CancerPhase 1NCT01173913
Weekly Administration of (bi-)Daily Oral Docetaxel in Combination With Ritonavir
A Phase 1 study testing ModraDoc001 10mg capsules, ModraDoc003 10mg tablets and ModraDoc004 10/50 mg and ModraDoc006 10 mg tablet in people with Cancer, run by The Netherlands Cancer Institute at 1 site in Netherlands.
Trial summary
Oral administration has many advantages above intravenously administrated drugs for patients. Up to now, oral administration of docetaxel as single agent has not been feasible due to low and variable bioavailability. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Cancer
- What is being tested?
- ModraDoc001 10mg capsules, ModraDoc003 10mg tablets and ModraDoc004 10/50 mg and ModraDoc006 10 mg tablet
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 57 participants
- Where
- 1 siteNetherlands
- Study dates
- Sep 2010to 26 Jan 2017
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Histological or cytological proof of cancer
- Patients for whom no standard therapy of proven benefit exist
- Patients who might benefit from treatment with docetaxel, e.g. advanced breast, gastric, esophagus, bladder, ovarian cancer and non-small cell lung cancer, head and neck cancers, prostate cancer and carcinoma of unknown primary site.
- Age _ 18 years
- Able and willing to give written informed consent
- Able and willing to undergo blood sampling for pharmacokinetics
Show all 15Show fewer
- Life expectancy _ 3 months allowing adequate follow up of toxicity evaluation and anti-tumor activity
- Minimal acceptable safety laboratory values
- ANC of _ 1.5 x 109 /L
- Platelet count of _ 100 x 109 /L
- Hepatic function as defined by serum bilirubin _ 1.5 x ULN, ALAT and ASAT _ 2.5 x ULN
- Renal function as defined by serum creatinine _ 1.5 x ULN or creatinine clearance _ 50 ml/min (by Cockcroft-Gault formula).
- WHO performance status of _ 2
- No radio- or chemotherapy within the last 4 weeks prior to study entry (palliative limited radiation for pain reduction is allowed)
- Able and willing to swallow oral medication
Who cannot join
- Patients with known alcoholism, drug addiction and/or psychotic disorders in the history that are not suitable for adequate follow up
- Women who are pregnant or breast feeding.
- Both men and women enrolled in this trial 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).
- 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 analoga, St. Johns wort or macrolide antibiotics as erythromycin and clarithromycin.
- Uncontrolled infectious disease or known HIV-1 or HIV-2 type patients
- Unresolved (>grade 1) toxicities of previous chemotherapy
Show all 12Show fewer
- Bowel obstructions or motility disorders that may influence the absorption of drugs
- Chronic use of H2-receptor antagonists or proton pump inhibitors
- Neurologic disease that may render a patient at increased risk for peripheral or central neurotoxicity
- Pre-existing neuropathy greater than CTC grade 1
- Symptomatic cerebral or leptomeningeal metastases
- 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 Hospital
Amsterdam, 1066 CX
About this study
Oral administration has many advantages above intravenously administrated drugs for patients. Up to now, oral administration of docetaxel as single agent has not been feasible due to low and variable bioavailability. This low systematic exposure to docetaxel can effectively be increased after co-administration of ritonavir. The department of pharmacy of the Slotervaart Hospital and Netherlands Cancer Institute developed a solid oral dosage form for docetaxel, ModraDoc001 10 mg capsules.
Two other novel dosage forms of docetaxel with improved pharmaceutical characteristics, have been developed: ModraDoc003 10 mg tablets and ModraDoc004 10/50 mg tablets. The systemic exposure after administration of those forms is now being investigated.
Read the detailed description
The bioavailability of docetaxel is limited due to metabolising cytochrome P450 (CYP) enzymes, which are abundantly present in the gastrointestinal tract.
Inhibition of CYP3A4 enzymes with ritonavir (an anti-retroviral drug) has in previously conducted proof-of-concept and phase I trials, proven to enhance the bioavailability of oral docetaxel.
Oral administration of docetaxel has been investigated in five clinical trials, all initiated by the Netherlands Cancer Institute - Antoni van Leeuwenhoek Hospital (NKI-AVL). The department of pharmacy of the Slotervaart Hospital and Netherlands Cancer Institute developed a solid oral dosage form for docetaxel, ModraDoc001 10 mg capsules. This formulation has now been investigated in more than 40 patients in a first clinical study. The preliminary results with ModraDoc001 10mg are promising and a linearity between systemic exposure to docetaxel and the applied dose of ModraDoc001 10mg capsules is seen. In an attempt to further improve and prolong the systemic exposure we will explore a twice daily dosing schedule.
