Pancreatic CancerPhase 1NCT02024633
Combination of Icotinib and Gemcitabine as First-line Treatment in Pancreatic Cancer
A Phase 1 study testing icotinib and Gemcitabine in people with Pancreatic Cancer, run by Betta Pharmaceuticals Co., Ltd. at 1 site in China.
Trial summary
Research Hypothesis: icotinib administered in combination with gemcitabine has an acceptable safety profile in subjects with locally advanced, unresectable or metastatic pancreatic adenocarcinoma.The primary objective is to determine the safety profile of icotinib in combination with gemcitabine in subjects with… Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Pancreatic Cancer
- What is being tested?
- icotinib and Gemcitabine
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 1 siteChina
- Study dates
- Dec 2013to Mar 2016
- 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 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Locally advanced, unresectable or metastatic pancreatic cancer by histologic or cytologic confirmation without previous chemotherapy or target therapy.
- ECOG Performance Status of 0 to 1.
- Adequate organ function as defined by study-specified laboratory tests.
- Signed informed consent form.
- Willing and able to comply with study procedures.
Who cannot join
- Previous chemotherapy or target therapy.
- Currently have or have history of certain study-specified heart, liver, kidney, lung, neurological, immune or other medical conditions.
- Systemically active steroids.
- Another investigational product within 28 days prior to receiving study drug.
- Major surgery or significant traumatic injury (or unhealed surgical wounds) occurring within 28 days prior to receiving study drug.
- Infection with HIV, hepatitis B or C at screening.
- Pregnant or lactating.
- Conditions, including alcohol or drug dependence, or intercurrent illness that would affect the patient's ability to comply with study visits and procedures.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Second Affiliated Hospital of Zhejiang Univercity School of Medcine
Hangzhou
Tingbo Liang, MD, liangtingbo@zju.edu.cn
About this study
Official title: Phase I, Open-label, Dose-escalation Study to Evaluate the Safety and Tolerability of Icotinib Combined With Gemcitabine as First-line Treatment in Locally Advanced, Unresectable or Metastatic Pancreatic Cancer
Research Hypothesis: icotinib administered in combination with gemcitabine has an acceptable safety profile in subjects with locally advanced, unresectable or metastatic pancreatic adenocarcinoma.The primary objective is to determine the safety profile of icotinib in combination with gemcitabine in subjects with locally advanced, unresectable or metastatic pancreatic adenocarcinoma.
- Conditions
- Pancreatic Cancer
- Being tested
- icotinib, Gemcitabine
- Medical subject headings
- Pancreatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
icotinibDrug
Also called Commana
Three dose levels of icotinib are designed to be evaluated, 125 mg three times per day, 250 mg three times per day, and 375 mg three times per day. Dose escalations are based on predefined dose escalation decision rules. The Maximum Administered Dose (MAD) was reached at the dose level when at least 30% patients developed a dose limited toxicity.
GemcitabineDrug
Also called Gemzar
Gemcitabine: 1000 mg/m2 on Days 1, 8, and 15 of a 28 day cycle by IV administration every 4 weeks.
| Study group | Role | What they receive |
|---|---|---|
| icotinib plus gemcitabine | Experimental | Three dose of icotinib are designed to be evaluated, 125 mg three times per day, 250 mg three times per day, and 375 mg three times per day. Dose escalations are based on predefined dose escalation decision rules. The Maximum Administered Dose (MAD) was reached at the dose level when at least 30% patients developed a dose limited toxicity.
Gemcitabine: 1000 mg/m2 on Days 1, 8, and 15 of a 28 day cycle by IV administration every 4 weeks. Receives: Drug: icotinib; Drug: Gemcitabine |
What is being measured
The primary outcome is the main question the study is designed to answer.
The number of patients who suffer adverse events
Measured: 24 months
Secondary outcomes (2)
Tumor response assessed by RECIST 1.1
Measured: 3 months
Progression-free survival
Measured: 4 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Dec 2013 (estimated)
- Study startDec 2013
- Primary completionDec 2015 (estimated)
- Study completionMar 2016 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pancreatic CancerStudies of the same condition, open and under way.
