Unspecified Adult Solid Tumor, Protocol SpecificPhase 1NCT01028859
Safety Study of Increasing Doses of CKD-516 in Patients With Advanced Solid Cancers
A Phase 1 study testing CKD-516 inj in people with Unspecified Adult Solid Tumor, Protocol Specific, run by Chong Kun Dang Pharmaceutical at 1 site in South Korea.
Trial summary
A phase I study is conducted to determine the maximum tolerated dose (MTD), dose limiting toxicity (DLT), safety and pharmacokinetics (PK) profile of a single agent CKD-516 injection on a weekly schedule in patients with advanced solid cancers failed to standard therapy. Read more about this study
- Who is it for?
- Ages 20 to 75 years
- Conditions the study is for
- Unspecified Adult Solid Tumor, Protocol Specific
- What is being tested?
- CKD-516 inj
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteSouth Korea
- Study dates
- Dec 2009to Apr 2011
- 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 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 20~75 years
- Histologically or cytologically confirmed solid tumors that have failed to standard therapy or for which no life prolonging treatment exists
- ECOG PS 0-2
- Life expectancy 12 weeks
- Hematopoietic: ANC ≥ 1,500/mm3, Platelet ≥ 100,000/mm3, Hemoglobin ≥ 9.0g/dL, Prothrombin time, Activated partial thromboplastin time: normal range
- Hepatic: total bilirubin ≤ 1.5×ULN(except Gilbert's syndrome patients), AST, ALT ≤ 3.0×ULN(AST, ALT ≤ 5.0×ULN in case of liver metastases)
- Renal: serum creatinine ≤ 1.5×ULN or Creatinine clearance ≥ 60 mL/min
- Signed a written informed consent
Who cannot join
- Brain or Leptomeningeal metastases
- History of Ischemic heart disease(e.g., myocardial infarction, unstable angina pectoris) or Clinically significant heart disease such as NYHA Class III and IV Congestive atrial arrhythmias, within 6 months prior to first dose of study drug
- Stable angina pectoris shown symptoms within 6 months prior to first dose of study durg, or Clinically significant abnormality on EKG or echocardiogram(e.g., LVEF < 50% or clinically significant heart wall abnormality or heart muscle damage)
- Cerebrovascular disease such as stroke
- Grade 2 or greater motor or sensory peripheral neuropathy
- Clinically significant eye diseases(e.g., Glaucoma or Proliferative diabetic retinopathy, Atrophic macular degeneration), or other clinically significant abnormality on screening visit
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- Uncontrolled hypertension(greater than 150 mmHg systolic anc 100 mmHg diastolic regardless of medication)
- acute infection or blooding tendencies that would preclude study compliance
- Serious vascular disease such as Aortic aneurysm
- Other psychiatric disorders or other conditions that would preclude study compliance
- Receiving anticoagulation with warfarin, heparin, etc.
- Receiving antitumor therapy(surgery, immunotherapy or chemotherapy) within 4 weeks prior to first dose of study drug(6 weeks for nitrosoureas and mitomycin C, 2 weeks for radiation therapy)
- Other concurrent antitumor therapy
- History of Serious hypersensitivity or allergy
- Pregnant or nursing, active serum pregnancy test. Fertile patients must use effective contraception
- Participation in a clinical trial within 4 weeks of first dose of study drug
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Phase I Clinical Trial to Assess the Safety and Pharmacokinetic Profile of CKD-516 in Patients With Advanced Solid Cancers Failed to Standard Therapy
A phase I study is conducted to determine the maximum tolerated dose (MTD), dose limiting toxicity (DLT), safety and pharmacokinetics (PK) profile of a single agent CKD-516 injection on a weekly schedule in patients with advanced solid cancers failed to standard therapy. The usefulness of the this regimen is evaluated by response rate, progression free survival and vascular disruption effect by Dynamic Contrast-Enhanced MRI (DCE-MRI).
Read the detailed description
OBJECTIVES:
- I. Determine the maximum tolerated dose of CKD-516 administered at single doses every 21 days in patients with advanced solid tumors.
