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| ID | Type | Description | Link |
|---|---|---|---|
| GO01352 | Other Identifier | Hoffmann-La Roche |
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This was a multicenter, open-label extension study. Patients who received vismodegib (GDC-0449) in a Genentech-sponsored study and who had completed the parent study or who continued to receive vismodegib at the time the parent study closed were eligible for continued treatment in this protocol.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Vismodegib 150 mg | Experimental | Participants received 150 mg vismodegib orally once a day until disease progression, intolerable toxicity, or withdrawal from the study. If a participant had been receiving combination chemotherapy and/or biotherapy (FOLFOX, FOLFIRI, bevacizumab) in a parent study, the same combination chemotherapy and/or biotherapy as specified in the parent study could be continued in this study at the discretion of the investigator. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Vismodegib | Drug | Vismodegib was supplied in capsules. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of Participants Who Experienced at Least One Adverse Event | From first dose of study treatment until 30 days following the last administration of study treatment (median [range] of treatment exposure: 397 [26 to 1493] days) | |
| Incidence of Participants Who Discontinued Treatment Due to an Adverse Event | From first dose of study treatment until 30 days following the last administration of study treatment (median [range] of treatment exposure: 397 [26 to 1493] days) |
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of All Adverse Events and Serious Adverse Events by Highest Severity Grade According to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) Version 3.0 | The investigator used the adverse event (AE) grading (severity) scale found in the NCI CTCAE v3.0 to assess AE severity, with grades ranging from 1 to 5 having the following descriptions: Grade 1 is mild, Grade 2 is moderate, Grade 3 is severe, Grade 4 is very severe, life threatening or disabling, and Grade 5 is death related to AE. |
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This study only enrolled participants who took part in previous studies of vismodegib conducted by Genentech.
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Josina Reddy, MD, PhD | Genentech, Inc. | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| TGen Clinical Research Srvs | Scottsdale | Arizona | 85258 | United States | ||
| Children's Hospital |
For eligible studies, qualified researchers may request access to individual patient level clinical data. See Roche's commitment to transparency of clinical study information here: https://go.roche.com/data\_sharing
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| ID | Title | Description |
|---|---|---|
| FG000 | Vismodegib 150 mg | Participants received 150 mg vismodegib orally once a day until disease progression, intolerable toxicity, or withdrawal from the study. If a participant had been receiving combination chemotherapy and/or biotherapy (FOLFOX, FOLFIRI, bevacizumab) in a parent study, the same combination chemotherapy and/or biotherapy as specified in the parent study could be continued in this study at the discretion of the investigator. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| FOLFOX | Drug | FOLFOX (folinic acid [FOL, leucovorin], fluorouracil [F, 5-FU], and oxaliplatin [OX]) was supplied as solutions for intravenous administration. |
|
| FOLFIRI | Drug | FOLFIRI (folinic acid [FOL, leucovorin], fluorouracil [F, 5-FU], and irinotecan [IRI]) was supplied as solutions for intravenous administration. |
|
| Bevacizumab | Drug | Bevacizumab was supplied as a solution for intravenous administration. |
|
|
| From first dose of study treatment until 30 days following the last administration of study treatment (median [range] of treatment exposure: 397 [26 to 1493] days) |
| Oakland |
| California |
| 94609 |
| United States |
| Comprehensive Cancer Care | Palm Springs | California | 92262 | United States |
| Stanford Univ Medical Center | Stanford | California | 94305 | United States |
| Johns Hopkins Univ Med Center | Baltimore | Maryland | 21231 | United States |
| University Of Michigan | Ann Arbor | Michigan | 48109-0934 | United States |
| Karmanos Cancer Institute.. | Detroit | Michigan | 48201 | United States |
| Nevada Cancer Research Foundation | Las Vegas | Nevada | 89169 | United States |
| Irfan Firdaus, D.O. | Cincinnati | Ohio | 45242 | United States |
| DermSurgery Associates, PA | Houston | Texas | 77030 | United States |
| COMPLETED |
|
| NOT COMPLETED |
|
|
Safety population: All participants who had received at least 1 dose of study medication.
