Solid TumorPhase 1NCT02648425
Safety and Tolerability of ASLAN001 in Combination With Cisplatin and 5-FU or Cisplatin and Capecitabine
A Phase 1 study testing ASLAN001, cisplatin + capecitabine and cisplatin + 5-fluorouracil (or+ Leucovorin) in people with Solid Tumor, run by ASLAN Pharmaceuticals at 3 sites in 2 countries.
Trial summary
This is a phase IB study to assess the safety and tolerability of ASLAN001 when given in combination with either Cisplatin and 5-Fluorouracil or Cisplatin and Capecitabine, with a view to identifying the recommended Phase II dose. Read more about this study
- Who is it for?
- Ages 20 years and older
- Conditions the study is for
- Solid Tumor
- What is being tested?
- ASLAN001, cisplatin + capecitabine and cisplatin + 5-fluorouracil (or+ Leucovorin)
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 31 participants
- Where
- 3 sitesin 2 countries
- Study dates
- 5 Aug 2014to 15 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 20 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male or female patients 20 years of age or older at the time written informed consent is obtained.
- Regimen A: Patients with metastatic solid tumors eligible for treatment with cisplatin and 5-fluorouracil. The standard dose and schedule of cisplatin and 5-fluorouracil will be according to the preference of investigators and institutions.
- Regimen B: Patients with metastatic solid tumors eligible for treatment with cisplatin in combination with capecitabine.
- Patients with a partial gastrectomy may be allowed to participate in the study as long as they can take oral medications and meet all other inclusion/exclusion criteria.
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
- Adequate organ and hematological function as evidenced by the following laboratory studies within 14 days prior to enrolment:
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- Hematological function, as follows:
- Absolute neutrophil count ≥ 1.5 x 109/L.
- Platelet count ≥ 100 x 109/L.
- Hemoglobin ≥ 9 g/dL.
- Coagulation function, as follows:
- Partial thromboplastin time or activated partial thromboplastin time ≤ 1.5 x upper limit of normal (ULN) per institutional laboratory normal range.
- International normalized ratio ≤ 1.5.
- Renal function, as follows:
- Creatinine clearance ≥ 50 mL/min as calculated by Cockcroft-Gault formula.
- Hepatic function, as follows:
- Total bilirubin ≤ 1.5 x ULN.
- AST and ALT ≤ 2.5 x ULN (≤ 5 x ULN if liver metastases are present).
Who cannot join
- Patients with persistent gastric outlet obstruction, complete dysphagia or feeding jejunostomy.
- Patients receiving proton pump inhibitors or H2 antagonists for established, symptomatic gastro duodenal ulceration or gastroesophageal reflux disease.
- Patients with unresolved toxicities of grade 2 or more from prior anti-cancer therapies.
- Untreated or symptomatic central nervous system metastases. Patients with a history of brain metastases are eligible if definitive therapy has been administered (surgery and/or radiation therapy), there is no planned treatment for brain metastases, and the patient is clinically stable and is off corticosteroids for at least 2 weeks prior to enrolment.
- Major surgical procedures within 28 days prior to enrolment.
- Clinically significant cardiovascular diseases that are symptomatic or uncontrolled.
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- Known positive test for human immunodeficiency virus, hepatitis C, or hepatitis B surface antigen.
- Pregnant or breast-feeding females.
- Patients who have hearing impairment, due to the potential for ototoxicity of cisplatin.
- Any history or presence of clinically significant cardiovascular, respiratory, hepatic, renal, hematologic, gastrointestinal, endocrine, immunologic, dermatologic, neurologic or psychiatric disease or any other condition which in the opinion of the Investigator could jeopardize the safety of the patient or the validity of the study results
Trial locations and contacts
3 sites in 2 countries.
3 sites in 2 countries
Taiwan2 sites
National Taiwan University Hospital
Taipei, 100
Taipei Veterans General Hospital
Taipei, 112
About this study
Official title: Phase I Study to Evaluate the Safety and Tolerability of ASLAN001 in Combination With Cisplatin and 5-Fluorouracil or Cisplatin and Capecitabine
This is a phase IB study to assess the safety and tolerability of ASLAN001 when given in combination with either Cisplatin and 5-Fluorouracil or Cisplatin and Capecitabine, with a view to identifying the recommended Phase II dose.
Read the detailed description
This is an open-label, Phase I, dose escalation study of ASLAN001 given in combination with Regimen A or Regimen B, in patients with metastatic solid tumors, eligible to receive the cisplatin/5-fluorouracil or cisplatin/capecitabine regimen.
