NL-OMON49519
Completed
Not Applicable
A Phase 1, Open-Label, Multicenter, Drug-Drug Interaction Study of TAK-788 and Midazolam, a Sensitive CYP3A Substrate, in Patients With Advanced Non*Small Cell Lung Cancer - Drug-Drug Interaction Study
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Not specified
- Sponsor
- Millenium Pharmaceuticals
- Enrollment
- 6
- Status
- Completed
- Last Updated
- 2 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •1\. Male or female patients aged \*18 years.
- •2\. Histologically or cytologically confirmed locally advanced NSCLC in which
- •the patient is not a candidate for definitive therapy; or, the patient has
- •recurrent or metastatic (Stage IV) disease.
- •3\. Refractory or intolerant to standard available therapies.
- •4\. Eastern Cooperative Oncology Group (ECOG) performance status 0 to 1\.
- •5\. Minimum life expectancy of 3 months or more.
- •6\. Adequate organ function as defined by the protocol criteria.
- •a) Total serum bilirubin \*1\.5 × upper limit of normal (ULN) (\*3 × ULN for
- •patients with Gilbert syndrome or if liver function abnormalities are due to
Exclusion Criteria
- •1\. Previously received TAK\-788\.
- •2\. Received a strong or moderate CYP3A inhibitor or strong or moderate CYP3A
- •inducer within 2 weeks prior to the first dose of TAK\-788\.
- •3\. Received small\-molecule anticancer therapy (including but not limited to
- •cytotoxic chemotherapy and investigational agents) within 2 weeks prior to the
- •first dose of TAK\-788\.
- •4\. Received antineoplastic monoclonal antibodies including check point
- •inhibitors within 28 days of the first dose of TAK\-788\.
- •5\. Received radiotherapy \*14 days prior to the first dose of TAK\-788\. However,
- •patients are allowed to receive any of the following treatments up to 7 days
Outcomes
Primary Outcomes
Not specified
Similar Trials
Not yet recruiting
Not Applicable
A phase I, multi-center, open-label, drug-drug interaction study to assess the effect of the CYP1A2 inhibitor, fluvoxamine, on TKI258 (dovitinib) pharmacokinetics in patients with advanced solid tumors.advanced cancersolid tumors10027655NL-OMON39285ovartis12
Completed
Phase 1
A Phase I, Open label, Multi-Center Clinical Pharmacological Study of nemolizumab with a Single-dose in Japanese Atopic Dermatitis Patients with moderate to severe pruritusAtopic dermatitis with pruritus who are inadequately controlled by existing therapiesJPRN-jRCT2080225290Maruho Co., Ltd.25
Completed
Not Applicable
A phase 1, open-label, fixed-sequence, drug-drug interaction study of APX001 to evaluate the effects of CYP3A4 inhibition and pan-CYP induction in two parallel groups of healthy male and female subjectsFungal infectionsNL-OMON47992Amplyx Pharmaceuticals, Inc.36
Completed
Not Applicable
A phase 1, open-label, fixed-sequence, drug-drug interaction study between multiple oral doses of Inarigivir Soproxil and a single oral dose of midazolam in healthy subjectsNL-OMON46790Spring Bank Pharmaceuticals, Inc.16
Active, not recruiting
Phase 1
A study to evaluate the safety, processing by the body and response of the body to tenecteplase in adults with acute ischemic strokeISRCTN13376195Roche (United States)20