Clinical trialPhase 1 / Phase 2Completed
Dose Escalation Trial of AZD1775 and Gemcitabine (+Radiation) for Unresectable Adenocarcinoma of the Pancreas
DOSE ESCALATION TRIAL OF THE Wee1 INHIBITOR AZD1775, IN COMBINATION WITH GEMCITABINE (+RADIATION) FOR PATIENTS WITH UNRESECTABLE ADENOCARCINOMA OF THE PANCREAS
- Outcome
- Outcome unknown
- Phase
- Phase 1 / Phase 2
- Status
- Completed
- Study type
- Interventional
- Start
- January 2014
- Expected end
- August 2018
- Enrollment
- 34 participants
- Sites
- 1
- Primary outcomes
- Maximum Tolerated Dose (MTD) of AZD1775 (MK-1775) When Used Concurrently With Gemcitabine and Radiation Therapy.
- Sponsor
- Other
- Results posted
- 2020-02-17
- Last update
- 17 February 2020
These are registry fields. A trial card, with population, design, endpoints and result direction each tied to a quote, is not in the data yet.
Ask this document
Answers come only from this document’s own text, as highlighted quotes. If it doesn’t say, you are told so instead of given a guess.
Try
Source text
Brief summary public domain (ClinicalTrials.gov)
The investigators' long-term goal is to improve the survival of patients with pancreatic cancer by enhancing the efficacy of gemcitabine-radiation by adding the Wee1 inhibitor MK-1775.
Posted results (ClinicalTrials.gov registry) · primary outcome public domain (ClinicalTrials.gov)
Maximum Tolerated Dose (MTD) of AZD1775 (MK-1775) When Used Concurrently With Gemcitabine and Radiation Therapy. [The observation period for MTD is defined as the first 4 cycles of treatment (with a 3 week break between cycle 3 and cycle 4), for a total of 105 days in length.]. Number, mg. AZD1775 (MK-1775), Gemcitabine, Radiation Therapy (n=34): 150.
Posted results (ClinicalTrials.gov registry) · secondary outcome public domain (ClinicalTrials.gov)
Number of Patients With Phosphorylation Inhibition of Greater Than 0 [First cycle of treatment]. Number, participants. AZD-1775 100 mg (n=1): 1; AZD-1775 125 mg (n=8): 7; AZD-1775 150 mg (n=5): 3; AZD-1775 175 mg (n=6): 5.
Posted results (ClinicalTrials.gov registry) · secondary outcome public domain (ClinicalTrials.gov)
Overall Survival [Up to 48 months following treatment]. Median, months (90% Confidence Interval). AZD-1775 100 mg (n=1): 21.96; AZD-1775 125 mg (n=13): 21.73 (16.67 to 39.81); AZD-1775 150 mg (n=9): 23.84 (8.28 to 34.88); AZD-1775 175 mg (n=11): 22.45 (6.81 to 25.35).
Posted results (ClinicalTrials.gov registry) · secondary outcome public domain (ClinicalTrials.gov)
Time From Date of Registration to Date of Documented Disease Progression [Up to 48 months following treatment]. Median, months (90% Confidence Interval). AZD-1775 100 mg (n=1): 8.05; AZD-1775 125 mg (n=13): 9.44 (7.96 to 9.93); AZD-1775 150 mg (n=9): 9.90 (4.90 to 18.02); AZD-1775 175 mg (n=11): 6.08 (5.49 to 20.09).