Diffuse Large B-Cell LymphomaPhase 1NCT03349346
Idelalisib With Rituximab, Ifosfamide, Carboplatin, Etoposide (RICE) in Children and Adolescents
A Phase 1 study testing Idelalisib, Rituximab and Ifosfamide in people with Diffuse Large B-Cell Lymphoma and Mediastinal B-cell Lymphoma, run by Gilead Sciences at 7 sites in 4 countries.
Trial summary
The primary objectives of this study are to evaluate safety, tolerability, pharmacokinetics (PK) and preliminary efficacy of idelalisib; and to establish recommended phase 2 doses (RP2D) of idelalisib in combination with rituximab, ifosfamide, carboplatin, etoposide (RICE) in children and adolescents with relapsed or… Read more about this study
- Who is it for?
- Ages 1 year to 18 years
- Conditions the study is for
- Diffuse Large B-Cell Lymphoma, Mediastinal B-cell Lymphoma
- What is being tested?
- Idelalisib, Rituximab and Ifosfamide
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 7 sitesin 4 countries
- Study dates
- Jun 2019to Feb 2026
- 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 1 year to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Histologically confirmed diagnosis of DLBCL or MBCL established by the World Health Organization (WHO) 2008 classification of tumors of hematopoietic and lymphoid tissues
- Relapsed or refractory disease
- Measurable or evaluable disease based on imaging or bone marrow examination
- Karnofsky ≥ 60% for participants > 16 years of age or Lansky ≥ 60 for participants ≤ 16 years of age. Participants who are unable to walk because of paralysis, but who are up in a wheelchair, will be considered ambulatory for the purpose of assessing the performance score.
- A negative serum pregnancy test is required for females of child bearing potential.
- Participants of child bearing potential who engage in heterosexual intercourse must agree to use protocol specified method(s) of contraception .
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- Lactating females must agree to discontinue nursing before idelalisib is administered
- Adequate bone marrow function as defined in the protocol
- Adequate renal function as defined in the protocol
Who cannot join
- Prior ifosfamide, carboplatin, etoposide (ICE) therapy, with or without an anti-CD20 antibody, or history of hypersensitivity to any components of RICE
- Known active central nervous system or leptomeningeal lymphoma or within 4 weeks from the last intrathecal therapy prior to the required diagnostic lumbar puncture (LP) for this study
- Disease progression within 6 months from last anti-CD20 therapy
- Ongoing toxicity from prior cytotoxic therapy (last dose at least 3 weeks prior to study entry)
- Less than 4 half-lives from the last dose of previous targeted therapy and ongoing acute toxicity of prior targeted therapy
- Active infection with human immunodeficiency virus (HIV), cytomegalovirus (CMV), hepatitis B virus (HBV), or hepatitis C virus (HCV) based on screening serology and polymerase chain reaction (PCR) results
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- Evidence of systemic bacterial, fungal, or viral infection at the time of treatment start (Day 1)
- Ongoing or history of drug-induced pneumonitis
- Ongoing or history of inflammatory bowel disease
- Pregnancy or breastfeeding
- Currently receiving other anti-cancer or other investigational drug
- Prior solid organ transplantation
- Prior allogeneic stem cell transplantation within 60 days or active acute graft versus host disease (GVHD) Grade 3 or higher
- Known hypersensitivity to idelalisib, the metabolites, or formulation excipients
- Any other clinical condition or prior therapy that, in the opinion of the Investigator, would make the participant unsuitable for the study or unable to comply with the study requirements
- NOTE: Other protocol defined Inclusion/ Exclusion criteria may apply.
Trial locations and contacts
7 sites in 4 countries.
