A Phase 2 interventional study of TAS-106 in Head and Neck Cancer, sponsored by Taiho Pharmaceutical Co., Ltd.. Terminated at 5 sites in 4 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2012-09-05.
Sponsored by Taiho Pharmaceutical Co., Ltd. · Phase 2, Interventional, and Treatment
The purpose of this study is to determine whether TAS-106 is effective to patients with recurrent or metastatic head and neck cancer refractory to platinum based chemotherapy.
2,344 studies on the registry are indexed under Head and Neck Neoplasms; 552 are open to participants now.
This study's enrollment of 27 is below the median of 47 across 1,751 interventional studies indexed under Head and Neck Neoplasms.
Browse Head and Neck Neoplasms studies →Taiho Pharmaceutical Co., Ltd. is the lead sponsor of 43 studies on the registry; 4 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Drug: TAS-106
6.5 mg/m2, IV on day 1 of each 21 day cycle. Number of cycles: until progression or unacceptable toxicity develops.
Progression Free Survival(PFS)
PFS was calculated as days from the date of registration until the earliest date of documented disease progression, death, or censoring event.
Time frame: From the date of registration until the earliest date of documented disease progression, death, or censoring event.
Antitumor Activity
Antitumor activity was evaluated by measuring the rate of objective response using the Response Evaluation Criteria in Solid Tumors (RECIST) guidelines. Per RECIST Criteria (V1.0) and assessed by CT: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), \>=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR)= CR + PR.", or similar text that was as accurate and appropriate.
Time frame: Obtain a contrast-enhanced CT scan of the chest, abdomen and pelvis (if clinically indicated) within 28 days prior to study entry and repeat at the end of every 2 courses thereafter.
Overall Survival
Patient survival for both subgroups was followed up every 2 months until 28 Feb 2011.
Time frame: 12 months after enrollment of the last patient
Safety
Toxicities were evaluated at each course of therapy using the CTCAE ver. 3.0 or a non-CTC grading scale for toxicities that were not covered by the NCI CTC.
Time frame: Monitor patients for untoward medical events from the time of signed informed consent form, including toxicities from previous treatment and any ongoing or newly reported AEs or SAEs during the 30 days after the last dose of study medication.
The patient enrollment was started from 24/Sep/2008 and terminated as of 30/Sep/2010. In the nasopharyngeal carcinoma (NPC) subgroup and squamous cell carcinoma (SCCHN) subgroup of stage 1, 13 and 14 patients were enrolled, respectively. For both subgroups subsequent enrollment was not reopened for the second stage, thus 27 patients were enrolled.
| Milestone | TAS-106 |
|---|---|
| Started | 27 |
| Completed | 27 |
| Not completed | 0 |
PFS was calculated as days from the date of registration until the earliest date of documented disease progression, death, or censoring event.
| day | TAS-106 |
|---|---|
| Progression Free Survival(PFS) | 51 (43.0 to 83.0) |
Antitumor activity was evaluated by measuring the rate of objective response using the Response Evaluation Criteria in Solid Tumors (RECIST) guidelines. Per RECIST Criteria (V1.0) and assessed by CT: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), \>=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR)= CR + PR.", or similar text that was as accurate and appropriate.
| participants | TAS-106 |
|---|---|
| Antitumor Activity | 0 |
Patient survival for both subgroups was followed up every 2 months until 28 Feb 2011.
| day | TAS-106 |
|---|---|
| Overall Survival | 213 (136.0 to 280.0) |
Toxicities were evaluated at each course of therapy using the CTCAE ver. 3.0 or a non-CTC grading scale for toxicities that were not covered by the NCI CTC.
| number of participants | TAS-106 |
|---|---|
| Safety | 27 |
Collected over Adverse events were summarized for all courses of study medication.. Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| TAS-106 | — | 15/27 (55.6%) | 27/27 (100%) |
| Event | TAS-106 |
|---|---|
| PneumoniaInfections and infestations | 5/27 |
| Febrile neutropeniaBlood and lymphatic system disorders | 2/27 |
| NeutropeniaBlood and lymphatic system disorders | 1/27 |
| Gastrointestinal perforationGastrointestinal disorders | 1/27 |
| Face oedemaGeneral disorders | 1/27 |
| Oedema peripheralGeneral disorders | 1/27 |
| PyrexiaGeneral disorders | 1/27 |
| HyperbilirubinaemiaHepatobiliary disorders | 1/27 |
| InfectionInfections and infestations | 1/27 |
| Lymph node abscessInfections and infestations | 1/27 |
| Event | TAS-106 |
|---|---|
| FatigueGeneral disorders | 11/27 |
| PyrexiaGeneral disorders | 10/27 |
| Skin exfoliationSkin and subcutaneous tissue disorders | 8/27 |
| NeutropeniaBlood and lymphatic system disorders | 7/27 |
| Injection site reactionGeneral disorders | 7/27 |
| AnaemiaBlood and lymphatic system disorders | 6/27 |
| NauseaGastrointestinal disorders | 6/27 |
| Neutrophil count decreasedInvestigations | 6/27 |
| ConstipationGastrointestinal disorders | 5/27 |
| DiarrhoeaGastrointestinal disorders | 5/27 |
| Age, Categorical(Participants) | TAS-106 |
|---|---|
| <=18 years | 0 |
| Between 18 and 65 years | 23 |
| >=65 years | 4 |
| Age Continuous(years) | TAS-106 |
|---|---|
| Mean | 56 ± 7.96 |
| Sex: Female, Male(Participants) | TAS-106 |
|---|---|
| Female | 5 |
| Male | 22 |
| Region of Enrollment(participants) | TAS-106 |
|---|---|
| United States | 12 |
| Taiwan | 1 |
| Hong Kong | 9 |
| Singapore | 5 |
This study is terminated, as verified in Aug 2012. You cannot join it, but the record below documents what was studied.
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Taiho Pharmaceutical Co., Ltd.