Dose of ASLAN001 starts from 400mg BID; then, dose escalation to 500mg BID or dose de-escalation to 300mg BID will depend on DLTs observed in cohort.
Regimen A: Depends on preferred medical practice, Cohort 1A will receive ASLAN001 400 mg BID in combination with cisplatin 80 mg/m2 IV infusion and 5 fluorouracil 800 mg/m2/day IV infusion for 5 days every 3 weeks; or will receive ASLAN001 400 mg BID in combination with Cisplatin 35 mg/m2 24-hour infusion for day 1 and day 8, 5-fluorouracil 2,000 mg/m2 and Leucovorin 300mg/m2 24-hour infusion for day 1, day 8 and day 15 every 4 weeks.
Regimen B: Cohort 1B will receive ASLAN001 400 mg BID in combination with cisplatin 80 mg/m2 IV infusion and oral capecitabine 1,000 mg/m2 BID for 14 days every 3 weeks.
- Conditions
- Solid Tumor
- Being tested
- ASLAN001, cisplatin + capecitabine, cisplatin + 5-fluorouracil (or+ Leucovorin)
- Keywords
- ASLAN001, Varlitinib
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ASLAN001Drug
Also called ARRY-334543, Varlitinib
ASLAN001 400mg BID daily; ASLAN001 500mg BID daily; or ASLAN001 300mg BID daily
cisplatin + capecitabineDrug
Cisplatin 80 mg/m2 IV infusion and capecitabine 1,000 mg/m2 orally BID for 14 days every 3 weeks
cisplatin + 5-fluorouracil (or+ Leucovorin)Drug
Cisplatin 80 mg/m2 IV infusion and 5-fluorouracil 800 mg/m2/day IV infusion for 5 days every 3 weeks;
Or
Cisplatin 35 mg/m2 24-hour infusion for day 1 and day 8, 5-fluorouracil 2,000 mg/m2 and Leucovorin 300mg/m2 24-hour infusion for day 1, day 8 and day 15 every 4 weeks.
| Study group | Role | What they receive |
|---|---|---|
| Regimen A / Amended Regimen A | Experimental | Regimen A: Cisplatin + 5-fluorouracil
ASLAN001 daily in combination with:
Cisplatin 80 mg/m2 IV infusion for 1 day and 5-fluorouracil 800 mg/m2/day IV infusion for 5 days every 3 weeks for up to 6 cycles.
Or
Amended Regimen A: Cisplatin + 5-fluorouracil + leucovorin
ASLAN001 daily in combination with:
Cisplatin 35 mg/m2 24-hour infusion for day 1 and day 8, 5-fluorouracil 2,000 mg/m2 and Leucovorin 300mg/m2 24-hour infusion for day 1, day 8 and day 15 every 4 weeks for up to 6 cycles. Receives: Drug: ASLAN001; Drug: cisplatin + 5-fluorouracil (or+ Leucovorin) |
| Regimen B | Experimental | Regimen B: Cisplatin + capecitabine
ASLAN001 daily in combination with:
Cisplatin 60-80 mg/m2 IV infusion on Day 1 and capecitabine 1,000 mg/m2 orally BID for 14 days every 3 weeks for up to 6 cycles. Receives: Drug: ASLAN001; Drug: cisplatin + capecitabine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety and Tolerability of ASALN001
Safety and tolerability as evaluated with:
DLTs (in first 2 cycles); Maximum tolerated dose (MTD) of ASLAN001 in combination with cisplatin/capecitabine or cisplatin/5-FU will be determined.
Measured: First 2 cycles
Safety and Tolerability of ASALN001
Safety and tolerability as evaluated with:
Adverse events.
Measured: Baseline to post-dose
Secondary outcomes (6)
Preliminary assessment of the efficacy
•To provide a preliminary assessment of the efficacy of ASLAN001 when given in combination in Regimen A or Regimen B as measured by the objective response rate (ORR).
Measured: Along the study duration
Pharmacokinetics profile (AUC) of ASLAN001
To evaluate the pharmacokinetics of ASLAN001, when given in combination with Regimen A or Regimen B. Pharmacokinetic parameters including, but not limited to area under the plasma concentration-time curve (AUC) from 0 to 6 hours (AUC0-6).
