Trial · NCT02613221
A Phase I/II Study for the Safety and Efficacy of Panitumumab in Combination With TAS-102 for Patients With Colorectal Cancer
NCT02613221, Phase 1, Phase 2, Completed, Takeda; results first posted 2019-06-24
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. A Phase I/II Study for the Safety and Efficacy of Panitumumab in Combination With TAS-102 for Patients With Colorectal Cancer. Trials, record NCT02613221. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02613221
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- A Phase I/II Study for the Safety and Efficacy of Panitumumab in Combination With TAS-102 for Patients With Colorectal Cancer
- NCT number
- NCT02613221
- Status
- Completed
- Phases
- Phase 1, Phase 2
- Enrollment
- 56 participants, actual
- Lead sponsor
- Takeda
- Conditions
- Colorectal Cancer
- Interventions
- Panitumumab + TAS-102
- First posted
- 2015-11-24
- Last updated
- 2019-07-31
- Results first posted
- 2019-06-24
Source ClinicalTrials.gov
Registered outcomes9
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Number of Participants With Dose Limiting Toxicity (DLT) With Panitumumab Plus TAS-102 Combination Therapy | Up to approximately 1 month | DLT was evaluated according to Common Terminology Criteria for Adverse Events (CTCAE) version 4.03 and was defined as any of the following events: 1. Grade 4 neutropenia for more than 7 days under maximum supportive therapy; 2. Febrile neutropenia; 3. Platelet counts decreased of Grade 3 requiring platelet transfusion or blood platelet decreased of Grade 4; 4. If Course 2 was not initiated within 14 days due to AE related to the protocol treatment; 5. Grade 3 or higher non-hematologic toxicity that was considered clinically significant, except the following cases, Grade 3 gastrointestinal symptoms that could be controlled with supportive therapy (eg, appropriate use of antiemetics, antidiarrheals), and Grade 3 or higher electrolyte abnormalities that were not deemed clinically significant. |
| Primary | Progression Free Survival (PFS) Rate at 6 Months | Up to 6 months | PFS rate at 6 months was defined as the crude rate of surviving participants who survived or were not determined as progressive at 6 months from the day of enrollment. Although the subjects who had no imaging data on progression at 6 months after enrollment or the subjects who had lost to follow-up were included in the denominator, these subjects were not handled as progression-free. Progression included both progression disease (PD) based on diagnostic imaging assessed according to response evaluation criteria in solid tumors (RECIST) ver 1.1 and primary disease progression that cannot be confirmed by diagnostic imaging (clinical progression). PD: at least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study (this includes the baseline sum if that is the smallest on study). |
| Secondary | Overall Survival (OS) | From date of enrollment until the death, assessed up to approximately 29 months | OS was defined as the period from the day of enrollment until death by all causes. |
| Secondary | Progression Free Survival (PFS) | From date of enrollment until the date of progression or death, assessed up to approximately 29 months | PFS was defined as the period from the day of enrollment until the day of documented progression or the day of death due to all causes whichever comes earlier. Progression included both PD based on diagnostic imaging assessed according to response evaluation criteria in solid tumors (RECIST) ver 1.1 and primary disease progression that cannot be confirmed by diagnostic imaging (clinical progression). PD: at least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study (this includes the baseline sum if that is the smallest on study). |
| Secondary | Response Rate (RR) | From date of enrollment until the end of follow-up period, assessed up to approximately 29 months | RR was defined as the percentage of participants who had shown complete response (CR) or partial response (PR) as the best overall response in accordance with the RECIST 1.1 criteria. The best overall response was CR, followed by PR, stable disease (SD), progressive disease (PD), and not evaluable (NE). CR: disappearance of all target lesions. Any pathological lymph nodes must have reduction in short axis to \<10 mm. PR: at least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters as the best overall response after randomization., SD: neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum diameters while on study. PD: at least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study (this includes the baseline sum if that is the smallest on study). |
