Adavosertib and Gemcitabine in Advanced Pancreatic
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|ClinicalTrials.gov Identifier: NCT05212025|
Recruitment Status : Withdrawn (manufacturer choice)
First Posted : January 27, 2022
Last Update Posted : June 14, 2022
This study is being done to test the safety and effectiveness of combining Adavosertib and Gemcitabine in patients with pancreatic cancer.
The names of the study drugs involved in this study are:
|Condition or disease||Intervention/treatment||Phase|
|Pancreatic Cancer||Drug: Adavosertib Drug: Gemcitabine||Phase 2|
This is an open label, single arm phase 2 trial evaluating adavosertib combined with gemcitabine in platinum-resistant advanced pancreatic cancer.
Laboratory studies suggest that adavosertib and gemcitabine can impair the growth of cancers by interfering with the way cancer cells repair their DNA.
The U.S. Food and Drug Administration (FDA) has not approved adavosertib as a treatment for any disease. The U.S. Food and Drug Administration (FDA) has approved gemcitabine as a treatment option for pancreatic cancer.
The research study procedures include screening for eligibility and study treatment including evaluations and follow up visits.
It is expected that about 32 people will take part in this research study.
The Lustgarten Foundation for Pancreatic Research and Stand Up to Cancer are supporting this research study by providing funding to conduct the study. AstraZeneca, a pharmaceutical company, is supplying the study drug, Adavosertib.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||0 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Phase 2 Single Arm Trial Testing Adavosertib and Gemcitabine in Platinum-Resistant Advanced Pancreatic Adenocarcinoma|
|Estimated Study Start Date :||June 2022|
|Estimated Primary Completion Date :||June 1, 2023|
|Estimated Study Completion Date :||December 31, 2023|
Experimental: Adavosertib and Gemcitabine
Participants will receive:
Other Name: AZD 1775
Other Name: Gemzar
- Overall Response Rate (ORR) [ Time Frame: Baseline and every 8 weeks during treatment until disease progression or unacceptable toxicity up to 2 years ]
The primary objective is the evaluation of the overall response rate (ORR) by RECIST 1.1 criteria.
Objective response rate (ORR) is defined as the proportion of participants achieving complete response (CR) or partial response (PR) based on RECIST 1.1 criteria on treatment. Per RECIST 1.1 for target lesions: CR is complete disappearance of all target lesions and PR is at least a 30% decrease in the sum of longest diameter (LD) of target lesions, taking as reference baseline sum LD. PR or better overall response assumes at a minimum incomplete response/stable disease (SD) for the evaluation of non-target lesions and absence of new lesions.
- Overall Survival (OS) [ Time Frame: Every 8 weeks during treatment, followed for survival after treatment discontinuation up to 2 years ]Overall Survival (OS) is based on the Kaplan-Meier method and is defined as the time from study entry to death or censored at date last known alive.
- Progression-free Survival (PFS) [ Time Frame: Every 8 weeks during treatment, followed for survival after treatment discontinuation up to 2 years. ]Progression-free Survival (PFS) is based on the Kaplan-Meier method and is defined as the duration of time from study entry to documented disease progression (PD) or death. Per RECIST 1.1 criteria: progressive disease (PD) is at least a 20% increase in the sum of longest diameter (LD) of target lesions taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions. PD for the evaluation of non-target lesions is the appearance of one or more new lesions and/or unequivocal progression of non-target lesions.
- Disease Control Rate (DCR) [ Time Frame: Baseline and every 8 weeks during treatment until disease progression or unacceptable toxicity up to 2 years ]Disease Control Rate (DCR) defined as stable disease for ≥16 weeks, confirmed complete response (CR), or confirmed partial response (PR). CR defined as Disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to <10 mm. PR defined as at least a 30% decrease in the sum of the diameters of target lesions, taking as reference the baseline sum diameters
- Incidence of Grade 3 or Higher Treatment-Related Toxicity [ Time Frame: Assessed day 1, 2, 3, 8, 9, 10, 15 and 22 at cycle 1, also day 1, 8, 9 and 15 at cycle 2+, and off-treatment up to 2 years. Each cycle is 28 days. ]Evaluation of the safety and tolerability of this combination in platinum-resistant pancreatic cancer patients as assessed by the Common Terminology Criteria for Adverse Events (CTCAE) version 5.0. All grade 3 or higher adverse events (AE) with treatment attribution of possibly, probably or definite based on CTCAEv5 as reported on case report forms were counted. Incidence is the number of patients experiencing at least one treatment-related grade 3 or higher AE of any type during the time of observation.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05212025
|Principal Investigator:||James Cleary, MD, PhD||Dana-Farber Cancer Institute|