Advanced Gastric CancerPhase 1NCT03286244
Second-line CM082 Combined With Paclitaxel For Patients With Advanced Gastric Cancer
A Phase 1 study testing CM082 plus paclitaxel in people with Advanced Gastric Cancer, run by AnewPharma at 1 site in China.
Trial summary
This is an open-label, Phase 1b study which will be conducted in two parts: part A is the dose escalation study while part B is dose expansion study. The purpose of the dose escalation part is to identify the maximum tolerated dose (MTD) and/or recommended phase II dose (RP2D) of CM082 combined with paclitaxel in… Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Advanced Gastric Cancer
- What is being tested?
- CM082 plus paclitaxel
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 21 participants
- Where
- 1 siteChina
- Study dates
- 15 Mar 2018to Aug 2020
- 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
- Fully understand the study and sign the informed consent voluntarily;
- Patients with local advanced and/or metastatic gastric adenocarcinoma and/or adenocarcinoma of gastroesophageal junction confirmed by histology and/or cytology;
- Progressed on previous first-line standard chemotherapy;
- Male or female with an age of 18-70 years(inclusive);
- Body weight ≥40 kg (inclusive);
- At least one measurable lesion (according to RECIST1.1);
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- Performance status score (ECOG score) 0-1;
- Expected survival >12 weeks;
- Adequate bonemarrow, liver, renal and cardiac function, based on blood tests, electrocardiograms, and cardiac echocardiograms.
Who cannot join
- Participating in another drug clinical trial in the past 4 weeks; history of systemic anti-tumor treatment within 4 weeks prior to administration of the study drug; history of any major surgery within 4 weeks prior to enrollment to the study;
- Who have not recovered from toxicity caused by previous anti-cancer treatment (CTCAE>grade 1), or not completely recovered from previous surgery;
- Having received previous chemotherapy regimens with taxanes;
- Take medications that may extend QTc and/or Tdp;
- Active brain metastasis or meningeal metastasis;
- Uncontrolled hypertension (BP>150/90 on medications);
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- Other malignancies within the last 5 years, except for adequately treated cervix carcinoma in situ or basal or squamous-cell or basal cell carcinoma;
- QT interval > 450 ms;
- Uncontrolled clinical active infection, e.g. acute pneumonia, active hepatitis B or hepatitis C; HIV positive; syphilitic spiral antibody positive;
- Dysphagia, intractable vomiting or known drug malabsorption;
- Drug or alcohol abuser.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
National Cancer Center/Cancer Hospital, Chinese Academy of Medical Sciences & Peking Union Medical College
Beijing, 100021
Aiping Zhou
About this study
Official title: Safety and Preliminary Efficacy of CM082 in Combination With Paclitaxel for Treating Advanced Gastric Cancer Who Progressed on Standard First-line Treatment: a Phase 1, Dose-escalation Study
This is an open-label, Phase 1b study which will be conducted in two parts: part A is the dose escalation study while part B is dose expansion study. The purpose of the dose escalation part is to identify the maximum tolerated dose (MTD) and/or recommended phase II dose (RP2D) of CM082 combined with paclitaxel in patients with advanced gastric cancer who did not respond to first-line standard chemotherapy. In the subsequent dose expansion part, additional subjects will be enrolled to further explore the safety and preliminary clinical activity of CM082 and paclitaxel.
Read the detailed description
In dose escalation part, 9-18 patients with advanced gastric cancer will be enrolled. Patients meeting enrollment eligibility will receive 28-day cycles of CM082 100-200 mg qd combined with paclitaxel 80 mg/m2. Safety information will be collected in cycle 1 to determine MTD and/or RP2D of CM082 combined with paclitaxel in patients with advanced gastric cancer.
Dose escalation study will use traditional 3+3 trial design to observe DLT and evaluate MTD. If there are 2 or more cases of DLT in one dose group, the group lower than this dose group by one level is MTD dose group. At least 6 subjects are required in MTD dose group for confirmation. If MTD is not achieved at the end of dose escalation and there are 6 subjects in the highest dose group, 200 mg qd will be determined as RP2D. Dose escalation and study in the next dose group can be initiated only after the first treatment cycle (DLT window observation period) is completed and safety and tolerability in subject is confirmed in this dose group (0/3 or ≤1/6 subjects experience DLT).