Measured: Along the study duration
Pharmacokinetics profile (Cmax) of ASLAN001
To evaluate the pharmacokinetics of ASLAN001, when given in combination with Regimen A or Regimen B. Pharmacokinetic parameters including, but not limited to maximum plasma concentration (Cmax).
Measured: Along the study duration
Pharmacokinetics profile (Cmin) of ASLAN001
To evaluate the pharmacokinetics of ASLAN001, when given in combination with Regimen A or Regimen B. Pharmacokinetic parameters including, but not limited to minimum (trough) plasma concentration (Cmin).
Measured: Along the study duration
Pharmacokinetics profile (RacAUC0-6) of ASLAN001
To evaluate the pharmacokinetics of ASLAN001, when given in combination with Regimen A or Regimen B. Pharmacokinetic parameters including, but not limited to accumulation ratio for AUC (RacAUC0-6).
Measured: Pharmacokinetic measurements will be from Cycle 1 Day 1 to Cycle 3 Day 1 (each cycle is 28 days for Amended Regimen A, and 21 days for Regimen A and B.
Pharmacokinetics profile (Tmax) of ASLAN001
To evaluate the pharmacokinetics of ASLAN001, when given in combination with
Measured: Along the study duration
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jan 2016 (estimated)
- Study start5 Aug 2014
- Primary completion12 Jun 2017
- Study completion15 Sep 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Solid TumorStudies 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
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 31 participants (actual)
Sponsor and investigators
- Lead sponsor
- ASLAN Pharmaceuticals
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- ASLAN Pharma, Study chair, ASLAN Pharmaceuticals
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02648425
- Sponsor's protocol ID
- ASLAN001-002
- Status last verified
- Oct 2018
- First submitted
- 21 Jun 2015
- Last updated
- 25 Oct 2018
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 25 Oct 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase I Study to Evaluate the Safety and Tolerability of ASLAN001 in Combination With Cisplatin and 5-Fluorouracil or Cisplatin and Capecitabine
- ClinicalTrials.gov ID
- NCT02648425
- Acronym / sponsor ID
- ASLAN001-002
- Conditions
- Solid Tumor
- Keywords
- ASLAN001, Varlitinib
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 31 participants (actual)
- Lead sponsor
- ASLAN PharmaceuticalsUniversity, hospital or other
- Study start
- 5 Aug 2014 (actual)
- Primary completion
- 12 Jun 2017 (actual)
- Study completion
- 15 Sep 2017 (actual)
- First posted
- 7 Jan 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.
This is a phase IB study to assess the safety and tolerability of ASLAN001 when given in combination with either Cisplatin and 5-Fluorouracil or Cisplatin and Capecitabine, with a view to identifying the recommended Phase II dose.
Detailed description
This is an open-label, Phase I, dose escalation study of ASLAN001 given in combination with Regimen A or Regimen B, in patients with metastatic solid tumors, eligible to receive the cisplatin/5-fluorouracil or cisplatin/capecitabine regimen.
Dose of ASLAN001 starts from 400mg BID; then, dose escalation to 500mg BID or dose de-escalation to 300mg BID will depend on DLTs observed in cohort.
Regimen A: Depends on preferred medical practice, Cohort 1A will receive ASLAN001 400 mg BID in combination with cisplatin 80 mg/m2 IV infusion and 5 fluorouracil 800 mg/m2/day IV infusion for 5 days every 3 weeks; or will receive ASLAN001 400 mg BID in combination with Cisplatin 35 mg/m2 24-hour infusion for day 1 and day 8, 5-fluorouracil 2,000 mg/m2 and Leucovorin 300mg/m2 24-hour infusion for day 1, day 8 and day 15 every 4 weeks.
Regimen B: Cohort 1B will receive ASLAN001 400 mg BID in combination with cisplatin 80 mg/m2 IV infusion and oral capecitabine 1,000 mg/m2 BID for 14 days every 3 weeks.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Regimen A / Amended Regimen A | Experimental | Drug: ASLAN001, Drug: cisplatin + 5-fluorouracil (or+ Leucovorin)Regimen A: Cisplatin + 5-fluorouracil ASLAN001 daily in combination with: Cisplatin 80 mg/m2 IV infusion for 1 day and 5-fluorouracil 800 mg/m2/day IV infusion for 5 days every 3 weeks for up to 6 cycles. Or Amended Regimen A: Cisplatin + 5-fluorouracil + leucovorin ASLAN001 daily in combination with: Cisplatin 35 mg/m2 24-hour infusion for day 1 and day 8, 5-fluorouracil 2,000 mg/m2 and Leucovorin 300mg/m2 24-hour infusion for day 1, day 8 and day 15 every 4 weeks for up to 6 cycles. |
| Regimen B | Experimental | Drug: ASLAN001, Drug: cisplatin + capecitabineRegimen B: Cisplatin + capecitabine ASLAN001 daily in combination with: Cisplatin 60-80 mg/m2 IV infusion on Day 1 and capecitabine 1,000 mg/m2 orally BID for 14 days every 3 weeks for up to 6 cycles. |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (18 listed)
- Male or female patients 20 years of age or older at the time written informed consent is obtained.
