Advanced CancerPhase 1NCT01863485
Phase 1 Study of CM082 (X-82) Tablets in Advanced Cancer Patients in China
A Phase 1 study testing CM082 Tablet in people with Advanced Cancer, run by AnewPharma at 3 sites in China.
Trial summary
This is a Phase I Dose-Escalation Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of CM082 tablets in Chinese Patients With Advanced Solid Tumors. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Advanced Cancer
- What is being tested?
- CM082 Tablet
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 44 participants
- Where
- 3 sitesChina
- Study dates
- May 2013to May 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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Histologically or cytologically confirmed diagnosis of advanced solid tumor malignancy that is not responsive to standard therapies or for which there is no effective therapy.
- Eastern Cooperative Group (ECOG) Performance Status score of 0 or 1.
- Life expectancy of at least 12 weeks.
- No immuno deficiency.
- Adequate organ system function, defined as follows:
- Absolute neutrophil count (ANC) ≥1.5 x 10**9/L
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- Platelets ≥100 x 10**9/L
- Hemoglobin ≥10 g/dL
- Total bilirubin ≤1.5 times the upper limit of normal (ULN)
- Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤1.5x the upper limit of normal (ULN) if no liver involvement or ≤2.5x the upper limit of normal with liver involvement.
- Creatinine ≤ 1.5 x ULN.
- At least 4 weeks or 5 half-life after receiving cancer therapy (i.e., chemotherapy, radiation therapy, immunotherapy, biologic therapy, hormonal therapy, surgery and/or tumor embolization.
- Willingness and ability to comply with trial and follow-up procedures.
- Ability to understand the nature of this trial and give written informed consent.
Who cannot join
- Not recovered from prior anti-cancer therapy or surgery.
- Have taken strong cytochrome P450 3A4 inhibitors or inducers in the last 2 weeks.
- Concomitant use of drugs with a risk of causing prolonged corrected QT interval and/or Torsades de Pointes.
- Patients with a history of intolerance to, or significant toxicity with, VEGFR tyrosine kinase inhibitor(s) (TKI).
- Females who are pregnant or breastfeeding.
- Those in reproductive ages who refuse to use contraception.
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- Those with concurrent condition(e.g. psychological, neuronal, cardiovascular, respiratory conditions or infections) that in the investigator's opinion would jeopardize compliance with the protocol.
- Patients with known central nervous system (CNS) metastases.
- Presence of active gastrointestinal (GI) disease or other condition that will interfere significantly with the absorption, distribution, metabolism, or excretion of CM082 (X-82).
- Patients with known GI disorders such as vomiting, diarrhea.
- Patients who are hepatitis B virus positive.
- Drug abuser.
Trial locations and contacts
3 sites in 1 country.
China3 sites
Beijing University First Hospital
Beijing, Beijing Municipality, 100034
Cancer Institute and Hospital, Chinese Academy of Medical Sciences
Beijing, 100021
Tianjin Cancer Hospital
Tianjin, Tianjin Municipality, 300060
About this study
Official title: Phase 1 Safety, Tolerability, and Pharmacokinetic Study of CM082 (X-82) Tablets in Advanced Cancer Patients in China
This is a Phase I Dose-Escalation Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of CM082 tablets in Chinese Patients With Advanced Solid Tumors.
Read the detailed description
This is a Phase I Dose-Escalation Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of CM082 tablets in Chinese Patients With Advanced Solid Tumors. After the maximum tolerated dose (MTD) or the optimal biological dose is identified, an expansion cohort of ~20 advanced renal cell carcinoma patients will be enrolled to further characterize the safety and tumor response by CT.
- Conditions
- Advanced Cancer
- Being tested
- CM082 Tablet
- Keywords
- advanced cancer
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CM082 TabletDrug
Also called X-82
CM082 tablets taken orally once a day on 28-day cycles
| Study group | Role | What they receive |
|---|---|---|
| CM082 | Experimental | CM082 tablet Receives: Drug: CM082 Tablet |
What is being measured
The primary outcome is the main question the study is designed to answer.
Maximum Tolerated Dose
To determine the Maximum Tolerated Dose in Chinese patients with advanced solid tumors.
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 May 2013 (estimated)
- Study startMay 2013
- Primary completionOct 2014
- Study completionMay 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Advanced 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
- 44 participants (actual)
Sponsor and investigators
- Lead sponsor
- AnewPharma
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Jin-Wan Wang, M.D., Principal investigator, Cancer Institute and Hospital, Chinese Academy of Medical Sciences, Beijing
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01863485
- Sponsor's protocol ID
- CM082-CA-I-001
- Other IDs
- 2013L00579、2013L00581
- Status last verified
- Jul 2019
- First submitted
- 22 May 2013
- Last updated
- 5 Jul 2019
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Jul 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase 1 Safety, Tolerability, and Pharmacokinetic Study of CM082 (X-82) Tablets in Advanced Cancer Patients in China
- ClinicalTrials.gov ID
- NCT01863485
- Acronym / sponsor ID
- CM082-CA-I-001
- Conditions
- Advanced Cancer
- Keywords
- advanced cancer
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 44 participants (actual)
- Lead sponsor
- AnewPharmaIndustry (pharma, biotech, devices)
- Collaborators
- Cancer Institute and Hospital, Chinese Academy of Medical Sciences
- Study start
- May 2013
- Primary completion
- Oct 2014 (actual)
- Study completion
- May 2016 (actual)
- First posted
- 29 May 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.
This is a Phase I Dose-Escalation Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of CM082 tablets in Chinese Patients With Advanced Solid Tumors.
Detailed description
This is a Phase I Dose-Escalation Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of CM082 tablets in Chinese Patients With Advanced Solid Tumors. After the maximum tolerated dose (MTD) or the optimal biological dose is identified, an expansion cohort of ~20 advanced renal cell carcinoma patients will be enrolled to further characterize the safety and tumor response by CT.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| CM082 | Experimental | Drug: CM082 TabletCM082 tablet |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (14 listed)
- Histologically or cytologically confirmed diagnosis of advanced solid tumor malignancy that is not responsive to standard therapies or for which there is no effective therapy.
- Eastern Cooperative Group (ECOG) Performance Status score of 0 or 1.
- Life expectancy of at least 12 weeks.
- No immuno deficiency.
- Adequate organ system function, defined as follows:
Key exclusion criteria (12 listed)
- Not recovered from prior anti-cancer therapy or surgery.
- Have taken strong cytochrome P450 3A4 inhibitors or inducers in the last 2 weeks.
- Concomitant use of drugs with a risk of causing prolonged corrected QT interval and/or Torsades de Pointes.
- Patients with a history of intolerance to, or significant toxicity with, VEGFR tyrosine kinase inhibitor(s) (TKI).
- Females who are pregnant or breastfeeding.
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 TabletAlso: X-82CM082 tablets taken orally once a day on 28-day cycles | Drug | CM082 |
Primary outcome
Maximum Tolerated Dose
Time frame: 12 months
To determine the Maximum Tolerated Dose in Chinese patients with advanced solid tumors.
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 5 Jul 2019.
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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.
Jin-Wan Wang, M.D. principal investigator
Cancer Institute and Hospital, Chinese Academy of Medical Sciences, Beijing
3 sites 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 Tablet in people with Advanced Cancer, run by AnewPharma at 3 sites 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 14 inclusion and 12 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 5 Jul 2019. 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 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?
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?
Maximum Tolerated Dose (time frame: 12 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 5 Jul 2019.