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| ID | Title | Description |
|---|---|---|
| BG000 | Vismodegib 150 mg | Participants received 150 mg vismodegib orally once a day until disease progression, intolerable toxicity, or withdrawal from the study. If a participant had been receiving combination chemotherapy and/or biotherapy (FOLFOX, FOLFIRI, bevacizumab) in a parent study, the same combination chemotherapy and/or biotherapy as specified in the parent study could be continued in this study at the discretion of the investigator. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
| |||||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||||
| Race/Ethnicity, Customized | Count of Participants | 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 | ||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Secondary | Incidence of All Adverse Events and Serious Adverse Events by Highest Severity Grade According to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) Version 3.0 | The investigator used the adverse event (AE) grading (severity) scale found in the NCI CTCAE v3.0 to assess AE severity, with grades ranging from 1 to 5 having the following descriptions: Grade 1 is mild, Grade 2 is moderate, Grade 3 is severe, Grade 4 is very severe, life threatening or disabling, and Grade 5 is death related to AE. | Posted | Count of Participants | Participants | From first dose of study treatment until 30 days following the last administration of study treatment (median [range] of treatment exposure: 397 [26 to 1493] days) |
|
|
| |||||||||||||||||||||||||||||||||||||
| Primary | Incidence of Participants Who Experienced at Least One Adverse Event | Safety population: All participants who had received at least 1 dose of study medication. | Posted | Count of Participants | Participants | From first dose of study treatment until 30 days following the last administration of study treatment (median [range] of treatment exposure: 397 [26 to 1493] days) |
|
| ||||||||||||||||||||||||||||||||||||||
| Primary | Incidence of Participants Who Discontinued Treatment Due to an Adverse Event | Safety population: All participants who had received at least 1 dose of study medication. | Posted | Count of Participants | Participants | From first dose of study treatment until 30 days following the last administration of study treatment (median [range] of treatment exposure: 397 [26 to 1493] days) |
|
|
For all-cause mortality: From enrollment until death, loss of follow-up, or study completion (up to 4 years, 4 months). For adverse events: From first dose of study treatment until 30 days following the last administration of study treatment (median [range] of treatment exposure: 397 [26 to 1493] days).
Safety population: All participants who had received at least 1 dose of study medication.
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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 | Vismodegib 150 mg | Participants received 150 mg vismodegib orally once a day until disease progression, intolerable toxicity, or withdrawal from the study. If a participant had been receiving combination chemotherapy and/or biotherapy (FOLFOX, FOLFIRI, bevacizumab) in a parent study, the same combination chemotherapy and/or biotherapy as specified in the parent study could be continued in this study at the discretion of the investigator. | 2 | 19 | 3 | 19 | 17 | 19 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Lung neoplasm malignant | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (Unspecified) | Systematic Assessment |
| |
| Bile duct obstruction | Hepatobiliary disorders | MedDRA (Unspecified) | Systematic Assessment |
| |
| Gastrointestinal haemorrhage | Gastrointestinal disorders | MedDRA (Unspecified) | Systematic Assessment |
| |
