NeoplasmsPhase 1NCT01901172
A Study of the Drug-Drug Interaction of RO5503781 and Posaconazole, the Relative Bioavailability of New Formulations of RO5503781 and the Food-Effect on the Pharmacokinetics of RO5503781 in Patients With Solid Tumors
A Phase 1 study testing RO5503781 and posaconazole in people with Neoplasms, run by Hoffmann-La Roche at 4 sites in 2 countries.
Trial summary
This multicenter, open-label study will evaluate the effect of posaconazole on the pharmacokinetics of RO5503781, the relative bioavailability of two new RO5503781 formulations, and the effect of food on the pharmacokinetics of RO5503781 in patients with solid tumors. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Neoplasms
- What is being tested?
- RO5503781 and posaconazole
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 61 participants
- Where
- 4 sitesin 2 countries
- Study dates
- Aug 2013to Jun 2015
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
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- 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
Who cannot join
- 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
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- 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 and Part 3: Patients who cannot tolerate high-fat and/or full meals.
Trial locations and contacts
4 sites in 2 countries.
4 sites in 2 countries
United States2 sites
Study site
Dallas, Texas, 75230
Study site
Scottsdale, Arizona, 85258
Canada2 sites
Study site
Montreal, Quebec, H3T 1E2
Study site
Toronto, Ontario, M5G 2M9
About this study
This multicenter, open-label study will evaluate the effect of posaconazole on the pharmacokinetics of RO5503781, the relative bioavailability of two new RO5503781 formulations, and the effect of food on the pharmacokinetics of RO5503781 in patients with solid tumors.
- Conditions
- Neoplasms
- Being tested
- RO5503781, posaconazole
- Medical subject headings
- Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RO5503781Drug
Single dose on Day 1 (high fat, low fat, or fasted), Day 10 (fasted, low fat, or high fat), and Day 19 (low fat, fasted, or high fat) in a crossover design
RO5503781Drug
Daily for 5 days followed by 23 days rest per cycle
RO5503781Drug
Single doses of current formulation, optimized MBP formulation and new SDP formulation, Days 1, 8 and 15 in a crossover design
RO5503781Drug
Single doses Days 1 and 11
posaconazoleDrug
Multiple doses Days 8-14
| Study group | Role | What they receive |
|---|---|---|
| Extension | Experimental | Not described Receives: Drug: RO5503781 |
| Part 1: Drug-drug interaction | Experimental | Not described Receives: Drug: RO5503781; Drug: posaconazole |
| Part 2: Relative bioavailability | Experimental | Not described Receives: Drug: RO5503781 |
| Part 3: Food effect | Experimental | Not described Receives: Drug: RO5503781 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Part 1: Area under the concentration-time curve (AUC)
Measured: 22 days
Part 1: Maximum concentration (Cmax)
Measured: 22 days
Part 1: Change in serum macrophage inhibitory cytokine-1 (MIC-1)
Measured: from baseline to Day 22
Part 2: Relative bioavailability: Area under the concentration-time curves (AUCs)
Measured: 22 days
Part 3: Food effect: Area under the concentration-time curves (AUCs)
Measured: 28 days
Secondary outcomes (3)
Safety: Incidence of adverse events in combination with posaconazole
Measured: 28 days
Safety: Incidence of adverse events (new formulations)
Measured: 28 days
Safety: Incidence of adverse events (optional treatment extension)
Measured: approximately 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jul 2013 (estimated)
- Study startAug 2013
- Primary completionJun 2015
- Study completionJun 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for NeoplasmsStudies of the same condition, open and under way.
- More trials run by Hoffmann-La RocheThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 61 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hoffmann-La Roche
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Clinical Trials, Study director, Hoffmann-La Roche
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01901172
- Sponsor's protocol ID
- NP28902
- Status last verified
- Aug 2015
- First submitted
- 9 Jul 2013
- Last updated
- 18 Aug 2015
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Aug 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Study of the Drug-Drug Interaction of RO5503781 and Posaconazole, the Relative Bioavailability of New Formulations of RO5503781 and the Food-Effect on the Pharmacokinetics of RO5503781 in Patients With Solid Tumors
- ClinicalTrials.gov ID
- NCT01901172
- Acronym / sponsor ID
- NP28902
- Conditions
- Neoplasms
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 61 participants (actual)
- Lead sponsor
- Hoffmann-La RocheIndustry (pharma, biotech, devices)
- Study start
- Aug 2013
- Primary completion
- Jun 2015 (actual)
- Study completion
- Jun 2015 (actual)
- First posted
- 17 Jul 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This multicenter, open-label study will evaluate the effect of posaconazole on the pharmacokinetics of RO5503781, the relative bioavailability of two new RO5503781 formulations, and the effect of food on the pharmacokinetics of RO5503781 in patients with solid tumors.
Study design
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Extension | Experimental | Drug: RO5503781 |
| Part 1: Drug-drug interaction | Experimental | Drug: RO5503781, Drug: posaconazole |
| Part 2: Relative bioavailability | Experimental | Drug: RO5503781 |
| Part 3: Food effect | Experimental | Drug: RO5503781 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- 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.
Key exclusion criteria (16 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| RO5503781Single dose on Day 1 (high fat, low fat, or fasted), Day 10 (fasted, low fat, or high fat), and Day 19 (low fat, fasted, or high fat) in a crossover design | Drug | Part 3: Food effect |
| RO5503781Daily for 5 days followed by 23 days rest per cycle | Drug | Extension |
| RO5503781Single doses of current formulation, optimized MBP formulation and new SDP formulation, Days 1, 8 and 15 in a crossover design | Drug | Part 2: Relative bioavailability |
| RO5503781Single doses Days 1 and 11 | Drug | Part 1: Drug-drug interaction |
| posaconazoleMultiple doses Days 8-14 | Drug | Part 1: Drug-drug interaction |
Primary outcome
Part 1: Area under the concentration-time curve (AUC)
Time frame: 22 days
Part 1: Maximum concentration (Cmax)
Time frame: 22 days
Part 1: Change in serum macrophage inhibitory cytokine-1 (MIC-1)
Time frame: from baseline to Day 22
Part 2: Relative bioavailability: Area under the concentration-time curves (AUCs)
Time frame: 22 days
Part 3: Food effect: Area under the concentration-time curves (AUCs)
Time frame: 28 days
3 secondary outcomes
Safety: Incidence of adverse events in combination with posaconazole
Time frame: 28 days
Safety: Incidence of adverse events (new formulations)
Time frame: 28 days
Safety: Incidence of adverse events (optional treatment extension)
Time frame: approximately 1 year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Aug 2015.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Clinical Trials study director
Hoffmann-La Roche
4 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing RO5503781 and posaconazole in people with Neoplasms, run by Hoffmann-La Roche at 4 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 Aug 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in United States, Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Part 1: Area under the concentration-time curve (AUC) (time frame: 22 days). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Aug 2015.