Trial Outcomes & Findings for A Study of R1507 in Combination With Letrozole in Postmenopausal Women With Advanced Breast Cancer (NCT NCT00796107)
NCT ID: NCT00796107
Last Updated: 2020-11-13
Results Overview
Recruitment status
TERMINATED
Study phase
PHASE2
Target enrollment
6 participants
Primary outcome timeframe
Up to 14 months
Results posted on
2020-11-13
Participant Flow
Participant milestones
| Measure |
R1507 in Combination With Letrozole
Participants received a full daily dose of 2.5 mg of orally administered Letrozole along with 16 mg/kg of intravenous R1507 administered q3w, and observed for dose limiting toxicity for the first 2 cycles of treatment.
|
|---|---|
|
Overall Study
STARTED
|
6
|
|
Overall Study
COMPLETED
|
0
|
|
Overall Study
NOT COMPLETED
|
6
|
Reasons for withdrawal
| Measure |
R1507 in Combination With Letrozole
Participants received a full daily dose of 2.5 mg of orally administered Letrozole along with 16 mg/kg of intravenous R1507 administered q3w, and observed for dose limiting toxicity for the first 2 cycles of treatment.
|
|---|---|
|
Overall Study
Lack of Efficacy
|
1
|
|
Overall Study
Progressive Disease
|
5
|
Baseline Characteristics
A Study of R1507 in Combination With Letrozole in Postmenopausal Women With Advanced Breast Cancer
Baseline characteristics by cohort
| Measure |
R1507 in Combination With Letrozole
n=6 Participants
Participants received a full daily dose of 2.5 mg of orally administered Letrozole along with 16 mg/kg of intravenous R1507 administered q3w, and observed for dose limiting toxicity for the first 2 cycles of treatment.
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
1 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
5 Participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
6 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
White
|
6 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Up to 14 monthsPopulation: Phase 2 of this study was not conducted.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Up to 14 monthsPopulation: Phase 2 of this study was not conducted.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Up to 14 monthsPopulation: Phase 2 of this study was not conducted.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Up to 14 monthsPopulation: Since Phase 2 of this study was not conducted, this outcome measure was not collected.
Outcome measures
Outcome data not reported
Adverse Events
R1507 in Combination With Letrozole
Serious events: 1 serious events
Other events: 6 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
R1507 in Combination With Letrozole
n=6 participants at risk
Participants received a full daily dose of 2.5 mg of orally administered Letrozole along with 16 mg/kg of intravenous R1507 administered q3w, and observed for dose limiting toxicity for the first 2 cycles of treatment.
|
|---|---|
|
Gastrointestinal disorders
Diarrhoea
|
16.7%
1/6 • Number of events 1 • Baseline up to 13 months
|
Other adverse events
| Measure |
R1507 in Combination With Letrozole
n=6 participants at risk
Participants received a full daily dose of 2.5 mg of orally administered Letrozole along with 16 mg/kg of intravenous R1507 administered q3w, and observed for dose limiting toxicity for the first 2 cycles of treatment.
|
|---|---|
|
Gastrointestinal disorders
Vomiting
|
16.7%
1/6 • Number of events 1 • Baseline up to 13 months
|
|
Gastrointestinal disorders
Diarrhoea
|
50.0%
3/6 • Number of events 4 • Baseline up to 13 months
|
|
Investigations
Blood creatinine increased
|
16.7%
1/6 • Number of events 1 • Baseline up to 13 months
|
|
Gastrointestinal disorders
Rectal Haemorrhage
|
16.7%
1/6 • Number of events 1 • Baseline up to 13 months
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
16.7%
1/6 • Number of events 1 • Baseline up to 13 months
|
|
Nervous system disorders
Headache
|
16.7%
1/6 • Number of events 1 • Baseline up to 13 months
|
|
Nervous system disorders
Dizziness
|
16.7%
1/6 • Number of events 1 • Baseline up to 13 months
|
|
Blood and lymphatic system disorders
Lymphopenia
|
16.7%
1/6 • Number of events 1 • Baseline up to 13 months
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
16.7%
1/6 • Number of events 1 • Baseline up to 13 months
|
|
Cardiac disorders
Diastolic Dysfunction
|
16.7%
1/6 • Number of events 1 • Baseline up to 13 months
|
|
Ear and labyrinth disorders
Vertigo
|
16.7%
1/6 • Number of events 1 • Baseline up to 13 months
|
|
Gastrointestinal disorders
Constipation
|
16.7%
1/6 • Number of events 1 • Baseline up to 13 months
|
|
Gastrointestinal disorders
Stomatitis
|
16.7%
1/6 • Number of events 1 • Baseline up to 13 months
|
|
General disorders
Chills
|
33.3%
2/6 • Number of events 2 • Baseline up to 13 months
|
|
General disorders
Fatigue
|
66.7%
4/6 • Number of events 5 • Baseline up to 13 months
|
|
General disorders
Irritability
|
16.7%
1/6 • Number of events 1 • Baseline up to 13 months
|
|
Infections and infestations
Oral Candidiasis
|
16.7%
1/6 • Number of events 1 • Baseline up to 13 months
|
|
Infections and infestations
Pneumonia
|
16.7%
1/6 • Number of events 1 • Baseline up to 13 months
|
|
Metabolism and nutrition disorders
Decreased Apetite
|
16.7%
1/6 • Number of events 2 • Baseline up to 13 months
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
16.7%
1/6 • Number of events 2 • Baseline up to 13 months
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
16.7%
1/6 • Number of events 1 • Baseline up to 13 months
|
|
Musculoskeletal and connective tissue disorders
Bone Pain
|
66.7%
4/6 • Number of events 5 • Baseline up to 13 months
|
|
Musculoskeletal and connective tissue disorders
Muscle Spasms
|
50.0%
3/6 • Number of events 3 • Baseline up to 13 months
|
|
Nervous system disorders
Dysgeusia
|
16.7%
1/6 • Number of events 1 • Baseline up to 13 months
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
16.7%
1/6 • Number of events 1 • Baseline up to 13 months
|
|
Respiratory, thoracic and mediastinal disorders
Sinus Congestion
|
16.7%
1/6 • Number of events 1 • Baseline up to 13 months
|
|
Skin and subcutaneous tissue disorders
Hyperhidrosis
|
16.7%
1/6 • Number of events 1 • Baseline up to 13 months
|
|
Vascular disorders
Deep Vein Thrombosis
|
16.7%
1/6 • Number of events 1 • Baseline up to 13 months
|
|
Injury, poisoning and procedural complications
Animal Bite
|
16.7%
1/6 • Number of events 1 • Baseline up to 13 months
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee The Study being conducted under this Agreement is part of the Overall Study. Investigator is free to publish in reputable journals or to present at professional conferences the results of the Study, but only after the first publication or presentation that involves the Overall Study. The Sponsor may request that Confidential Information be deleted and/or the publication be postponed in order to protect the Sponsor's intellectual property rights.
- Publication restrictions are in place
Restriction type: OTHER