Extended Use Protocol for Participants With Cancer to Receive Continued Treatment With CS-7017

A Phase 1 study testing CS-7017 in people with Advanced Cancer, run by Daiichi Sankyo at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Trial summary

This is a study of CS-7017 designed to allow participants who completed participation in a clinical study of CS-7017 without experiencing disease progression or unacceptable toxicity to continue treatment with study drug. Read more about this study

Who is it for?: Any age
Conditions the study is for: Advanced Cancer
What is being tested?: CS-7017
Type of treatment: Pill or oral medicine
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 2 participants
Where: 1 siteUnited States
Study dates: Mar 2009to Sep 2011
Phase: Phase 1
Are there results?: Yes, posted in the registrySummary in the doctors' view

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 Any age
All sexes
No healthy volunteers
Child, Adult, Older adult

Who may be able to join

Participant previously treated with CS-7017 as part of a study that included CS-7017 and has shown clinical benefits from treatment with CS-7017.

Who cannot join

Anticipation of need for a major surgical procedure or radiation therapy during the study.
Any of the following conditions within 6 months prior to initiating study treatment: Myocardial infarction with significant impairment of cardiac function (eg, ejection fraction ≤ 50%), severe/unstable angina pectoris, coronary/peripheral artery bypass graft, New York Heart Association (NYHA) class II or higher congestive heart failure.
Participants with clinically significant pleural or pericardial effusions.
Clinically significant active infection, which requires antibiotic therapy, or human immune deficiency virus (HIV)-positive subjects receiving antiretroviral therapy.
Participants with diabetes mellitus requiring treatment with insulin, sulfonylureas or thiazolidinediones (TZDs) agents, malabsorption syndrome, chronic diarrhea, inflammatory bowel disease, or partial bowel obstruction.

Trial locations and contacts

1 site in 1 country.

United States1 site

Study site
Washington D.C., District of Columbia

Other trials in United States

About this study

Official title: Extended Use of CS 7017 Upon Completion of Participation in a Clinical Study of CS-7017 in Subjects With Cancer

Read the detailed description

This is an open-label non-randomized study of CS-7017 designed to allow participants who completed participation in a clinical study of CS-7017 without experiencing disease progression or unacceptable toxicity to continue treatment with study drug.

Conditions: Advanced Cancer
Being tested: CS-7017
Keywords: CS-7017, Advanced Cancer

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

CS-7017Drug
CS-7017 administered orally, twice daily continuously for 6 weeks

Study groups in NCT00881569
Study group	Role	What they receive
1	Experimental	CS-7017 tablets twice daily at strength ranging from 0.5 mg to 0.75 mg Receives: Drug: CS-7017

What is being measured

The primary outcome is the main question the study is designed to answer.

Best Response Following Extended Use of CS-7017 Upon Completion of Participation in a Clinical Study of CS-7017 in Participants With Cancer
At each evaluation, the participant's status was assessed as complete response (CR), partial response (PR), stable disease (SD), or progressive disease (PD); the best response was then identified. CR was defined as a disappearance of all target lesions, PR was defined as at least a 30% decrease in the sum of diameters of target lesions, and stable disease (SD) was defined as neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for progressive disease (PD; at least a 20% increase in the sum of diameters of target lesions).
Measured: From baseline and every 6 weeks postdose, up to 2 years 6 months

Secondary outcomes (2)

Response/Stable Disease Duration and Time to Progression Following Extended Use of CS-7017 Upon Completion of Participation in a Clinical Study of CS-7017 in Participants With Cancer
Duration of response was to be calculated as the date of progression minus the earliest date of complete response (CR) or partial response (PR), plus 1. The earliest date of CR or PR was to be taken from the earlier study (CS7017-A-U102). If any participant entered the study with stable disease (SD), then the duration of SD was to be calculated as the date of progression minus the date of first dose, plus 1. Time to progression was to be calculated as the date of progression minus the date of first dose of study medication in the earlier study, plus 1.
Measured: Baseline and every 6 weeks postdose, up to 2 years 6 months
Treatment-Emergent Adverse Events Occurring in Participants Following Extended Use of CS-7017 Upon Completion of Participation in a Clinical Study of CS-7017 in Participants With Cancer
Adverse events (AEs) were graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) version 3.0. AE intensity was assessed according to the following scale: Mild (Grade 1), Awareness of sign or symptom, but easily tolerated, ie, does not interfere with subject's usual function; Moderate (Grade 2), Discomfort enough to cause interference with usual activity; Severe (Grade 3), Incapacitating with inability to work or do usual activity, ie, interferes significantly with participant's usual function. Severe (Grade 3) AEs indicate worse outcomes.
Measured: Baseline up to 30 days after last dose, up to 2 years 6 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Mar 2009Sep 2011

