Trial Outcomes & Findings for Gamma-secretase/Notch Signalling Pathway Inhibitor RO4929097 in Treating Patients With Advanced, Metastatic, or Recurrent Triple Negative Invasive Breast Cancer (NCT NCT01151449)
NCT ID: NCT01151449
Last Updated: 2017-04-11
Results Overview
Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1) for target lesions and assessed by CT or MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), \>=30% decrease in the sum of the diameters of target lesions; Overall Response (OR) = CR + PR.
TERMINATED
PHASE2
6 participants
From start of treatment until disease progression or removal from treatment.
2017-04-11
Participant Flow
Participant milestones
| Measure |
Treatment (Gamma-secretase/Notch Signalling Pathway Inhibitor)
Patients receive gamma-secretase/Notch signalling pathway inhibitor RO4929097 PO once daily on days 1-3, 8-10, and 15-17. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
gamma-secretase/Notch signalling pathway inhibitor RO4929097: Given orally
laboratory biomarker analysis: Correlative studies
|
|---|---|
|
Overall Study
STARTED
|
6
|
|
Overall Study
COMPLETED
|
6
|
|
Overall Study
NOT COMPLETED
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Gamma-secretase/Notch Signalling Pathway Inhibitor RO4929097 in Treating Patients With Advanced, Metastatic, or Recurrent Triple Negative Invasive Breast Cancer
Baseline characteristics by cohort
| Measure |
Treatment (Gamma-secretase/Notch Signalling Pathway Inhibitor)
n=6 Participants
Patients receive gamma-secretase/Notch signalling pathway inhibitor RO4929097 PO once daily on days 1-3, 8-10, and 15-17. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
gamma-secretase/Notch signalling pathway inhibitor RO4929097: Given orally
laboratory biomarker analysis: Correlative studies
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=99 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
6 Participants
n=99 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=99 Participants
|
|
Age, Continuous
|
51 years
n=99 Participants
|
|
Sex: Female, Male
Female
|
6 Participants
n=99 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=99 Participants
|
|
Region of Enrollment
Canada
|
6 participants
n=99 Participants
|
PRIMARY outcome
Timeframe: From start of treatment until disease progression or removal from treatment.Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1) for target lesions and assessed by CT or MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), \>=30% decrease in the sum of the diameters of target lesions; Overall Response (OR) = CR + PR.
Outcome measures
| Measure |
Treatment (Gamma-secretase/Notch Signalling Pathway Inhibitor)
n=6 Participants
Patients receive gamma-secretase/Notch signalling pathway inhibitor RO4929097 PO once daily on days 1-3, 8-10, and 15-17. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
gamma-secretase/Notch signalling pathway inhibitor RO4929097: Given orally
laboratory biomarker analysis: Correlative studies
|
|---|---|
|
Overall Response Rate Using RECIST
|
1 participants
|
PRIMARY outcome
Timeframe: Time from start of study treatment to the date of first progression or death from any cause, whichever occurs first, assessed at 6 monthsPopulation: Inadequate data for PFS estimates as only 6 patients were accrued in the study.
Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1), as a 20% increase in the sum of the diameters of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions. Computed using the Kaplan-Meier method.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Time from start of study treatment to the date of first progression or death from any cause, whichever occurs first, assessed at 3 monthsPopulation: Inadequate data for PFS estimates as only 6 patients were accrued in the study.
Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1), as a 20% increase in the sum of the diameters of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions. Computed using the Kaplan-Meier method.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: From the time measurement criteria are met for CR or PR (whichever is first recorded) until the first date that recurrent or progressive disease is objectively documented.The duration of radiologic response is measured from the time measurement criteria are met for CR or PR (whichever is first recorded) until the first date that recurrent or progressive disease is objectively documented.
Outcome measures
| Measure |
Treatment (Gamma-secretase/Notch Signalling Pathway Inhibitor)
n=1 Participants
Patients receive gamma-secretase/Notch signalling pathway inhibitor RO4929097 PO once daily on days 1-3, 8-10, and 15-17. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
gamma-secretase/Notch signalling pathway inhibitor RO4929097: Given orally
laboratory biomarker analysis: Correlative studies
|
|---|---|
|
Duration of Radiologic Response
|
6.9 months
|
SECONDARY outcome
Timeframe: Within the protocol defined follow-up period.Population: Inadequate data for OS estimates as only 6 patients were accrued in the study.
Computed using the Kaplan-Meier method.
