Advanced or Metastatic Biliary Tract CancerPhase 1NCT03082053
A Study of Varlitinib in Japanese Subjects With Advanced or Metastatic Solid Tumours
A Phase 1 study testing varlitinib and capecitabine in people with Advanced or Metastatic Biliary Tract Cancer and Advanced or Metastatic Solid Tumors, run by ASLAN Pharmaceuticals at 1 site in Japan.
Trial summary
The purpose of this study is to explore safety and efficacy of varlitinib administered as monotherapy in Japanese subjects with advanced or metastatic solid tumors, and administered as combination with capecitabine in Japanese subjects with advanced or metastatic biliary tract cancer. Read more about this study
- Who is it for?
- Ages 20 years and older
- Conditions the study is for
- Advanced or Metastatic Biliary Tract Cancer, Advanced or Metastatic Solid Tumors
- What is being tested?
- varlitinib and capecitabine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 1 siteJapan
- Study dates
- 31 Jan 2017to 6 Jun 2018
- 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 20 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Study I: Subjects with a solid tumour (excluding haematologic tumors) in advanced or metastatic stage
- Study II: Subjects with advanced (unresectable) or metastatic biliary tract cancer (IHCC, EHCC, gallbladder cancer or ampullary carcinoma)
Who cannot join
- Subjects with concurrent multiple primary cancers.
- Subjects with a history of (non-infectious) pneumonitis that required steroids or current pneumonitis, or with a history of interstitial lung disease or current interstitial lung disease
- Subjects receiving proton pump inhibitors for established, symptomatic gastro-duodenal ulceration or gastroesophageal reflux disease (including the preventive use)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Phase Ib Study of Varlitinib in Japanese Subjects With Advanced or Metastatic Solid Tumours
The purpose of this study is to explore safety and efficacy of varlitinib administered as monotherapy in Japanese subjects with advanced or metastatic solid tumors, and administered as combination with capecitabine in Japanese subjects with advanced or metastatic biliary tract cancer. Also to evaluate pharmacokinetics (PK) of varlitinib, capecitabine and its metabolite.
- Being tested
- varlitinib, capecitabine
- Medical subject headings
- Biliary Tract Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
varlitinibDrug
Also called ASLAN001
IMP
capecitabineDrug
Also called Xeloda
Companion Medication
| Study group | Role | What they receive |
|---|---|---|
| Study I | Experimental | Varlitinib given as monotherapy to Japanese subjects with advanced or metastatic solid tumors Receives: Drug: varlitinib |
| Study II | Experimental | Varlitinib given in combination with capecitabine to Japanese subjects with advanced or metastatic biliary tract cancer Receives: Drug: varlitinib; Drug: capecitabine |
What is being measured
The primary outcome is the main question the study is designed to answer.
The number of patients with a dose limiting toxicity (DLT) in the first treatment cycle
Measured: 3 weeks
Determine the DLT(Dose Limiting Toxicity) and MTD(Maximum Tolerated Dose) or Recommended Phase II Dose (RP2D) in Phase I setting.