First posted15 Apr 2009 (estimated)
Study startMar 2009
Primary completionMar 2011
Study completionSep 2011

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Advanced CancerStudies of the same condition, open and under way.
More trials run by Daiichi SankyoThe 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: 2 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00881569
Sponsor's protocol ID: CS7017-A-U102E
Status last verified: Sep 2020
First submitted: 14 Apr 2009
Last updated: 28 Sep 2020
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
Individual data sharing: Yes: De-identified individual participant data (IPD) and applicable supporting clinical trial documents may be available upon request at https://vivli.org/. In cases where clinical trial data and supporting documents are provided pursuant to our company policies and procedures, Daiichi Sankyo will continue to protect the privacy of our clinical trial participants. Details on data sharing criteria and the procedure for requesting access can be found at this web address: https://vivli.org/ourmember/daiichi-sankyo/

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

Enrolling by invitationPhase 2
A Single-Arm Study of Nimotuzumab Combined With NALIRIFOX as First-Line Treatment for Pancreatic Cancer
Pancreatic Cancer Metastatic
RecruitingPhase 1/2
Study of INBRX-106 and INBRX-106 in Combination With Pembrolizumab (Keytruda®) in Subjects With Locally Advanced or Metastatic Solid Tumors (Hexavalent OX40 Agonist)
Solid Tumor, Non-Small Cell Lung Cancer
Active, not recruitingPhase 3
A Study of Belzutifan (MK-6482) in Combination With Lenvatinib Versus Cabozantinib for Treatment of Renal Cell Carcinoma (MK-6482-011)
Carcinoma, Renal Cell
RecruitingPhase 3
A Study Evaluating Sotorasib Platinum Doublet Combination Versus Pembrolizumab Platinum Doublet Combination as a Front-Line Therapy in Participants With Stage IV or Advanced Stage IIIB/C Nonsquamous Non-Small Cell Lung Cancers (CodeBreaK 202)
Non-Small Cell Lung Cancer (NSCLC)
Active, not recruitingPhase 1
A Study to Assess Safety, Tolerability, and Pharmacokinetics of ABSK043 in Patients With Advanced Solid Tumor
Neoplasms

All Advanced Cancer trials

Study at a glance

From the registry record, last updated by the sponsor on 28 Sep 2020. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Extended Use of CS 7017 Upon Completion of Participation in a Clinical Study of CS-7017 in Subjects With Cancer
ClinicalTrials.gov ID: NCT00881569
Acronym / sponsor ID: CS7017-A-U102E
Conditions: Advanced Cancer
Keywords: CS-7017, Advanced Cancer
Phase: Phase 1
Study type: Interventional
Recruitment status: Completed
Enrolment: 2 participants (actual)
Lead sponsor: Daiichi SankyoIndustry (pharma, biotech, devices)
Study start: Mar 2009
Primary completion: Mar 2011 (actual)
Study completion: Sep 2011 (actual)
First posted: 15 Apr 2009 (estimated)
Results: Posted 14 Aug 2020

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1

Arm	Type	Receives
1	Experimental	Drug: CS-7017CS-7017 tablets twice daily at strength ranging from 0.5 mg to 0.75 mg

Who may qualify

Sex: All
Healthy volunteers: Not accepted
Age groups: Child, Adult, Older adult

Key inclusion criteria (1 listed)

Participant previously treated with CS-7017 as part of a study that included CS-7017 and has shown clinical benefits from treatment with CS-7017.

Key exclusion criteria (5 listed)

Anticipation of need for a major surgical procedure or radiation therapy during the study.
Any of the following conditions within 6 months prior to initiating study treatment: Myocardial infarction with significant impairment of cardiac function (eg, ejection fraction ≤ 50%), severe/unstable angina pectoris, coronary/peripheral artery bypass graft, New York Heart Association (NYHA) class II or higher congestive heart failure.
Participants with clinically significant pleural or pericardial effusions.
Clinically significant active infection, which requires antibiotic therapy, or human immune deficiency virus (HIV)-positive subjects receiving antiretroviral therapy.
Participants with diabetes mellitus requiring treatment with insulin, sulfonylureas or thiazolidinediones (TZDs) agents, malabsorption syndrome, chronic diarrhea, inflammatory bowel disease, or partial bowel obstruction.

