Trial Outcomes & Findings for Phase II Study of TAS-106 to Treat Head and Neck Cancer (NCT NCT00737360)

NCT ID: NCT00737360

Last Updated: 2012-09-05

Results Overview

PFS was calculated as days from the date of registration until the earliest date of documented disease progression, death, or censoring event.

• Recruitment status: TERMINATED
• Study phase: PHASE2
• Target enrollment: 27 participants
• Primary outcome timeframe: From the date of registration until the earliest date of documented disease progression, death, or censoring event.
• Results posted on: 2012-09-05

Participant Flow

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.

Participant milestones

Measure	TAS-106
Overall Study STARTED	27
Overall Study COMPLETED	27
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Phase II Study of TAS-106 to Treat Head and Neck Cancer

Baseline characteristics by cohort

Measure	TAS-106 n=27 Participants
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	23 Participants n=5 Participants
Age, Categorical >=65 years	4 Participants n=5 Participants
Age Continuous	56 years STANDARD_DEVIATION 7.96 • n=5 Participants
Sex: Female, Male Female	5 Participants n=5 Participants
Sex: Female, Male Male	22 Participants n=5 Participants
Region of Enrollment United States	12 participants n=5 Participants
Region of Enrollment Taiwan	1 participants n=5 Participants
Region of Enrollment Hong Kong	9 participants n=5 Participants
Region of Enrollment Singapore	5 participants n=5 Participants

PRIMARY outcome

Timeframe: From the date of registration until the earliest date of documented disease progression, death, or censoring event.

Population: One patient enrolled was discontinued without any post-baseline tumor assessment, therefore, 26 patients were included in the efficacy analyzes.

PFS was calculated as days from the date of registration until the earliest date of documented disease progression, death, or censoring event.

Outcome measures

Measure	TAS-106 n=26 Participants
Progression Free Survival(PFS)	51 day Interval 43.0 to 83.0

SECONDARY outcome

Timeframe: 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.

Population: Antitumor activity was the rate of best overall objective responses(complete response + partial response).

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.

Outcome measures

Measure	TAS-106 n=26 Participants
Antitumor Activity	0 participants

SECONDARY outcome

Timeframe: 12 months after enrollment of the last patient

Patient survival for both subgroups was followed up every 2 months until 28 Feb 2011.

Outcome measures

Measure	TAS-106 n=26 Participants
Overall Survival	213 day Interval 136.0 to 280.0

SECONDARY outcome

Timeframe: 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.

Population: All patients who received at least 1 dose of TAS-106 were the primary population for the safety evaluation.

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.

Outcome measures

Measure	TAS-106 n=27 Participants
Safety	27 number of participants

Adverse Events

TAS-106

Serious events: 15 serious events

Other events: 27 other events

Deaths: 0 deaths

Serious adverse events

Measure	TAS-106 n=27 participants at risk
Blood and lymphatic system disorders Febrile neutropenia	7.4% 2/27 • Adverse events were summarized for all courses of study medication.
Blood and lymphatic system disorders Neutropenia	3.7% 1/27 • Adverse events were summarized for all courses of study medication.
Gastrointestinal disorders Gastrointestinal perforation	3.7% 1/27 • Adverse events were summarized for all courses of study medication.
General disorders Face oedema	3.7% 1/27 • Adverse events were summarized for all courses of study medication.
General disorders Oedema peripheral	3.7% 1/27 • Adverse events were summarized for all courses of study medication.
General disorders Pyrexia	3.7% 1/27 • Adverse events were summarized for all courses of study medication.
Hepatobiliary disorders Hyperbilirubinaemia	3.7% 1/27 • Adverse events were summarized for all courses of study medication.
Infections and infestations Infection	3.7% 1/27 • Adverse events were summarized for all courses of study medication.
Infections and infestations Lymph node abscess	3.7% 1/27 • Adverse events were summarized for all courses of study medication.
Infections and infestations Pneumonia	18.5% 5/27 • Adverse events were summarized for all courses of study medication.
Infections and infestations Respiratory tract infection	3.7% 1/27 • Adverse events were summarized for all courses of study medication.
Investigations Hemoglobin decreased	3.7% 1/27 • Adverse events were summarized for all courses of study medication.
Nervous system disorders Peripheral motor neuropathy	3.7% 1/27 • Adverse events were summarized for all courses of study medication.
Nervous system disorders Somnolence	3.7% 1/27 • Adverse events were summarized for all courses of study medication.
Respiratory, thoracic and mediastinal disorders Pneumonia aspiration	3.7% 1/27 • Adverse events were summarized for all courses of study medication.

