An Open Label Study to Evaluate the Safety, Tolerability and Effect on Tumor Response of R1507 in Combination With Letrozole in Postmenopausal Women With Advanced Breast Cancer.
| Registry | NCT00796107 |
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| Status | Terminated - Due to the discontinuation of compound development, this study has been terminated. |
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| Phase | Phase 2 |
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| Study type | Interventional; na, single group, masking: none, treatment |
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| Enrollment | 6 (Actual) |
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| Sponsor | Hoffmann-La Roche (Industry) |
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| Conditions | Breast Cancer |
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| Interventions | RG1507, Letrozole (Drug) |
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| Dates | start 2009-01-28, primary completion 2010-03-03, completion 2010-03-03, first posted 2008-11-24, last updated 2020-11-13 |
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| Locations | 6 sites in United States |
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Related Papers Related Patents Related Grants Related Experts
All trials for Breast Cancer All trials of RG1507 All trials of Letrozole
-Summary
This study aim was to determine the safety and efficacy of R1507 in combination with letrozole in patients with advanced breast cancer. In the first part of the study a cohort of patients with advanced breast cancer received letrozole 2.5mg po daily in combination with R1507 16mg/kg every 3 weeks.
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+Arms and interventions
| Arm | Type | Interventions | Description |
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| R1507 in Combination With Letrozole | Experimental | Drug: RG1507; Drug: 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. |
- RG1507 (Drug): R1507 was administered at a dose 16 mg/kg every 3 weeks.
- Letrozole (Drug): Letrozole was administered orally at a dose 2.5 mg daily.
+Outcome measures
Primary outcomes
- Objective Tumor Response (Part 2) [Up to 14 months]
Secondary outcomes
- Pharmacokinetics (PK) Profile (Part 2) [Up to 14 months]
- Progression-free Survival (Part 2) [Up to 14 months]
- Number of Participants With Adverse Events (Part 2) [Up to 14 months]
+Eligibility
Sex: Female, ages: 18 Years to any
Inclusion Criteria:
* postmenopausal female patients;
* stage IV or locally advanced breast cancer;
* measurable disease;
* letrozole failure (Part 2);
* Eastern Cooperative Oncology Group (ECOG) performance status <=2.
Exclusion Criteria:
* previous chemotherapy for metastatic breast cancer;
* concurrent antibody or immunotherapy for advanced disease, within 4 weeks prior to receipt of study drug;
* history of primary malignancy in 5 years prior to study, excluding adequately treated basal or squamous cell cancer of skin, or cancer in situ of cervix;
* concurrent radiotherapy, or radiotherapy within 28 days prior to receipt of study drug.
+Posted results
Participant flow
| Milestone | R1507 in Combination With Letrozole |
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| Started | 6 |
| Completed | 0 |
| Not completed | 6 |
Outcome results
- Objective Tumor Response (Part 2) (Primary)
- Pharmacokinetics (PK) Profile (Part 2) (Secondary)
- Progression-free Survival (Part 2) (Secondary)
- Number of Participants With Adverse Events (Part 2) (Secondary)
Adverse events
Time frame: Baseline up to 13 months
| Arm | Deaths | Serious adverse events | Other adverse events |
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| R1507 in Combination With Letrozole | 0/6 (0.0%) | 1/6 (16.7%) | 6/6 (100.0%) |
Serious adverse events by term
| Term | Organ system | R1507 in Combination With Letrozole |
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| Diarrhoea | Gastrointestinal disorders | 1/6 |
Other adverse events by term
| Term | Organ system | R1507 in Combination With Letrozole |
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| Vomiting | Gastrointestinal disorders | 1/6 |
| Diarrhoea | Gastrointestinal disorders | 3/6 |
| Blood creatinine increased | Investigations | 1/6 |
| Rectal Haemorrhage | Gastrointestinal disorders | 1/6 |
| Hypokalaemia | Metabolism and nutrition disorders | 1/6 |
| Headache | Nervous system disorders | 1/6 |
| Dizziness | Nervous system disorders | 1/6 |
| Lymphopenia | Blood and lymphatic system disorders | 1/6 |
| Thrombocytopenia | Blood and lymphatic system disorders | 1/6 |
| Diastolic Dysfunction | Cardiac disorders | 1/6 |
| Vertigo | Ear and labyrinth disorders | 1/6 |
| Constipation | Gastrointestinal disorders | 1/6 |
| Stomatitis | Gastrointestinal disorders | 1/6 |
| Chills | General disorders | 2/6 |
| Fatigue | General disorders | 4/6 |
| Irritability | General disorders | 1/6 |
| Oral Candidiasis | Infections and infestations | 1/6 |
| Pneumonia | Infections and infestations | 1/6 |
| Decreased Apetite | Metabolism and nutrition disorders | 1/6 |
| Hyperglycaemia | Metabolism and nutrition disorders | 1/6 |
| Arthralgia | Musculoskeletal and connective tissue disorders | 1/6 |
| Bone Pain | Musculoskeletal and connective tissue disorders | 4/6 |
| Muscle Spasms | Musculoskeletal and connective tissue disorders | 3/6 |
| Dysgeusia | Nervous system disorders | 1/6 |
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | 1/6 |
| Sinus Congestion | Respiratory, thoracic and mediastinal disorders | 1/6 |
| Hyperhidrosis | Skin and subcutaneous tissue disorders | 1/6 |
| Deep Vein Thrombosis | Vascular disorders | 1/6 |
| Animal Bite | Injury, poisoning and procedural complications | 1/6 |
Limitations and caveats: Phase 2 of this study was not conducted.
+Locations (6)
| Facility | City | Country | Status |
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| Birmingham, Alabama | United States | |
| Washington D.C., District of Columbia | United States | |
| Miami, Florida | United States | |
| Atlanta, Georgia | United States | |
| St Louis, Missouri | United States | |
| Houston, Texas | United States | |
+Investigators
- Clinical Trials, Study director, Hoffmann-La Roche