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
CS-7017CS-7017 administered orally, twice daily continuously for 6 weeks	Drug	1

Primary outcome

Best Response Following Extended Use of CS-7017 Upon Completion of Participation in a Clinical Study of CS-7017 in Participants With Cancer
Time frame: From baseline and every 6 weeks postdose, up to 2 years 6 months
At each evaluation, the participant's status was assessed as complete response (CR), partial response (PR), stable disease (SD), or progressive disease (PD); the best response was then identified. CR was defined as a disappearance of all target lesions, PR was defined as at least a 30% decrease in the sum of diameters of target lesions, and stable disease (SD) was defined as neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for progressive disease (PD; at least a 20% increase in the sum of diameters of target lesions).

2 secondary outcomes

Response/Stable Disease Duration and Time to Progression Following Extended Use of CS-7017 Upon Completion of Participation in a Clinical Study of CS-7017 in Participants With Cancer
Time frame: Baseline and every 6 weeks postdose, up to 2 years 6 months
Treatment-Emergent Adverse Events Occurring in Participants Following Extended Use of CS-7017 Upon Completion of Participation in a Clinical Study of CS-7017 in Participants With Cancer
Time frame: Baseline up to 30 days after last dose, up to 2 years 6 months

Results and safety

Results posted to the registry on 14 Aug 2020, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
CS-7017 0.75 mg BID	1	0
CS-7017 0.50 mg BID	1	0

Primary outcome: Best Response Following Extended Use of CS-7017 Upon Completion of Participation in a Clinical Study of CS-7017 in Participants With Cancer

Time frame: From baseline and every 6 weeks postdose, up to 2 years 6 months. Count of participants. Unit: Participants

Measure	CS-7017 0.50 mg BID n = 1	CS-7017 0.75 mg BID n = 1
Partial response (PR)	0	1
Stable disease (SD)	1	0

Population analysed: Best response was assessed in All Enrolled Participants.

2 secondary outcomes are reported in the full results.

Adverse events

Time frame: Treatment-emergent adverse events (TEAEs) were collected from baseline up to 30 days after last dose, up to 2 years 6 months.. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
CS-7017 0.50 mg BID	0 of 1 (0%)	1 of 1 (100%)	0 of 1
CS-7017 0.75 mg BID	0 of 1 (0%)	1 of 1 (100%)	0 of 1

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 28 Sep 2020.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Individual participant dataSharing planned: Yes. De-identified individual participant data (IPD) and applicable supporting clinical trial documents may be available upon request at https://vivli.org/. In cases where clinical trial data and supporting documents are provided pursuant to our company policies and procedures, Daiichi Sankyo will continue to protect the privacy of our clinical trial participants. Details on data sharing criteria and the procedure for requesting access can be found at this web address: https://vivli.org/ourmember/daiichi-sankyo/

Related trials for Advanced Cancer

Enrolling by invitationPhase 2
A Single-Arm Study of Nimotuzumab Combined With NALIRIFOX as First-Line Treatment for Pancreatic Cancer
Pancreatic Cancer Metastatic
RecruitingPhase 1/2
Study of INBRX-106 and INBRX-106 in Combination With Pembrolizumab (Keytruda®) in Subjects With Locally Advanced or Metastatic Solid Tumors (Hexavalent OX40 Agonist)
Solid Tumor, Non-Small Cell Lung Cancer
Active, not recruitingPhase 3
A Study of Belzutifan (MK-6482) in Combination With Lenvatinib Versus Cabozantinib for Treatment of Renal Cell Carcinoma (MK-6482-011)
Carcinoma, Renal Cell
RecruitingPhase 3
A Study Evaluating Sotorasib Platinum Doublet Combination Versus Pembrolizumab Platinum Doublet Combination as a Front-Line Therapy in Participants With Stage IV or Advanced Stage IIIB/C Nonsquamous Non-Small Cell Lung Cancers (CodeBreaK 202)
Non-Small Cell Lung Cancer (NSCLC)
Active, not recruitingPhase 1
A Study to Assess Safety, Tolerability, and Pharmacokinetics of ABSK043 in Patients With Advanced Solid Tumor
Neoplasms

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.

Clinical Study Leader study director

Daiichi Sankyo

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 CS-7017 in people with Advanced Cancer, run by Daiichi Sankyo at 1 site in United States.

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 1 inclusion and 5 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 28 Sep 2020. 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 United States. 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?

Yes. Results are posted in the registry (first posted 14 Aug 2020). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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?

Best Response Following Extended Use of CS-7017 Upon Completion of Participation in a Clinical Study of CS-7017 in Participants With Cancer (time frame: From baseline and every 6 weeks postdose, up to 2 years 6 months). 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 NCT00881569.

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 Sep 2020.