Ignite Creation Date:
2024-10-26 @ 3:42 PM
Last Modification Date:
2024-10-26 @ 3:42 PM
Study NCT ID:
NCT06630325
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-09-26
Brief Title:
A Precision Medicine Approach SMMART-ACT for the Treatment of Patients With Advanced Recurrent Sarcoma Prostate Breast Ovarian or Pancreatic Cancer
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Serial Measurements of Molecular and Architectural Responses to Therapy SMMART Adaptive Clinical Treatment ACT
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This phase II trial tests the how well a precision medicine approach serial measurements of molecular and architectural response to therapy SMMART-adaptive clinical treatment ACT works in treating patients with sarcoma prostate breast ovarian or pancreatic cancer that may have spread from where it first started to nearby tissue lymph nodes or distant parts of the body advanced SMMART testing uses genetic and protein tests to learn how cancer changes and to understand what drugs may work against a persons cancer or why drugs stop working These test results are reviewed by a group of physicians and scientists during a SMMART tumor board who then recommend precision therapy
Detailed Description:
PRIMARY OBJECTIVE
I Feasibility of utilizing a SMMART-adaptive clinical treatment ACT tumor board to select personalized advanced cancer treatment plans based on a pre-determined set of drug agents with recommended phase 2 doses RP2Ds
SECONDARY OBJECTIVES
I Safety and tolerability of assigned ACT intervention per cancer type II Preliminary indications of efficacy based on disease-specific responses III Estimated survival benefit per cancer type
EXPLORATORY OBJECTIVES
I Durability of response compared to the most recent therapy on which progression occurred
II Changes in ability to conduct activities of daily living ADL III Changes in quality of life QoL
IV Feasibility of SMMART-centric assessments of ongoing responses to treatment to identify mechanisms of therapy induced change per investigator discretion Such mechanisms may include but will not be limited to the following
IVa Changes in tumor and tumor ecosystem biology IVb Response and resistance to therapy
OUTLINE Patients are assigned to 1 of 14 arms Participants may re-enter the study and receive a new arm assignment in the event of progressive disease or unacceptable toxicity
ARM I Patients receive abemaciclib orally PO twice per day BID on days 1-21 and gemcitabine intravenously IV over 30 minutes on days 1 and 8 of each cycle Cycles repeat every 21 days for up to 8 cycles in the absence of disease progression or unacceptable toxicity Patients undergo blood sample collection throughout the study Patients also undergo tumor biopsy on study and optionally at the end of treatment
ARM II Patients receive abemaciclib PO BID on days 1-21 and pemetrexed IV over 10 minutes on day 1 of each cycle Cycles repeat every 21 days for up to 8 cycles in the absence of disease progression or unacceptable toxicity Patients undergo blood sample collection throughout the study Patients undergo blood sample collection throughout the study Patients also undergo tumor biopsy on study and optionally at the end of treatment
ARM III Patients receive abemaciclib PO BID on days 1-28 of each cycle Cycles repeat every 28 days for up to 6 cycles in the absence of disease progression or unacceptable toxicity Patients undergo blood sample collection throughout the study Patients also undergo tumor biopsy on study and optionally at the end of treatment
ARM IV Patients receive abemaciclib PO BID and exemestane PO once per day QD on days 1-28 of each cycle Cycles repeat every 28 days for up to 6 cycles in the absence of disease progression or unacceptable toxicity Patients undergo blood sample collection throughout the study Patients also undergo tumor biopsy on study and optionally at the end of treatment
ARM V Patients receive abemaciclib PO BID and letrozole PO QD on days 1-28 of each cycle Cycles repeat every 28 days for up to 6 cycles in the absence of disease progression or unacceptable toxicity Patients undergo blood sample collection throughout the study Patients also undergo tumor biopsy on study and optionally at the end of treatment
ARM VI Patients receive abemaciclib PO BID and tamoxifen PO QD on days 1-28 of each cycle Cycles repeat every 28 days for up to 6 cycles in the absence of disease progression or unacceptable toxicity Patients undergo blood sample collection throughout the study Patients also undergo tumor biopsy on study and optionally at the end of treatment
