Age
18 - 75
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Detailed Description
Cohort A and B (Phase I, PM14 monotherapy, advanced STS): 20-25 patients approximately per cohort.
Cohort E (Phase II, PM14 monotherapy, advanced L-sarcomas): 28 patients; (Simon's two-stage Minimax design), errors: α= 0.05; β=0.80, option related to efficacy = 35% (6-month PFSR) (Sample size 15+13), success in 6-month PFSR of ≤ 15% will be considered as unacceptable (H0), and would not warrant further investigation (null hypothesis). Success in 6-month PFSR of ≥ 35% will be considered as an acceptable result warranting further investigation of the investigational drug (H1, alternative hypothesis). A total of 15 eligible and treated patients will be included in the first stage of the study. If ≤ 2 successes are observed, the trial will be stopped in this cohort with the conclusion that the experimental treatment should not be further investigated. Else (≥ 3 successes), patients will continue to be accrued until 28 eligible patients enter the study. If 8 or more successes are observed in those 28 patients, it will be concluded that the results of this trial warrant further investigation.
Cohort F (Phase II, PM14 monotherapy, other advanced sarcomas): 29 patients; (Simon's two-stage Optimal design), errors: α= 0.05; β=0.80. option related to efficacy = 30% (6-month PFSR) (Sample size 10+19), success in 6-month PFSR of ≤ 10% will be considered as unacceptable (H0), and would not warrant further investigation (null hypothesis). Success in 6-month PFSR of ≥ 30% will be considered as an acceptable result warranting further investigation of the investigational drug (H1, alternative hypothesis). A total of 10 eligible and treated patients will be included in the first stage of the study. If ≤ 1 successes are observed, the trial will be stopped in this cohort with the conclusion that the experimental treatment should not be further investigated. Else (≥ 2 successes), patients will continue to be accrued until 29 eligible patients enter the study. If 6 or more successes are observed in those 29 patients, it will be concluded that the results of this trial warrant further investigation.
Cohort C (Best scheme of PM14 plus RTP in advanced sarcoma, head & neck, other solid tumors)
Phase I (advanced): pulmonary and/or abdominal cohort (2 dose levels), head and neck cohort (2dose levels). 25 patients approximately.
Phase II (advanced STS): errors: α=0.05; β=0.80, option related to efficacy = 50% (ORR in irradiated nodules) (Sample size 9+15), success in ORR of ≤ 25 % will be considered as unacceptable (H0), and would not warrant further investigation (null hypothesis). Success in ORR of ≥ 50% will be considered as an acceptable result warranting further investigation of the investigational drug (H1, alternative hypothesis). A total of 9 eligible and treated patients will be included in the first stage of the study. If ≤ 2 successes are observed, the trial will be stopped in this cohort with the conclusion that the investigational combination should not be further investigated. Else (≥ 3 successes), patients will continue to be accrued until 24 eligible patients enter the study. If 10 or more successes are observed in those 24 patients, it will be concluded that the results of this trial warrant further investigation.
Cohort D (Best scheme of PM14 plus RTP in localized intermediate sarcoma)
Phase I (localized sarcoma): 2 dose levels, 10 patients approximate ly. Phase II (localized "intermediate risk" STS): errors: α=0.05; β=0.80, option related to efficacy = 30% (ORR in irradiated nodules) (Sample size 10+19), success in ORR of ≤ 10% will be considered as unacceptable (H0), and would not warrant further investigation (null hypothesis). Success in ORR of ≥ 30% will be considered as an acceptable result warranting further investigation of the investigational drug (H1, alternative hypothesis). A total of 10 eligible and treated patients will be included in the first stage of the study. If ≤ 1 successes are observed, the trial will be stopped in this cohort with the conclusion that the investigational combination should not be further investigated. Else (≥ 2 successes), patients will continue to be accrued until 29 eligible patients enter the study. If 6 or more successes are observed in those 29 patients, it will be concluded that the results of this trial warrant further investigation.
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Call 1800-9860-568 now to find out if you are eligible.
Check your eligibility
Take up this questionnaire to help us determine if you have symptoms
that are common to this clinical study. If you have the common
symptoms, you may be eligible to take part in the study.
Gender
All
NCT ID
NCT05146440
Phase
5
Status
Recruiting Now
Medical Condition
Advanced Solid Tumor
How is Plaque Psoriasis treated?
Medical Condition
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Learn moreThe Study
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Learn moreAbout Clinical Trials
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Learn moreYour Journey
01
Receiving the medication
You would receive etanercept (Enbrel) twice a week for 12 weeks and
then once a week for 12 weeks. Etanercept, as well as study related
medical care, is provided at no cost.
02
Visiting the study site
Study participation involves approximately 8 visits to your local
study center over 6 to 7 months.
03
Follow-up
There would also be a follow-up telephone call 30days after
completing the study. No visits are required after participation is
complete.