Two other novel dosage forms for docetaxel, ModraDoc003 10 mg tablets and ModraDoc004 10/50 mg tablets, were developed. Both are spray-dried solid dispersions of docetaxel pressed in tablets. The distinction between both is that ritonavir is included in the co-formulation of ModraDoc004 10/50 mg tablets (10 mg docetaxel and 50 mg ritonavir). Both dosage forms will be investigated in arm B to see whether these new formulations have comparable pharmacokinetic characteristics of docetaxel to the capsule formulation.
Arm A Arm A is a dose escalation study to establish the maximum tolerated dose (MTD)of weekly bi-daily ModraDoc001 10 mg capsules. This study will be done with a classical dose escalation design. The starting dose will be 40 mg BID. This dose is based on a safety of weekly 80 mg single dose in the previously conducted study.
Arm B ModraDoc003 10 mg tablets and ModraDoc004 10/50 mg tablets will be investigated in arm B to see whether these new formulations have comparable pharmacokinetic characteristics of docetaxel to the capsule formulation od ModraDoc001 10 mg.
Another part of this study is the screening for 2 different polymorphism, C1236T (for MDR1)and CYP3A4*1B. Polymorphic variants may influence the absorption and elimination of docetaxel and ritonavir.
Arm D is a dose escalation study to establish the maximum tolerated dose (MTD)of weekly bi-daily ModraDoc006 10 mg tablets. This study will be done with a classical dose escalation design. The starting dose will be 20 mg BID. This dose is based on a safety of BID weekly ModraDoc001 mg in the previously conducted arm A.
- Conditions
- Cancer
- Being tested
- ModraDoc001 10mg capsules, ModraDoc003 10mg tablets and ModraDoc004 10/50 mg, ModraDoc006 10 mg tablet
- Keywords
- oral docetaxel, ModraDoc, pharmacokinetics, safety, MTD, DLT
- Medical subject headings
- Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ModraDoc001 10mg capsulesDrug
Bi-daily administration. One cycle will last 7 days
ModraDoc003 10mg tablets and ModraDoc004 10/50 mgDrug
The patients will receive 40 mg docetaxel and 200 mg ritonavir once daily as different dosage forms (ModraDoc001 10 mg capsules, ModraDoc003 10 mg tablets and ModraDoc004 10/50 mg tablets). Patients continue in Week 4 with 80 mg docetaxel (as ModraDoc001 10 mg capsules) in combination with 100 mg ritonavir once daily in a weekly schedule until progressive disease or adverse events, which require dose modifications or discontinuation of therapy, are observed.
ModraDoc006 10 mg tabletDrug
Bi-daily administration. One cycle will last 7 days
| Study group | Role | What they receive |
|---|---|---|
| ModraDoc001 10 mg capsules | Experimental | The optimal dose weekly bi-daily oral docetaxel - ModraDoc001 10 mg in combination with ritonavir will be determined with a classical dose escalation design. Approximately 24 patients will be enrolled depending on required number of dose levels before MTD is reached. Receives: Drug: ModraDoc001 10mg capsules |
| ModraDoc003 10mg tablets and ModraDoc004 10/50 mg | Experimental | Both new oral dosage forms, ModraDoc003 10 mg tablets and ModraDoc004 10/50 mg tablets will be investigated to see whether these new formulations have comparable pharmacokinetic characteristics, in terms of systemic exposure to docetaxel, as ModraDoc001 10 mg capsule. Receives: Drug: ModraDoc003 10mg tablets and ModraDoc004 10/50 mg |
| ModraDoc006 10 mg tablet | Experimental | The optimal dose weekly bi-daily oral docetaxel - ModraDoc006 10 mg in combination with ritonavir will be determined with a classical dose escalation design. Approximately 24 patients will be enrolled depending on required number of dose levels before MTD is reached. Receives: Drug: ModraDoc006 10 mg tablet |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number and percentage of Participants with Adverse Events
The maximal tolerated dose (defined as the highest dose resulting in no more that 1/6 probability of causing a dose limiting toxicities defined in the protocol) of bi-daily ModraDoc001 10mg capsules with ritonavir will be assessed in Arm A. Weekly safety assessments for Arm A and Arm B: signs and symptoms/adverse events, physical examination, clinical laboratory tests (hematology, clinical chemistry and urinalysis), 12-lead ECG monitoring (Day 0, End of Th). The incidence of serious AEs (SAEs) and AE related to oral docetaxel and/or to ritonavir will be determined.