7 sites in 4 countries
Italy3 sites
Istituto Giannina Gaslini
Genova, 16147
Ospedale Pediatrico Bambino Gesu
Roma, 00165
Infantile Regina Margherita Hospital
Torino, 10126
Spain2 sites
Hospital Vall d´Hebrón
Barcelona, 08035
Hospital Universitario HM Monteprincipe
Madrid, 28660
Poland1 site
Uniwersytecki Szpital Kliniczny im. Jana Mikulicza-Radeckiego we Wroclawiu
Wroclaw, 50-556
About this study
Official title: Phase 1b Trial Evaluating Idelalisib in Children and Adolescents With Relapsed or Refractory Diffuse Large B-cell Lymphoma or Mediastinal B-cell Lymphoma in Combination With RICE
The primary objectives of this study are to evaluate safety, tolerability, pharmacokinetics (PK) and preliminary efficacy of idelalisib; and to establish recommended phase 2 doses (RP2D) of idelalisib in combination with rituximab, ifosfamide, carboplatin, etoposide (RICE) in children and adolescents with relapsed or refractory diffuse large B-cell lymphoma (DLBCL) or mediastinal B-cell lymphoma (MBCL)
- Being tested
- Idelalisib, Rituximab, Ifosfamide, Carboplatin, Etoposide
- Medical subject headings
- Lymphoma, Large B-Cell, Diffuse
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
IdelalisibDrug
Also called Zydelig®
Tablet (s) or dispersible tablets for suspension administered orally twice daily
RituximabDrug
375 mg/m^2 administered intravenously
IfosfamideDrug
3 mg/m^2 administered intravenously
CarboplatinDrug
635 mg/m^2 administered intravenously
EtoposideDrug
100 mg/m^2 administered intravenously
| Study group | Role | What they receive |
|---|---|---|
| Cohort 1- Participants 12 to less than 18 years of age | Experimental | Participants will receive idelalisib monotherapy (from day 1 to day 21), followed by combination therapy with RICE. Upon enrollment, participants will be assigned to one of the 3 dose levels during idelalisib monotherapy (Dose level 1 = 55 mg/m^2 twice daily (BID), Dose level 2 = 85 mg/m^2 BID, Dose level 3 = 125 mg/m^2 BID) administered as 50 mg, 100 mg or 150 mg tablets as appropriate, or as 10 mg dispersible tablets for oral suspension for participants who cannot swallow tablets.
* Day 1: single dose of idelalisib
* Day 2 up to Day 21: initiate and continue idelalisib BID dosing
* Day 22 for up to 12 months: idelalisib twice per day in combination with RICE. Cycles of RICE will be administered over 5 days every 3 weeks (Day 1: rituximab; Day 3: rituximab, ifosfamide, carboplatin, etoposide; Days 4 and 5: ifosfamide, etoposide) starting day 22 (or earlier if there is evidence of clinical progression while on idelalisib monotherapy) for up to 12 months. Receives: Drug: Idelalisib; Drug: Rituximab; Drug: Ifosfamide; Drug: Carboplatin; Drug: Etoposide |
| Cohort 2- Participants 1 to less than 12 years of age | Experimental | Participants will receive one of the 3 doses of idelalisib monotherapy (from day 1 to day 21) followed by combination therapy with RICE. Idelalisib will be administered as as 50 mg, 100 mg or 150 mg tablets as appropriate, or as 10 mg dispersible tablets for oral suspension for participants who cannot swallow tablets. Participants will will be enrolled at dose level 1 once tolerability is demonstrated in the older cohort (Cohort 1). Thereafter, both age cohorts will be dose escalated independently.
* Day 1: single dose of idelalisib
* Day 2 up to Day 21: initiate and continue idelalisib BID
* Day 22 for up to 12 months: idelalisib twice per day in combination with RICE. Cycles of RICE will be administered over 5 days every 3 weeks (Day 1: rituximab; Day 3: rituximab, ifosfamide, carboplatin, etoposide; Days 4 and 5: ifosfamide, etoposide) starting day 22 (or earlier if there is evidence of clinical progression while on idelalisib monotherapy) for up to 12 months. Receives: Drug: Idelalisib; Drug: Rituximab; Drug: Ifosfamide; Drug: Carboplatin; Drug: Etoposide |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence Rate of Dose Limiting Toxicities (DLTs)
DLTs refer to toxicities experienced during the first 21 days of study treatment that have been judged to be clinically significant and related to study treatment.
Measured: Up to Day 21
Proportion of Participants Experiencing Adverse Events (AEs)
Measured: Up to 12 months
Proportion of Participants Experiencing Serious Adverse Events (SAEs)
Measured: Up to 12 months
Proportion of Participants Experiencing Adverse Events (AEs) Leading to Idelalisib Interruption, Idelalisib Dose Reduction, Premature Discontinuation of Idelalisib, or Death
Measured: Up to 12 months
Secondary outcomes (12)
Rate of Grade ≥ 3 Transaminase Elevations Based on Laboratory Findings
Measured: Up to 12 months
Overall Response Rate (ORR)
Overall response rate (ORR) is defined as the proportion of participants who achieve a best response of Complete Response (CR) or Partial Response (PR) after the first dose of idelalisib (either as a result of monotherapy or in combination with RICE chemoimmunotherapy). The screening imaging study will serve as the reference for ORR.
