Ribociclib and Doxorubicin in Treating Patients With Metastatic or Advanced Soft Tissue Sarcomas That Cannot Be Removed by Surgery
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|ClinicalTrials.gov Identifier: NCT03009201|
Recruitment Status : Active, not recruiting
First Posted : January 4, 2017
Last Update Posted : June 29, 2020
|Condition or disease||Intervention/treatment||Phase|
|Advanced Soft Tissue Sarcoma Locally Advanced Angiosarcoma Locally Advanced Leiomyosarcoma Locally Advanced Liposarcoma Locally Advanced Malignant Peripheral Nerve Sheath Tumor Locally Advanced Myxofibrosarcoma Locally Advanced Undifferentiated Pleomorphic Sarcoma Metastatic Angiosarcoma Metastatic Epithelioid Sarcoma Metastatic Fibrosarcoma Metastatic Liposarcoma Metastatic Malignant Peripheral Nerve Sheath Tumor Metastatic Myxofibrosarcoma Metastatic Soft Tissue Sarcoma Metastatic Synovial Sarcoma Metastatic Undifferentiated Pleomorphic Sarcoma Myxofibrosarcoma Pleomorphic Rhabdomyosarcoma Stage III Soft Tissue Sarcoma AJCC v7 Stage IV Soft Tissue Sarcoma AJCC v7 Undifferentiated (Embryonal) Sarcoma Unresectable Leiomyosarcoma Unresectable Liposarcoma Unresectable Malignant Peripheral Nerve Sheath Tumor Unresectable Soft Tissue Sarcoma Unresectable Synovial Sarcoma Unresectable Undifferentiated Pleomorphic Sarcoma||Drug: Doxorubicin Hydrochloride Other: Laboratory Biomarker Analysis Other: Pharmacological Study Drug: Ribociclib||Phase 1|
I. To determine the recommended phase 2 dose (RP2D) of ribociclib in combination with doxorubicin in subjects with advanced soft tissue sarcomas.
I. To assess preliminary anti-tumor activity of ribociclib in combination with doxorubicin in subjects with advanced soft tissue sarcomas.
II. To characterize the safety and tolerability of ribociclib in combination with doxorubicin.
OUTLINE: This is a dose-escalation study of ribociclib.
Patients receive ribociclib orally (PO) daily on days 1-7, and doxorubicin hydrochloride intravenously (IV) on day 10. Treatment repeats every 21 days for up to 6 cycles in the absence of disease progression or unacceptable toxicity.
MAINTENANCE: Patients without disease progression after 6 cycles receive ribociclib PO daily on days 1-21. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity.
After completion of study treatment, patients are followed up within 30 days and then every 12 weeks for 12 months.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||16 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Phase 1B Study of Ribociclib in Combination With Doxorubicin in Advanced Soft Tissue Sarcomas|
|Actual Study Start Date :||March 10, 2017|
|Actual Primary Completion Date :||October 8, 2019|
|Estimated Study Completion Date :||June 30, 2022|
Experimental: Treatment (ribociclib, doxorubicin hydrochloride)
Patients receive ribociclib PO daily on days 1-7, and doxorubicin hydrochloride IV on day 10. Treatment repeats every 21 days for up to 6 cycles in the absence of disease progression or unacceptable toxicity.
MAINTENANCE: Patients receive ribociclib PO daily on days 1-21. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity.
Drug: Doxorubicin Hydrochloride
Other: Laboratory Biomarker Analysis
Other: Pharmacological Study
- Incidence of dose limiting toxicities (DLTs) of adverse events [ Time Frame: Up to 21 days ]Will be graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version (v) 4.03. All adverse events (AEs) will be tabulated and summarized by major organ category, grade, anticipation, and drug attribution. Serious adverse events (SAE) specific incidence and exact 95% confidence interval will be provided where appropriate.
- Progression-free survival (PFS) [ Time Frame: From first dose of protocol therapy to time of documented radiographic and/or clinical disease progression or death from any cause, whichever occurs first, assessed up to 12 months ]The Kaplan-Meier product limit method will be used to estimate PFS of the median PFS and PFS rates at clinically relevant time points will be provided with the 90% confidence interval (CI).
- Objective response rate (ORR) [ Time Frame: Up to 12 months ]Will be defined as the proportion of patients who achieved a complete response or a partial response. Will be assessed based on Response Evaluation Criteria in Solid Tumors (RECIST) version (v)1. The ORR, along with exact two-sided 95% confidence intervals, will be reported for the study.
- Incidence of adverse events, SAEs [ Time Frame: Up to 12 months ]Will be assessed by NCI CTCAE v 4.03. Analyses will be performed for all patients having received at least one dose of study drug. Serious adverse events, AEs will be summarized using descriptive statistics.
- Incidence of dose modifications (interruptions, reductions, intensity) due to adverse events [ Time Frame: Up to 12 months ]Analyses will be performed for all patients having received at least one dose of study drug. AEs leading to withdrawal/dose interruptions/dose modification will be summarized using descriptive statistics.
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): NCT03009201
|United States, Oregon|
|OHSU Knight Cancer Institute|
|Portland, Oregon, United States, 97239|
|Principal Investigator:||Lara E Davis||OHSU Knight Cancer Institute|