Pancreatic CancerPhase 2NCT00521404
Open-label Study of CS-1008 for Subjects With Untreated and Unresectable Pancreatic Cancer
A Phase 2 study testing CS-1008 (humanized anti-DR5 antibody) and gemcitabine in people with Pancreatic Cancer, run by Daiichi Sankyo at 12 sites in United States.
Trial summary
Phase 2 study to determine the efficacy and safety of CS-1008 when given with gemcitabine to subjects with previously untreated and unresectable (unable to be surgically removed) or metastatic (spread to other areas beyond the pancreas) pancreatic cancer. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pancreatic Cancer
- What is being tested?
- CS-1008 (humanized anti-DR5 antibody) and gemcitabine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 65 participants
- Where
- 12 sitesUnited States
- Study dates
- 15 Aug 2007to 20 Aug 2010
- Phase
- Phase 2
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Histologically or cytologically confirmed resectable or metastatic pancreatic cancer; not previously treated with chemotherapy; measurable disease; 18 years of age or older
Who cannot join
- Anticipation of need for major surgery or radiation therapy during the study
- Heart Disease exclusions: myocardial infarction or unstable angina within the past 6 months; severe or unstable angina pectoris within the past 6 months; coronary or peripheral artery bypass graft within the past 6 mo., etc.
- Clinically significant active infection or history of HIV
- Partial or complete bowel obstruction
- Poorly controlled psychiatric illness
Trial locations and contacts
12 sites in 1 country.
12 sites in 1 country
United States12 sites
Study site
Atlanta, Georgia
Study site
Birmingham, Alabama
Study site
Chattanooga, Tennessee
Study site
Cincinnati, Ohio
Study site
Decatur, Illinois
Study site
Fort Myers, Florida
Study site
Minneapolis, Minnesota
Study site
Nashville, Tennessee
Study site
Richmond, Virginia
Study site
Temple, Texas
Georgia Cancer Specialists
Tucker, Georgia, 30084
Study site
Washington D.C., District of Columbia
About this study
Official title: Phase 2 Multicenter, Open-Label Study of CS-1008, A Humanized Monoclonal Antibody Targeting Death Receptor 5 (DR5), In Combination With Gemcitabine in Chemotherapy Naive Subjects With Unresectable or Metastatic Pancreatic Cancer
Phase 2 study to determine the efficacy and safety of CS-1008 when given with gemcitabine to subjects with previously untreated and unresectable (unable to be surgically removed) or metastatic (spread to other areas beyond the pancreas) pancreatic cancer.
Read the detailed description
Primary Objective:
- To evaluate the efficacy of CS-1008 administered in combination with gemcitabine to chemotherapy naive subjects with unresectable or metastatic pancreatic cancer, based on the progression-free survival at 16 weeks.
Secondary Objectives:
- To evaluate the efficacy of CS-1008 administered in combination with gemcitabine on overall progression-free survival rate, objective response rate, duration of response, and overall survival.
- To determine the pharmacokinetics of BIP CS-1008 and DSC CS-1008.
- To study potential biomarkers of CS-1008 activity
- To assess possible human anti-human antibody formation after exposure to CS-1008
- To evaluate the safety profile of CS-1008 when administered in combination with gemcitabine to chemotherapy naive subjects with unresectable or metastatic pancreatic cancer.
- Conditions
- Pancreatic Cancer
- Being tested
- CS-1008 (humanized anti-DR5 antibody), gemcitabine
- Keywords
- Pancreatic cancer, chemotherapy naive, unresectable or metastatic pancreatic cancer, CS1008, Gemcitabine, Gemzar
- Medical subject headings
- Pancreatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CS-1008 (humanized anti-DR5 antibody)Drug
Also called CS1008
CS-1008: 8mg/kg loading dose followed by 3mg/kg weekly.
gemcitabineDrug
Also called Gemzar
Gemcitabine - 1000mg/meter sq
| Study group | Role | What they receive |
|---|---|---|
| CS-1008 + gemcitabine | Experimental | CS-1008 + gemcitabine Receives: Drug: CS-1008 (humanized anti-DR5 antibody); Drug: gemcitabine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Progression-Free Survival Rate at 16 Weeks Following Treatment With CS-1008 in Combination With Gemcitabine in Chemotherapy-Naïve Participants With Unresectable or Metastatic Pancreatic Cancer
Progression-free survival rate (PFS) was defined as the time from the date of the first administration of the study drug (Day 1) to the date of the first objective documentation of disease progression or death resulting from any cause, whichever came first at 16 weeks post-treatment with CS-1008.
Measured: Baseline to the date of disease progression or death due to any cause (whichever occurs first), up to 16 weeks post dose.
Secondary outcomes (5)
Kaplan-Meier (Non-Parametric) Analysis of Progression-Free Survival Following Treatment With CS-1008 in Combination With Gemcitabine in Chemotherapy-Naïve Participants With Unresectable or Metastatic Pancreatic Cancer
PFS (Progression-free survival) was defined as the time from the date of the first administration of study drug (Day 1) to the date of the first objective documentation of disease progression or death resulting from any cause, whichever came first.