Measured: Up to 12 months
Overall Survival (OS)
Overall Survival (OS) is defined as the interval from the first dose date of idelalisib to death from any cause.
Measured: Up to 5 years
Progression-Free Survival (PFS)
Progression-Free Survival (PFS) is defined as the interval from the start date of RICE to the earlier of the first documentation of disease progression or death from any cause. Computed tomography/ magnetic resonance imaging (CT/MRI) scan at the conclusion of idelalisib monotherapy will serve as the reference for progression.
Measured: Up to 12 months
Pharmacokinetic Parameter: Cmax of Idelalisib
Cmax is defined as the maximum observed concentration of drug.
Measured: Predose and up to 24 hours postdose on Day 1 and Cycle 1, Day 5 of idelalisib + RICE combination therapy
Pharmacokinetic Parameter: Cmax of GS-563117
GS-563117 is the metabolite of idelalisib. Cmax is defined as the maximum observed concentration of drug.
Measured: Predose and up to 24 hours postdose on Day 1 and Cycle 1, Day 5 of idelalisib + RICE combination therapy
Pharmacokinetic Parameter: Ctrough of Idelalisib
Ctrough is defined as the plasma concentration at the end of the dosing interval.
Measured: Predose and up to 24 hours postdose on Day 1 and Cycle 1, Day 5 of idelalisib + RICE combination therapy
Pharmacokinetic Parameter: Ctrough of GS-563117
Ctrough is defined as the plasma concentration at the end of the dosing interval.
Measured: Predose and up to 24 hours postdose on Day 1 and Cycle 1, Day 5 of idelalisib + RICE combination therapy
Pharmacokinetic Parameter: Area Under the Concentration-Time Curve (AUC) of Idelalisib
AUC is defined as the plasma concentration at the end of the dosing interval.
Measured: Predose and up to 24 hours postdose on Day 1 and Cycle 1, Day 5 of idelalisib + RICE combination therapy
Pharmacokinetic Parameter: Area Under the Concentration-Time Curve (AUC) of GS-563117
AUC is defined as the plasma concentration at the end of the dosing interval.
Measured: Predose and up to 24 hours postdose on Day 1 and Cycle 1, Day 5 of idelalisib + RICE combination therapy
Levels of Optional Exploratory Biomarkers on Bone Marrow Samples (eg pAKT, pS6 ribosomal protein) and plasma cytokines
Measured: Baseline and Day 21
Acceptability and Palatability of Idelalisib 10-mg Dispersible Tablet
For participants who cannot swallow a whole tablet, the investigator will ask if the tablet administered as a suspension is palatable and will observe if the participant is able to swallow the dosage form. The acceptability and palatability of idelalisib dispersible tablets administered as an oral suspension (for participants unable to swallow the tablet) will be evaluated by a questionnaire administered to the participant and/or the parent/legal guardian.
Measured: Day 1 of idelalisib monotherapy and at Day 1, Cycle 1 of idelalisib in combination with RICE chemoimmunotherapy
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Nov 2017
- Study startJun 2019 (estimated)
- Primary completionFeb 2021 (estimated)
- Study completionFeb 2026 (estimated)
Why it stopped: The European Medical Agency granted a Paediatric Investigational Product-specific waiver on the grounds that idelalisib is likely to be unsafe in paediatrics
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diffuse Large B-Cell LymphomaStudies of the same condition, open and under way.
- More trials run by Gilead SciencesThe 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
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Gilead Sciences
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Gilead Study Director, Study director, Gilead Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03349346
- Sponsor's protocol ID
- GS-US-313-1090
- Other IDs
- 2017-001468-39, 2017
- Status last verified
- Dec 2018
- First submitted
- 17 Nov 2017
- Last updated
- 11 Dec 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Dec 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase 1b Trial Evaluating Idelalisib in Children and Adolescents With Relapsed or Refractory Diffuse Large B-cell Lymphoma or Mediastinal B-cell Lymphoma in Combination With RICE
- ClinicalTrials.gov ID
- NCT03349346
- Acronym / sponsor ID
- GS-US-313-1090
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: The European Medical Agency granted a Paediatric Investigational Product-specific waiver on the grounds that idelalisib is likely to be unsafe in paediatrics
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Gilead SciencesIndustry (pharma, biotech, devices)
- Study start
- Jun 2019 (estimated)
- Primary completion
- Feb 2021 (estimated)
- Study completion
- Feb 2026 (estimated)
- First posted
- 21 Nov 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.
