A Phase 2 interventional study of dasatinib and Placebo in Pancreatic Cancer, sponsored by Otsuka Pharmaceutical Development & Commercialization, Inc.. Completed at 77 sites in 15 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2016-04-08.
Sponsored by Otsuka Pharmaceutical Development & Commercialization, Inc. · Phase 2, Interventional, and Treatment
The purpose of this study is to determine whether patients with locally advanced pancreatic cancer who receive dasatinib added to standard of care (gemcitabine) live longer, compared to patients who receive standard of care (gemcitabine) plus placebo; i.e. gemcitabine alone.
3,235 studies on the registry are indexed under Pancreatic Neoplasms; 899 are open to participants now.
This study's enrollment of 202 is above the median of 46 across 2,424 interventional studies indexed under Pancreatic Neoplasms.
Browse Pancreatic Neoplasms studies →Otsuka Pharmaceutical Development & Commercialization, Inc. is the lead sponsor of 289 studies on the registry; 18 are open to participants now.
Of its 104 completed or terminated interventional studies of FDA-regulated products, 69 (66%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
One arm will receive standard of care treatment (ie, GEM 1000 mg/m2 by intravenous \[IV\] infusion weekly for 3 weeks of a 4-week cycle) plus dasatinib 100 mg by mouth once daily (QD).
Drug: dasatinib
The other arm will receive standard of care treatment (ie, GEM 1000 mg/m2 by intravenous \[IV\] infusion weekly for 3 weeks of a 4-week cycle) plus matched placebo by mouth once daily (QD).
Drug: Placebo
GEM 1000 mg/m2 by intravenous \[IV\] infusion weekly for 3 weeks of a 4-week cycle plus dasatinib 100 mg (or matched placebo) by mouth once daily (QD). Subjects will continue to receive study treatment until disease progression, unacceptable toxicity, withdrawal of consent, or study termination.
Also known as: BMS-354825
Matching Placebo
Overall Survival
Overall survival (OS) is the time from randomization until time of death from any cause by 02 December 2013.
Time frame: From randomization until date of death from any cause by 02 December 2013
Progression Free Survival (PFS)
PFS - time from randomization to unequivocal local or distant disease progression, death or discontinuation from trial for any reason by 02 December 2013. Progression events were determined according to Response Evaluation Criteria in Solid Tumor (RECIST) 1.1 every 8 weeks.
Time frame: Time from randomization to earliest PFS event by 02 December 2013
202 participants were enrolled at 79 study sites in 15 countries.
| Milestone | Dasatinib + GEM | Placebo + GEM |
|---|---|---|
| Started | 100 | 102 |
| Treated | 98 | 101 |
| Completed | 0 | 0 |
| Not completed | 100 | 102 |
| Withdrew: Lost to follow-up | 1 | 0 |
| Withdrew: Adverse event | 26 | 12 |
| Withdrew: Physician decision | 11 | 15 |
| Withdrew: Withdrawal by subject | 14 | 8 |
| Withdrew: Protocol deviation | 1 | 2 |
| Withdrew: Death | 4 | 3 |
| Withdrew: Disease progression | 42 | 58 |
| Withdrew: Sponsor discontinued study | 1 | 4 |
Overall survival (OS) is the time from randomization until time of death from any cause by 02 December 2013.
| Days | Dasatinib + GEM | Placebo + GEM |
|---|---|---|
| Overall Survival | 375 (310 to 450) | 393 (356 to 467) |
PFS - time from randomization to unequivocal local or distant disease progression, death or discontinuation from trial for any reason by 02 December 2013. Progression events were determined according to Response Evaluation Criteria in Solid Tumor (RECIST) 1.1 every 8 weeks.
| Days | Dasatinib + GEM | Placebo + GEM |
|---|---|---|
| Progression Free Survival (PFS) | 167 (114 to 212) | 166 (160 to 199) |
Collected over Adverse events (AEs) were collected from randomization, throughout each treatment cycle to final study visit. Follow-up visits conducted until all ongoing AEs resolved or clinically stable.. Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Dasatinib + GEM | — | 53/98 (54.1%) | 93/98 (94.9%) |
| Placebo + GEM | — | 48/101 (47.5%) | 98/101 (97%) |
| Event | Dasatinib + GEM | Placebo + GEM |
|---|---|---|
| Pleural effusionRespiratory, thoracic and mediastinal disorders | 6/98 | 2/101 |
| Device occlusionGeneral disorders | 5/98 | 5/101 |
| HyperbilirubinaemiaHepatobiliary disorders | 5/98 | 1/101 |
| Cardiac failureCardiac disorders | 4/98 | 2/101 |
| Bile duct obstructionHepatobiliary disorders | 4/98 | 2/101 |
| CholangitisHepatobiliary disorders | 4/98 | 2/101 |
| PyrexiaGeneral disorders | 1/98 | 4/101 |
| AnemiaBlood and lymphatic system disorders | 3/98 | 1/101 |
| Abdominal painGastrointestinal disorders | 3/98 | 1/101 |
| DiarrhoeaGastrointestinal disorders | 3/98 | 0/101 |
| Event | Dasatinib + GEM | Placebo + GEM |
|---|---|---|
| NauseaGastrointestinal disorders | 65/98 | 49/101 |
| NeutropeniaBlood and lymphatic system disorders | 53/98 | 49/101 |
| AnemiaBlood and lymphatic system disorders | 50/98 | 28/101 |
| FatigueGeneral disorders | 50/98 | 46/101 |
| Decreased appetiteMetabolism and nutrition disorders | 48/98 | 23/101 |
| DiarrhoeaGastrointestinal disorders | 41/98 | 29/101 |
| VomitingGastrointestinal disorders | 40/98 | 34/101 |
| ThrombocytopeniaBlood and lymphatic system disorders | 38/98 | 39/101 |
| Abdominal painGastrointestinal disorders | 33/98 | 36/101 |
| ConstipationGastrointestinal disorders | 33/98 | 28/101 |
| Age, Continuous(Years) | Dasatinib + GEM | Placebo + GEM | Total |
|---|---|---|---|
| Mean | 64.8 ± 9.1 | 64.7 ± 9.6 | 64.8 ± 9.4 |
| Sex: Female, Male(Participants) | Dasatinib + GEM | Placebo + GEM | Total |
|---|---|---|---|
| Female | 43 | 56 | 99 |
| Male | 57 | 46 | 103 |
This study is completed, as verified in Mar 2016. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Otsuka Pharmaceutical Development & Commercialization, Inc.