Subjects in the original dose group will continue to receive the next cycle of treatment at the original dose until it meets the following discontinued treatment criteria: 1) death, 2) intolerable toxicity, 3) pregnancy, 4) the investigator considers the study should be terminated for the subject's best interests, 5) the subject or legal representative requests withdrawal, 6) loss to follow-up, 7) the investigator considers the subject has poor compliance, 8) disease progression, 9) the investigator considers the toxicity effect will be intensified if the study continues, 10) use other anti-tumor drugs.
In dose-expansion part, additional patients will be treated at the RP2D established in dose escalation part until it meets the discontinued treatment criteria.
- Conditions
- Advanced Gastric Cancer
- Being tested
- CM082 plus paclitaxel
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CM082 plus paclitaxelDrug
CM082 treatment: A treatment cycle is defined as 28 days. Oral CM082 tablets was given once daily for 3 weeks followed by 1-week break with escalating dose (100 mg, 150 mg and 200mg).
Drug: Paclitaxel Paclitaxel 80 mg/m2 will be administrated by intravenous injection on days 1, 8, 15 of a 28-day cycle for no more than 6 cycles.
| Study group | Role | What they receive |
|---|---|---|
| CM082 plus paclitaxel | Experimental | In dose-escalation part, patients will be treated in dose levels at the following daily doses of CM082 and paclitaxel to establish the MTD and RP2D:
CM082 100mg qd + paclitaxel 80mg/m2/day; CM082 150mg qd + paclitaxel 80mg/m2/day; CM082 200mg qd + paclitaxel 80mg/m2/day; In dose-expansion part, patients will be treated at the RP2D established in dose escalation part. Receives: Drug: CM082 plus paclitaxel |
What is being measured
The primary outcome is the main question the study is designed to answer.
DLT and MTD
DLTs were defined as grade 4 hematological toxicity; grade 3 or more severe nonhematologic toxicity including nausea/vomit, constipation , Hypertension , not controlled by adequate supportive treatment (with exceptions of alopecia); grade 3 febrile neutropenia. The MTD was defined as the highest dose at which no DLT was experienced by the first 3 patients in that cohort, or the dose at which a DLT was experienced by no more than 1 of 6 patients evaluable for toxicity.
Measured: 4 weeks
Percentage of patients who suffer at least one adverse event
Adverse event assessment and changes in safety assessments include laboratory parameters, vital signs, and ECOG score
Measured: From first dose to within 28 days after the last dose
Secondary outcomes (2)
Objective response rate
Defined as the rate of either a complete response or a partial response in evaluable patients
Measured: 12 weeks
Progression-free survival
Defined as the time from randomisation to disease progression or death
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Sep 2017
- Study start15 Mar 2018
- Primary completionAug 2019 (estimated)
- Study completionAug 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Advanced Gastric 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 21 participants (estimated)
Sponsor and investigators
- Lead sponsor
- AnewPharma
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Aiping Zhou, MD, Study chair, National Cancer Center/Cancer Hospital, Chinese Academy of Medical Sciences & Peking Union Medical College
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03286244
- Sponsor's protocol ID
- CM082-CA-I-104
- Status last verified
- Feb 2019
- First submitted
- 15 Sep 2017
- Last updated
- 21 Feb 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 21 Feb 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Safety and Preliminary Efficacy of CM082 in Combination With Paclitaxel for Treating Advanced Gastric Cancer Who Progressed on Standard First-line Treatment: a Phase 1, Dose-escalation Study
- ClinicalTrials.gov ID
- NCT03286244
- Acronym / sponsor ID
- CM082-CA-I-104
- Conditions
- Advanced Gastric Cancer
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 21 participants (estimated)
- Lead sponsor
- AnewPharmaIndustry (pharma, biotech, devices)
- Study start
- 15 Mar 2018 (actual)
- Primary completion
- Aug 2019 (estimated)
- Study completion
- Aug 2020 (estimated)
- First posted
- 18 Sep 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.
This is an open-label, Phase 1b study which will be conducted in two parts: part A is the dose escalation study while part B is dose expansion study. The purpose of the dose escalation part is to identify the maximum tolerated dose (MTD) and/or recommended phase II dose (RP2D) of CM082 combined with paclitaxel in patients with advanced gastric cancer who did not respond to first-line standard chemotherapy. In the subsequent dose expansion part, additional subjects will be enrolled to further explore the safety and preliminary clinical activity of CM082 and paclitaxel.
Detailed description
In dose escalation part, 9-18 patients with advanced gastric cancer will be enrolled. Patients meeting enrollment eligibility will receive 28-day cycles of CM082 100-200 mg qd combined with paclitaxel 80 mg/m2. Safety information will be collected in cycle 1 to determine MTD and/or RP2D of CM082 combined with paclitaxel in patients with advanced gastric cancer.