Outcome measures
Outcome data not reported
Adverse Events
Treatment (Gamma-secretase/Notch Signalling Pathway Inhibitor)
Serious adverse events
| Measure |
Treatment (Gamma-secretase/Notch Signalling Pathway Inhibitor)
n=6 participants at risk
Patients receive gamma-secretase/Notch signalling pathway inhibitor RO4929097 PO once daily on days 1-3, 8-10, and 15-17. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
gamma-secretase/Notch signalling pathway inhibitor RO4929097: Given orally
laboratory biomarker analysis: Correlative studies
|
|---|---|
|
Investigations
ALKALINE PHOSPHATASE INCREASED
|
16.7%
1/6 • Number of events 1
|
|
Investigations
ASPARTATE AMINOTRANSFERASE INCREASED
|
16.7%
1/6 • Number of events 1
|
|
General disorders
DEATH NOS
|
16.7%
1/6 • Number of events 1
|
|
Metabolism and nutrition disorders
DEHYDRATION
|
16.7%
1/6 • Number of events 1
|
|
General disorders
FATIGUE
|
16.7%
1/6 • Number of events 1
|
|
Metabolism and nutrition disorders
HYPERKALEMIA
|
16.7%
1/6 • Number of events 1
|
|
Metabolism and nutrition disorders
HYPONATREMIA
|
16.7%
1/6 • Number of events 1
|
|
Investigations
PLATELET COUNT DECREASED
|
16.7%
1/6 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
PLEURAL EFFUSION
|
16.7%
1/6 • Number of events 1
|
|
Investigations
WHITE BLOOD CELL DECREASED
|
16.7%
1/6 • Number of events 1
|
Other adverse events
| Measure |
Treatment (Gamma-secretase/Notch Signalling Pathway Inhibitor)
n=6 participants at risk
Patients receive gamma-secretase/Notch signalling pathway inhibitor RO4929097 PO once daily on days 1-3, 8-10, and 15-17. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
gamma-secretase/Notch signalling pathway inhibitor RO4929097: Given orally
laboratory biomarker analysis: Correlative studies
|
|---|---|
|
Blood and lymphatic system disorders
ANEMIA
|
50.0%
3/6
|
|
Psychiatric disorders
ANXIETY
|
16.7%
1/6
|
|
Musculoskeletal and connective tissue disorders
ARTHRALGIA
|
16.7%
1/6
|
|
Investigations
ASPARTATE AMINOTRANSFERASE INCREASED
|
33.3%
2/6
|
|
Musculoskeletal and connective tissue disorders
BACK PAIN
|
33.3%
2/6
|
|
Investigations
BLOOD BILIRUBIN INCREASED
|
33.3%
2/6
|
|
Musculoskeletal and connective tissue disorders
BONE PAIN
|
16.7%
1/6
|
|
Reproductive system and breast disorders
BREAST PAIN
|
16.7%
1/6
|
|
Cardiac disorders
CHEST PAIN - CARDIAC
|
16.7%
1/6
|
|
Musculoskeletal and connective tissue disorders
CHEST WALL PAIN
|
33.3%
2/6
|
|
Gastrointestinal disorders
CONSTIPATION
|
50.0%
3/6
|
|
Respiratory, thoracic and mediastinal disorders
COUGH
|
50.0%
3/6
|
|
Investigations
CREATININE INCREASED
|
16.7%
1/6
|
|
Psychiatric disorders
DEPRESSION
|
16.7%
1/6
|
|
Nervous system disorders
DYSGEUSIA
|
16.7%
1/6
|
|
General disorders
EDEMA TRUNK
|
16.7%
1/6
|
|
Investigations
ELECTROCARDIOGRAM QT CORRECTED INTERVAL PROLONGED
|
16.7%
1/6
|
|
Skin and subcutaneous tissue disorders
ERYTHEMA MULTIFORME
|
16.7%
1/6
|
|
General disorders
FATIGUE
|
66.7%
4/6
|
|
General disorders
FEVER
|
16.7%
1/6
|
|
Eye disorders
FLASHING LIGHTS
|
16.7%
1/6
|
|
Gastrointestinal disorders
GASTROESOPHAGEAL REFLUX DISEASE
|
16.7%
1/6
|
|
Investigations
GGT INCREASED
|
16.7%
1/6
|
|
Nervous system disorders
HEADACHE
|
33.3%
2/6
|
|
Vascular disorders
HOT FLASHES
|
16.7%
1/6
|
|
Metabolism and nutrition disorders
HYPERMAGNESEMIA
|
16.7%
1/6
|
|
Vascular disorders
HYPERTENSION
|
33.3%
2/6
|
|
Metabolism and nutrition disorders
HYPOALBUMINEMIA
|
50.0%
3/6
|
|
Metabolism and nutrition disorders
HYPOCALCEMIA
|
16.7%
1/6
|
|
Metabolism and nutrition disorders
HYPOMAGNESEMIA
|
50.0%
3/6
|
|
Metabolism and nutrition disorders
HYPONATREMIA
|
33.3%
2/6
|
|
Metabolism and nutrition disorders
HYPOPHOSPHATEMIA
|
16.7%
1/6
|
|
Psychiatric disorders
INSOMNIA
|
16.7%
1/6
|
|
Vascular disorders
LYMPHEDEMA
|
16.7%
1/6
|
|
Investigations
LYMPHOCYTE COUNT DECREASED
|
83.3%
5/6
|
|
Gastrointestinal disorders
MALABSORPTION
|
33.3%
2/6
|
|
Respiratory, thoracic and mediastinal disorders
NASAL CONGESTION
|
16.7%
1/6
|
|
Gastrointestinal disorders
NAUSEA
|
50.0%
3/6
|
|
Musculoskeletal and connective tissue disorders
NECK PAIN
|
16.7%
1/6
|
|
Eye disorders
OTHER
|
33.3%
2/6
|
|
General disorders
PAIN
|
16.7%
1/6
|
|
Musculoskeletal and connective tissue disorders
PAIN IN EXTREMITY
|
16.7%
1/6
|
|
Cardiac disorders
PERICARDIAL EFFUSION
|
16.7%
1/6
|
|
Skin and subcutaneous tissue disorders
PRURITUS
|
16.7%
1/6
|
|
Infections and infestations
SKIN INFECTION
|
16.7%
1/6
|
|
Infections and infestations
UPPER RESPIRATORY INFECTION
|
16.7%
1/6
|
|
Gastrointestinal disorders
VOMITING
|
33.3%
2/6
|
|
Investigations
WEIGHT GAIN
|
16.7%
1/6
|
|
Gastrointestinal disorders
ABDOMINAL PAIN
|
16.7%
1/6
|
|
Investigations
ALANINE AMINOTRANSFERASE INCREASED
|
16.7%
1/6
|
|
Immune system disorders
ALLERGIC REACTION
|
16.7%
1/6
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: LTE60