ARM VII Patients receive gefitinib PO QD on days 1-21 pemetrexed IV on day 1 of each cycle and carboplatin IV on day 1 of cycles 1-6 Cycles repeat every 21 days for up to 8 cycles in the absence of disease progression or unacceptable toxicity Patients undergo blood sample collection throughout the study Patients also undergo tumor biopsy on study and optionally at the end of treatment
ARM VIII Patients receive olaparib PO BID and temozolomide PO QD on days 1-7 of each cycle Cycles repeat every 21 days for up to 8 cycles in the absence of disease progression or unacceptable toxicity Patients undergo blood sample collection throughout the study Patients also undergo tumor biopsy on study and optionally at the end of treatment
ARM IX Patients receive fulvestrant intramuscularly IM on days 1 15 and 29 of cycle 1 and day 1 of subsequent cycles Cycles repeat every 28 days for up to 6 cycles in the absence of disease progression or unacceptable toxicity Patients undergo blood sample collection throughout the study Patients also undergo tumor biopsy on study and optionally at the end of treatment
ARM X Patients receive gefitinib PO QD on days 1-28 of each cycle Cycles repeat every 28 days for up to 6 cycles in the absence of disease progression or unacceptable toxicity Patients undergo blood sample collection throughout the study Patients also undergo tumor biopsy on study and optionally at the end of treatment
ARM XI Patients receive olaparib PO BID on days 1-28 of each cycle Cycles repeat every 28 days for up to 6 cycles in the absence of disease progression or unacceptable toxicity Patients undergo tumor biopsy CT scan MRI scan PET scan andor bone scan and blood sample collection throughout the study
ARM XII Patients receive olaparib PO BID on days 1-3 8-10 15-17 21-23 and carboplatin IV and paclitaxel IV on days 1 8 and 15 of each cycle Cycles repeat every 28 days for up to 6 cycles in the absence of disease progression or unacceptable toxicity Patients undergo blood sample collection throughout the study Patients also undergo tumor biopsy on study as clinically indicated and optionally at the end of treatment
ARM XIII Patients receive olaparib PO BID on days 1-28 and liposomal doxorubicin IV on day 1 of each cycle Cycles repeat every 28 days for up to 6 cycles in the absence of disease progression or unacceptable toxicity Patients undergo echocardiography or multigated acquisition MUGA scan and blood sample collection throughout the study Patients also undergo tumor biopsy on study and optionally at the end of treatment
ARM XIV Patients receive osimertinib PO QD on days 1-28 of each cycle Cycles repeat every 28 days for up to 6 cycles in the absence of disease progression or unacceptable toxicity Patients undergo echocardiography or MUGA scan and blood sample collection throughout the study Patients also undergo tumor biopsy on study and optionally at the end of treatment
After completion of study treatment patients are followed up 30 days every 3 months for 1 year then every 6 months until year 5
I Feasibility of utilizing a SMMART-adaptive clinical treatment ACT tumor board to select personalized advanced cancer treatment plans based on a pre-determined set of drug agents with recommended phase 2 doses RP2Ds
SECONDARY OBJECTIVES
I Safety and tolerability of assigned ACT intervention per cancer type II Preliminary indications of efficacy based on disease-specific responses III Estimated survival benefit per cancer type
EXPLORATORY OBJECTIVES
I Durability of response compared to the most recent therapy on which progression occurred
II Changes in ability to conduct activities of daily living ADL III Changes in quality of life QoL
IV Feasibility of SMMART-centric assessments of ongoing responses to treatment to identify mechanisms of therapy induced change per investigator discretion Such mechanisms may include but will not be limited to the following
IVa Changes in tumor and tumor ecosystem biology IVb Response and resistance to therapy
OUTLINE Patients are assigned to 1 of 14 arms Participants may re-enter the study and receive a new arm assignment in the event of progressive disease or unacceptable toxicity
ARM I Patients receive abemaciclib orally PO twice per day BID on days 1-21 and gemcitabine intravenously IV over 30 minutes on days 1 and 8 of each cycle Cycles repeat every 21 days for up to 8 cycles in the absence of disease progression or unacceptable toxicity Patients undergo blood sample collection throughout the study Patients also undergo tumor biopsy on study and optionally at the end of treatment
