Advanced MalignanciesPhase 1NCT02678260
Phase I Study of PDR001 in Patients With Advanced Malignancies.
A Phase 1 study testing PDR001 in people with Advanced Malignancies, run by Novartis Pharmaceuticals at 3 sites in Japan.
Trial summary
The purpose of this study is to characterize the safety, tolerability, Pharmacokinetics (PK), and antitumor activity of PDR001 administered intravenous (i.v.) as a single agent to Japanese patients. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Advanced Malignancies
- What is being tested?
- PDR001
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 18 participants
- Where
- 3 sitesJapan
- Study dates
- 19 Feb 2016to 1 Sep 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients with advanced/metastatic solid tumors, with measurable or non-measurable disease as determined by response evaluation criteria in solid tumors (RECIST) version 1.1, who have progressed despite standard therapy or are intolerant of standard therapy, or for whom no standard therapy exists
- ECOG Performance Status ≤ 2
Who cannot join
- Active autoimmune disease
- Active hepatitis B virus (HBV) or hepatitis C virus (HCV) infection
- Prior PD-1- or PD-L1-directed therapy
- Other protocol defined inclusion/exclusion may apply.
Trial locations and contacts
3 sites in 1 country.
Japan3 sites
Novartis Investigative Site
Kashiwa, Chiba, 277-8577
Novartis Investigative Site
Kobe, Hyōgo, 650-0017
Novartis Investigative Site
Nagoya, Aichi-ken, 466-8560
About this study
Official title: A Phase-I Study of PDR001 Administered to Japanese Patients With Advanced Malignancies
The purpose of this study is to characterize the safety, tolerability, Pharmacokinetics (PK), and antitumor activity of PDR001 administered intravenous (i.v.) as a single agent to Japanese patients.
- Conditions
- Advanced Malignancies
- Being tested
- PDR001
- Keywords
- Advanced malignancies, PDR001, Japanese patients, adults
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PDR001Drug
PDR001 is a high-affinity, ligand-blocking, humanized anti-PD-1 IgG4 antibody that blocks the binding of PD-L1 and PD-L2 to PD-1.
| Study group | Role | What they receive |
|---|---|---|
| PDR001 | Experimental | PDR001 will be administered i.v. every two weeks until a patient experiences unacceptable toxicity, progressive disease as per irRC and/or treatment is discontinued at the discretion of the investigator or the patient. The treatment period will begin on Cycle 1 Day 1. For the purpose of scheduling and evaluations, a treatment cycle will consist of 28 days. During the study, cohorts of patients will be treated with PDR001 until the maximum tolerated dose (MTD) is reached or a lower recommended dose (RD) is established. Receives: Drug: PDR001 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of dose limiting toxicities (DLTs)
cycle = 28 days
Measured: 28 days
Secondary outcomes (9)
PK parameter: AUC
To characterize the PK profile of PDR001; cycle = 28 days
Measured: Cycle 1 Day 1 (C1D1), Cycle 3 Day 1 (C3D1)
Serum concentration vs. time profiles
Serum concentration of PDR001 at the scheduled timepoints up to 336 hours after administration
Measured: C1D1, C3D1
Presence and/or concentration of anti-PDR001 antibodies
To assess the emergence of anti-PDR001 antibodies following one or more intravenous infusions of PDR001.
Measured: Day 1 on from C1 to C6
Objective response rate (ORR)
cycle = 28 days
Measured: up to cycle 11; every 2 cycles (8 weeks), after cycle 12; every 3 cycles (12 weeks)
Duration of response rate (DOR)
cycle = 28 days
Measured: up to cycle 11; every 2 cycles (8 weeks), after cycle 12; every 3 cycles (12 weeks)
Disease control rate (DCR)
cycle = 28 days
Measured: up to cycle 11; every 2 cycles (8 weeks), after cycle 12; every 3 cycles (12 weeks)
PK parameter: Cmax
To characterize the PK profile of PDR001; cycle = 28 days
Measured: Cycle 1 Day 1 (C1D1), Cycle 3 Day 1 (C3D1)
PK parameter: Tmax
To characterize the PK profile of PDR001; cycle = 28 days
Measured: Cycle 1 Day 1 (C1D1), Cycle 3 Day 1 (C3D1)
PK parameter: half-life
To characterize the PK profile of PDR001; cycle = 28 days
Measured: Cycle 1 Day 1 (C1D1), Cycle 3 Day 1 (C3D1)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Feb 2016 (estimated)
- Study start19 Feb 2016
- Primary completion1 Sep 2017
- Study completion1 Sep 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Advanced MalignanciesStudies of the same condition, open and under way.