Measured: Baseline up to date of disease progression or death due to any cause (whichever occurs first), up to approximately 36 months post dose.
Overall Survival Following Treatment With CS-1008 in Combination With Gemcitabine in Chemotherapy-Naïve Participants With Unresectable or Metastatic Pancreatic Cancer
OS (Overall Survival) was defined as the time from the date of the first administration of study drug (Day 1) to the date of death. If there was no death reported for a subject before the cut-off date for overall survival analysis, overall survival was censored at the last contact date at which the subject was known to be alive.
Measured: Baseline to death due to any cause, up to approximately 36 months post dose.
Best Overall Tumor Response Following Treatment With CS-1008 in Combination With Gemcitabine in Chemotherapy-Naïve Participants With Unresectable or Metastatic Pancreatic Cancer
The best overall response the best response (in the order of confirmed complete response [CR], confirmed partial response [PR], unconfirmed CR, unconfirmed PR, stable disease [SD], and progressive disease[PD]) among all overall responses recorded from the start of treatment until the subject withdrew from the study. If there was no tumor assessment after the first infusion of study drug and no clinical disease progression recorded, the best overall response was classified as Unknown. CR was defined as the disappearance of all target lesions, PR was defined as at least a 30% decrease in the sum of diameters of target lesions, PD was defined as at least a 20% increase in the sum of diameters of target lesions, and SD was defined as neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for progressive disease PD according to RECIST guideline (version 1.1).
Measured: Baseline to up to date of first documented objective response or disease progression (whichever occurs first), up to approximately 36 months post dose.
Number of Participants With Treatment-Emergent Adverse Events Considered by the Investigator at Least Possibly Related to CS-1008 Experienced by ≥5% of Participants by System Organ Class and Preferred Term
A treatment-emergent adverse event (TEAE) was defined as an adverse event (AE) that: emerges during treatment, having been absent at pre-treatment; or reemerges during treatment, having been present at baseline but stopped prior to treatment or worsens in severity during treatment relative to the pre-treatment state when the AE was continuous. The AEs with an onset date on Day 1 (the date on which the first dose of study medication was administered) were counted as a TEAE. An AE that occurred more than 30 days after the last dose of study medication was not included as a TEAE unless it was considered drug-related. A TEAE was considered related to CS-1008 or gemcitabine if the investigator considered the event as possibly, probably, or definitely related to treatment, or if the investigator's assessment of the relationship was unknown.
Measured: Baseline up to 30 days post last dose, up to approximately 36 months post dose.
Number of Participants With Treatment-Emergent Adverse Events Considered by the Investigator at Least Possibly Related to Gemcitabine Experienced by ≥5% of Participants by System Organ Class and Preferred Term
A treatment-emergent adverse event (TEAE) was defined as an adverse event (AE) that: emerges during treatment, having been absent at pre-treatment; or reemerges during treatment, having been present at baseline but stopped prior to treatment or worsens in severity during treatment relative to the pre-treatment state when the AE was continuous. The AEs with an onset date on Day 1 (the date on which the first dose of study medication was administered) were counted as a TEAE. An AE that occurred more than 30 days after the last dose of study medication was not included as a TEAE unless it was considered drug-related. A TEAE was considered related to CS-1008 or gemcitabine if the investigator considered the event as possibly, probably, or definitely related to treatment, or if the investigator's assessment of the relationship was unknown.
Measured: Baseline up to 30 days post last dose, up to approximately 36 months post dose.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Aug 2007 (estimated)
- Study start15 Aug 2007
- Primary completion20 Aug 2010
- Study completion20 Aug 2010
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 Pancreatic 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 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 65 participants (actual)
Sponsor and investigators
- Lead sponsor
- Daiichi Sankyo
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Global Clinical Leader, Study director, Daiichi Sankyo
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00521404
- Sponsor's protocol ID
- CS1008-A-U201
- Status last verified
- Mar 2021
- First submitted
- 24 Aug 2007
- Last updated
- 8 Apr 2021
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Apr 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase 2 Multicenter, Open-Label Study of CS-1008, A Humanized Monoclonal Antibody Targeting Death Receptor 5 (DR5), In Combination With Gemcitabine in Chemotherapy Naive Subjects With Unresectable or Metastatic Pancreatic Cancer
- ClinicalTrials.gov ID
- NCT00521404
- Acronym / sponsor ID
- CS1008-A-U201
- Conditions
- Pancreatic Cancer
- Keywords
- Pancreatic cancer, chemotherapy naive, unresectable or metastatic pancreatic cancer, CS1008, Gemcitabine, Gemzar
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 65 participants (actual)
- Lead sponsor
- Daiichi SankyoIndustry (pharma, biotech, devices)
- Study start
- 15 Aug 2007 (actual)
- Primary completion
- 20 Aug 2010 (actual)
- Study completion
- 20 Aug 2010 (actual)
- First posted
- 27 Aug 2007 (estimated)
- Results
- Posted 3 Dec 2020
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Phase 2 study to determine the efficacy and safety of CS-1008 when given with gemcitabine to subjects with previously untreated and unresectable (unable to be surgically removed) or metastatic (spread to other areas beyond the pancreas) pancreatic cancer.