ARM II Patients receive abemaciclib PO BID on days 1-21 and pemetrexed IV over 10 minutes on day 1 of each cycle Cycles repeat every 21 days for up to 8 cycles in the absence of disease progression or unacceptable toxicity Patients undergo blood sample collection throughout the study Patients undergo blood sample collection throughout the study Patients also undergo tumor biopsy on study and optionally at the end of treatment
ARM III Patients receive abemaciclib PO BID on days 1-28 of each cycle Cycles repeat every 28 days for up to 6 cycles in the absence of disease progression or unacceptable toxicity Patients undergo blood sample collection throughout the study Patients also undergo tumor biopsy on study and optionally at the end of treatment
ARM IV Patients receive abemaciclib PO BID and exemestane PO once per day QD on days 1-28 of each cycle Cycles repeat every 28 days for up to 6 cycles in the absence of disease progression or unacceptable toxicity Patients undergo blood sample collection throughout the study Patients also undergo tumor biopsy on study and optionally at the end of treatment
ARM V Patients receive abemaciclib PO BID and letrozole PO QD on days 1-28 of each cycle Cycles repeat every 28 days for up to 6 cycles in the absence of disease progression or unacceptable toxicity Patients undergo blood sample collection throughout the study Patients also undergo tumor biopsy on study and optionally at the end of treatment
ARM VI Patients receive abemaciclib PO BID and tamoxifen PO QD on days 1-28 of each cycle Cycles repeat every 28 days for up to 6 cycles in the absence of disease progression or unacceptable toxicity Patients undergo blood sample collection throughout the study Patients also undergo tumor biopsy on study and optionally at the end of treatment
ARM VII Patients receive gefitinib PO QD on days 1-21 pemetrexed IV on day 1 of each cycle and carboplatin IV on day 1 of cycles 1-6 Cycles repeat every 21 days for up to 8 cycles in the absence of disease progression or unacceptable toxicity Patients undergo blood sample collection throughout the study Patients also undergo tumor biopsy on study and optionally at the end of treatment
ARM VIII Patients receive olaparib PO BID and temozolomide PO QD on days 1-7 of each cycle Cycles repeat every 21 days for up to 8 cycles in the absence of disease progression or unacceptable toxicity Patients undergo blood sample collection throughout the study Patients also undergo tumor biopsy on study and optionally at the end of treatment
ARM IX Patients receive fulvestrant intramuscularly IM on days 1 15 and 29 of cycle 1 and day 1 of subsequent cycles Cycles repeat every 28 days for up to 6 cycles in the absence of disease progression or unacceptable toxicity Patients undergo blood sample collection throughout the study Patients also undergo tumor biopsy on study and optionally at the end of treatment
ARM X Patients receive gefitinib PO QD on days 1-28 of each cycle Cycles repeat every 28 days for up to 6 cycles in the absence of disease progression or unacceptable toxicity Patients undergo blood sample collection throughout the study Patients also undergo tumor biopsy on study and optionally at the end of treatment
ARM XI Patients receive olaparib PO BID on days 1-28 of each cycle Cycles repeat every 28 days for up to 6 cycles in the absence of disease progression or unacceptable toxicity Patients undergo tumor biopsy CT scan MRI scan PET scan andor bone scan and blood sample collection throughout the study
ARM XII Patients receive olaparib PO BID on days 1-3 8-10 15-17 21-23 and carboplatin IV and paclitaxel IV on days 1 8 and 15 of each cycle Cycles repeat every 28 days for up to 6 cycles in the absence of disease progression or unacceptable toxicity Patients undergo blood sample collection throughout the study Patients also undergo tumor biopsy on study as clinically indicated and optionally at the end of treatment
ARM XIII Patients receive olaparib PO BID on days 1-28 and liposomal doxorubicin IV on day 1 of each cycle Cycles repeat every 28 days for up to 6 cycles in the absence of disease progression or unacceptable toxicity Patients undergo echocardiography or multigated acquisition MUGA scan and blood sample collection throughout the study Patients also undergo tumor biopsy on study and optionally at the end of treatment
ARM XIV Patients receive osimertinib PO QD on days 1-28 of each cycle Cycles repeat every 28 days for up to 6 cycles in the absence of disease progression or unacceptable toxicity Patients undergo echocardiography or MUGA scan and blood sample collection throughout the study Patients also undergo tumor biopsy on study and optionally at the end of treatment
After completion of study treatment patients are followed up 30 days every 3 months for 1 year then every 6 months until year 5
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None