| Tubo-ovarian abscess | Reproductive system and breast disorders | MedDRA (Unspecified) | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Diarrhoea | Gastrointestinal disorders | MedDRA (Unspecified) | Systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA (Unspecified) | Systematic Assessment |
| |
| Constipation | Gastrointestinal disorders | MedDRA (Unspecified) | Systematic Assessment |
| |
| Flatulence | Gastrointestinal disorders | MedDRA (Unspecified) | Systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA (Unspecified) | Systematic Assessment |
| |
| Gastritis | Gastrointestinal disorders | MedDRA (Unspecified) | Systematic Assessment |
| |
| Abdominal discomfort | Gastrointestinal disorders | MedDRA (Unspecified) | Systematic Assessment |
| |
| Abdominal pain upper | Gastrointestinal disorders | MedDRA (Unspecified) | Systematic Assessment |
| |
| Dental caries | Gastrointestinal disorders | MedDRA (Unspecified) | Systematic Assessment |
| |
| Dyspepsia | Gastrointestinal disorders | MedDRA (Unspecified) | Systematic Assessment |
| |
| Gastrointestinal haemorrhage | Gastrointestinal disorders | MedDRA (Unspecified) | Systematic Assessment |
| |
| Inguinal hernia | Gastrointestinal disorders | MedDRA (Unspecified) | Systematic Assessment |
| |
| Fatigue | General disorders | MedDRA (Unspecified) | Systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA (Unspecified) | Systematic Assessment |
| |
| Asthenia | General disorders | MedDRA (Unspecified) | Systematic Assessment |
| |
| Chest pain | General disorders | MedDRA (Unspecified) | Systematic Assessment |
| |
| Hernia | General disorders | MedDRA (Unspecified) | Systematic Assessment |
| |
| Influenza like illness | General disorders | MedDRA (Unspecified) | Systematic Assessment |
| |
| Local swelling | General disorders | MedDRA (Unspecified) | Systematic Assessment |
| |
| Oedema peripheral | General disorders | MedDRA (Unspecified) | Systematic Assessment |
| |
| Pain | General disorders | MedDRA (Unspecified) | Systematic Assessment |
| |
| Polyp | General disorders | MedDRA (Unspecified) | Systematic Assessment |
| |
| Swelling | General disorders | MedDRA (Unspecified) | Systematic Assessment |
| |
| Muscle spasms | Musculoskeletal and connective tissue disorders | MedDRA (Unspecified) | Systematic Assessment |
| |
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA (Unspecified) | Systematic Assessment |
| |
| Arthritis | Musculoskeletal and connective tissue disorders | MedDRA (Unspecified) | Systematic Assessment |
| |
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA (Unspecified) | Systematic Assessment |
| |
| Muscular weakness | Musculoskeletal and connective tissue disorders | MedDRA (Unspecified) | Systematic Assessment |
| |
| Musculoskeletal chest pain | Musculoskeletal and connective tissue disorders | MedDRA (Unspecified) | Systematic Assessment |
| |
| Myalgia | Musculoskeletal and connective tissue disorders | MedDRA (Unspecified) | Systematic Assessment |
| |
| Spinal osteoarthritis | Musculoskeletal and connective tissue disorders | MedDRA (Unspecified) | Systematic Assessment |
| |
| Trismus | Musculoskeletal and connective tissue disorders | MedDRA (Unspecified) | Systematic Assessment |
| |
| Alopecia | Skin and subcutaneous tissue disorders | MedDRA (Unspecified) | Systematic Assessment |
| |
| Ecchymosis | Skin and subcutaneous tissue disorders | MedDRA (Unspecified) | Systematic Assessment |
| |
| Rash | Skin and subcutaneous tissue disorders | MedDRA (Unspecified) | Systematic Assessment |
| |
| Rash pruritic | Skin and subcutaneous tissue disorders | MedDRA (Unspecified) | Systematic Assessment |
| |
| Actinic keratosis | Skin and subcutaneous tissue disorders | MedDRA (Unspecified) | Systematic Assessment |
| |
| Eczema | Skin and subcutaneous tissue disorders | MedDRA (Unspecified) | Systematic Assessment |
| |
| Erythema | Skin and subcutaneous tissue disorders | MedDRA (Unspecified) | Systematic Assessment |
| |
| Hyperhidrosis | Skin and subcutaneous tissue disorders | MedDRA (Unspecified) | Systematic Assessment |
