A Study of Pharmacokinetic Drug Interaction Study of the Hedgehog Pathway Inhibitor GDC-0449 in Combination With Rosiglitazone or Combined Oral Contraceptive in Patients With Locally Advanced or Metastatic Solid Tumors That Are Refractory to Standard Therapy or for Whom No Standard Therapy Exists

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Genentech, Inc.
ClinicalTrials.gov Identifier:
NCT01209143
First received: September 23, 2010
Last updated: June 5, 2015
Last verified: June 2015
Results First Received: June 5, 2015  
Study Type: Interventional
Study Design: Allocation: Non-Randomized;   Intervention Model: Parallel Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Condition: Solid Cancers
Interventions: Drug: Vismodegib
Drug: Rosiglitazone
Drug: Norethindrone/ethinyl estradiol

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
Vismodegib + Rosiglitazone

Participants received rosiglitazone 4 mg orally on Days 1 and 8 of the study. Participants also received vismodegib 150 mg orally once a day beginning on Day 2 until one of the following occurred; disease progression, intolerable toxicity, most probably attributable to vismodegib, or patient withdrawal of consent.

Vismodegib: Vismodegib was supplied in hard gelatin capsules.

Rosiglitazone: Rosiglitazone was supplied in tablets.

Vismodegib + Oral Contraceptive

Participants received the oral contraceptive norethindrone 1 mg/ethinyl estradiol 35 µg (Ortho-Novum 1/35®) orally on Days 1 and 8 of the study. Participants also received vismodegib 150 mg orally once a day beginning on Day 2 until one of the following occurred; disease progression, intolerable toxicity, most probably attributable to vismodegib, or patient withdrawal of consent.

Vismodegib: Vismodegib was supplied in hard gelatin capsules.

Norethindrone/ethinyl estradiol: Norethindrone/ethinyl estradiol was supplied in tablets.


Participant Flow:   Overall Study
    Vismodegib + Rosiglitazone     Vismodegib + Oral Contraceptive  
STARTED     24     28  
COMPLETED     5     8  
NOT COMPLETED     19     20  
Adverse Event                 2                 1  
Death                 0                 1  
Physician Decision                 3                 1  
Lost to Follow-up                 1                 0  
Withdrawal by Subject                 2                 1  
Disease progression                 11                 16  



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Safety-evaluable population: All participants who received any amount of study drug (vismodegib or rosiglitazone or norethindrone/ethinyl estradiol).

Reporting Groups
  Description
Vismodegib + Rosiglitazone

Participants received rosiglitazone 4 mg orally on Days 1 and 8 of the study. Participants also received vismodegib 150 mg orally once a day beginning on Day 2 until one of the following occurred; disease progression, intolerable toxicity, most probably attributable to vismodegib, or patient withdrawal of consent.

Vismodegib: Vismodegib was supplied in hard gelatin capsules.

Rosiglitazone: Rosiglitazone was supplied in tablets.

Vismodegib + Oral Contraceptive

Participants received the oral contraceptive norethindrone 1 mg/ethinyl estradiol 35 µg (Ortho-Novum 1/35®) orally on Days 1 and 8 of the study. Participants also received vismodegib 150 mg orally once a day beginning on Day 2 until one of the following occurred; disease progression, intolerable toxicity, most probably attributable to vismodegib, or patient withdrawal of consent.

Vismodegib: Vismodegib was supplied in hard gelatin capsules.

Norethindrone/ethinyl estradiol: Norethindrone/ethinyl estradiol was supplied in tablets.

Total Total of all reporting groups

Baseline Measures
    Vismodegib + Rosiglitazone     Vismodegib + Oral Contraceptive     Total  
Number of Participants  
[units: participants]
  24     28     52  
Age  
[units: years]
Mean (Standard Deviation)
  62.1  (14.4)     59.2  (14.6)     60.5  (14.4)  
Gender  
[units: participants]
     
Female     0     27     27  
Male     24     1     25  



  Outcome Measures
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1.  Primary:   Geometric Mean Ratio of the Area Under the Plasma Concentration-time Curve From 0 to Infinity (AUC[0-inf]) of Rosiglitazone   [ Time Frame: Pre-dose and 30 minutes, and 1, 2, 3, 4, and 6 hours, between 8 and 12 hours, and 24 hours post-dose ]

2.  Primary:   Geometric Mean Ratio of the Maximum Plasma Concentration (Cmax) of Rosiglitazone   [ Time Frame: Pre-dose and 30 minutes, and 1, 2, 3, 4, and 6 hours, between 8 and 12 hours, and 24 hours post-dose ]

3.  Primary:   Geometric Mean Ratio of the Area Under the Plasma Concentration-time Curve From 0 to Infinity (AUC[0-inf]) of Ethinyl Estradiol and Norethindrone   [ Time Frame: Pre-dose and 30 minutes, and 1, 2, 3, 4, and 6 hours, between 8 and 12 hours, and 24 hours post-dose ]

4.  Primary:   Geometric Mean Ratio of the Maximum Plasma Concentration (Cmax) of Ethinyl Estradiol and Norethindrone   [ Time Frame: Pre-dose and 30 minutes, and 1, 2, 3, 4, and 6 hours, between 8 and 12 hours, and 24 hours post-dose ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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  More Information
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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 agreement is:
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.


Results Point of Contact:  
Name/Title: Medical Communications
Organization: Genentech, Inc.
phone: 800 821-8590
e-mail: genentech@druginfo.com


No publications provided


Responsible Party: Genentech, Inc.
ClinicalTrials.gov Identifier: NCT01209143     History of Changes
Other Study ID Numbers: SHH4593g, GO01353
Study First Received: September 23, 2010
Results First Received: June 5, 2015
Last Updated: June 5, 2015
Health Authority: United States: Food and Drug Administration