| Secondary | Duration of Response (DOR) | From date of CR or PR until the date of PD or death, assessed up to approximately 29 months | DOR means that the period from the day when either CR or PR is first confirmed until the day of documented PD or the day of death due to all causes, whichever occurs earlier. |
| Secondary | Disease Control Rate (DCR) | From date of enrollment until the end of follow-up period, assessed up to approximately 29 months | DCR was defined as the percentage of participants who had shown CR, PR, or SD as the best overall response in accordance with the RECIST version 1.1 criteria. |
| Secondary | Time to Treatment Failure (TTF) | From date of enrollment until the date of the protocol treatment discontinuation, progression or death, assessed up to approximately 29 months | TTF was defined as the time from the date of enrollment to the date of the decision to discontinue the protocol treatment, the date of documented progression during the protocol treatment, or the date of death from any cause, whichever had come earlier. |
| Secondary | Number of Participants Reporting One or More Treatment-Emergent Adverse Events (TEAEs) | From first dose of the study drug through 30 days after the last dose of study drug or start of subsequent antineoplastic therapy, assessed up to approximately 29 months | Adverse events (AEs) were any unfavorable medical events encountered in a participant treated with a drug. They were not limited to the events with clear causal relationship with treatment with the concerned drug. Treatment-emergent adverse events (TEAEs) were defined as AEs that had occurred after the initiation of protocol treatment. |
Source ClinicalTrials.gov
Outcomes9
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Number of Participants With Dose Limiting Toxicity (DLT) With Panitumumab Plus TAS-102 Combination Therapy | Up to approximately 1 month | DLT Evaluation Set; DLT Evaluation Set was defined as participants who were enrolled and received at least one dose of the study drug in order to assess recommended dose of panitumumab in combination with TAS-102 (Total number of DLT Evaluation Set was 6). | Participants | COUNT_OF_PARTICIPANTS |
| PRIMARY | Progression Free Survival (PFS) Rate at 6 Months | Up to 6 months | Full analysis set (FAS); FAS was defined as participants who were enrolled and received at least one dose of protocol treatment (the recommended dose confirmed in the phase I part). | Percentage of Participants | NUMBER |
| SECONDARY | Overall Survival (OS) | From date of enrollment until the death, assessed up to approximately 29 months | Full analysis set (FAS); FAS was defined as participants who were enrolled and received at least one dose of protocol treatment (the recommended dose confirmed in the phase I part). | Months | MEDIAN |
| SECONDARY | Progression Free Survival (PFS) | From date of enrollment until the date of progression or death, assessed up to approximately 29 months | Full analysis set (FAS); FAS was defined as participants who were enrolled and received at least one dose of protocol treatment (the recommended dose confirmed in the phase I part). | Months | MEDIAN |
| SECONDARY | Response Rate (RR) | From date of enrollment until the end of follow-up period, assessed up to approximately 29 months | Full analysis set (FAS); FAS was defined as participants who were enrolled and received at least one dose of protocol treatment (the recommended dose confirmed in the phase I part). | Percentage of Participants | NUMBER |
| SECONDARY | Duration of Response (DOR) | From date of CR or PR until the date of PD or death, assessed up to approximately 29 months | Full analysis set (FAS); FAS was defined as participants who were enrolled and received at least one dose of protocol treatment (the recommended dose confirmed in the phase I part). | Months | MEDIAN |
