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Due to the discontinuation of compound development, this study has been terminated.
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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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| R1507 in Combination With Letrozole | Experimental | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| RG1507 | Drug | R1507 was administered at a dose 16 mg/kg every 3 weeks. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Objective Tumor Response (Part 2) | Up to 14 months |
| Measure | Description | Time Frame |
|---|---|---|
| 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) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Clinical Trials | Hoffmann-La Roche | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Birmingham | Alabama | 35294-3300 | United States | |||
Qualified researchers may request access to individual patient level data through the clinical study data request platform (www.vivli.org). Further details on Roche's criteria for eligible studies are available here (https://vivli.org/members/ourmembers/). For further details on Roche's Global Policy on the Sharing of Clinical Information and how to request access to related clinical study documents, see here (https://www.roche.com/research\_and\_development/who\_we\_are\_how\_we\_work/clinical\_trials/our\_commitment\_to\_data\_sharing.htm).
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Objective Tumor Response (Part 2) | Phase 2 of this study was not conducted. | Posted | Up to 14 months |
|
|
Baseline up to 13 months
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Diarrhoea | Gastrointestinal disorders | MedDRA version 12.1. | Non-systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Vomiting | Gastrointestinal disorders | MedDRA version 12.1. | Non-systematic Assessment |
Phase 2 of this study was not conducted.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Study Director | Hoffmann-La Roche, Ltd. | 888-662-6728 (U.S.) | global-roche-genentech-trials@gene.com |
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| ID | Term |
|---|---|
| D001943 | Breast Neoplasms |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D001941 | Breast Diseases |
| D012871 | Skin Diseases |
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| ID | Term |
|---|---|
| C558734 | RG-1507 monoclonal antibody |
| D000077289 | Letrozole |
| ID | Term |
|---|---|
| D009570 | Nitriles |
| D009930 | Organic Chemicals |
| D014230 | Triazoles |
| D001393 | Azoles |
| D006573 |
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| Letrozole | Drug | Letrozole was administered orally at a dose 2.5 mg daily. |
|
| Up to 14 months |
| Washington D.C. |
| District of Columbia |
| 20007 |
| United States |
| Miami | Florida | 33136 | United States |
| Atlanta | Georgia | 30322 | United States |
| St Louis | Missouri | 63110 | United States |
| Houston | Texas | 77030 | United States |
| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | Number | Participants |
|
| Secondary | Pharmacokinetics (PK) Profile (Part 2) | Phase 2 of this study was not conducted. | Posted | Up to 14 months |
|
|
| Secondary | Progression-free Survival (Part 2) | Phase 2 of this study was not conducted. | Posted | Up to 14 months |
|
|
| Secondary | Number of Participants With Adverse Events (Part 2) | Since Phase 2 of this study was not conducted, this outcome measure was not collected. | Posted | Up to 14 months |
|
|
| 0 |
| 6 |
| 1 |
| 6 |
| 6 |
| 6 |
| Diarrhoea | Gastrointestinal disorders | MedDRA version 12.1. | Non-systematic Assessment |
|
| Blood creatinine increased | Investigations | MedDRA version 12.1. | Non-systematic Assessment |
|
| Rectal Haemorrhage | Gastrointestinal disorders | MedDRA version 12.1. | Non-systematic Assessment |
|
| Hypokalaemia | Metabolism and nutrition disorders | MedDRA version 12.1. | Non-systematic Assessment |
|
| Headache | Nervous system disorders | MedDRA version 12.1. | Non-systematic Assessment |
|
| Dizziness | Nervous system disorders | MedDRA version 12.1. | Non-systematic Assessment |
|
| Lymphopenia | Blood and lymphatic system disorders | MedDRA version 12.1. | Non-systematic Assessment |
|
| Thrombocytopenia | Blood and lymphatic system disorders | MedDRA version 12.1. | Non-systematic Assessment |
|
| Diastolic Dysfunction | Cardiac disorders | MedDRA version 12.1. | Non-systematic Assessment |
|
| Vertigo | Ear and labyrinth disorders | MedDRA version 12.1. | Non-systematic Assessment |
|
| Constipation | Gastrointestinal disorders | MedDRA version 12.1. | Non-systematic Assessment |
|
| Stomatitis | Gastrointestinal disorders | MedDRA version 12.1. | Non-systematic Assessment |
|
| Chills | General disorders | MedDRA version 12.1. | Non-systematic Assessment |
|
| Fatigue | General disorders | MedDRA version 12.1. | Non-systematic Assessment |
|
| Irritability | General disorders | MedDRA version 12.1. | Non-systematic Assessment |
|
| Oral Candidiasis | Infections and infestations | MedDRA version 12.1. | Non-systematic Assessment |
|
| Pneumonia | Infections and infestations | MedDRA version 12.1. | Non-systematic Assessment |
|
| Decreased Apetite | Metabolism and nutrition disorders | MedDRA version 12.1. | Non-systematic Assessment |
|
| Hyperglycaemia | Metabolism and nutrition disorders | MedDRA version 12.1. | Non-systematic Assessment |
|
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA version 12.1. | Non-systematic Assessment |
|
| Bone Pain | Musculoskeletal and connective tissue disorders | MedDRA version 12.1. | Non-systematic Assessment |
|
| Muscle Spasms | Musculoskeletal and connective tissue disorders | MedDRA version 12.1. | Non-systematic Assessment |
|
| Dysgeusia | Nervous system disorders | MedDRA version 12.1. | Non-systematic Assessment |
|
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA version 12.1. | Non-systematic Assessment |
|
| Sinus Congestion | Respiratory, thoracic and mediastinal disorders | MedDRA version 12.1. | Non-systematic Assessment |
|
| Hyperhidrosis | Skin and subcutaneous tissue disorders | MedDRA version 12.1. | Non-systematic Assessment |
|
| Deep Vein Thrombosis | Vascular disorders | MedDRA version 12.1. | Non-systematic Assessment |
|
| Animal Bite | Injury, poisoning and procedural complications | MedDRA version 12.1. | Non-systematic Assessment |
|
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.
| D017437 |
| Skin and Connective Tissue Diseases |
| Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |