Trial record 1 of 1 for:    NCT01901172
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A Study of the Drug-Drug Interaction of RO5503781 and Posaconazole and of the Relative Bioavailability of New Formulations of RO5503781 in Patients With Solid Tumors

This study is currently recruiting participants.
Verified April 2014 by Hoffmann-La Roche
Sponsor:
Information provided by (Responsible Party):
Hoffmann-La Roche
ClinicalTrials.gov Identifier:
NCT01901172
First received: July 9, 2013
Last updated: April 7, 2014
Last verified: April 2014

July 9, 2013
April 7, 2014
August 2013
January 2015   (final data collection date for primary outcome measure)
  • Part 1: Area under the concentration-time curve (AUC) [ Time Frame: 22 days ] [ Designated as safety issue: No ]
  • Part 1: Maximum concentration (Cmax) [ Time Frame: 22 days ] [ Designated as safety issue: No ]
  • Part 1: Change in serum macrophage inhibitory cytokine-1 (MIC-1) [ Time Frame: from baseline to Day 22 ] [ Designated as safety issue: No ]
  • Part 2: Relative bioavailability: Area under the concentration-time curves (AUCs) [ Time Frame: 22 days ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01901172 on ClinicalTrials.gov Archive Site
  • Safety: Incidence of adverse events in combination with posaconazole [ Time Frame: 28 days ] [ Designated as safety issue: No ]
  • Safety: Incidence of adverse events (new formulations) [ Time Frame: 28 days ] [ Designated as safety issue: No ]
  • Safety: Incidence of adverse events (optional treatment extension) [ Time Frame: approximately 1 year ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
A Study of the Drug-Drug Interaction of RO5503781 and Posaconazole and of the Relative Bioavailability of New Formulations of RO5503781 in Patients With Solid Tumors
A MULTIPLE-CENTER, OPEN-LABEL CLINICAL PHARMACOLOGY STUDY WITH RO5503781, AN MDM2 ANTAGONIST, IN PATIENTS WITH SOLID TUMORS TO DETERMINE: PART 1 ONE-SEQUENCE, 2-PERIOD CROSSOVER DESIGN TO INVESTIGATE THE EFFECT OF POSACONAZOLE, A STRONG CYP3A4 INHIBITOR, ON THE PHARMACOKINETICS AND PHARMACODYNAMICS OF RO5503781 PART 2 A RANDOMIZED, SINGLE DOSE, 3 PERIOD CROSSOVER DESIGN TO INVESTIGATE THE RELATIVE BIOAVAILABILITY OF TWO NEW RO5503781 TABLET FORMULATIONS FOLLOWING ORAL ADMINISTRATION

This multicenter, open-label study will evaluate the effect of posaconazole on the pharmacokinetics of RO5503781 and the relative bioavailability of two new RO5503781 formulations in patients with solid tumors.

Not Provided
Interventional
Phase 1
Allocation: Randomized
Endpoint Classification: Pharmacokinetics/Dynamics Study
Intervention Model: Crossover Assignment
Masking: Open Label
Neoplasms
  • Drug: RO5503781
    Single doses Days 1 and 11
  • Drug: posaconazole
    Multiple doses Days 8-14
  • Drug: RO5503781
    Single doses of current formulation, optimized MBP formulation and new SDP formulation, Days 1, 8 and 15 in a crossover design
  • Drug: RO5503781
    Daily for 5 days followed by 23 days rest per cycle
  • Experimental: Part 1: Drug-drug interaction
    Interventions:
    • Drug: RO5503781
    • Drug: posaconazole
  • Experimental: Part 2: Relative bioavailability
    Intervention: Drug: RO5503781
  • Experimental: Extension
    Intervention: Drug: RO5503781
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
30
January 2015
January 2015   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Adult patients, >/= 18 years of age
  • Histologically or cytologically confirmed advanced malignancies, except all forms of leukemia and lymphoma, for which standard curative or palliative measures do not exist, are no longer effective, or are not acceptable to the patient
  • Measureable or evaluable disease (by RECIST criteria version 1.1 for solid tumors prior to the administration of study drug
  • Life expectancy of >/= 12 weeks.
  • Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1.
  • Female patients of childbearing potential and male patients who are not surgically sterile must be willing to use effective methods of contraception as defined by protocol during the treatment period and for 10 days after the last dose of RO5503781.
  • There are no limitations on additional, allowable type and amount of prior anti-tumor therapy. Acute toxicities from any prior anti-tumor therapy, surgery, or radiotherapy must have resolved to NCI-CTCAE version 4.03 Grade </= 1. The last dose of prior therapy must >/= 21 days prior to the first administration of study drug RO5503781 (or >/= 5 x terminal half-life of that therapy).
  • Adequate bone marrow, hepatic and renal function
  • Patients with stable CNS metastases (have had therapy or do not require therapy, are off steroids, have no change on screening CT or MRI and are asymptomatic), are eligible

Exclusion Criteria:

  • Any form of leukemia except for Stage 0 and 1 chronic lymphocytic leukemia (CLL) not requiring treatment in addition to the underlying malignancy
  • Hormonal therapy within the 2 weeks prior to the first dose of study medication. Patients with prostate cancer who are not surgically castrated should remain on GnRH analogues.
  • Patients who are using other investigational agents or who received investigational drugs </= 4 weeks prior to study treatment start.
  • Pre-existing GI disorders that may interfere with proper absorption of the drug(s), as per investigator discretion.
  • History of allergic reactions attributed to components of the formulated product
  • History of seizure disorders or unstable CNS metastases
  • Any severe and/or uncontrolled medical conditions or other conditions that could affect their participation in the study
  • Patients who must receive CYP2C8 inhibitors, substrates or inducers, strong CYP 3A4 inducers or moderate/strong CYP3A4 inhibitors listed in protocol while on study. Substrates, inducers, and inhibitors listed in protocol must be discontinued 7 or 14 days prior to start of study medication.
  • Evidence of electrolyte imbalance (treatment for correction of electrolyte imbalances is permitted during screening to meet eligibility)
  • Pregnant or breast feeding women
  • HIV-positive patients who are currently receiving combination anti-retroviral therapy
  • Patients with known coagulopathy, platelet disorder or history of non-drug induced thrombocytopenia.
  • Patients receiving oral or parenteral anticoagulants/antiplatelet agents (e.g., chronic daily treatment with aspirin (> 325 mg/day), clopidogrel, low molecular weight heparin, or subcutaneous anticoagulant prophylaxis). A washout period of at least 7 days prior to the start of study is required. Patients may receive anticoagulant flushes for maintenance of indwelling catheters.
  • Patients who refuse to potentially receive blood products and/or have a hypersensitivity to blood products.
  • Part 1 only: Hypersensitivity to posaconazole, or any of the other ingredients, or any other azole antifungal
  • Part 1 only: Patients who cannot tolerate high-fat and/or full meals.
Both
18 Years and older
No
Contact: Reference Study ID Number: NP28902 www.roche.com/about_roche/roche_worldwide.htm 888-662-6728 (U.S. Only) global.rochegenentechtrials@roche.com
United States,   Canada
 
NCT01901172
NP28902
Not Provided
Hoffmann-La Roche
Hoffmann-La Roche
Not Provided
Study Director: Clinical Trials Hoffmann-La Roche
Hoffmann-La Roche
April 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP