Solid TumorsPhase 1NCT02435927
ASLAN001 in Combination With Oxaliplatin and Capecitabine or Oxaliplatin and 5-FU With Leucovorin
A Phase 1 study testing ASLAN001+ CAPOX (Oxaliplatin, capecitabine) and ASLAN001 + mFolfox6 (5-FU, leucovorin) in people with Solid Tumors, run by National Cancer Centre, Singapore at 1 site in Singapore.
Trial summary
This is a Phase I, open-label, dose escalation study of ASLAN001 given in combination with CAPOX or mFolfox6, in patients with metastatic solid tumours, whom are suitable to receive CAPOX or mFolfox6, or with tumours that have dysregulated EGFR or HER2 signaling. Read more about this study
- Who is it for?
- Ages 21 years and older
- Conditions the study is for
- Solid Tumors
- What is being tested?
- ASLAN001+ CAPOX (Oxaliplatin, capecitabine) and ASLAN001 + mFolfox6 (5-FU, 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
- 60 participants
- Where
- 1 siteSingapore
- Study dates
- Aug 2014to Jun 2021
- 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 21 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients with metastatic solid tumours eligible for treatment with oxaliplatin in combination with capecitabine / 5-FU (fluorouracil) and leucovorin or who progressed following standard therapy or patients with EGFR (epidermal growth factor receptor ) or HER2 dysregulated tumours.
- 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 performance status of 0 or 1.
- Adequate organ and hematological function as evidenced by the following laboratory studies within 14 days prior to enrolment:
- 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: Prothrombin time and activated partial thromboplastin time ≤ 1.5 x upper limit of normal (ULN) per institutional laboratory normal range.
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- 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. Aspartate aminotransferase and alanine aminotransferase ≤ 2.5 x ULN (≤ 5 x ULN if liver metastases are present).
- Patients undergoing mandatory biopsy in dose expansion of a non-DLT cohort should have any of the following:
- known HER2 or EGFR dysregulation
- Patients with T790M mutation will be excluded.
- Co-expression of HER2 and EGFR
- Archival tumour sample is available for molecular profiling, unless undergoing tumour biopsy as part of the trial.
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. H2 antagonist can be prescribed after DLT (dose-limiting toxicity) period (the first 2 cycles) at the discretion of the investigator.
- Patients with unresolved toxicities of grade 2 or more from prior anti-cancer therapies excluding alopecia.
- Untreated or symptomatic central nervous system metastases. Patients with treated brain metastases stable for 3 months are eligible to enroll.
- Major surgical procedures within 28 days prior to enrolment.
- Clinically significant cardiovascular diseases that are symptomatic or uncontrolled.
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- Known active infection for human immunodeficiency virus, hepatitis B and C.
- Pregnant or breast-feeding females.
- Treatment with any of the following anti-cancer therapies prior to the first dose of study drugs within the stated timeframes
- Cyclical chemotherapy within a period of time that is shorter than the cycle length used for that treatment. Exception for weekly chemotherapy regimens, where a minimum of 2 week washout from the last dose is required.
- Biological therapy (e.g., antibodies) within a period of time that is ≤ 5 t1/2 or ≤ 4 weeks, whichever is shorter, prior to starting study drug
- Continuous or intermittent small molecule therapeutics within a period of time that is ≤ 5 t1/2 or ≤ 4 weeks (whichever is shorter) prior to starting study drug
- Any other investigational agents within a period of time that is ≤ 5 t1/2 or less than the cycle length used for that treatment or ≤ 4 weeks (whichever is shortest) prior to starting study drug
- Wide field radiotherapy ≤ 4 weeks or limited field radiation for palliation ≤ 2 weeks prior to starting study drug
- Previous combination therapy with xeloda and oxaliplatin within 6 months of study treatment.
- Previous combination therapy with Oxaliplatin, 5-FU and Leucovorin (mFolfox6) within 6 months of study treatment
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Phase I Study to Evaluate the Safety and Tolerability of ASLAN001 in Combination With Oxaliplatin and Capecitabine or Oxaliplatin and 5-FU With Leucovorin
This is a Phase I, open-label, dose escalation study of ASLAN001 given in combination with CAPOX or mFolfox6, in patients with metastatic solid tumours, whom are suitable to receive CAPOX or mFolfox6, or with tumours that have dysregulated EGFR or HER2 signaling.
Read the detailed description
The study will use standard 3+3 design to determine the MTD (maximum tolerated dose) of ASLAN001 in combination with fixed dose of Oxaliplatin/Capecitabine (CAPOX) or 5-FU/leucovorin (mFolfox6).
MTD of ASLAN001 in combination with CAPOX will first be determined followed by the combination with mFolfox6.
The recommended Phase II dose will be the highest dose of the combination therapy that is considered to be tolerated in 6 patients.
- Conditions
- Solid Tumors
- Being tested
- ASLAN001+ CAPOX (Oxaliplatin, capecitabine), ASLAN001 + mFolfox6 (5-FU, leucovorin)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ASLAN001+ CAPOX (Oxaliplatin, capecitabine)Drug
Also called eloxatin, xeloda
ASLAN001 in combination with oxaliplatin and capecitabine
ASLAN001 + mFolfox6 (5-FU, leucovorin)Drug
Also called 5-Fluorouracil, Folinic acid
ASLAN001 in combination with 5-FU and leucovorin
| Study group | Role | What they receive |
|---|---|---|
| ASLAN001 + CAPOX | Experimental | ASLAN001 + CAPOX: ASLAN001 twice daily in combination with oxaliplatin 130 mg/m2 intravenously on day 1 and capecitabine 850 mg/m2 orally twice daily on days 1 to 14 every 3 weeks Receives: Drug: ASLAN001+ CAPOX (Oxaliplatin, capecitabine) |
| ASLAN001 + mFolfox6 | Experimental | ASLAN001 + mFolfox6: ASLAN001 twice daily in combination with mFolfox6 (oxaliplatin 85 mg/m2 intravenously on day 1 and 5-FU bolus 400mg/m2 i.v on day 1 and as a continuous infusion 2400mg/ m2 over 46h and leucovorin 400mg/2 i.v on day 1) every 2 weeks Receives: Drug: ASLAN001 + mFolfox6 (5-FU, leucovorin) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Maximum tolerated dose (MTD) of ASLAN001 when used in combination with Oxaliplatin and Capecitabine (CAPOX) or Oxaliplatin and 5-FU with leucovorin (mFolfox6)
Measured: one year
Secondary outcomes (4)
Pharmacokinetic parameter Area under the plasma concentration time curve (AUC)
Measured: Day 1 and Day 15 of Cycle 1 and Day 1 of Cycle 3
Pharmacokinetic parameter Maximum plasma concentration (Cmax)
Measured: Day 1 and Day 15 of Cycle 1 and Day 1 of Cycle 3
Pharmacokinetic parameter Minimum (trough) plasma concentration (Cmin)
Measured: Day 1 and Day 15 of Cycle 1 and Day 1 of Cycle 3
Efficacy of ASLAN001 when given in combination in CAPOX or mFolfox6 as measured by the objective response rate (ORR)
Measured: one year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 May 2015 (estimated)
- Study startAug 2014
- Primary completionJun 2021 (estimated)
- Study completionJun 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Solid TumorsStudies 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
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- National Cancer Centre, Singapore
- Sponsor type
- University, hospital or other
- Collaborators
- ASLAN Pharmaceuticals, National Medical Research Council (NMRC), Singapore
- Responsible party
- Sponsor
- Investigators
- Matthew CH Ng, Principal investigator, National Cancer Centre, Singapore
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02435927
- Sponsor's protocol ID
- ASLAN001-002SG
- Status last verified
- Apr 2021
- First submitted
- 23 Apr 2015
- Last updated
- 28 Apr 2021
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Apr 2021. 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 Oxaliplatin and Capecitabine or Oxaliplatin and 5-FU With Leucovorin
- ClinicalTrials.gov ID
- NCT02435927
- Acronym / sponsor ID
- ASLAN001-002SG
- Conditions
- Solid Tumors
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- National Cancer Centre, SingaporeUniversity, hospital or other
- Collaborators
- ASLAN Pharmaceuticals, National Medical Research Council (NMRC), Singapore
- Study start
- Aug 2014 (actual)
- Primary completion
- Jun 2021 (estimated)
- Study completion
- Jun 2021 (estimated)
- First posted
- 6 May 2015 (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 I, open-label, dose escalation study of ASLAN001 given in combination with CAPOX or mFolfox6, in patients with metastatic solid tumours, whom are suitable to receive CAPOX or mFolfox6, or with tumours that have dysregulated EGFR or HER2 signaling.
Detailed description
The study will use standard 3+3 design to determine the MTD (maximum tolerated dose) of ASLAN001 in combination with fixed dose of Oxaliplatin/Capecitabine (CAPOX) or 5-FU/leucovorin (mFolfox6).
MTD of ASLAN001 in combination with CAPOX will first be determined followed by the combination with mFolfox6.
The recommended Phase II dose will be the highest dose of the combination therapy that is considered to be tolerated in 6 patients.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| ASLAN001 + CAPOX | Experimental | Drug: ASLAN001+ CAPOX (Oxaliplatin, capecitabine)ASLAN001 + CAPOX: ASLAN001 twice daily in combination with oxaliplatin 130 mg/m2 intravenously on day 1 and capecitabine 850 mg/m2 orally twice daily on days 1 to 14 every 3 weeks |
| ASLAN001 + mFolfox6 | Experimental | Drug: ASLAN001 + mFolfox6 (5-FU, leucovorin)ASLAN001 + mFolfox6: ASLAN001 twice daily in combination with mFolfox6 (oxaliplatin 85 mg/m2 intravenously on day 1 and 5-FU bolus 400mg/m2 i.v on day 1 and as a continuous infusion 2400mg/ m2 over 46h and leucovorin 400mg/2 i.v on day 1) every 2 weeks |
Who may qualify
- Ages
- 21 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (13 listed)
- Patients with metastatic solid tumours eligible for treatment with oxaliplatin in combination with capecitabine / 5-FU (fluorouracil) and leucovorin or who progressed following standard therapy or patients with EGFR (epidermal growth factor receptor ) or HER2 dysregulated tumours.
- 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 performance status of 0 or 1.
- Adequate organ and hematological function as evidenced by the following laboratory studies within 14 days prior to enrolment:
- Patients undergoing mandatory biopsy in dose expansion of a non-DLT cohort should have any of the following:
Key exclusion criteria (16 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. H2 antagonist can be prescribed after DLT (dose-limiting toxicity) period (the first 2 cycles) at the discretion of the investigator.
- Patients with unresolved toxicities of grade 2 or more from prior anti-cancer therapies excluding alopecia.
- Untreated or symptomatic central nervous system metastases. Patients with treated brain metastases stable for 3 months are eligible to enroll.
- 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 |
|---|---|---|
| ASLAN001+ CAPOX (Oxaliplatin, capecitabine)Also: eloxatin, xelodaASLAN001 in combination with oxaliplatin and capecitabine | Drug | ASLAN001 + CAPOX |
| ASLAN001 + mFolfox6 (5-FU, leucovorin)Also: 5-Fluorouracil, Folinic acidASLAN001 in combination with 5-FU and leucovorin | Drug | ASLAN001 + mFolfox6 |
Primary outcome
Maximum tolerated dose (MTD) of ASLAN001 when used in combination with Oxaliplatin and Capecitabine (CAPOX) or Oxaliplatin and 5-FU with leucovorin (mFolfox6)
Time frame: one year
4 secondary outcomes
Pharmacokinetic parameter Area under the plasma concentration time curve (AUC)
Time frame: Day 1 and Day 15 of Cycle 1 and Day 1 of Cycle 3
Pharmacokinetic parameter Maximum plasma concentration (Cmax)
Time frame: Day 1 and Day 15 of Cycle 1 and Day 1 of Cycle 3
Pharmacokinetic parameter Minimum (trough) plasma concentration (Cmin)
Time frame: Day 1 and Day 15 of Cycle 1 and Day 1 of Cycle 3
Efficacy of ASLAN001 when given in combination in CAPOX or mFolfox6 as measured by the objective response rate (ORR)
Time frame: one year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Apr 2021.
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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.
Matthew CH Ng principal investigator
National Cancer Centre, Singapore
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 ASLAN001+ CAPOX (Oxaliplatin, capecitabine) and ASLAN001 + mFolfox6 (5-FU, leucovorin) in people with Solid Tumors, run by National Cancer Centre, Singapore at 1 site in Singapore.
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 13 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: status not confirmed, as of the sponsor's last update on 28 Apr 2021. 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 Singapore. 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?
Results are not available in the source record.
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?
Maximum tolerated dose (MTD) of ASLAN001 when used in combination with Oxaliplatin and Capecitabine (CAPOX) or Oxaliplatin and 5-FU with leucovorin (mFolfox6) (time frame: one year). 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 Apr 2021.