Carcinoma, Non-Small-Cell Lung, Colorectal Neoplasm, Esophageal Neoplasm, Head and Neck Neoplasm
Conditions
Brief summary
This study is proposed to evaluate the efficacy and safety of temozolomide, an oral anti-cancer agent, in a participant population selected for a biomarker. Participants with colorectal cancer, non-small-cell lung cancer, head and neck cancer, or esophageal cancer will be included.
Interventions
DRUGTemozolomide
Temozolomide capsules 150 mg/m\^2 daily on a 7-day on / 7-day off schedule for each 28-day cycle, until disease progression, intolerable toxicity, or withdrawal of consent.
Sponsors
Merck Sharp & Dohme LLC
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Participants must be at least 18 years of age. * Participants must have metastatic colorectal cancer (CRC), recurrent or metastatic head & neck (H&N) or esophageal cancer, or locally advanced, inoperable, or metastatic non-small cell lung cancer (NSCLC). * Participants must have a tumor sample or a blood sample tested positive for the presence of the biomarker. * Participants may have up to 3 prior regimens for CRC, up to 3 prior regimens for NSCLC, up to 2 prior regimens for H&N and esophageal cancer. * Participants must have at least one measurable lesion. * Participants must have an Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1, or 2. * Participants must have adequate hematologic, renal, and liver functions. * Participants must be able to take the study medication capsules orally, or through a feeding tube without the capsules being opened. * Participants of childbearing potential must agree to use a medically accepted method of contraception.
Exclusion criteria
* Participants who have received treatment for a second malignancy within 1 year before screening, and are considered to be at risk of relapse within 1 year after screening. * Participants with unstable or progressing central nervous system (CNS) metastasis. Participants with known CNS metastasis may be included if a) the subject is asymptomatic, b) there is no requirement for steroids or antiseizure medications, or the required doses are stable, and c) there is no associated midline shift or (in the opinion of the investigator) significant edema. * Participants who received prior temozolomide or dacarbazine treatment
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Tumor Responses (Complete and Partial Response) | From start of treatment until participant's disease progression, intolerable toxicity or death, which ever comes first | Tumor response rate was based on Response Evaluation Criteria in Solid Tumors (RECIST). Complete Response (CR): Disappearance of all target lesions. Partial Response (PR): At least a 30% decrease in the sum of the longest diameter (LD) of target lesions, taking as reference the baseline sum LD. |
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Temozolomide Temozolomide capsules 150 mg/m\^2 daily on a 7-day on/7-day off schedule for each 28-day cycle. Temozolomide is the only treatment group, and and all participants received the same dosing regimen. | 86 |
| Total | 86 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Administrative | 4 |
| Overall Study | Adverse Event | 11 |
| Overall Study | Non-compliance with protocol | 1 |
| Overall Study | Progression of disease being studied | 69 |
| Overall Study | Withdrawal by Subject | 1 |
Baseline characteristics
| Characteristic | Temozolomide |
|---|---|
| Age, Continuous | 62.9 years STANDARD_DEVIATION 10.4 |
| Sex: Female, Male Female | 29 Participants |
| Sex: Female, Male Male | 57 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 83 / 86 |
| serious Total, serious adverse events | 37 / 86 |
Outcome results
Primary
Tumor Responses (Complete and Partial Response)
Tumor response rate was based on Response Evaluation Criteria in Solid Tumors (RECIST). Complete Response (CR): Disappearance of all target lesions. Partial Response (PR): At least a 30% decrease in the sum of the longest diameter (LD) of target lesions, taking as reference the baseline sum LD.
Time frame: From start of treatment until participant's disease progression, intolerable toxicity or death, which ever comes first
Population: Population for the primary outcome measure is all evaluable participants per protocol definition (82 participants).~Complete response is defined as disappearance of all target lesions.~Partial response is defined as at least 30% decrease in the sum of the longest diameter (LD) of target lesions, taking as reference the baseline sum LD.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Temozolomide | Tumor Responses (Complete and Partial Response) | Number of participants with Complete Response | 0 Participants |
| Temozolomide | Tumor Responses (Complete and Partial Response) | Number of participants with Partial Response | 5 Participants |