The primary objectives of this study are to evaluate safety, tolerability, pharmacokinetics (PK) and preliminary efficacy of idelalisib; and to establish recommended phase 2 doses (RP2D) of idelalisib in combination with rituximab, ifosfamide, carboplatin, etoposide (RICE) in children and adolescents with relapsed or refractory diffuse large B-cell lymphoma (DLBCL) or mediastinal B-cell lymphoma (MBCL)
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Cohort 1- Participants 12 to less than 18 years of age | Experimental | Drug: Idelalisib, Drug: Rituximab, Drug: Ifosfamide, Drug: Carboplatin, Drug: EtoposideParticipants will receive idelalisib monotherapy (from day 1 to day 21), followed by combination therapy with RICE. Upon enrollment, participants will be assigned to one of the 3 dose levels during idelalisib monotherapy (Dose level 1 = 55 mg/m^2 twice daily (BID), Dose level 2 = 85 mg/m^2 BID, Dose level 3 = 125 mg/m^2 BID) administered as 50 mg, 100 mg or 150 mg tablets as appropriate, or as 10 mg dispersible tablets for oral suspension for participants who cannot swallow tablets. * Day 1: single dose of idelalisib * Day 2 up to Day 21: initiate and continue idelalisib BID dosing * Day 22 for up to 12 months: idelalisib twice per day in combination with RICE. Cycles of RICE will be administered over 5 days every 3 weeks (Day 1: rituximab; Day 3: rituximab, ifosfamide, carboplatin, etoposide; Days 4 and 5: ifosfamide, etoposide) starting day 22 (or earlier if there is evidence of clinical progression while on idelalisib monotherapy) for up to 12 months. |
| Cohort 2- Participants 1 to less than 12 years of age | Experimental | Drug: Idelalisib, Drug: Rituximab, Drug: Ifosfamide, Drug: Carboplatin, Drug: EtoposideParticipants will receive one of the 3 doses of idelalisib monotherapy (from day 1 to day 21) followed by combination therapy with RICE. Idelalisib will be administered as as 50 mg, 100 mg or 150 mg tablets as appropriate, or as 10 mg dispersible tablets for oral suspension for participants who cannot swallow tablets. Participants will will be enrolled at dose level 1 once tolerability is demonstrated in the older cohort (Cohort 1). Thereafter, both age cohorts will be dose escalated independently. * Day 1: single dose of idelalisib * Day 2 up to Day 21: initiate and continue idelalisib BID * Day 22 for up to 12 months: idelalisib twice per day in combination with RICE. Cycles of RICE will be administered over 5 days every 3 weeks (Day 1: rituximab; Day 3: rituximab, ifosfamide, carboplatin, etoposide; Days 4 and 5: ifosfamide, etoposide) starting day 22 (or earlier if there is evidence of clinical progression while on idelalisib monotherapy) for up to 12 months. |
Who may qualify
- Ages
- 1 year to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (9 listed)
- Histologically confirmed diagnosis of DLBCL or MBCL established by the World Health Organization (WHO) 2008 classification of tumors of hematopoietic and lymphoid tissues
- Relapsed or refractory disease
- Measurable or evaluable disease based on imaging or bone marrow examination
- Karnofsky ≥ 60% for participants > 16 years of age or Lansky ≥ 60 for participants ≤ 16 years of age. Participants who are unable to walk because of paralysis, but who are up in a wheelchair, will be considered ambulatory for the purpose of assessing the performance score.
- A negative serum pregnancy test is required for females of child bearing potential.
