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Atu027 & gemcitabine in lead in safety period · 1 trial · 1 indication
Time frame will be 18 weeks if patient will be withdrawn after 3 cycles because of disease progression or toxicity.
Additional time frames in arm 1: 8 days after baseline. Additional time frames in arm 2 and safety cohort (cycle 1 only): 4 and 15 days after baseline.
End of treatment visit will be after 13 weeks only when patient is withdrawn after 3 cycles. Additional time frames in arm 1: 8 days after baseline. Additional time frames in arm 2 and safety cohort (cycle 1 only): 4 and 15 days after baseline.
End of treatment visit will be after 13 weeks only when patient is withdrawn after 3 cycles. Additional time frames in arm 1: 8 days after baseline. Additional time frames in arm 2 and safety cohort (cycle 1 only): 4 and 15 days after baseline.
Additional time frames in arm 1: During treatment on days 1, 8, 15 of each cycle. Additional time frames in arm 2 and safety cohort (cycle 1 only): During treatment on days 1, 4, 8, 11, 15, 18, 22, 25 of each cycle.
Additional time frames in arm 1: During cycles 1 and 2 of treatment on days 1, 8, 15 of each cycle; in cycle 3 and following only on day 1; Additional time frames in arm 2 and safety cohort (cycle 1 only): During the first treatment cycle on days 1, 4, 8, 11, 15, 18; in cycle 3 and following odd numbered cycles only on day 1; in all even numbered cycles no samples are taken. Pharmacokinetics will be assessed in subjects of the safety cohort and in the first 4 subjects per treatment arm.
| Arm | Type | Description |
|---|---|---|
| Lead in safety period | OTHER | Cohort of three subjects with non-pancreatic cancer for whom conventional treatment options have failed, will be treated. If one of the subjects in the safety cohort experiences an unacceptable toxicity, the safety cohort is expanded to six subjects. |
| Treatment arm 1 | EXPERIMENTAL | Subjects with advanced pancreatic cancer will be treated. |
| Treatment arm 2 | EXPERIMENTAL | Subjects with advanced pancreatic cancer will be treated. |
| Name | Type | Description |
|---|---|---|
| Atu027 & gemcitabine in lead in safety period | DRUG | Subjects will be treated in a 28-day cycle with Atu027 twice weekly for 4 weeks and gemcitabine once weekly for the first three weeks. |
| Atu027 & gemcitabine in treatment arm 1 | DRUG | Subjects will be treated in a 28-day cycle with Atu027 and gemcitabine once weekly for three consecutive weeks (on days 1, 8, and 15). During week four no treatment is administered. Treatment will be continued in consecutive 28-day cycles until unacceptable toxicity or disease progression occurs. |
| Atu027 & gemcitabine in treatment arm 2 | DRUG | Subjects will be treated in a 28-day cycle with gemcitabine once weekly (on days 4, 11, and 18) and Atu027 twice weekly (on days 1, 4, 8, 11, 15, 18, 22, and 25). The 28-day combination cycle is followed by a 28-day gemcitabine monotherapy cycle. Treatment will be continued in consecutive 28-day cycles until unacceptable toxicity or disease progression occurs. |
Inclusion Criteria: Lead-in safety period: * Subjects between the age of 18 and 84 years * Histologically or cytologically confirmed advanced or refractory cholangiocellular carcinoma, biliary tract cancer, non-small-cell lung carcinoma, duodenal cancer, soft tissue sarcoma, ovarian carcinoma, or ...
Atu027 is an investigational small molecule being studied in combination with gemcitabine for the treatment of advanced or metastatic pancreatic ductal carcinoma. It was evaluated in a Phase 1 clinical trial in Germany involving 29 patients. The trial has been completed, and Atu027 remains in clinical development.
Atu027 is a small molecule therapeutic being investigated for pancreatic ductal carcinoma. Its specific molecular target has not been disclosed in the available information. The drug is being studied in combination with gemcitabine in a Phase 1 clinical trial.
Atu027 is being developed by Silence Therapeutics Plc, a biopharmaceutical company listed on the stock exchange under the ticker symbol SLN. The company conducted a Phase 1 clinical trial of Atu027 in combination with gemcitabine for pancreatic ductal carcinoma in Germany.
Atu027 is in Phase 1 clinical development. A Phase 1 trial combining Atu027 with gemcitabine for advanced or metastatic pancreatic ductal carcinoma has been completed. The drug is investigational and has not been approved by regulatory authorities.
Atu027 has been studied in one clinical trial, identified as NCT01808638, titled "Atu027 Plus Gemcitabine in Advanced or Metastatic Pancreatic Cancer (Atu027-I-02)." This Phase 1 trial enrolled 29 patients with pancreatic ductal carcinoma in Germany and has been completed.
No, Atu027 is not the same as gemcitabine. Atu027 is an investigational small molecule being developed by Silence Therapeutics, while gemcitabine is an established chemotherapy drug. In the clinical trial, Atu027 was studied in combination with gemcitabine for pancreatic ductal carcinoma.