- More trials run by Betta Pharmaceuticals Co., Ltd.The 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 24 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Betta Pharmaceuticals Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Tingbo Liang, MD, Principal investigator, Second Affiliated Hospital of Zhejiang Univercity School of Medcine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02024633
- Sponsor's protocol ID
- BD-IC-IV48
- Status last verified
- Jul 2015
- First submitted
- 26 Dec 2013
- Last updated
- 15 Jul 2015
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 15 Jul 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase I, Open-label, Dose-escalation Study to Evaluate the Safety and Tolerability of Icotinib Combined With Gemcitabine as First-line Treatment in Locally Advanced, Unresectable or Metastatic Pancreatic Cancer
- ClinicalTrials.gov ID
- NCT02024633
- Acronym / sponsor ID
- BD-IC-IV48
- Conditions
- Pancreatic Cancer
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 24 participants (estimated)
- Lead sponsor
- Betta Pharmaceuticals Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- Dec 2013
- Primary completion
- Dec 2015 (estimated)
- Study completion
- Mar 2016 (estimated)
- First posted
- 31 Dec 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.
Research Hypothesis: icotinib administered in combination with gemcitabine has an acceptable safety profile in subjects with locally advanced, unresectable or metastatic pancreatic adenocarcinoma.The primary objective is to determine the safety profile of icotinib in combination with gemcitabine in subjects with locally advanced, unresectable or metastatic pancreatic adenocarcinoma.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| icotinib plus gemcitabine | Experimental | Drug: icotinib, Drug: GemcitabineThree dose of icotinib are designed to be evaluated, 125 mg three times per day, 250 mg three times per day, and 375 mg three times per day. Dose escalations are based on predefined dose escalation decision rules. The Maximum Administered Dose (MAD) was reached at the dose level when at least 30% patients developed a dose limited toxicity. Gemcitabine: 1000 mg/m2 on Days 1, 8, and 15 of a 28 day cycle by IV administration every 4 weeks. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Locally advanced, unresectable or metastatic pancreatic cancer by histologic or cytologic confirmation without previous chemotherapy or target therapy.
- ECOG Performance Status of 0 to 1.
- Adequate organ function as defined by study-specified laboratory tests.
- Signed informed consent form.
- Willing and able to comply with study procedures.
Key exclusion criteria (8 listed)
- Previous chemotherapy or target therapy.
- Currently have or have history of certain study-specified heart, liver, kidney, lung, neurological, immune or other medical conditions.
- Systemically active steroids.
- Another investigational product within 28 days prior to receiving study drug.
- Major surgery or significant traumatic injury (or unhealed surgical wounds) occurring within 28 days prior to receiving study drug.
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 |
|---|---|---|
| icotinibAlso: CommanaThree dose levels of icotinib are designed to be evaluated, 125 mg three times per day, 250 mg three times per day, and 375 mg three times per day. Dose escalations are based on predefined dose escalation decision rules. The Maximum Administered Dose (MAD) was reached at the dose level when at least 30% patients developed a dose limited toxicity. | Drug | icotinib plus gemcitabine |
| GemcitabineAlso: GemzarGemcitabine: 1000 mg/m2 on Days 1, 8, and 15 of a 28 day cycle by IV administration every 4 weeks. | Drug | icotinib plus gemcitabine |
Primary outcome
The number of patients who suffer adverse events
Time frame: 24 months
2 secondary outcomes
Tumor response assessed by RECIST 1.1
Time frame: 3 months
Progression-free survival
Time frame: 4 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Jul 2015.
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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.
Tingbo Liang, MD principal investigator
Second Affiliated Hospital of Zhejiang Univercity School of Medcine
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 icotinib and Gemcitabine in people with Pancreatic Cancer, run by Betta Pharmaceuticals Co., Ltd. at 1 site in China.
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 5 inclusion and 8 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 15 Jul 2015. 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 China. 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?
Contact Tingbo Liang, MD (0086-13666676128, liangtingbo@zju.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The number of patients who suffer adverse events (time frame: 24 months). 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 15 Jul 2015.