.00%
0/3
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
11.1%
1/9 • Number of events 1
|
0.00%
0/3
|
Other adverse events
| Measure |
Pilot Phase - Vornistat 200 to 400mg + Lapatinib
n=9 participants at risk
lapatinib 1,250 mg continuous daily and escalating doses of vorinistat (200mg run-up, 300mg, and 400mg 4 days on 3 days off)
|
Phase II - Vorinistat 400mg + Lapatinib
n=3 participants at risk
lapatinib 1,250 mg continuous daily and vorinostat 400 mg 4 days on 3 days
|
|---|---|---|
|
General disorders
Fatigue
|
33.3%
3/9 • Number of events 3
|
33.3%
1/3 • Number of events 1
|
|
Gastrointestinal disorders
Diarrhea
|
55.6%
5/9 • Number of events 9
|
33.3%
1/3 • Number of events 3
|
|
Gastrointestinal disorders
Nausea
|
44.4%
4/9 • Number of events 4
|
33.3%
1/3 • Number of events 2
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/9
|
33.3%
1/3 • Number of events 2
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
22.2%
2/9 • Number of events 2
|
0.00%
0/3
|
|
Blood and lymphatic system disorders
Anemia
|
22.2%
2/9 • Number of events 2
|
0.00%
0/3
|
|
Gastrointestinal disorders
Anorexia
|
11.1%
1/9 • Number of events 1
|
0.00%
0/3
|
|
Skin and subcutaneous tissue disorders
Skin Atrophy
|
11.1%
1/9 • Number of events 1
|
0.00%
0/3
|
|
Blood and lymphatic system disorders
Bony lesion
|
11.1%
1/9 • Number of events 1
|
0.00%
0/3
|
|
Gastrointestinal disorders
Constipation
|
11.1%
1/9 • Number of events 1
|
0.00%
0/3
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
33.3%
3/9 • Number of events 3
|
0.00%
0/3
|
|
Gastrointestinal disorders
Dehydration
|
11.1%
1/9 • Number of events 1
|
0.00%
0/3
|
|
Infections and infestations
Dental abscess
|
11.1%
1/9 • Number of events 2
|
0.00%
0/3
|
|
Psychiatric disorders
Depression
|
33.3%
3/9 • Number of events 3
|
0.00%
0/3
|
|
Nervous system disorders
Dizziness
|
11.1%
1/9 • Number of events 3
|
0.00%
0/3
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
11.1%
1/9 • Number of events 1
|
0.00%
0/3
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
11.1%
1/9 • Number of events 1
|
0.00%
0/3
|
|
Ear and labyrinth disorders
Ear ache
|
11.1%
1/9 • Number of events 1
|
0.00%
0/3
|
|
Metabolism and nutrition disorders
Elevated chloride
|
11.1%
1/9 • Number of events 1
|
0.00%
0/3
|
|
Metabolism and nutrition disorders
Elevated creatinine
|
11.1%
1/9 • Number of events 1
|
0.00%
0/3
|
|
Metabolism and nutrition disorders
Elevated phosphorus
|
11.1%
1/9 • Number of events 1
|
0.00%
0/3
|
|
Metabolism and nutrition disorders
Elevated protein
|
11.1%
1/9 • Number of events 1
|
0.00%
0/3
|
|
Metabolism and nutrition disorders
Elevated SGPT
|
11.1%
1/9 • Number of events 3
|
0.00%
0/3
|
|
Metabolism and nutrition disorders
Elevated uric acid
|
11.1%
1/9 • Number of events 2
|
0.00%
0/3
|
|
Skin and subcutaneous tissue disorders
Erythema
|
11.1%
1/9 • Number of events 1
|
0.00%
0/3
|
|
Gastrointestinal disorders
Headache
|
22.2%
2/9 • Number of events 3
|
0.00%
0/3
|
|
Respiratory, thoracic and mediastinal disorders
Hoarseness
|
11.1%
1/9 • Number of events 1
|
0.00%
0/3
|
|
Endocrine disorders
Hot flashes
|
22.2%
2/9 • Number of events 2
|
0.00%
0/3
|
|
Metabolism and nutrition disorders
Hyperbilirubinemia
|
11.1%
1/9 • Number of events 2
|
0.00%
0/3
|
|
Metabolism and nutrition disorders
Hyperglycemia
|
33.3%
3/9 • Number of events 3
|
0.00%
0/3
|
|
Cardiac disorders
Hypertension
|
11.1%
1/9 • Number of events 1
|
0.00%
0/3
|
|
Metabolism and nutrition disorders
Hypokalemia
|
33.3%
3/9 • Number of events 5
|
0.00%
0/3
|
|
General disorders
Insomnia
|
11.1%
1/9 • Number of events 1
|
0.00%
0/3
|
|
Blood and lymphatic system disorders
Leukopenia
|
11.1%
1/9 • Number of events 1
|
0.00%
0/3
|
|
General disorders
Migranes
|
11.1%
1/9 • Number of events 1
|
0.00%
0/3
|
|
Musculoskeletal and connective tissue disorders
Muscle cramps
|
22.2%
2/9 • Number of events 2
|
0.00%
0/3
|
|
Nervous system disorders
Neuropathy
|
22.2%
2/9 • Number of events 2
|
0.00%
0/3
|
|
Blood and lymphatic system disorders
Neutropenia
|
11.1%
1/9 • Number of events 2
|
0.00%
0/3
|
|
Eye disorders
Ocular discharge
|
11.1%
1/9 • Number of events 1
|
0.00%
0/3
|
|
General disorders
Pain - back, chest or shoulder
|
33.3%
3/9 • Number of events 3
|
0.00%
0/3
|
|
General disorders
Pain - limbs
|
33.3%
3/9 • Number of events 3
|
0.00%
0/3
|
|
Cardiac disorders
Prolonged QTc
|
11.1%
1/9 • Number of events 1
|
0.00%
0/3
|
|
Skin and subcutaneous tissue disorders
Pruritis/itching
|
11.1%
1/9 • Number of events 1
|
0.00%
0/3
|
|
Skin and subcutaneous tissue disorders
Radiation dermatitis
|
11.1%
1/9 • Number of events 1
|
0.00%
0/3
|
|
Skin and subcutaneous tissue disorders
Rash
|
33.3%
3/9 • Number of events 5
|
0.00%
0/3
|
|
Skin and subcutaneous tissue disorders
Skin nodules
|
22.2%
2/9 • Number of events 2
|
0.00%
0/3
|
|
Respiratory, thoracic and mediastinal disorders
Sore throat
|
11.1%
1/9 • Number of events 1
|
0.00%
0/3
|
|
Gastrointestinal disorders
Stomatitis
|
11.1%
1/9 • Number of events 1
|
0.00%
0/3
|
|
Nervous system disorders
Syncope
|
11.1%
1/9 • Number of events 1
|
0.00%
0/3
|
|
Infections and infestations
Thrush
|
11.1%
1/9 • Number of events 1
|
0.00%
0/3
|
|
Metabolism and nutrition disorders
Weight loss
|
11.1%
1/9 • Number of events 1
|
0.00%
0/3
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: LTE60