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Trial record 42 of 78 for:    vismodegib

A Study of Vismodegib (GDC-0449) in Patients Treated With Vismodegib in a Previous Genentech-sponsored Phase I or II Cancer Study

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ClinicalTrials.gov Identifier: NCT00959647
Recruitment Status : Completed
First Posted : August 14, 2009
Results First Posted : January 7, 2015
Last Update Posted : January 7, 2015
Sponsor:
Information provided by (Responsible Party):
Genentech, Inc.

Study Type Interventional
Study Design Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Conditions Ovarian Cancer
Basal Cell Carcinoma
Metastatic Colorectal Cancer
Interventions Drug: Vismodegib
Drug: FOLFOX
Drug: FOLFIRI
Drug: Bevacizumab
Enrollment 19
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Vismodegib 150 mg
Hide Arm/Group Description 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.
Period Title: Overall Study
Started 19
Completed 0
Not Completed 19
Reason Not Completed
Adverse Event             2
Progressive disease             6
Study terminated by sponsor             4
Withdrawal by Subject             7
Arm/Group Title Vismodegib 150 mg
Hide Arm/Group Description 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.
Overall Number of Baseline Participants 19
Hide Baseline Analysis Population Description
Safety population: All participants who had received at least 1 dose of study medication.
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 19 participants
57.4  (15.4)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 19 participants
Female
4
  21.1%
Male
15
  78.9%
1.Primary Outcome
Title Percentage of Participants Who Experienced at Least 1 Adverse Event
Hide Description [Not Specified]
Time Frame Baseline until 30 days following the last administration of study treatment
Hide Outcome Measure Data
Hide Analysis Population Description
Safety population: All participants who had received at least 1 dose of study medication.
Arm/Group Title Vismodegib 150 mg
Hide Arm/Group Description:
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.
Overall Number of Participants Analyzed 19
Measure Type: Number
Unit of Measure: Percentage of participants
89.5
2.Primary Outcome
Title Percentage of Participants Who Discontinued Treatment Due to an Adverse Event
Hide Description [Not Specified]
Time Frame Baseline until 30 days following the last administration of study treatment
Hide Outcome Measure Data
Hide Analysis Population Description
Safety population: All participants who had received at least 1 dose of study medication.
Arm/Group Title Vismodegib 150 mg
Hide Arm/Group Description:
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.
Overall Number of Participants Analyzed 19
Measure Type: Number
Unit of Measure: Percentage of participants
10.5
3.Secondary Outcome
Title Incidence and Severity of All Adverse Events and Serious Adverse Events
Hide Description [Not Specified]
Time Frame 30 days following the last administration of study treatment
Outcome Measure Data Not Reported
4.Secondary Outcome
Title Incidence of Adverse Events Leading to GDC-0449 Discontinuation
Hide Description [Not Specified]
Time Frame 30 days following the last administration of study treatment
Outcome Measure Data Not Reported
Time Frame From Baseline until 30 days following the last administration of study treatment.
Adverse Event Reporting Description Safety population: All participants who had received at least 1 dose of study medication.
 