- II. Determine both the toxicity and dose limiting toxicity of this regimen in these patients.
- III. Determine the plasma and urine pharmacokinetics of CKD-516.
- IV. Gather preliminary data regarding possible antitumor effects in those patients with measurable diseae. Assess the effects of CKD-516 on tumor blood flow using DCE-MRI scanning techniques, and establish the dose at which these effects occur.
OUTLINE: This is an open label, dose escalation study. Patients receive CKD-516 IV over 30 minutes on day 1, 8 every 3 weeks in the absence of unacceptable toxicity or disease progression. Cohorts of 3~6 patients receive escalating doses of CKD-516 until the maximum tolerated dose(MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 3 or 2 of 6 patients experience dose limiting toxicity.
- Being tested
- CKD-516 inj
- Keywords
- Tubulin polymerization inhibitor, CKD-516, Phase I, Vascular disrupting agent, DCE MRI
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CKD-516 injDrug
Also called CKD-516
5.0 mg/2ml; 1.0, 2.0, 3.3, 5, 7, 9 ~ mg/m2; Day 1, Day 8 every 3 weeks
| Study group | Role | What they receive |
|---|---|---|
| CKD-516 inj | Experimental | Not described Receives: Drug: CKD-516 inj |
What is being measured
The primary outcome is the main question the study is designed to answer.
MTD, Maximum Tolerated Dose
Measured: 1st cycle
PK parameters of CKD-516 and its metabolite, S516, when CKD-516 administered on Days 1 and 8 of a 21-day cycle
Measured: 1st cycle
Dose-limiting Toxicity
Measured: 1st cycle
Secondary outcomes (3)
ORR%, Objective response rate
Measured: every 2 cycle
PFS, Progression Free Survival
Measured: 30 days before or after last patient out
Vascular disruption effect(with DCE-MRI)
Measured: 24hr after 1st cycle day 1 treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Dec 2009 (estimated)
- Study startDec 2009
- Primary completionApr 2011
- Study completionApr 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Unspecified Adult Solid Tumor, Protocol SpecificStudies of the same condition, open and under way.
- More trials run by Chong Kun Dang PharmaceuticalThe 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
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Chong Kun Dang Pharmaceutical
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Seoul National University Hospital
- Investigators
- Yung-Jue Bang, MD., PhD., Principal investigator, Seoul National University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01028859
- Sponsor's protocol ID
- 127ASC09E
- Status last verified
- Dec 2009
- First submitted
- 3 Dec 2009
- Last updated
- 22 Dec 2011
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Kim KW, Lee JM, Jeon YS, Kang SE, Baek JH, Han JK, Choi BI, Bang YJ, Kiefer B, Block KT, Ji H, Bauer S, Kim C. Free-breathing dynamic contrast-enhanced MRI of the abdomen and chest using a radial gradient echo sequence with K-space weighted image contrast (KWIC). Eur Radiol. 2013 May;23(5):1352-60. doi: 10.1007/s00330-012-2699-4. Epub 2012 Nov 28.
PubMed 23187728
Study at a glance
From the registry record, last updated by the sponsor on 22 Dec 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase I Clinical Trial to Assess the Safety and Pharmacokinetic Profile of CKD-516 in Patients With Advanced Solid Cancers Failed to Standard Therapy
- ClinicalTrials.gov ID
- NCT01028859
- Acronym / sponsor ID
- 127ASC09E
- Keywords
- Tubulin polymerization inhibitor, CKD-516, Phase I, Vascular disrupting agent, DCE MRI
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Chong Kun Dang PharmaceuticalIndustry (pharma, biotech, devices)
- Collaborators
- Seoul National University Hospital
- Study start
- Dec 2009
- Primary completion
- Apr 2011 (actual)
- Study completion
- Apr 2011 (actual)
- First posted
- 9 Dec 2009 (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.
A phase I study is conducted to determine the maximum tolerated dose (MTD), dose limiting toxicity (DLT), safety and pharmacokinetics (PK) profile of a single agent CKD-516 injection on a weekly schedule in patients with advanced solid cancers failed to standard therapy. The usefulness of the this regimen is evaluated by response rate, progression free survival and vascular disruption effect by Dynamic Contrast-Enhanced MRI (DCE-MRI).
