2020-01-23
2023-01-31
2023-03-30
105
NCT04247126
Syros Pharmaceuticals
Syros Pharmaceuticals
INTERVENTIONAL
A Study of SY 5609, a Selective CDK7 Inhibitor, in Advanced Solid Tumors
The study consists of 2 parts. Part 1 is dose escalation and will first administer SY-5609 alone to participants with select advanced solid tumors and then in combination with fulvestrant to participants with HR positive, HER2-negative breast cancer. Part 2 is a dose expansion and will first administer SY-5609 in combination with gemcitabine and then SY-5609 in combination with gemcitabine and nab-paclitaxel in participants with pancreatic ductal adenocarcinoma (PDAC) .
N/A
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Registration Dates | Results Reporting Dates | Study Record Updates |
---|---|---|
2020-01-22 | N/A | 2023-10-26 |
2020-01-27 | N/A | 2023-10-27 |
2020-01-29 | N/A | 2023-10 |
This section provides details of the study plan, including how the study is designed and what the study is measuring.
Primary Purpose:
Treatment
Allocation:
Non Randomized
Interventional Model:
Sequential
Masking:
None
Arms and Interventions
Participant Group/Arm | Intervention/Treatment |
---|---|
EXPERIMENTAL: Group 1: Single Agent Dose Escalation Dose escalation phase to explore maximum tolerated dose of SY-5609 given as a single agent. | DRUG: SY-5609
|
EXPERIMENTAL: Group 2: SY-5609 + Fulvestrant Participants with hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2) negative advanced or metastatic breast cancer (BC) that has progressed following prior treatment with a cyclin-dependent kinase (CDK)4/6 inhibitor in combina | DRUG: SY-5609
DRUG: Fulvestrant
|
EXPERIMENTAL: Group 3: SY-5609 + Gemcitabine Participants with PDAC will receive SY-5609 in combination with gemcitabine in Safety Lead-in to identify a recommended combination dose for the expansion. The expansion part will assess the safety, tolerability, and preliminary clinical activity of SY-56 | DRUG: SY-5609
DRUG: Gemcitabine
|
EXPERIMENTAL: Group 4: SY-5609 + Gemcitabine + Nab-paclitaxel Participants with PDAC will receive SY-5609 in combination with gemcitabine plus nab-paclitaxel in Safety Lead-in to identify a recommended combination dose for the expansion. The expansion part will assess the safety, tolerability, and preliminary clinic | DRUG: SY-5609
DRUG: Gemcitabine
DRUG: Nab-paclitaxel
|
Primary Outcome Measures | Measure Description | Time Frame |
---|---|---|
Groups 1 and 2: Dose-Limiting Toxicity of SY-5609 | Up to 28 days after first administration | |
Groups 1 and 2: Number of Participants With Treatment Emergent Adverse Events | From Baseline up to 30 days after last dose of study drug (up to 1 year) | |
Groups 3 and 4 (Safety Lead-ins): Number of Participants With Dose-Limiting Toxicity | Up to 28 days after first administration | |
Groups 3 and 4 (Safety Lead-ins): Number of Participants With TEAEs | From Baseline up to 30 days after last dose of study drug (up to 1 year) | |
Groups 3 and 4 (Expansions): Progression Free Survival | Up to 1 year |
Secondary Outcome Measures | Measure Description | Time Frame |
---|---|---|
Groups 1 and 2: Area Under The Concentration Versus Time Curve of SY-6509 | Predose, 0.5, 1, 2, 4, 6, 8 hours postdose on Day 1 and 4 or 15 of Cycle 1; 24 hours predose on Day 2 and 5 of Cycle 1; 24 hours predose on Day 1 of Cycle 2, 3 and 4 (Each Cycle=28 days) | |
Groups 1 and 2: Apparent Clearance of SY-5609 | Predose, 0.5, 1, 2, 4, 6, 8 hours postdose on Day 1 and 4 or 15 of Cycle 1; 24 hours predose on Day 2 and 5 of Cycle 1; 24 hours predose on Day 1 of Cycle 2, 3 and 4 (Each Cycle=28 days) | |
Groups 1 and 2: Apparent Volume of Distribution of SY-5609 | Predose, 0.5, 1, 2, 4, 6, 8 hours postdose on Day 1 and 4 or 15 of Cycle 1; 24 hours predose on Day 2 and 5 of Cycle 1; 24 hours predose on Day 1 of Cycle 2, 3 and 4 (Each Cycle=28 days) | |