| |
| Hyperkeratosis | Skin and subcutaneous tissue disorders | MedDRA (Unspecified) | Systematic Assessment |
| |
| Rash follicular | Skin and subcutaneous tissue disorders | MedDRA (Unspecified) | Systematic Assessment |
| |
| Weight decreased | Investigations | MedDRA (Unspecified) | Systematic Assessment |
| |
| Hepatic enzyme increased | Investigations | MedDRA (Unspecified) | Systematic Assessment |
| |
| Aspartate aminotransferase increased | Investigations | MedDRA (Unspecified) | Systematic Assessment |
| |
| Blood bilirubin increased | Investigations | MedDRA (Unspecified) | Systematic Assessment |
| |
| Blood pressure increased | Investigations | MedDRA (Unspecified) | Systematic Assessment |
| |
| Prostatic specific antigen increased | Investigations | MedDRA (Unspecified) | Systematic Assessment |
| |
| Decreased appetite | Metabolism and nutrition disorders | MedDRA (Unspecified) | Systematic Assessment |
| |
| Hypokalaemia | Metabolism and nutrition disorders | MedDRA (Unspecified) | Systematic Assessment |
| |
| Dehydration | Metabolism and nutrition disorders | MedDRA (Unspecified) | Systematic Assessment |
| |
| Hyperglycaemia | Metabolism and nutrition disorders | MedDRA (Unspecified) | Systematic Assessment |
| |
| Hyperlipidaemia | Metabolism and nutrition disorders | MedDRA (Unspecified) | Systematic Assessment |
| |
| Hypomagnesaemia | Metabolism and nutrition disorders | MedDRA (Unspecified) | Systematic Assessment |
| |
| Lactose intolerance | Metabolism and nutrition disorders | MedDRA (Unspecified) | Systematic Assessment |
| |
| Dysgeusia | Nervous system disorders | MedDRA (Unspecified) | Systematic Assessment |
| |
| Dizziness | Nervous system disorders | MedDRA (Unspecified) | Systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA (Unspecified) | Systematic Assessment |
| |
| Parkinson's disease | Nervous system disorders | MedDRA (Unspecified) | Systematic Assessment |
| |
| Parosmia | Nervous system disorders | MedDRA (Unspecified) | Systematic Assessment |
| |
| Contusion | Injury, poisoning and procedural complications | MedDRA (Unspecified) | Systematic Assessment |
| |
| Excoriation | Injury, poisoning and procedural complications | MedDRA (Unspecified) | Systematic Assessment |
| |
| Incision site pain | Injury, poisoning and procedural complications | MedDRA (Unspecified) | Systematic Assessment |
| |
| Laceration | Injury, poisoning and procedural complications | MedDRA (Unspecified) | Systematic Assessment |
| |
| Muscle strain | Injury, poisoning and procedural complications | MedDRA (Unspecified) | Systematic Assessment |
| |
| Post procedural discharge | Injury, poisoning and procedural complications | MedDRA (Unspecified) | Systematic Assessment |
| |
| Procedural pain | Injury, poisoning and procedural complications | MedDRA (Unspecified) | Systematic Assessment |
| |
| Rib fracture | Injury, poisoning and procedural complications | MedDRA (Unspecified) | Systematic Assessment |
| |
| Insomnia | Psychiatric disorders | MedDRA (Unspecified) | Systematic Assessment |
| |
| Anxiety | Psychiatric disorders | MedDRA (Unspecified) | Systematic Assessment |
| |
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA (Unspecified) | Systematic Assessment |
| |
| Epistaxis | Respiratory, thoracic and mediastinal disorders | MedDRA (Unspecified) | Systematic Assessment |
| |
| Lung disorder | Respiratory, thoracic and mediastinal disorders | MedDRA (Unspecified) | Systematic Assessment |
| |
| Nasal congestion | Respiratory, thoracic and mediastinal disorders | MedDRA (Unspecified) | Systematic Assessment |
| |
| Rhinorrhoea | Respiratory, thoracic and mediastinal disorders | MedDRA (Unspecified) | Systematic Assessment |
| |
| Anaemia | Blood and lymphatic system disorders | MedDRA (Unspecified) | Systematic Assessment |
| |
| Anaemia macrocytic | Blood and lymphatic system disorders | MedDRA (Unspecified) | Systematic Assessment |