Dose escalation study will use traditional 3+3 trial design to observe DLT and evaluate MTD. If there are 2 or more cases of DLT in one dose group, the group lower than this dose group by one level is MTD dose group. At least 6 subjects are required in MTD dose group for confirmation. If MTD is not achieved at the end of dose escalation and there are 6 subjects in the highest dose group, 200 mg qd will be determined as RP2D. Dose escalation and study in the next dose group can be initiated only after the first treatment cycle (DLT window observation period) is completed and safety and tolerability in subject is confirmed in this dose group (0/3 or ≤1/6 subjects experience DLT).
Subjects in the original dose group will continue to receive the next cycle of treatment at the original dose until it meets the following discontinued treatment criteria: 1) death, 2) intolerable toxicity, 3) pregnancy, 4) the investigator considers the study should be terminated for the subject's best interests, 5) the subject or legal representative requests withdrawal, 6) loss to follow-up, 7) the investigator considers the subject has poor compliance, 8) disease progression, 9) the investigator considers the toxicity effect will be intensified if the study continues, 10) use other anti-tumor drugs.
In dose-expansion part, additional patients will be treated at the RP2D established in dose escalation part until it meets the discontinued treatment criteria.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| CM082 plus paclitaxel | Experimental | Drug: CM082 plus paclitaxelIn dose-escalation part, patients will be treated in dose levels at the following daily doses of CM082 and paclitaxel to establish the MTD and RP2D: CM082 100mg qd + paclitaxel 80mg/m2/day; CM082 150mg qd + paclitaxel 80mg/m2/day; CM082 200mg qd + paclitaxel 80mg/m2/day; In dose-expansion part, patients will be treated at the RP2D established in dose escalation part. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Fully understand the study and sign the informed consent voluntarily;
- Patients with local advanced and/or metastatic gastric adenocarcinoma and/or adenocarcinoma of gastroesophageal junction confirmed by histology and/or cytology;
- Progressed on previous first-line standard chemotherapy;
- Male or female with an age of 18-70 years(inclusive);
- Body weight ≥40 kg (inclusive);
Key exclusion criteria (11 listed)
- Participating in another drug clinical trial in the past 4 weeks; history of systemic anti-tumor treatment within 4 weeks prior to administration of the study drug; history of any major surgery within 4 weeks prior to enrollment to the study;
- Who have not recovered from toxicity caused by previous anti-cancer treatment (CTCAE>grade 1), or not completely recovered from previous surgery;
- Having received previous chemotherapy regimens with taxanes;
- Take medications that may extend QTc and/or Tdp;
- Active brain metastasis or meningeal metastasis;
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 |
|---|---|---|
| CM082 plus paclitaxelCM082 treatment: A treatment cycle is defined as 28 days. Oral CM082 tablets was given once daily for 3 weeks followed by 1-week break with escalating dose (100 mg, 150 mg and 200mg). Drug: Paclitaxel Paclitaxel 80 mg/m2 will be administrated by intravenous injection on days 1, 8, 15 of a 28-day cycle for no more than 6 cycles. | Drug | CM082 plus paclitaxel |
Primary outcome
DLT and MTD
Time frame: 4 weeks
DLTs were defined as grade 4 hematological toxicity; grade 3 or more severe nonhematologic toxicity including nausea/vomit, constipation , Hypertension , not controlled by adequate supportive treatment (with exceptions of alopecia); grade 3 febrile neutropenia. The MTD was defined as the highest dose at which no DLT was experienced by the first 3 patients in that cohort, or the dose at which a DLT was experienced by no more than 1 of 6 patients evaluable for toxicity.
Percentage of patients who suffer at least one adverse event
Time frame: From first dose to within 28 days after the last dose
Adverse event assessment and changes in safety assessments include laboratory parameters, vital signs, and ECOG score
2 secondary outcomes
Objective response rate
Time frame: 12 weeks
Progression-free survival
Time frame: 6 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Feb 2019.
- Individual participant dataSharing planned: Undecided
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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.
Aiping Zhou, MD study chair
National Cancer Center/Cancer Hospital, Chinese Academy of Medical Sciences & Peking Union Medical College
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 CM082 plus paclitaxel in people with Advanced Gastric Cancer, run by AnewPharma 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 9 inclusion and 11 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 21 Feb 2019. 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 Aiping Zhou, MD (8610-87788800, zhouap1825@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
DLT and MTD (time frame: 4 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 21 Feb 2019.