Advanced Solid TumoursPhase 1NCT03150368
Extended Use of ModraDoc006/r
A Phase 1 study testing ModraDoc006/r in people with Advanced Solid Tumours, run by Modra Pharmaceuticals at 1 site in Netherlands.
Trial summary
This is a study for extended use of ModraDoc006/r in patients with advanced solid tumours, available after completed treatment in one of the phase I trials with ModraDoc006/r. The primary goal is to explore the safety of extended use. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Advanced Solid Tumours
- What is being tested?
- ModraDoc006/r
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 17 participants
- Where
- 1 siteNetherlands
- Study dates
- 10 May 2017to 16 May 2019
- 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
- Histological or cytological proof of cancer
- Patients who might benefit from a weekly (oral) docetaxel regime as judged by the treating oncologist.
- Patients who received treatment with ModraDoc006/r with acceptable safety (as judged by the PI; for criteria see below in section 3 of exclusion criteria) in phase I trials with ModraDoc006/r, including (but not limited to) the N15FED (food-interaction study), N16AED (absorption-excretion study), N16DOL (normal or impaired liver function). A maximum delay of 21 days between the last dose in the previous phase I trial and the first dose in the N17DEX is allowed.
- Age ≥ 18 years
- WHO performance status of 0, 1 or 2;
- Minimal acceptable laboratory values defined as:
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- ANC of ≥ 1.5 x 109 /L
- Platelet count of ≥ 100 x 109 /L
- Renal function as defined by serum creatinine ≤ 1.5 x ULN or creatinine clearance ≥ 50 ml/min (by Cockcroft-Gault formula)
- Hepatic function as defined by serum bilirubin ≤ 2 x ULN, ALAT and ASAT ≤ 5.0 x ULN, except for patients who have been treated in the N16DOL study.
- Negative pregnancy test (urine/serum) for female patients with childbearing potential, assessed at the screening visit of the previous phase I trial with ModraDoc006/r.
- Able and willing to swallow oral medication
Who cannot join
- Concomitant use of MDR and CYP3A modulating drugs such as Ca+-entry blockers (verapamil, dihydropyridines), cyclosporine, quinidine, quinine, tamoxifen, megestrol and grapefruit juice, concomitant use of HIV medications; other protease inhibitors, (non) nucleoside analogs, St. John's wort or macrolide antibiotics.
- Symptomatic brain metastases or leptomeningeal metastases. Patients with brain metastases are allowed if they received adequate treatment, are asymptomatic in the absence of corticosteroid therapy and anticonvulsant therapy for at least 6 weeks. Radiotherapy for brain metastases must have been completed at least 4 weeks prior to start of study treatment.
- Clinically significant safety issues during previous therapy with ModraDoc006/r as judged by the PI, which cannot be solved by dose reduction and/or treatment delay.
- Unreliable contraceptive methods. Both men and women using ModraDoc006/r must agree to use a reliable contraceptive method throughout the study (adequate contraceptive methods are: condom, sterilization, other barrier contraceptive measures preferably in combination with condoms).
- Anti-cancer therapy or any treatment with investigational drugs other than ModraDoc006/r between the completion of the phase I trial with ModraDoc006/r and the start of extended use of ModraDoc006/r Palliative radiation on limited field is allowed.
- Uncontrolled infectious disease or known Human Immunodeficiency Virus HIV-1 or HIV-2 type patients. Patients with a known history of hepatitis B or C.
- Bowel obstructions or motility disorders that may influence the resorption of drugs as judged by the treating physician.
- Patients with known alcoholism, drug addiction and/or psychiatric of physiological condition which in the opinion of the investigator would impair study compliance; Evidence of any other disease, neurological or metabolic dysfunction, physical examination finding or laboratory finding giving reasonable suspicion of a disease or condition that contraindicates the use of an investigational drug or puts the patient at high risk for treatment-related complications.
Trial locations and contacts
1 site in 1 country.