| SECONDARY | Disease Control Rate (DCR) | From date of enrollment until the end of follow-up period, assessed up to approximately 29 months | Full analysis set (FAS); FAS was defined as participants who were enrolled and received at least one dose of protocol treatment (the recommended dose confirmed in the phase I part). | Percentage of Participants | NUMBER |
| SECONDARY | Time to Treatment Failure (TTF) | From date of enrollment until the date of the protocol treatment discontinuation, progression or death, assessed up to approximately 29 months | Full analysis set (FAS); FAS was defined as participants who were enrolled and received at least one dose of protocol treatment (the recommended dose confirmed in the phase I part). | Months | MEDIAN |
| SECONDARY | Number of Participants Reporting One or More Treatment-Emergent Adverse Events (TEAEs) | From first dose of the study drug through 30 days after the last dose of study drug or start of subsequent antineoplastic therapy, assessed up to approximately 29 months | Safety Analysis Set, The safety analysis set was defined as all participants who received at least one dose of the study drug during the study. | Participants | COUNT_OF_PARTICIPANTS |
Source ClinicalTrials.gov
Results by group9
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Number of Participants With Dose Limiting Toxicity (DLT) With Panitumumab Plus TAS-102 Combination Therapy | Panitumumab + TAS-102 | 0 | Participants | ||
| Progression Free Survival (PFS) Rate at 6 Months | Panitumumab + TAS-102 | 33.3 | 90% Confidence Interval 22.77 to 45.32 | Percentage of Participants | |
| Overall Survival (OS) | Panitumumab + TAS-102 | 14.1 | 95% Confidence Interval 12.18 to 19.29 | Months | |
| Progression Free Survival (PFS) | Panitumumab + TAS-102 | 5.8 | 95% Confidence Interval 4.46 to 6.50 | Months | |
| Response Rate (RR) | Panitumumab + TAS-102 | 37.0 | 95% Confidence Interval 24.29 to 51.26 | Percentage of Participants | |
| Duration of Response (DOR) | Panitumumab + TAS-102 | 4.1 | 95% Confidence Interval 2.29 to 6.29 | Months | |
| Disease Control Rate (DCR) | Panitumumab + TAS-102 | 81.5 | 95% Confidence Interval 68.57 to 90.75 | Percentage of Participants | |
| Time to Treatment Failure (TTF) | Panitumumab + TAS-102 | 5.8 | 95% Confidence Interval 4.29 to 6.21 | Months | |
| Number of Participants Reporting One or More Treatment-Emergent Adverse Events (TEAEs) | Panitumumab + TAS-102 | 55 | Participants |
Source ClinicalTrials.gov
Participant flow4
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Panitumumab + TAS-102 | 56 | |
| Overall Study | Safety Population: Received Study Drug | Panitumumab + TAS-102 | 55 | |
| Overall Study | COMPLETED | Panitumumab + TAS-102 | 1 | |
| Overall Study | NOT COMPLETED | Panitumumab + TAS-102 | 55 |
Source ClinicalTrials.gov
Adverse events43
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Anaemia | Blood and lymphatic system disorders | Panitumumab + TAS-102 | 9 | 55 | |
| other | Vertigo | Ear and labyrinth disorders | Panitumumab + TAS-102 | 3 | 55 | |
| other | Abdominal pain | Gastrointestinal disorders | Panitumumab + TAS-102 | 6 | 55 | |
| other | Diarrhoea | Gastrointestinal disorders | Panitumumab + TAS-102 | 17 | 55 | |
| other | Nausea | Gastrointestinal disorders | Panitumumab + TAS-102 | 23 | 55 | |
| other | Stomatitis | Gastrointestinal disorders | Panitumumab + TAS-102 | 39 | 55 | |
| other | Vomiting | Gastrointestinal disorders | Panitumumab + TAS-102 | 8 | 55 | |
| other | Fatigue | General disorders | Panitumumab + TAS-102 | 27 | 55 | |
| other | Malaise | General disorders | Panitumumab + TAS-102 | 10 | 55 | |
| other | Pyrexia | General disorders | Panitumumab + TAS-102 | 9 | 55 |
1 to 10 of 43Source ClinicalTrials.gov
See all 43 adverse eventsAdverse event totals3
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Panitumumab + TAS-102 | 6 | 55 |
| Total, other adverse events | Panitumumab + TAS-102 | 54 | 55 |
| Total, serious adverse events | Panitumumab + TAS-102 | 13 | 55 |
Source ClinicalTrials.gov
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT02613221
GET https://conductscience.org/api/trials/v1/NCT02613221/events?page=2