Have clinically significant cardiac disease.Trauma with increased risk of life-threatening bleeding.Diffuse alveolar hemorrhage from vasculitis.Known past or current coagulation defects.Following receipt of verbal and written information about the study, patients must provide signed informed consent before any study-related activity is carried out.Patients, both females and males, of reproductive potential must agree to use adequate contraception during and for six months after the last infusion of HuMax-TF-ADC.Women who are pregnant or breast feeding are not to be included.A negative serum pregnancy test (if female and aged between 18-55 years old).Life expectancy of at least three months.Have an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.Acceptable hematological status (hematologic support allowed under certain circumstances).Patients must have measurable disease according to RECIST v1.1 Patients with relapsed, advanced and/or metastatic cancer who have failed available standard treatments or who are not candidates for standard therapy. Part 1: Number of Participants Who Experienced Disease Control.Based on non-target lesions, stable disease was defined as persistence of 1 or more non-target lesion(s) or/and maintenance of tumor marker level above the normal limits. Stable Disease: neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for progressive disease (PD), taking as reference the smallest sum of LDs while in trial. Stable disease: neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for progressive disease (PD), taking as reference the smallest sum of LDs while in trial. Partial response (PR): ≥ 30% decrease in the sum of the longest diameter (LD) of target lesions, taking as reference the baseline sum of LDs. All lymph nodes must be non-pathological in size (< 10 mm short axis). Based on non-target lesions, complete response was defined as disappearance of all non-target lesions and normalization of tumor marker level. Any pathological lymph nodes must have reduction in short axis to < 10 mm. Complete response: the disappearance of all target lesions. Part 1: Best Overall Response (OR) īest OR (by investigators assessment) was the best response recorded from the start of the treatment until disease progression or death.Part 2: Response Evaluation Based on CA125 (Cancer Antigen 125 ): Percentage of Change From Baseline to End of Study.Part 1: Response Evaluation Based on CA125 (Cancer Antigen 125 ): Percentage of Change From Baseline to End of Study.Part 1: Response Evaluation Based on PSA (Prostate Specific Antigen ): Percentage Change From Baseline to End of Study.Part 2: Anti-tumor Activity Measured by Percentage of Change in Sum of Lesion Measurements.Part 1: Number of Patients Who Experienced Anti-tumor Activity Measured by Tumor Shrinkage.Part 2: Number of Participants With a Positive Anti-drug Antibody (ADA) Immunogenicity Result.Part 1: Number of Participants With a Positive Anti-drug Antibody (ADA) Immunogenicity Result.Part 2: AUC0-t: Area Under the Plasma Concentration-Time Curve From Time 0 to the Time of Last Quantifiable Concentration for Tisotumab Vedotin (HuMax-TF-ADC) ĭata is only available for Part 1, for Part 2 inadequate samples were collected to fully evaluate separate PK parameters after doses 1, 2, and 3.Part 1: AUC0-t: Area Under the Plasma Concentration-Time Curve From Time 0 to the Time of Last Quantifiable Concentration for Tisotumab Vedotin (HuMax-TF-ADC).Part 2: Number of Participants Who Experienced a Neuropathy Event.Part 1: Number of Participants Who Experienced a Neuropathy Event.Part 2: Number of Participants Who Experienced a Bleeding Event.Part 1: Number of Participants Who Experienced a Bleeding Event.Part 2: Number of Participants Who Experienced a Skin Rash.Part 1: Number of Participants Who Experienced a Skin Rash.Markedly abnormal laboratory values are defined as any grade >=3 laboratory abnormality events. ![]() ![]() The number of participants with any markedly abnormal standard safety laboratory values collected throughout study. Why Should I Register and Submit Results?.
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