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The purpose of this study is to evaluate the effect of trametinib once daily on the pharmacokinetics (PK) of a daily dosing oral contraceptives (OCs) containing norethindrone (NE) and ethinyl estradiol (EE) in female patients with solid tumors. The PK of trametinib and its metabolite M5 will also be assessed.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Oral Contraceptive / Trametinib | Experimental | In treatment period 1 of the PK Phase patients will take the Oral Contraceptive once daily from Days 1-5. Period 2 of the PK Phase starts on Day 6 when patients take both the Oral Contraceptive and trametinib once daily from Days 6 to 21. Patients may continue dosing with trametinib only once daily from Day 22 onwards (post PK Phase). |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Trametinib | Drug | Each tablet is 2mg trametinib to be taken orally once daily. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Pharmacokinetics parameter: AUCtau of NE and EE alone and in combination with trametinib | To evaluate the effect of multiple doses of trametinib (2 mg once daily) on the steady state pharmacokinetics of combination OC (NE and EE) in female patients with solid tumors. | Day 5 and 6 and 21 and 22 |
| Pharmacokinetics parameter: AUClast of NE and EE alone and in combination with trametinib | To evaluate the effect of multiple doses of trametinib (2 mg once daily) on the steady state pharmacokinetics of combination OC (NE and EE) in female patients with solid tumors. | Day 5 and 6 and 21 and 22 |
| Pharmacokinetics parameter: Cmax of NE and EE alone and in combination with trametinib | To evaluate the effect of multiple doses of trametinib (2 mg once daily) on the steady state pharmacokinetics of combination OC (NE and EE) in female patients with solid tumors. | Day 5 and 6 and 21 and 22 |
| Pharmacokinetics parameter: Tmax of NE and EE alone and incombination with trametinib | To evaluate the effect of multiple doses of trametinib (2 mg once daily) on the steady state pharmacokinetics of combination OC (NE and EE) in female patients with solid tumors. | Days 5 and 6 and 21 and 22 |
| Measure | Description | Time Frame |
|---|---|---|
| Pharmacokinetics parameter: AUClast of M5 | Characterize PK of metabolite M5 | Day 21 and 22 |
| Pharmacokinetics parameter: AUCtau of M5 | Characterize PK of metabolite M5 |
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Inclusion Criteria:
Exclusion Criteria:
Other protocol-defined Inclusion/Exclusion criteria may apply.
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| Name | Affiliation | Role |
|---|---|---|
| Novartis Pharmaceuticals | Novartis Pharmaceuticals | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Karmanos Cancer Institute Karmanos Cancer Institute | Detroit | Michigan | 48201 | United States | ||
| University of Oklahoma |
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| Label | URL |
|---|---|
| Results for CTMT212X2102 can be found on the Novartis Clinical Trial Results Website | View source |
| A Plain Language Trial Summary is available on novartisclinicaltrials.com | View source |
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| Trametinib | Drug | Each tablet is 0.5mg trametinib to be taken orally once daily. 0.5mg tablets may be used if a dose reduction is required. |
|
| Oral Contraceptive (1mg norethindrone, 0.035mg ethinyl estradiol) | Drug | Combined oral contraceptive to be taken orally once daily. |
|
| Day 21 and 22 |
| Pharmacokinetics parameter: Cmax of M5 | Characterize PK of metabolite M5 | Day 21 and 22 |
| Pharmacokinetics parameter: Tmax of M5 | Characterize PK of metabolite M5 | Day 21 and 22 |
| Oklahoma City |
| Oklahoma |
| 73104 |
| United States |
| Novartis Investigative Site | Edegem | 2650 | Belgium |
| Novartis Investigative Site | Namur | 5000 | Belgium |
| Novartis Investigative Site | Maastricht | 6229 HX | Netherlands |
| Novartis Investigative Site | Málaga | 29010 | Spain |
| Novartis Investigative Site | London | W1G 6AD | United Kingdom |
| ID | Term |
|---|---|
| C560077 | trametinib |
| D003276 | Contraceptives, Oral |
| D009640 | Norethindrone |
| D004997 | Ethinyl Estradiol |
| ID | Term |
|---|---|
| D003271 | Contraceptive Agents, Female |
| D003270 | Contraceptive Agents |
| D012102 | Reproductive Control Agents |
| D045505 | Physiological Effects of Drugs |
| D020228 | Pharmacologic Actions |
| D020164 | Chemical Actions and Uses |
| D045506 | Therapeutic Uses |
| D009652 | Norpregnenes |
| D009650 | Norpregnanes |
| D009654 | Norsteroids |
| D013256 | Steroids |
| D000072473 | Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |
| D009651 | Norpregnatrienes |
| D042782 | Estrogenic Steroids, Alkylated |
| D045166 | Estradiol Congeners |
| D012739 | Gonadal Steroid Hormones |
| D042341 | Gonadal Hormones |
| D006728 | Hormones |
| D006730 | Hormones, Hormone Substitutes, and Hormone Antagonists |
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