Netherlands1 site
Netherlands Cancer Institute - Antoni van Leeuwenhoek
Amsterdam, 1066 CX
About this study
Official title: Safety of Extended Use of ModraDoc006/r in Patients With Advanced Solid Tumours
This is a study for extended use of ModraDoc006/r in patients with advanced solid tumours, available after completed treatment in one of the phase I trials with ModraDoc006/r. The primary goal is to explore the safety of extended use.
Read the detailed description
This is an open label extended use programme, designed to make extended use treatment with weekly ModraDoc006/r available for patients who completed treatment in one of the phase I trials with ModraDoc006/r, who might have clinical benefit of continued treatment with the oral docetaxel formulation.
Patients will receive oral docetaxel (as ModraDoc006 10 mg tablets) and ritonavir (100 mg tablet) once- or bi-daily, once a week in a fasted condition. Treatment can be continued weekly as long as the patient experiences clinical benefit from the treatment as judged by the treating oncologist, unless unacceptable toxicity despite dose modifications and supportive measures occurs.
- Conditions
- Advanced Solid Tumours
- Being tested
- ModraDoc006/r
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ModraDoc006/rDrug
Also called oral docetaxel formulation
Treatment with weekly ModraDoc006 (oral docetaxel) 10mg tablets in combination with ritonavir 100mg tablets
| Study group | Role | What they receive |
|---|---|---|
| ModraDoc006/r | Experimental | Weekly ModraDoc006/r treatment as ModraDoc006 (oral docetaxel) 10mg tablets combined with ritonavir 100mg tablets Receives: Drug: ModraDoc006/r |
What is being measured
The primary outcome is the main question the study is designed to answer.
The hematological and non-hematological toxicity profile of oral docetaxel in combination with ritonavir
The number of CTCAE v.4.03 grade 3-4 toxicities during treatment with ModraDoc006/r
Measured: Safety and tolerance will be evaluated during the complete study treatment until 28 days after the last intake, using the CTCAE v.4.03 grading system
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 May 2017
- Study start10 May 2017
- Primary completion16 May 2018
- Study completion16 May 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Advanced Solid TumoursStudies of the same condition, open and under way.
- 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
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- After completion of a phase 1 trial with ModraDoc006/r, patients are able to continue weekly treatment with oral docetaxel (ModraDoc006) in combination with ritonavir, for as long as safe clinical benefit from the treatment is experienced, as judged by the treating oncologist.
- Masking
- None (open label)
- Enrolment
- 17 participants (actual)
Sponsor and investigators
- Lead sponsor
- Modra Pharmaceuticals
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Serena Marchetti, MD, PhD, Principal investigator, The Netherlands Cancer Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03150368
- Sponsor's protocol ID
- N17DEX
- Status last verified
- Oct 2021
- First submitted
- 10 May 2017
- Last updated
- 19 Oct 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Oct 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Safety of Extended Use of ModraDoc006/r in Patients With Advanced Solid Tumours
- ClinicalTrials.gov ID
- NCT03150368
- Acronym / sponsor ID
- N17DEX
- Conditions
- Advanced Solid Tumours
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 17 participants (actual)
- Lead sponsor
- Modra PharmaceuticalsIndustry (pharma, biotech, devices)
- Study start
- 10 May 2017 (actual)
- Primary completion
- 16 May 2018 (actual)
- Study completion
- 16 May 2019 (actual)
- First posted
- 12 May 2017 (actual)
- 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 is a study for extended use of ModraDoc006/r in patients with advanced solid tumours, available after completed treatment in one of the phase I trials with ModraDoc006/r. The primary goal is to explore the safety of extended use.
Detailed description
This is an open label extended use programme, designed to make extended use treatment with weekly ModraDoc006/r available for patients who completed treatment in one of the phase I trials with ModraDoc006/r, who might have clinical benefit of continued treatment with the oral docetaxel formulation.