Other adverse events

Measure	TAS-106 n=27 participants at risk
Blood and lymphatic system disorders Anaemia	22.2% 6/27 • Adverse events were summarized for all courses of study medication.
Blood and lymphatic system disorders Febrile neutropenia	11.1% 3/27 • Adverse events were summarized for all courses of study medication.
Blood and lymphatic system disorders Leukopenia	7.4% 2/27 • Adverse events were summarized for all courses of study medication.
Blood and lymphatic system disorders Neutropenia	25.9% 7/27 • Adverse events were summarized for all courses of study medication.
Gastrointestinal disorders Ascites	7.4% 2/27 • Adverse events were summarized for all courses of study medication.
Gastrointestinal disorders Constipation	18.5% 5/27 • Adverse events were summarized for all courses of study medication.
Gastrointestinal disorders Diarrhoea	18.5% 5/27 • Adverse events were summarized for all courses of study medication.
Gastrointestinal disorders Nausea	22.2% 6/27 • Adverse events were summarized for all courses of study medication.
Gastrointestinal disorders Salivary hypersecretion	7.4% 2/27 • Adverse events were summarized for all courses of study medication.
Gastrointestinal disorders Stomatitis	7.4% 2/27 • Adverse events were summarized for all courses of study medication.
Gastrointestinal disorders Vomiting	18.5% 5/27 • Adverse events were summarized for all courses of study medication.
General disorders Chills	11.1% 3/27 • Adverse events were summarized for all courses of study medication.
General disorders Face oedema	7.4% 2/27 • Adverse events were summarized for all courses of study medication.
General disorders Fatigue	40.7% 11/27 • Adverse events were summarized for all courses of study medication.
General disorders Infusion site discolouration	7.4% 2/27 • Adverse events were summarized for all courses of study medication.
General disorders Injection site reaction	25.9% 7/27 • Adverse events were summarized for all courses of study medication.
General disorders Mucosal inflammation	7.4% 2/27 • Adverse events were summarized for all courses of study medication.
General disorders Oedema peripheral	7.4% 2/27 • Adverse events were summarized for all courses of study medication.
General disorders Pain	7.4% 2/27 • Adverse events were summarized for all courses of study medication.
General disorders Pyrexia	37.0% 10/27 • Adverse events were summarized for all courses of study medication.
Hepatobiliary disorders Hyperbilirubinaemia	7.4% 2/27 • Adverse events were summarized for all courses of study medication.
Infections and infestations Oral candidiasis	7.4% 2/27 • Adverse events were summarized for all courses of study medication.
Infections and infestations Pneumonia	18.5% 5/27 • Adverse events were summarized for all courses of study medication.
Infections and infestations Respiratory tract infection	7.4% 2/27 • Adverse events were summarized for all courses of study medication.
Investigations Haemoglobin decreased	14.8% 4/27 • Adverse events were summarized for all courses of study medication.
Investigations Neutrophil count decreased	22.2% 6/27 • Adverse events were summarized for all courses of study medication.
Metabolism and nutrition disorders Decreased appetite	18.5% 5/27 • Adverse events were summarized for all courses of study medication.
Metabolism and nutrition disorders Hypokalaemia	7.4% 2/27 • Adverse events were summarized for all courses of study medication.
Metabolism and nutrition disorders Hyponatraemia	18.5% 5/27 • Adverse events were summarized for all courses of study medication.
Musculoskeletal and connective tissue disorders Back pain	11.1% 3/27 • Adverse events were summarized for all courses of study medication.
Musculoskeletal and connective tissue disorders Muscle twitching	7.4% 2/27 • Adverse events were summarized for all courses of study medication.
Musculoskeletal and connective tissue disorders Neck pain	7.4% 2/27 • Adverse events were summarized for all courses of study medication.
Nervous system disorders Dizziness	14.8% 4/27 • Adverse events were summarized for all courses of study medication.
Nervous system disorders Headache	7.4% 2/27 • Adverse events were summarized for all courses of study medication.
Nervous system disorders Neuropathy peripheral	7.4% 2/27 • Adverse events were summarized for all courses of study medication.
Respiratory, thoracic and mediastinal disorders Cough	18.5% 5/27 • Adverse events were summarized for all courses of study medication.
Respiratory, thoracic and mediastinal disorders Dyspnoea	11.1% 3/27 • Adverse events were summarized for all courses of study medication.
Respiratory, thoracic and mediastinal disorders Haemoptysis	7.4% 2/27 • Adverse events were summarized for all courses of study medication.
Skin and subcutaneous tissue disorders Dry skin	11.1% 3/27 • Adverse events were summarized for all courses of study medication.
Skin and subcutaneous tissue disorders Erythema	7.4% 2/27 • Adverse events were summarized for all courses of study medication.
Skin and subcutaneous tissue disorders Palmar-plantar erythrodysaesthesia syndrome	14.8% 4/27 • Adverse events were summarized for all courses of study medication.
Skin and subcutaneous tissue disorders Pruritus	7.4% 2/27 • Adverse events were summarized for all courses of study medication.
Skin and subcutaneous tissue disorders Rash	11.1% 3/27 • Adverse events were summarized for all courses of study medication.
Skin and subcutaneous tissue disorders Skin exfoliation	29.6% 8/27 • Adverse events were summarized for all courses of study medication.
Vascular disorders Hypotension	7.4% 2/27 • Adverse events were summarized for all courses of study medication.

Additional Information

Dr. Anne Tsao, Principal Investigator

The University of Texas M.D, Anderson Cancer Center

Phone: 713-792-6363

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place

Restriction type: LTE60