Detailed description
Primary Objective:
- To evaluate the efficacy of CS-1008 administered in combination with gemcitabine to chemotherapy naive subjects with unresectable or metastatic pancreatic cancer, based on the progression-free survival at 16 weeks.
Secondary Objectives:
- To evaluate the efficacy of CS-1008 administered in combination with gemcitabine on overall progression-free survival rate, objective response rate, duration of response, and overall survival.
- To determine the pharmacokinetics of BIP CS-1008 and DSC CS-1008.
- To study potential biomarkers of CS-1008 activity
- To assess possible human anti-human antibody formation after exposure to CS-1008
- To evaluate the safety profile of CS-1008 when administered in combination with gemcitabine to chemotherapy naive subjects with unresectable or metastatic pancreatic cancer.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| CS-1008 + gemcitabine | Experimental | Drug: CS-1008 (humanized anti-DR5 antibody), Drug: gemcitabineCS-1008 + gemcitabine |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Histologically or cytologically confirmed resectable or metastatic pancreatic cancer; not previously treated with chemotherapy; measurable disease; 18 years of age or older
Key exclusion criteria (5 listed)
- Anticipation of need for major surgery or radiation therapy during the study
- Heart Disease exclusions: myocardial infarction or unstable angina within the past 6 months; severe or unstable angina pectoris within the past 6 months; coronary or peripheral artery bypass graft within the past 6 mo., etc.
- Clinically significant active infection or history of HIV
- Partial or complete bowel obstruction
- Poorly controlled psychiatric illness
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-1008 (humanized anti-DR5 antibody)Also: CS1008CS-1008: 8mg/kg loading dose followed by 3mg/kg weekly. | Drug | CS-1008 + gemcitabine |
| gemcitabineAlso: GemzarGemcitabine - 1000mg/meter sq | Drug | CS-1008 + gemcitabine |
Primary outcome
Progression-Free Survival Rate at 16 Weeks Following Treatment With CS-1008 in Combination With Gemcitabine in Chemotherapy-Naïve Participants With Unresectable or Metastatic Pancreatic Cancer
Time frame: Baseline to the date of disease progression or death due to any cause (whichever occurs first), up to 16 weeks post dose.
Progression-free survival rate (PFS) was defined as the time from the date of the first administration of the study drug (Day 1) to the date of the first objective documentation of disease progression or death resulting from any cause, whichever came first at 16 weeks post-treatment with CS-1008.
5 secondary outcomes
Kaplan-Meier (Non-Parametric) Analysis of Progression-Free Survival Following Treatment With CS-1008 in Combination With Gemcitabine in Chemotherapy-Naïve Participants With Unresectable or Metastatic Pancreatic Cancer
Time frame: Baseline up to date of disease progression or death due to any cause (whichever occurs first), up to approximately 36 months post dose.
Overall Survival Following Treatment With CS-1008 in Combination With Gemcitabine in Chemotherapy-Naïve Participants With Unresectable or Metastatic Pancreatic Cancer
Time frame: Baseline to death due to any cause, up to approximately 36 months post dose.
Best Overall Tumor Response Following Treatment With CS-1008 in Combination With Gemcitabine in Chemotherapy-Naïve Participants With Unresectable or Metastatic Pancreatic Cancer
Time frame: Baseline to up to date of first documented objective response or disease progression (whichever occurs first), up to approximately 36 months post dose.
Number of Participants With Treatment-Emergent Adverse Events Considered by the Investigator at Least Possibly Related to CS-1008 Experienced by ≥5% of Participants by System Organ Class and Preferred Term
Time frame: Baseline up to 30 days post last dose, up to approximately 36 months post dose.
Number of Participants With Treatment-Emergent Adverse Events Considered by the Investigator at Least Possibly Related to Gemcitabine Experienced by ≥5% of Participants by System Organ Class and Preferred Term
Time frame: Baseline up to 30 days post last dose, up to approximately 36 months post dose.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Apr 2021.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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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.
Global Clinical Leader study director
Daiichi Sankyo
12 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing CS-1008 (humanized anti-DR5 antibody) and gemcitabine in people with Pancreatic Cancer, run by Daiichi Sankyo at 12 sites 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 8 Apr 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 12 sites 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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 3 Dec 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?
Progression-Free Survival Rate at 16 Weeks Following Treatment With CS-1008 in Combination With Gemcitabine in Chemotherapy-Naïve Participants With Unresectable or Metastatic Pancreatic Cancer (time frame: Baseline to the date of disease progression or death due to any cause (whichever occurs first), up to 16 weeks post dose.). 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 8 Apr 2021.