- More trials run by Novartis PharmaceuticalsThe 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
- Single group
- Masking
- None (open label)
- Enrolment
- 18 participants (actual)
Sponsor and investigators
- Lead sponsor
- Novartis Pharmaceuticals
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Novartis Pharmaceuticals, Study director, Novartis Pharmaceuticals
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02678260
- Sponsor's protocol ID
- CPDR001X1101
- Status last verified
- Jun 2018
- First submitted
- 21 Jan 2016
- Last updated
- 8 Jun 2018
- 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 8 Jun 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase-I Study of PDR001 Administered to Japanese Patients With Advanced Malignancies
- ClinicalTrials.gov ID
- NCT02678260
- Acronym / sponsor ID
- CPDR001X1101
- Conditions
- Advanced Malignancies
- Keywords
- Advanced malignancies, PDR001, Japanese patients, adults
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 18 participants (actual)
- Lead sponsor
- Novartis PharmaceuticalsIndustry (pharma, biotech, devices)
- Study start
- 19 Feb 2016 (actual)
- Primary completion
- 1 Sep 2017 (actual)
- Study completion
- 1 Sep 2017 (actual)
- First posted
- 9 Feb 2016 (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.
The purpose of this study is to characterize the safety, tolerability, Pharmacokinetics (PK), and antitumor activity of PDR001 administered intravenous (i.v.) as a single agent to Japanese patients.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| PDR001 | Experimental | Drug: PDR001PDR001 will be administered i.v. every two weeks until a patient experiences unacceptable toxicity, progressive disease as per irRC and/or treatment is discontinued at the discretion of the investigator or the patient. The treatment period will begin on Cycle 1 Day 1. For the purpose of scheduling and evaluations, a treatment cycle will consist of 28 days. During the study, cohorts of patients will be treated with PDR001 until the maximum tolerated dose (MTD) is reached or a lower recommended dose (RD) is established. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Patients with advanced/metastatic solid tumors, with measurable or non-measurable disease as determined by response evaluation criteria in solid tumors (RECIST) version 1.1, who have progressed despite standard therapy or are intolerant of standard therapy, or for whom no standard therapy exists
- ECOG Performance Status ≤ 2
Key exclusion criteria (4 listed)
- Active autoimmune disease
- Active hepatitis B virus (HBV) or hepatitis C virus (HCV) infection
- Prior PD-1- or PD-L1-directed therapy
- Other protocol defined inclusion/exclusion may apply.
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 |
|---|---|---|
| PDR001PDR001 is a high-affinity, ligand-blocking, humanized anti-PD-1 IgG4 antibody that blocks the binding of PD-L1 and PD-L2 to PD-1. | Drug | PDR001 |
Primary outcome
Incidence of dose limiting toxicities (DLTs)
Time frame: 28 days
cycle = 28 days
9 secondary outcomes
PK parameter: AUC
Time frame: Cycle 1 Day 1 (C1D1), Cycle 3 Day 1 (C3D1)
Serum concentration vs. time profiles
Time frame: C1D1, C3D1
Presence and/or concentration of anti-PDR001 antibodies
Time frame: Day 1 on from C1 to C6
Objective response rate (ORR)
Time frame: up to cycle 11; every 2 cycles (8 weeks), after cycle 12; every 3 cycles (12 weeks)
Duration of response rate (DOR)
Time frame: up to cycle 11; every 2 cycles (8 weeks), after cycle 12; every 3 cycles (12 weeks)
Disease control rate (DCR)
Time frame: up to cycle 11; every 2 cycles (8 weeks), after cycle 12; every 3 cycles (12 weeks)
PK parameter: Cmax
Time frame: Cycle 1 Day 1 (C1D1), Cycle 3 Day 1 (C3D1)
PK parameter: Tmax
Time frame: Cycle 1 Day 1 (C1D1), Cycle 3 Day 1 (C3D1)
PK parameter: half-life
Time frame: Cycle 1 Day 1 (C1D1), Cycle 3 Day 1 (C3D1)
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 8 Jun 2018.
- 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.
Novartis Pharmaceuticals study director
Novartis Pharmaceuticals
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing PDR001 in people with Advanced Malignancies, run by Novartis Pharmaceuticals at 3 sites in Japan.
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 2 inclusion and 4 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 8 Jun 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Japan. 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?
Incidence of dose limiting toxicities (DLTs) (time frame: 28 days). 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 8 Jun 2018.