Measured: AE will be collected during the study treatment and 30 days after discontinuation of the study treatment due to disease progression or unacceptable treatment related toxicity
Secondary outcomes (4)
Pharmacokinetics assessments
The PK of bi-daily ModraDoc001 10mg, ModraDoc003 10mg tablets both in combination with ritonavir capsules and ModraDoc004 10/50mg tablets will be determed using non-compartmental methods and compartmental methods using NONMEM. Correlation between PK data and toxicity are subsequently analyzed for their significance.
Measured: Day 1 of week: 1, 2 and 3
Number and percentage of Participants with Adverse Events
Weekly safety assessments for Arm B (administration of ModraDoc003 10mg capsules and ritonavir and ModraDoc004 10/50 mg tablets) are: signs and symptoms/adverse events, physical examination, clinical laboratory tests (hematology, clinical chemistry and urinalysis), 12-lead ECG monitoring (Day 0, End of Th). The incidence of serious AEs (SAEs) and AE related to oral docetaxel and/or to ritonavir will be determined.
Measured: during the study treatment and 30 days after the study discontinuation
Radiological antitumor activity
Tumor measurement according to RECIST
Measured: at least every six weeks
Pharmacogenetic sampling
To establish the effect of functional genetic polymorphisms, C1236T (for MDR1) and CYP3A4*1B, on pharmacokinetics of orally administered docetaxel.
Measured: Day 1 - predose
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Aug 2010 (estimated)
- Study startSep 2010
- Primary completion4 Oct 2016
- Study completion26 Jan 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for CancerStudies of the same condition, open and under way.
- More trials run by The Netherlands Cancer InstituteThe 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
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 57 participants (actual)
Sponsor and investigators
- Lead sponsor
- The Netherlands Cancer Institute
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- JHM Schellens, MD, PhD, Principal investigator, The Netherlands Cancer Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01173913
- Sponsor's protocol ID
- N10BOM
- Status last verified
- Jan 2019
- First submitted
- 30 Jul 2010
- Last updated
- 10 Jan 2019
- Results posted
- No
- Data monitoring committee
- No
Publications
Vermunt MAC, van der Heijden LT, Hendrikx JJMA, Schinkel AH, de Weger VA, van der Putten E, van Triest B, Bergman AM, Beijnen JH. Pharmacokinetics of docetaxel and ritonavir after oral administration of ModraDoc006/r in patients with prostate cancer versus patients with other advanced solid tumours. Cancer Chemother Pharmacol. 2021 Jun;87(6):855-869. doi: 10.1007/s00280-021-04259-5. Epub 2021 Mar 20.
PubMed 33744986
Study at a glance
From the registry record, last updated by the sponsor on 10 Jan 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Weekly Administration of (bi-)Daily Oral Docetaxel in Combination With Ritonavir
- ClinicalTrials.gov ID
- NCT01173913
- Acronym / sponsor ID
- N10BOM
- Conditions
- Cancer
- Keywords
- oral docetaxel, ModraDoc, pharmacokinetics, safety, MTD, DLT
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 57 participants (actual)
- Lead sponsor
- The Netherlands Cancer InstituteUniversity, hospital or other
- Study start
- Sep 2010 (actual)
- Primary completion
- 4 Oct 2016 (actual)
- Study completion
- 26 Jan 2017 (actual)
- First posted
- 2 Aug 2010 (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.
Oral administration has many advantages above intravenously administrated drugs for patients. Up to now, oral administration of docetaxel as single agent has not been feasible due to low and variable bioavailability. This low systematic exposure to docetaxel can effectively be increased after co-administration of ritonavir. The department of pharmacy of the Slotervaart Hospital and Netherlands Cancer Institute developed a solid oral dosage form for docetaxel, ModraDoc001 10 mg capsules.
Two other novel dosage forms of docetaxel with improved pharmaceutical characteristics, have been developed: ModraDoc003 10 mg tablets and ModraDoc004 10/50 mg tablets. The systemic exposure after administration of those forms is now being investigated.