- Regimen A: Patients with metastatic solid tumors eligible for treatment with cisplatin and 5-fluorouracil. The standard dose and schedule of cisplatin and 5-fluorouracil will be according to the preference of investigators and institutions.
- Regimen B: Patients with metastatic solid tumors eligible for treatment with cisplatin in combination with capecitabine.
- Patients with a partial gastrectomy may be allowed to participate in the study as long as they can take oral medications and meet all other inclusion/exclusion criteria.
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
Key exclusion criteria (10 listed)
- Patients with persistent gastric outlet obstruction, complete dysphagia or feeding jejunostomy.
- Patients receiving proton pump inhibitors or H2 antagonists for established, symptomatic gastro duodenal ulceration or gastroesophageal reflux disease.
- Patients with unresolved toxicities of grade 2 or more from prior anti-cancer therapies.
- Untreated or symptomatic central nervous system metastases. Patients with a history of brain metastases are eligible if definitive therapy has been administered (surgery and/or radiation therapy), there is no planned treatment for brain metastases, and the patient is clinically stable and is off corticosteroids for at least 2 weeks prior to enrolment.
- Major surgical procedures within 28 days prior to enrolment.
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 |
|---|---|---|
| ASLAN001Also: ARRY-334543, VarlitinibASLAN001 400mg BID daily; ASLAN001 500mg BID daily; or ASLAN001 300mg BID daily | Drug | Regimen A / Amended Regimen A, Regimen B |
| cisplatin + capecitabineCisplatin 80 mg/m2 IV infusion and capecitabine 1,000 mg/m2 orally BID for 14 days every 3 weeks | Drug | Regimen B |
| cisplatin + 5-fluorouracil (or+ Leucovorin)Cisplatin 80 mg/m2 IV infusion and 5-fluorouracil 800 mg/m2/day IV infusion for 5 days every 3 weeks; Or Cisplatin 35 mg/m2 24-hour infusion for day 1 and day 8, 5-fluorouracil 2,000 mg/m2 and Leucovorin 300mg/m2 24-hour infusion for day 1, day 8 and day 15 every 4 weeks. | Drug | Regimen A / Amended Regimen A |
Primary outcome
Safety and Tolerability of ASALN001
Time frame: First 2 cycles
Safety and tolerability as evaluated with: DLTs (in first 2 cycles); Maximum tolerated dose (MTD) of ASLAN001 in combination with cisplatin/capecitabine or cisplatin/5-FU will be determined.
Safety and Tolerability of ASALN001
Time frame: Baseline to post-dose
Safety and tolerability as evaluated with: Adverse events.
6 secondary outcomes
Preliminary assessment of the efficacy
Time frame: Along the study duration
Pharmacokinetics profile (AUC) of ASLAN001
Time frame: Along the study duration
Pharmacokinetics profile (Cmax) of ASLAN001
Time frame: Along the study duration
Pharmacokinetics profile (Cmin) of ASLAN001
Time frame: Along the study duration
Pharmacokinetics profile (RacAUC0-6) of ASLAN001
Time frame: Pharmacokinetic measurements will be from Cycle 1 Day 1 to Cycle 3 Day 1 (each cycle is 28 days for Amended Regimen A, and 21 days for Regimen A and B.
Pharmacokinetics profile (Tmax) of ASLAN001
Time frame: Along the study duration
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 25 Oct 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.
ASLAN Pharma study chair
ASLAN Pharmaceuticals
3 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing ASLAN001, cisplatin + capecitabine and cisplatin + 5-fluorouracil (or+ Leucovorin) in people with Solid Tumor, run by ASLAN Pharmaceuticals at 3 sites in 2 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 18 inclusion and 10 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 25 Oct 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 Taiwan, Hong Kong. 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?
Safety and Tolerability of ASALN001 (time frame: First 2 cycles). 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 25 Oct 2018.