Groups 1 and 2: Elimination Half-Life of SY-5609 | Predose, 0.5, 1, 2, 4, 6, 8 hours postdose on Day 1 and 4 or 15 of Cycle 1; 24 hours predose on Day 2 and 5 of Cycle 1; 24 hours predose on Day 1 of Cycle 2, 3 and 4 (Each Cycle=28 days) | |
Groups 1 and 2: Maximum Plasma Concentration (Cmax) of SY-5609 | Predose, 0.5, 1, 2, 4, 6, 8 hours postdose on Day 1 and 4 or 15 of Cycle 1; 24 hours predose on Day 2 and 5 of Cycle 1; 24 hours predose on Day 1 of Cycle 2, 3 and 4 (Each Cycle=28 days) | |
Groups 1 and 2: Time of Maximum Plasma Concentration (Tmax) of SY-5609 | Predose, 0.5, 1, 2, 4, 6, 8 hours postdose on Day 1 and 4 or 15 of Cycle 1; 24 hours predose on Day 2 and 5 of Cycle 1; 24 hours predose on Day 1 of Cycle 2, 3 and 4 (Each Cycle=28 days) | |
Groups 1 and 2: Minimum or Trough Plasma Concentration (Cmin) of SY-5609 | Predose, 0.5, 1, 2, 4, 6, 8 hours postdose on Day 1 and 4 or 15 of Cycle 1; 24 hours predose on Day 2 and 5 of Cycle 1; 24 hours predose on Day 1 of Cycle 2, 3 and 4 (Each Cycle=28 days) | |
Groups 1 and 2: Time of Minimum or Trough Plasma Concentration (Tmin) of SY-5609 | Predose, 0.5, 1, 2, 4, 6, 8 hours postdose on Day 1 and 4 or 15 of Cycle 1; 24 hours predose on Day 2 and 5 of Cycle 1; 24 hours predose on Day 1 of Cycle 2, 3 and 4 (Each Cycle=28 days) | |
Groups 3 and 4 (Safety Lead-ins): Progression Free Survival | Up to 1 year | |
Groups 3 and 4 (Safety Lead-ins): Objective Response Rate (ORR) | ORR is defined as the proportion of participants who achieve complete response (CR) and partial remission (PR) (as determined by the investigator). | Up to 1 year |
Groups 3 and 4 (Safety Lead-ins): Complete Response/Remission (CR) Rate | CR rate is defined as proportion of participants who achieve CR (as determined by the investigator). | Up to 1 year |
Groups 3 and 4 (Safety Lead-ins): Disease Control Rate | Up to 1 year | |
Groups 3 and 4 (Safety Lead-ins): Time to Response | Time to response is defined as the duration from the date of randomization to the date of the first documented evidence of response as determined by the investigator. | Up to 1 year |
Groups 3 and 4 (Safety Lead-ins): Duration of Response | Duration of response is defined as duration from the date of first documented evidence of response to the date of relapse of disease (as determined by the investigator), or death due to any cause, whichever occurs first. | Up to 1 year |
Groups 3 and 4 (Expansions): Objective Response Rate | ORR is defined as the proportion of participants who achieve CR and partial remission (PR) (as determined by the investigator). | Up to 1 year |
Groups 3 and 4 (Expansions): Complete Response Rate | CR rate is defined as proportion of participants who achieve CR (as determined by the investigator). | Up to 1 year |
Groups 3 and 4 (Expansions): Disease Control Rate | Up to 1 year | |
Groups 3 and 4 (Expansions): Time to Response | Time to response is defined as the duration from the date of randomization to the date of the first documented evidence of response as determined by the investigator. | Up to 1 year |
Groups 3 and 4 (Expansions): Duration of Response | Duration of response is defined as duration from the date of first documented evidence of response to the date of relapse of disease (as determined by the investigator), or death due to any cause, whichever occurs first. | Up to 1 year |
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person’s general health condition or prior treatments.
Ages Eligible for Study:
ALL
Sexes Eligible for Study:
18 Years
Accepts Healthy Volunteers:
This is where you will find people and organizations involved with this study.
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
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