Detailed description
The bioavailability of docetaxel is limited due to metabolising cytochrome P450 (CYP) enzymes, which are abundantly present in the gastrointestinal tract.
Inhibition of CYP3A4 enzymes with ritonavir (an anti-retroviral drug) has in previously conducted proof-of-concept and phase I trials, proven to enhance the bioavailability of oral docetaxel.
Oral administration of docetaxel has been investigated in five clinical trials, all initiated by the Netherlands Cancer Institute - Antoni van Leeuwenhoek Hospital (NKI-AVL). The department of pharmacy of the Slotervaart Hospital and Netherlands Cancer Institute developed a solid oral dosage form for docetaxel, ModraDoc001 10 mg capsules. This formulation has now been investigated in more than 40 patients in a first clinical study. The preliminary results with ModraDoc001 10mg are promising and a linearity between systemic exposure to docetaxel and the applied dose of ModraDoc001 10mg capsules is seen. In an attempt to further improve and prolong the systemic exposure we will explore a twice daily dosing schedule.
Two other novel dosage forms for docetaxel, ModraDoc003 10 mg tablets and ModraDoc004 10/50 mg tablets, were developed. Both are spray-dried solid dispersions of docetaxel pressed in tablets. The distinction between both is that ritonavir is included in the co-formulation of ModraDoc004 10/50 mg tablets (10 mg docetaxel and 50 mg ritonavir). Both dosage forms will be investigated in arm B to see whether these new formulations have comparable pharmacokinetic characteristics of docetaxel to the capsule formulation.
Arm A Arm A is a dose escalation study to establish the maximum tolerated dose (MTD)of weekly bi-daily ModraDoc001 10 mg capsules. This study will be done with a classical dose escalation design. The starting dose will be 40 mg BID. This dose is based on a safety of weekly 80 mg single dose in the previously conducted study.
Arm B ModraDoc003 10 mg tablets and ModraDoc004 10/50 mg tablets will be investigated in arm B to see whether these new formulations have comparable pharmacokinetic characteristics of docetaxel to the capsule formulation od ModraDoc001 10 mg.
Another part of this study is the screening for 2 different polymorphism, C1236T (for MDR1)and CYP3A4*1B. Polymorphic variants may influence the absorption and elimination of docetaxel and ritonavir.
Arm D is a dose escalation study to establish the maximum tolerated dose (MTD)of weekly bi-daily ModraDoc006 10 mg tablets. This study will be done with a classical dose escalation design. The starting dose will be 20 mg BID. This dose is based on a safety of BID weekly ModraDoc001 mg in the previously conducted arm A.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| ModraDoc001 10 mg capsules | Experimental | Drug: ModraDoc001 10mg capsulesThe optimal dose weekly bi-daily oral docetaxel - ModraDoc001 10 mg in combination with ritonavir will be determined with a classical dose escalation design. Approximately 24 patients will be enrolled depending on required number of dose levels before MTD is reached. |
| ModraDoc003 10mg tablets and ModraDoc004 10/50 mg | Experimental | Drug: ModraDoc003 10mg tablets and ModraDoc004 10/50 mgBoth new oral dosage forms, ModraDoc003 10 mg tablets and ModraDoc004 10/50 mg tablets will be investigated to see whether these new formulations have comparable pharmacokinetic characteristics, in terms of systemic exposure to docetaxel, as ModraDoc001 10 mg capsule. |
| ModraDoc006 10 mg tablet | Experimental | Drug: ModraDoc006 10 mg tabletThe optimal dose weekly bi-daily oral docetaxel - ModraDoc006 10 mg in combination with ritonavir will be determined with a classical dose escalation design. Approximately 24 patients will be enrolled depending on required number of dose levels before MTD is reached. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (15 listed)
- Histological or cytological proof of cancer
- Patients for whom no standard therapy of proven benefit exist
- Patients who might benefit from treatment with docetaxel, e.g. advanced breast, gastric, esophagus, bladder, ovarian cancer and non-small cell lung cancer, head and neck cancers, prostate cancer and carcinoma of unknown primary site.
- Age _ 18 years
- Able and willing to give written informed consent
Key exclusion criteria (12 listed)
- Patients with known alcoholism, drug addiction and/or psychotic disorders in the history that are not suitable for adequate follow up
- Women who are pregnant or breast feeding.
- Both men and women enrolled in this trial 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).
- 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 analoga, St. Johns wort or macrolide antibiotics as erythromycin and clarithromycin.