Key exclusion criteria (16 listed)
- Prior ifosfamide, carboplatin, etoposide (ICE) therapy, with or without an anti-CD20 antibody, or history of hypersensitivity to any components of RICE
- Known active central nervous system or leptomeningeal lymphoma or within 4 weeks from the last intrathecal therapy prior to the required diagnostic lumbar puncture (LP) for this study
- Disease progression within 6 months from last anti-CD20 therapy
- Ongoing toxicity from prior cytotoxic therapy (last dose at least 3 weeks prior to study entry)
- Less than 4 half-lives from the last dose of previous targeted therapy and ongoing acute toxicity of prior targeted therapy
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 |
|---|---|---|
| IdelalisibAlso: Zydelig®Tablet (s) or dispersible tablets for suspension administered orally twice daily | Drug | Cohort 1- Participants 12 to less than 18 years of age, Cohort 2- Participants 1 to less than 12 years of age |
| Rituximab375 mg/m^2 administered intravenously | Drug | Cohort 1- Participants 12 to less than 18 years of age, Cohort 2- Participants 1 to less than 12 years of age |
| Ifosfamide3 mg/m^2 administered intravenously | Drug | Cohort 1- Participants 12 to less than 18 years of age, Cohort 2- Participants 1 to less than 12 years of age |
| Carboplatin635 mg/m^2 administered intravenously | Drug | Cohort 1- Participants 12 to less than 18 years of age, Cohort 2- Participants 1 to less than 12 years of age |
| Etoposide100 mg/m^2 administered intravenously | Drug | Cohort 1- Participants 12 to less than 18 years of age, Cohort 2- Participants 1 to less than 12 years of age |
Primary outcome
Incidence Rate of Dose Limiting Toxicities (DLTs)
Time frame: Up to Day 21
DLTs refer to toxicities experienced during the first 21 days of study treatment that have been judged to be clinically significant and related to study treatment.
Proportion of Participants Experiencing Adverse Events (AEs)
Time frame: Up to 12 months
Proportion of Participants Experiencing Serious Adverse Events (SAEs)
Time frame: Up to 12 months
Proportion of Participants Experiencing Adverse Events (AEs) Leading to Idelalisib Interruption, Idelalisib Dose Reduction, Premature Discontinuation of Idelalisib, or Death
Time frame: Up to 12 months
12 secondary outcomes
Rate of Grade ≥ 3 Transaminase Elevations Based on Laboratory Findings
Time frame: Up to 12 months
Overall Response Rate (ORR)
Time frame: Up to 12 months
Overall Survival (OS)
Time frame: Up to 5 years
Progression-Free Survival (PFS)
Time frame: Up to 12 months
Pharmacokinetic Parameter: Cmax of Idelalisib
Time frame: Predose and up to 24 hours postdose on Day 1 and Cycle 1, Day 5 of idelalisib + RICE combination therapy
Pharmacokinetic Parameter: Cmax of GS-563117
Time frame: Predose and up to 24 hours postdose on Day 1 and Cycle 1, Day 5 of idelalisib + RICE combination therapy
Pharmacokinetic Parameter: Ctrough of Idelalisib
Time frame: Predose and up to 24 hours postdose on Day 1 and Cycle 1, Day 5 of idelalisib + RICE combination therapy
Pharmacokinetic Parameter: Ctrough of GS-563117
Time frame: Predose and up to 24 hours postdose on Day 1 and Cycle 1, Day 5 of idelalisib + RICE combination therapy
Pharmacokinetic Parameter: Area Under the Concentration-Time Curve (AUC) of Idelalisib
Time frame: Predose and up to 24 hours postdose on Day 1 and Cycle 1, Day 5 of idelalisib + RICE combination therapy
Pharmacokinetic Parameter: Area Under the Concentration-Time Curve (AUC) of GS-563117
Time frame: Predose and up to 24 hours postdose on Day 1 and Cycle 1, Day 5 of idelalisib + RICE combination therapy
Levels of Optional Exploratory Biomarkers on Bone Marrow Samples (eg pAKT, pS6 ribosomal protein) and plasma cytokines
Time frame: Baseline and Day 21
Acceptability and Palatability of Idelalisib 10-mg Dispersible Tablet
Time frame: Day 1 of idelalisib monotherapy and at Day 1, Cycle 1 of idelalisib in combination with RICE chemoimmunotherapy
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Dec 2018.
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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.
Gilead Study Director study director
Gilead Sciences
7 sites in 4 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Idelalisib, Rituximab and Ifosfamide in people with Diffuse Large B-Cell Lymphoma and Mediastinal B-cell Lymphoma, run by Gilead Sciences at 7 sites in 4 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: withdrawn, as of the sponsor's last update on 11 Dec 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 sites in Italy, Spain, France, Poland. 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 was withdrawn before enrolling participants, so there are no results.
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?
Incidence Rate of Dose Limiting Toxicities (DLTs) (time frame: Up to Day 21). The study lists 4 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 11 Dec 2018.