Patients will receive oral docetaxel (as ModraDoc006 10 mg tablets) and ritonavir (100 mg tablet) once- or bi-daily, once a week in a fasted condition. Treatment can be continued weekly as long as the patient experiences clinical benefit from the treatment as judged by the treating oncologist, unless unacceptable toxicity despite dose modifications and supportive measures occurs.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- After completion of a phase 1 trial with ModraDoc006/r, patients are able to continue weekly treatment with oral docetaxel (ModraDoc006) in combination with ritonavir, for as long as safe clinical benefit from the treatment is experienced, as judged by the treating oncologist.
| Arm | Type | Receives |
|---|---|---|
| ModraDoc006/r | Experimental | Drug: ModraDoc006/rWeekly ModraDoc006/r treatment as ModraDoc006 (oral docetaxel) 10mg tablets combined with ritonavir 100mg tablets |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- Histological or cytological proof of cancer
- Patients who might benefit from a weekly (oral) docetaxel regime as judged by the treating oncologist.
- Patients who received treatment with ModraDoc006/r with acceptable safety (as judged by the PI; for criteria see below in section 3 of exclusion criteria) in phase I trials with ModraDoc006/r, including (but not limited to) the N15FED (food-interaction study), N16AED (absorption-excretion study), N16DOL (normal or impaired liver function). A maximum delay of 21 days between the last dose in the previous phase I trial and the first dose in the N17DEX is allowed.
- Age ≥ 18 years
- WHO performance status of 0, 1 or 2;
Key exclusion criteria (8 listed)
- Concomitant use of MDR and CYP3A modulating drugs such as Ca+-entry blockers (verapamil, dihydropyridines), cyclosporine, quinidine, quinine, tamoxifen, megestrol and grapefruit juice, concomitant use of HIV medications; other protease inhibitors, (non) nucleoside analogs, St. John's wort or macrolide antibiotics.
- Symptomatic brain metastases or leptomeningeal metastases. Patients with brain metastases are allowed if they received adequate treatment, are asymptomatic in the absence of corticosteroid therapy and anticonvulsant therapy for at least 6 weeks. Radiotherapy for brain metastases must have been completed at least 4 weeks prior to start of study treatment.
- Clinically significant safety issues during previous therapy with ModraDoc006/r as judged by the PI, which cannot be solved by dose reduction and/or treatment delay.
- Unreliable contraceptive methods. Both men and women using ModraDoc006/r must agree to use a reliable contraceptive method throughout the study (adequate contraceptive methods are: condom, sterilization, other barrier contraceptive measures preferably in combination with condoms).
- Anti-cancer therapy or any treatment with investigational drugs other than ModraDoc006/r between the completion of the phase I trial with ModraDoc006/r and the start of extended use of ModraDoc006/r Palliative radiation on limited field is allowed.
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 |
|---|---|---|
| ModraDoc006/rAlso: oral docetaxel formulationTreatment with weekly ModraDoc006 (oral docetaxel) 10mg tablets in combination with ritonavir 100mg tablets | Drug | ModraDoc006/r |
Primary outcome
The hematological and non-hematological toxicity profile of oral docetaxel in combination with ritonavir
Time frame: Safety and tolerance will be evaluated during the complete study treatment until 28 days after the last intake, using the CTCAE v.4.03 grading system
The number of CTCAE v.4.03 grade 3-4 toxicities during treatment with ModraDoc006/r
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 19 Oct 2021.
- Individual participant dataSharing planned: No
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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.
Serena Marchetti, MD, PhD principal investigator
The Netherlands Cancer Institute
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing ModraDoc006/r in people with Advanced Solid Tumours, run by Modra Pharmaceuticals at 1 site in Netherlands.
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 12 inclusion and 8 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 19 Oct 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Netherlands. 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?
The hematological and non-hematological toxicity profile of oral docetaxel in combination with ritonavir (time frame: Safety and tolerance will be evaluated during the complete study treatment until 28 days after the last intake, using the CTCAE v.4.03 grading system). 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 19 Oct 2021.