- Uncontrolled infectious disease or known HIV-1 or HIV-2 type patients
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 |
|---|---|---|
| ModraDoc001 10mg capsulesBi-daily administration. One cycle will last 7 days | Drug | ModraDoc001 10 mg capsules |
| ModraDoc003 10mg tablets and ModraDoc004 10/50 mgThe patients will receive 40 mg docetaxel and 200 mg ritonavir once daily as different dosage forms (ModraDoc001 10 mg capsules, ModraDoc003 10 mg tablets and ModraDoc004 10/50 mg tablets). Patients continue in Week 4 with 80 mg docetaxel (as ModraDoc001 10 mg capsules) in combination with 100 mg ritonavir once daily in a weekly schedule until progressive disease or adverse events, which require dose modifications or discontinuation of therapy, are observed. | Drug | ModraDoc003 10mg tablets and ModraDoc004 10/50 mg |
| ModraDoc006 10 mg tabletBi-daily administration. One cycle will last 7 days | Drug | ModraDoc006 10 mg tablet |
Primary outcome
Number and percentage of Participants with Adverse Events
Time frame: AE will be collected during the study treatment and 30 days after discontinuation of the study treatment due to disease progression or unacceptable treatment related toxicity
The maximal tolerated dose (defined as the highest dose resulting in no more that 1/6 probability of causing a dose limiting toxicities defined in the protocol) of bi-daily ModraDoc001 10mg capsules with ritonavir will be assessed in Arm A. Weekly safety assessments for Arm A and Arm B: signs and symptoms/adverse events, physical examination, clinical laboratory tests (hematology, clinical chemistry and urinalysis), 12-lead ECG monitoring (Day 0, End of Th). The incidence of serious AEs (SAEs) and AE related to oral docetaxel and/or to ritonavir will be determined.
4 secondary outcomes
Pharmacokinetics assessments
Time frame: Day 1 of week: 1, 2 and 3
Number and percentage of Participants with Adverse Events
Time frame: during the study treatment and 30 days after the study discontinuation
Radiological antitumor activity
Time frame: at least every six weeks
Pharmacogenetic sampling
Time frame: Day 1 - predose
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 10 Jan 2019.
- Derived from this study: PubMed 33744986Vermunt MAC, van der Heijden LT, Hendrikx JJMA, Schinkel AH, de Weger VA, van der Putten E, van Triest B, Bergman AM, Beijnen JH. Pharmacokinetics of docetaxel and ritonavir after oral administration of ModraDoc006/r in patients with prostate cancer versus patients with other advanced solid tumours. Cancer Chemother Pharmacol. 2021 Jun;87(6):855-869. doi: 10.1007/s00280-021-04259-5. Epub 2021 Mar 20.
- Article on the studyLink provided by the sponsor.
Related trials for Cancer
Not yet recruitingPhase 1
Hepatic Artery Infusion of Carfilzomib in Participants With Liver Metastatic Disease Previously Treated With Hepatic Artery Infusion Pump Therapy
Colorectal Neoplasms, Neoplasms
RecruitingPhase 2
Tafasitamab With Acalabrutinib and Venetoclax for the Treatment of Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma
Chronic Lymphocytic Leukemia, Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma
Active, not recruitingPhase 1/2
Selumetinib in Treating Young Patients With Recurrent or Refractory Low Grade Glioma
Low Grade Glioma, Recurrent Childhood Pilocytic Astrocytoma
Enrolling by invitationPhase 2
A Single-Arm Study of Nimotuzumab Combined With NALIRIFOX as First-Line Treatment for Pancreatic Cancer
Pancreatic Cancer Metastatic
Recruiting
Methylation Profiling in Self-Samples for Identification of (Epi)Genetic Biomarkers for Gynecological Cancers
Gynaecological Cancers, Ovarian Cancer
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.
JHM Schellens, 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 ModraDoc001 10mg capsules, ModraDoc003 10mg tablets and ModraDoc004 10/50 mg and ModraDoc006 10 mg tablet in people with Cancer, run by The Netherlands Cancer Institute 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 15 inclusion and 12 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 10 Jan 2019. 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?
Number and percentage of Participants with Adverse Events (time frame: AE will be collected during the study treatment and 30 days after discontinuation of the study treatment due to disease progression or unacceptable treatment related toxicity). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01173913, which also lists 1 linked publication.
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 10 Jan 2019.