Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Norethindrone/ethinyl estradiol · 1 trial · 1 indication
On Days 1 and 8, blood samples were taken prior to the administration of rosiglitazone and 30 minutes, and 1, 2, 3, 4, and 6 hours, between 8 and 12 hours, and 24 hours post-dose. Plasma concentrations of rosiglitazone were determined using a validated liquid chromatography mass spectrometry/mass spectrometry (LC MS/MS) assay. Individual and mean plasma rosiglitazone concentration versus time data were tabulated and plotted by analyte. The pharmacokinetic parameters of each analyte were calculated using standard non-compartmental methods (WinNonlin version 5.2.1, Pharsight Corp., Mountain View, CA). The geometric mean ratio of AUC(0-inf) of rosiglitazone was defined as the AUC(0-inf) of rosiglitazone on Day 8/AUC(0-inf) of rosiglitazone on Day 1.
On Days 1 and 8, blood samples were taken prior to the administration of rosiglitazone and 30 minutes, and 1, 2, 3, 4, and 6 hours, between 8 and 12 hours, and 24 hours post-dose. Plasma concentrations of rosiglitazone were determined using a validated liquid chromatography mass spectrometry/mass spectrometry (LC MS/MS) assay. Individual and mean plasma rosiglitazone concentration versus time data were tabulated and plotted by analyte. The pharmacokinetic parameters of each analyte were calculated using standard non-compartmental methods (WinNonlin version 5.2.1, Pharsight Corp., Mountain View, CA). The geometric mean ratio of Cmax of rosiglitazone was defined as the Cmax of rosiglitazone on Day 8/ Cmax of rosiglitazone on Day 1.
On Days 1 and 8, blood samples were taken prior to the administration of the contraceptive norethindrone 1 mg/ethinyl estradiol 35 µg (Ortho-Novum 1/35®) and 30 minutes, and 1, 2, 3, 4, and 6 hours, between 8 and 12 hours, and 24 hours post-dose. Plasma concentrations of ethinyl estradiol and norethindrone were determined using a validated liquid chromatography mass spectrometry/mass spectrometry (LC MS/MS) assay. Individual and mean plasma ethinyl estradiol and norethindrone concentration versus time data were tabulated and plotted by analyte. The pharmacokinetic parameters of each analyte were calculated using standard non-compartmental methods (WinNonlin version 5.2.1, Pharsight Corp., Mountain View, CA). The geometric mean ratios of AUC(0-inf) of ethinyl estradiol and norethindrone were defined as the ratios of AUC(0-inf) of ethinyl estradiol and norethindrone on Day 8 divided by AUC(0-inf) of ethinyl estradiol and norethindrone on Day 1, respectively.
On Days 1 and 8, blood samples were taken prior to the administration of the contraceptive norethindrone 1 mg/ethinyl estradiol 35 µg (Ortho-Novum 1/35®) and 30 minutes, and 1, 2, 3, 4, and 6 hours, between 8 and 12 hours, and 24 hours post-dose. Plasma concentrations of ethinyl estradiol and norethindrone were determined using a validated liquid chromatography mass spectrometry/mass spectrometry (LC MS/MS) assay. Individual and mean plasma ethinyl estradiol and norethindrone concentration versus time data were tabulated and plotted by analyte. The pharmacokinetic parameters of each analyte were calculated using standard non-compartmental methods (WinNonlin version 5.2.1, Pharsight Corp., Mountain View, CA). The geometric mean ratios of Cmax of ethinyl estradiol and norethindrone were defined as the ratios of Cmax of ethinyl estradiol and norethindrone on Day 8 divided by Cmax of ethinyl estradiol and norethindrone on Day 1, respectively.
| Arm | Type | Description |
|---|---|---|
| Vismodegib + rosiglitazone | EXPERIMENTAL | 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 + oral contraceptive | EXPERIMENTAL | 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. |
| Name | Type | Description |
|---|---|---|
| Vismodegib | DRUG | Vismodegib was supplied in hard gelatin capsules. |
| Rosiglitazone | DRUG | Rosiglitazone was supplied in tablets. |
| Norethindrone/ethinyl estradiol | DRUG | Norethindrone/ethinyl estradiol was supplied in tablets. |
Inclusion Criteria: * Histologic documentation of incurable, locally advanced, or metastatic solid malignancy that has failed to respond to at least one prior regimen or for which there is no standard therapy * Documented negative serum pregnancy test for women of childbearing potential and use of ...
Norethindrone/ethinyl estradiol is a small molecule being studied for use in solid cancers. It was evaluated in a Phase 1 clinical trial in patients with locally advanced or metastatic solid tumors that are refractory to standard therapy or for whom no standard therapy exists. The trial has been completed.
Norethindrone/ethinyl estradiol is being developed by Roche Holding AG, which trades under the ticker RHHBY. The company conducted a Phase 1 clinical trial of the drug in patients with solid cancers. The trial has been completed.
Norethindrone/ethinyl estradiol is in Phase 1 clinical development. It has completed one Phase 1 trial in patients with solid cancers. The drug is investigational and has not been approved for any use.
Norethindrone/ethinyl estradiol has been studied in one completed clinical trial, NCT01209143. This Phase 1 trial was a pharmacokinetic drug interaction study of the hedgehog pathway inhibitor GDC-0449 in combination with rosiglitazone or combined oral contraceptive in patients with solid tumors. The trial enrolled 52 participants in the United States.
Norethindrone/ethinyl estradiol is a combined oral contraceptive. In the completed Phase 1 trial NCT01209143, it was used as a combined oral contraceptive in combination with the hedgehog pathway inhibitor GDC-0449 in patients with solid tumors. The study evaluated drug interactions between these agents.