Measured: 52 weeks
Secondary outcomes (4)
Pharmacokinetics: varlinitib, capecitabine and 5-FU metabolites levels in terms of Peak Plasma Concentration (Cmax)
Measured: Through, Day 1, Day 3, Day 22
Pharmacokinetics: varlinitib, capecitabine and 5-FU metabolites levels in terms of Area under the plasma concentration-time curve (AUC) from 0 to 12 hours (AUC0-12)
Measured: Through, Day 1, Day 3, Day 22
Pharmacokinetics: varlinitib, capecitabine and 5-FU metabolites levels in terms of Minimum (trough) plasma concentration (Cmin)
Measured: Through, Day 1, Day 3, Day 22
Pharmacokinetics: varlinitib, capecitabine and 5-FU metabolites levels in terms of Elimination half-life of Phase β (t1/2β)
Measured: Through, Day 1, Day 3, Day 22
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Mar 2017
- Study start31 Jan 2017
- Primary completion7 Dec 2017
- Study completion6 Jun 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Advanced or Metastatic Biliary Tract CancerStudies 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
- Non-randomised
- Intervention model
- Sequential
- Model description
- 2 studies of single group in 1 protocol
- Masking
- None (open label)
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- ASLAN Pharmaceuticals
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03082053
- Sponsor's protocol ID
- ASLAN001-010
- Status last verified
- Jun 2018
- First submitted
- 2 Feb 2017
- Last updated
- 28 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 28 Jun 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase Ib Study of Varlitinib in Japanese Subjects With Advanced or Metastatic Solid Tumours
- ClinicalTrials.gov ID
- NCT03082053
- Acronym / sponsor ID
- ASLAN001-010
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- ASLAN PharmaceuticalsUniversity, hospital or other
- Study start
- 31 Jan 2017 (actual)
- Primary completion
- 7 Dec 2017 (actual)
- Study completion
- 6 Jun 2018 (actual)
- First posted
- 17 Mar 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 purpose of this study is to explore safety and efficacy of varlitinib administered as monotherapy in Japanese subjects with advanced or metastatic solid tumors, and administered as combination with capecitabine in Japanese subjects with advanced or metastatic biliary tract cancer. Also to evaluate pharmacokinetics (PK) of varlitinib, capecitabine and its metabolite.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- 2 studies of single group in 1 protocol
| Arm | Type | Receives |
|---|---|---|
| Study I | Experimental | Drug: varlitinibVarlitinib given as monotherapy to Japanese subjects with advanced or metastatic solid tumors |
| Study II | Experimental | Drug: varlitinib, Drug: capecitabineVarlitinib given in combination with capecitabine to Japanese subjects with advanced or metastatic biliary tract cancer |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Study I: Subjects with a solid tumour (excluding haematologic tumors) in advanced or metastatic stage
- Study II: Subjects with advanced (unresectable) or metastatic biliary tract cancer (IHCC, EHCC, gallbladder cancer or ampullary carcinoma)
Key exclusion criteria (3 listed)
- Subjects with concurrent multiple primary cancers.
- Subjects with a history of (non-infectious) pneumonitis that required steroids or current pneumonitis, or with a history of interstitial lung disease or current interstitial lung disease
- Subjects receiving proton pump inhibitors for established, symptomatic gastro-duodenal ulceration or gastroesophageal reflux disease (including the preventive use)
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 |
|---|---|---|
| varlitinibAlso: ASLAN001IMP | Drug | Study I, Study II |
| capecitabineAlso: XelodaCompanion Medication | Drug | Study II |
Primary outcome
The number of patients with a dose limiting toxicity (DLT) in the first treatment cycle
Time frame: 3 weeks
Determine the DLT(Dose Limiting Toxicity) and MTD(Maximum Tolerated Dose) or Recommended Phase II Dose (RP2D) in Phase I setting.
Time frame: 52 weeks
4 secondary outcomes
Pharmacokinetics: varlinitib, capecitabine and 5-FU metabolites levels in terms of Peak Plasma Concentration (Cmax)
Time frame: Through, Day 1, Day 3, Day 22
Pharmacokinetics: varlinitib, capecitabine and 5-FU metabolites levels in terms of Area under the plasma concentration-time curve (AUC) from 0 to 12 hours (AUC0-12)
Time frame: Through, Day 1, Day 3, Day 22
Pharmacokinetics: varlinitib, capecitabine and 5-FU metabolites levels in terms of Minimum (trough) plasma concentration (Cmin)
Time frame: Through, Day 1, Day 3, Day 22
Pharmacokinetics: varlinitib, capecitabine and 5-FU metabolites levels in terms of Elimination half-life of Phase β (t1/2β)
Time frame: Through, Day 1, Day 3, Day 22
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 28 Jun 2018.
- Individual participant dataSharing planned: No
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AVENTINE-1: Study of AVZO-1418 as a Single Agent and in Combination Therapy in Patients With Locally Advanced or Metastatic Solid Tumors (AVZO-1418-1001)
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 varlitinib and capecitabine in people with Advanced or Metastatic Biliary Tract Cancer and Advanced or Metastatic Solid Tumors, run by ASLAN Pharmaceuticals at 1 site 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 3 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 28 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 1 site 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?
The number of patients with a dose limiting toxicity (DLT) in the first treatment cycle (time frame: 3 weeks). The study lists 2 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 28 Jun 2018.