Detailed description
OBJECTIVES:
- I. Determine the maximum tolerated dose of CKD-516 administered at single doses every 21 days in patients with advanced solid tumors.
- II. Determine both the toxicity and dose limiting toxicity of this regimen in these patients.
- III. Determine the plasma and urine pharmacokinetics of CKD-516.
- IV. Gather preliminary data regarding possible antitumor effects in those patients with measurable diseae. Assess the effects of CKD-516 on tumor blood flow using DCE-MRI scanning techniques, and establish the dose at which these effects occur.
OUTLINE: This is an open label, dose escalation study. Patients receive CKD-516 IV over 30 minutes on day 1, 8 every 3 weeks in the absence of unacceptable toxicity or disease progression. Cohorts of 3~6 patients receive escalating doses of CKD-516 until the maximum tolerated dose(MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 3 or 2 of 6 patients experience dose limiting toxicity.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| CKD-516 inj | Experimental | Drug: CKD-516 inj |
Who may qualify
- Ages
- 20 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 20~75 years
- Histologically or cytologically confirmed solid tumors that have failed to standard therapy or for which no life prolonging treatment exists
- ECOG PS 0-2
- Life expectancy 12 weeks
- Hematopoietic: ANC ≥ 1,500/mm3, Platelet ≥ 100,000/mm3, Hemoglobin ≥ 9.0g/dL, Prothrombin time, Activated partial thromboplastin time: normal range
Key exclusion criteria (16 listed)
- Brain or Leptomeningeal metastases
- History of Ischemic heart disease(e.g., myocardial infarction, unstable angina pectoris) or Clinically significant heart disease such as NYHA Class III and IV Congestive atrial arrhythmias, within 6 months prior to first dose of study drug
- Stable angina pectoris shown symptoms within 6 months prior to first dose of study durg, or Clinically significant abnormality on EKG or echocardiogram(e.g., LVEF < 50% or clinically significant heart wall abnormality or heart muscle damage)
- Cerebrovascular disease such as stroke
- Grade 2 or greater motor or sensory peripheral neuropathy
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 |
|---|---|---|
| CKD-516 injAlso: CKD-5165.0 mg/2ml; 1.0, 2.0, 3.3, 5, 7, 9 ~ mg/m2; Day 1, Day 8 every 3 weeks | Drug | CKD-516 inj |
Primary outcome
MTD, Maximum Tolerated Dose
Time frame: 1st cycle
PK parameters of CKD-516 and its metabolite, S516, when CKD-516 administered on Days 1 and 8 of a 21-day cycle
Time frame: 1st cycle
Dose-limiting Toxicity
Time frame: 1st cycle
3 secondary outcomes
ORR%, Objective response rate
Time frame: every 2 cycle
PFS, Progression Free Survival
Time frame: 30 days before or after last patient out
Vascular disruption effect(with DCE-MRI)
Time frame: 24hr after 1st cycle day 1 treatment
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 22 Dec 2011.
- Derived from this study: PubMed 23187728Kim KW, Lee JM, Jeon YS, Kang SE, Baek JH, Han JK, Choi BI, Bang YJ, Kiefer B, Block KT, Ji H, Bauer S, Kim C. Free-breathing dynamic contrast-enhanced MRI of the abdomen and chest using a radial gradient echo sequence with K-space weighted image contrast (KWIC). Eur Radiol. 2013 May;23(5):1352-60. doi: 10.1007/s00330-012-2699-4. Epub 2012 Nov 28.
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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.
Yung-Jue Bang, MD., PhD. principal investigator
Seoul National University Hospital
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 CKD-516 inj in people with Unspecified Adult Solid Tumor, Protocol Specific, run by Chong Kun Dang Pharmaceutical at 1 site in South Korea.
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 8 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: finished, as of the sponsor's last update on 22 Dec 2011. 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 South Korea. 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?
MTD, Maximum Tolerated Dose (time frame: 1st cycle). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01028859, which also lists 1 linked publication.
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 22 Dec 2011.