| |
| Iron deficiency anaemia | Blood and lymphatic system disorders | MedDRA (Unspecified) | Systematic Assessment |
| |
| Upper respiratory tract infection | Infections and infestations | MedDRA (Unspecified) | Systematic Assessment |
| |
| Cellulitis | Infections and infestations | MedDRA (Unspecified) | Systematic Assessment |
| |
| Herpes zoster | Infections and infestations | MedDRA (Unspecified) | Systematic Assessment |
| |
| Purulent discharge | Infections and infestations | MedDRA (Unspecified) | Systematic Assessment |
| |
| Rash pustular | Infections and infestations | MedDRA (Unspecified) | Systematic Assessment |
| |
| Respiratory tract infection | Infections and infestations | MedDRA (Unspecified) | Systematic Assessment |
| |
| Sinusitis | Infections and infestations | MedDRA (Unspecified) | Systematic Assessment |
| |
| Urinary tract infection | Infections and infestations | MedDRA (Unspecified) | Systematic Assessment |
| |
| Dry eye | Eye disorders | MedDRA (Unspecified) | Systematic Assessment |
| |
| Eyelid cyst | Eye disorders | MedDRA (Unspecified) | Systematic Assessment |
| |
| Vision blurred | Eye disorders | MedDRA (Unspecified) | Systematic Assessment |
| |
| Adenocarcinoma pancreas | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (Unspecified) | Systematic Assessment |
| |
| Metastases to bone | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (Unspecified) | Systematic Assessment |
| |
| Tumour pain | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (Unspecified) | Systematic Assessment |
| |
| Haematuria | Renal and urinary disorders | MedDRA (Unspecified) | Systematic Assessment |
| |
| Nocturia | Renal and urinary disorders | MedDRA (Unspecified) | Systematic Assessment |
| |
| Urinary straining | Renal and urinary disorders | MedDRA (Unspecified) | Systematic Assessment |
| |
| Hot flush | Vascular disorders | MedDRA (Unspecified) | Systematic Assessment |
| |
| Hypertension | Vascular disorders | MedDRA (Unspecified) | Systematic Assessment |
| |
| Seasonal allergy | Immune system disorders | MedDRA (Unspecified) | 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.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Medical Communications | Genentech, Inc. | 800 821-8590 | genentech@druginfo.com |
| ID | Term |
|---|---|
| D010051 | Ovarian Neoplasms |
| D002280 | Carcinoma, Basal Cell |
| D015179 | Colorectal Neoplasms |
| ID | Term |
|---|---|
| D004701 | Endocrine Gland Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D010049 | Ovarian Diseases |
| D000291 | Adnexal Diseases |
| D005831 | Genital Diseases, Female |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D005833 | Genital Neoplasms, Female |
| D014565 | Urogenital Neoplasms |
| D000091662 | Genital Diseases |
| D004700 | Endocrine System Diseases |
| D006058 | Gonadal Disorders |
| D002277 | Carcinoma |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009370 | Neoplasms by Histologic Type |
| D018295 | Neoplasms, Basal Cell |
| D007414 | Intestinal Neoplasms |
| D005770 | Gastrointestinal Neoplasms |
| D004067 | Digestive System Neoplasms |
| D004066 | Digestive System Diseases |
| D005767 | Gastrointestinal Diseases |
| D003108 | Colonic Diseases |
| D007410 | Intestinal Diseases |
| D012002 | Rectal Diseases |
Not provided
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| ID | Term |
|---|---|
| C538724 | HhAntag691 |
| C410216 | Folfox protocol |
| C480833 | IFL protocol |
| D000068258 | Bevacizumab |
| ID | Term |
|---|---|
| D061067 | Antibodies, Monoclonal, Humanized |
| D000911 | Antibodies, Monoclonal |
| D000906 | Antibodies |
| D007136 | Immunoglobulins |
| D007162 | Immunoproteins |
| D001798 | Blood Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D012712 | Serum Globulins |
| D005916 | Globulins |
Not provided
Not provided
| Title | Measurements |
|---|---|
|
| NCI CTCAE Grade 3 |
|
|
|