Arm/Group Title Vismodegib 150 mg
Hide Arm/Group Description 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.
All-Cause Mortality
Vismodegib 150 mg
Affected / at Risk (%)
Total   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Vismodegib 150 mg
Affected / at Risk (%)
Total   3/19 (15.79%) 
Gastrointestinal disorders   
Gastrointestinal haemorrhage  1  1/19 (5.26%) 
Hepatobiliary disorders   
Bile duct obstruction  1  1/19 (5.26%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)   
Lung neoplasm malignant  1  1/19 (5.26%) 
Reproductive system and breast disorders   
Tubo-ovarian abscess  1  1/19 (5.26%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA (Unspecified)
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Vismodegib 150 mg
Affected / at Risk (%)
Total   17/19 (89.47%) 
Blood and lymphatic system disorders   
Anaemia  1  3/19 (15.79%) 
Anaemia macrocytic  1  1/19 (5.26%) 
Iron deficiency anaemia  1  1/19 (5.26%) 
Eye disorders   
Dry eye  1  1/19 (5.26%) 
Eyelid cyst  1  1/19 (5.26%) 
Vision blurred  1  1/19 (5.26%) 
Gastrointestinal disorders   
Diarrhoea  1  10/19 (52.63%) 
Nausea  1  6/19 (31.58%) 
Constipation  1  5/19 (26.32%) 
Flatulence  1  3/19 (15.79%) 
Vomiting  1  3/19 (15.79%) 
Gastritis  1  2/19 (10.53%) 
Abdominal discomfort  1  1/19 (5.26%) 
Abdominal pain upper  1  1/19 (5.26%) 
Dental caries  1  1/19 (5.26%) 
Dyspepsia  1  1/19 (5.26%) 
Gastrointestinal haemorrhage  1  1/19 (5.26%) 
Inguinal hernia  1  1/19 (5.26%) 
General disorders   
Fatigue  1  8/19 (42.11%) 
Pyrexia  1  2/19 (10.53%) 
Asthenia  1  1/19 (5.26%) 
Chest pain  1  1/19 (5.26%) 
Hernia  1  1/19 (5.26%) 
Influenza like illness  1  1/19 (5.26%) 
Local swelling  1  1/19 (5.26%) 
Oedema peripheral  1  1/19 (5.26%) 
Pain  1  1/19 (5.26%) 
Polyp  1  1/19 (5.26%) 
Swelling  1  1/19 (5.26%) 
Immune system disorders   
Seasonal allergy  1  1/19 (5.26%) 
Infections and infestations   
Upper respiratory tract infection  1  2/19 (10.53%) 
Cellulitis  1  1/19 (5.26%) 
Herpes zoster  1  1/19 (5.26%) 
Purulent discharge  1  1/19 (5.26%) 
Rash pustular  1  1/19 (5.26%) 
Respiratory tract infection  1  1/19 (5.26%) 
Sinusitis  1  1/19 (5.26%) 
Urinary tract infection  1  1/19 (5.26%) 
Injury, poisoning and procedural complications   
Contusion  1  1/19 (5.26%) 
Excoriation  1  1/19 (5.26%) 
Incision site pain  1  1/19 (5.26%) 
Laceration  1  1/19 (5.26%) 
Muscle strain  1  1/19 (5.26%) 
Post procedural discharge  1  1/19 (5.26%) 
Procedural pain  1  1/19 (5.26%) 
Rib fracture  1  1/19 (5.26%) 
Investigations   
Weight decreased  1  6/19 (31.58%) 
Hepatic enzyme increased  1  2/19 (10.53%) 
Aspartate aminotransferase increased  1  1/19 (5.26%) 
Blood bilirubin increased  1  1/19 (5.26%) 
Blood pressure increased  1  1/19 (5.26%) 
Prostatic specific antigen increased  1  1/19 (5.26%) 
Metabolism and nutrition disorders   
Decreased appetite  1  3/19 (15.79%) 
Hypokalaemia  1  3/19 (15.79%) 
Dehydration  1  2/19 (10.53%) 
Hyperglycaemia  1  1/19 (5.26%) 
Hyperlipidaemia  1  1/19 (5.26%) 
Hypomagnesaemia  1  1/19 (5.26%) 
Lactose intolerance  1  1/19 (5.26%) 
Musculoskeletal and connective tissue disorders   
Muscle spasms  1  9/19 (47.37%) 
Arthralgia  1  2/19 (10.53%) 
Arthritis  1  1/19 (5.26%) 
Back pain  1  1/19 (5.26%) 
Muscular weakness  1  1/19 (5.26%) 
Musculoskeletal chest pain  1  1/19 (5.26%) 
Myalgia  1  1/19 (5.26%) 
Spinal osteoarthritis  1  1/19 (5.26%) 
Trismus  1  1/19 (5.26%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)   
Adenocarcinoma pancreas  1  1/19 (5.26%) 
Metastases to bone  1  1/19 (5.26%) 
Tumour pain  1  1/19 (5.26%) 
Nervous system disorders   
Dysgeusia  1  6/19 (31.58%) 
Dizziness  1  3/19 (15.79%) 
Headache  1  1/19 (5.26%) 
Parkinson’s disease  1  1/19 (5.26%) 
Parosmia  1  1/19 (5.26%) 
Psychiatric disorders   
Insomnia  1  4/19 (21.05%) 
Anxiety  1  2/19 (10.53%) 
Renal and urinary disorders   
Haematuria  1  1/19 (5.26%) 
Nocturia  1  1/19 (5.26%) 
Urinary straining  1  1/19 (5.26%) 
Respiratory, thoracic and mediastinal disorders   
Dyspnoea  1  2/19 (10.53%) 
Epistaxis  1  1/19 (5.26%) 
Lung disorder  1  1/19 (5.26%) 
Nasal congestion  1  1/19 (5.26%) 
Rhinorrhoea  1  1/19 (5.26%) 
Skin and subcutaneous tissue disorders   
Alopecia  1  6/19 (31.58%) 
Ecchymosis  1  2/19 (10.53%) 
Rash  1  2/19 (10.53%) 
Rash pruritic  1  2/19 (10.53%) 
Actinic keratosis  1  1/19 (5.26%) 
Eczema  1  1/19 (5.26%) 
Erythema  1  1/19 (5.26%) 
Hyperhidrosis  1  1/19 (5.26%) 
Hyperkeratosis  1  1/19 (5.26%) 
Rash follicular  1  1/19 (5.26%) 
Vascular disorders   
Hot flush  1  1/19 (5.26%) 
Hypertension  1  1/19 (5.26%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA (Unspecified)
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
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.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Medical Communications
Organization: Genentech, Inc.
Phone: 800 821-8590
EMail: genentech@druginfo.com
Layout table for additonal information
Responsible Party: Genentech, Inc.
ClinicalTrials.gov Identifier: NCT00959647     History of Changes
Other Study ID Numbers: SHH4437g
GO01352 ( Other Identifier: Hoffmann-La Roche )
First Submitted: August 10, 2009
First Posted: August 14, 2009
Results First Submitted: December 23, 2014
Results First Posted: January 7, 2015
Last Update Posted: January 7, 2015