NeoplasmsPhase 1NCT01911936
A Phase I Study of LJM716 in Japanese Patients With Advanced Solid Tumors
A Phase 1 study testing LM716 in people with Neoplasms, run by Novartis Pharmaceuticals at 2 sites in Japan.
Trial summary
This study will evaluate safety and tolerability to estimate the MTDand/or recommended dose. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Neoplasms
- What is being tested?
- LM716
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- 2 sitesJapan
- Study dates
- Sep 2013to Mar 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
- Patients with the following indications:
- (Dose escalation part only): HER2 overexpressing locally advanced/ metastatic breast cancer or gastric cancer for which no effective treatment option exists:
- For breast cancer: documented 3+ by immunohistochemistry, or amplification by in situ hybridization
- For gastric cancer (including GE junction tumors): documented 3+ by immunohistochemistry, or 2+ by immunohistochemistry and amplification by in situ hybridization OR, ii) (Dose escalation part only): Recurrent or metastatic SCCHN regardless of HER2 status for which no effective treatment option exists OR, iii) Recurrent or metastatic ESCC regardless of HER2 status for which no effective treatment option exists
- ECOG Performance Status of 0-2
- Must have recovered from the adverse effects of any prior surgery, radiotherapy or other antineoplastic therapy. Alopecia and CTCAE Grade 1 peripheral neuropathy is acceptable.
Show all 9Show fewer
- Willingness and ability to comply with all study procedures
- Written informed consent obtained prior to any screening procedures
- During dose expansion part of the study, patients must have at least one measurable lesion as defined by RECIST v1.1 criteria
Who cannot join
None listed.
Trial locations and contacts
2 sites in 1 country.
Japan2 sites
Novartis Investigative Site
Fukuoka, 811-1395
Novartis Investigative Site
Koto, Tokyo, 135-8550
About this study
This study will evaluate safety and tolerability to estimate the MTDand/or recommended dose.
Read the detailed description
This is a phase I, open-label, dose-escalation study to establish the MTD and/or RDE of LJM716 as single agent in Japanese patients that have advanced solid tumors. The study consists of a dose escalation part and a dose expansion part.
- Conditions
- Neoplasms
- Being tested
- LM716
- Keywords
- CLJM716,, Japanese patients,, Neoplasms
- Medical subject headings
- Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LM716Drug
| Study group | Role | What they receive |
|---|---|---|
| LJM716 | Experimental | Not described Receives: Drug: LM716 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of dose-limiting toxicities (DLTs) in the dose escalation part
Measured: First cycle (28 days)
Secondary outcomes (4)
Frequency and severity of adverse events, number of and reasons for
Measured: from informed consent till 30 days after end of treatment
LJM716 serum concentration-time- profile and estimated PK
Measured: up to 10 cycle (1 cycle = 28 days)
Tumor response according to RECIST 1.1
Measured: every 2 months until end of treatment up to 2 years
Incidence of antibodies against LJM716
Measured: up to 10 cycle ( 1cycle = 28 days)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jul 2013 (estimated)
- Study startSep 2013
- Primary completionMar 2015
- Study completionMar 2015
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 NeoplasmsStudies 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
- 12 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
- NCT01911936
- Sponsor's protocol ID
- CLJM716X1101
- Status last verified
- May 2015
- First submitted
- 24 Jul 2013
- Last updated
- 17 Dec 2020
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Takahashi S, Kobayashi T, Tomomatsu J, Ito Y, Oda H, Kajitani T, Kakizume T, Tajima T, Takeuchi H, Maacke H, Esaki T. LJM716 in Japanese patients with head and neck squamous cell carcinoma or HER2-overexpressing breast or gastric cancer. Cancer Chemother Pharmacol. 2017 Jan;79(1):131-138. doi: 10.1007/s00280-016-3214-4. Epub 2016 Dec 9.
PubMed 27942917
Study at a glance
From the registry record, last updated by the sponsor on 17 Dec 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I Study of LJM716 in Japanese Patients With Advanced Solid Tumors
- ClinicalTrials.gov ID
- NCT01911936
- Acronym / sponsor ID
- CLJM716X1101
- Conditions
- Neoplasms
- Keywords
- CLJM716,, Japanese patients,, Neoplasms
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 12 participants (actual)
- Lead sponsor
- Novartis PharmaceuticalsIndustry (pharma, biotech, devices)
- Study start
- Sep 2013
- Primary completion
- Mar 2015 (actual)
- Study completion
- Mar 2015 (actual)
- First posted
- 30 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 study will evaluate safety and tolerability to estimate the MTDand/or recommended dose.
Detailed description
This is a phase I, open-label, dose-escalation study to establish the MTD and/or RDE of LJM716 as single agent in Japanese patients that have advanced solid tumors. The study consists of a dose escalation part and a dose expansion part.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| LJM716 | Experimental | Drug: LM716 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Patients with the following indications:
- ECOG Performance Status of 0-2
- Must have recovered from the adverse effects of any prior surgery, radiotherapy or other antineoplastic therapy. Alopecia and CTCAE Grade 1 peripheral neuropathy is acceptable.
- Willingness and ability to comply with all study procedures
- Written informed consent obtained prior to any screening procedures
Key exclusion criteria (0 listed)
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 |
|---|---|---|
| LM716 | Drug | LJM716 |
Primary outcome
Incidence of dose-limiting toxicities (DLTs) in the dose escalation part
Time frame: First cycle (28 days)
4 secondary outcomes
Frequency and severity of adverse events, number of and reasons for
Time frame: from informed consent till 30 days after end of treatment
LJM716 serum concentration-time- profile and estimated PK
Time frame: up to 10 cycle (1 cycle = 28 days)
Tumor response according to RECIST 1.1
Time frame: every 2 months until end of treatment up to 2 years
Incidence of antibodies against LJM716
Time frame: up to 10 cycle ( 1cycle = 28 days)
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 17 Dec 2020.
- Derived from this study: PubMed 27942917Takahashi S, Kobayashi T, Tomomatsu J, Ito Y, Oda H, Kajitani T, Kakizume T, Tajima T, Takeuchi H, Maacke H, Esaki T. LJM716 in Japanese patients with head and neck squamous cell carcinoma or HER2-overexpressing breast or gastric cancer. Cancer Chemother Pharmacol. 2017 Jan;79(1):131-138. doi: 10.1007/s00280-016-3214-4. Epub 2016 Dec 9.
- Results for CLJM716X1101 can be found on the Novartis Clinical Trial Results WebsiteLink provided by the sponsor.
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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
2 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 LM716 in people with Neoplasms, run by Novartis Pharmaceuticals at 2 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 9 inclusion and 0 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 17 Dec 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 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) in the dose escalation part (time frame: First cycle (28 days)). 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 NCT01911936, 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 17 Dec 2020.