Ribociclib and Doxorubicin in Treating Patients With Metastatic or Advanced Soft Tissue Sarcomas That Cannot Be Removed by Surgery

Part of paid clinical trials in Portland, Oregon.

Sponsor
OHSU Knight Cancer Institute
Study ID
NCT03009201
Phase
PHASE1
Status
Completed

Conditions

  • 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

Eligibility Criteria

Sex
ALL
Age
12 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Doxorubicin Hydrochloride — DRUG
    Given IV
  • Laboratory Biomarker Analysis — OTHER
    Correlative studies
  • Pharmacological Study — OTHER
    Correlative studies
  • Ribociclib — DRUG
    Given PO

Study Details

This phase Ib trial studies the side effects and best dose of ribociclib when giving together with doxorubicin hydrochloride in treating patients with soft tissue sarcomas that has spread to other places or that cannot be removed by surgery (advanced). Ribociclib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Drugs used in chemotherapy, such as doxorubicin hydrochloride, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Giving ribociclib and doxorubicin hydrochloride may work better in treating patients with soft tissue sarcoma.

Key Dates

Start date
Mar 10, 2017
Status verified
Aug 2023
Primary completion
Oct 8, 2019
Completion
Jun 30, 2023

Study Design

Enrollment
16 participants (actual)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • 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.

Primary Outcome Measure

Incidence of dose limiting toxicities (DLTs) of adverse events [ Time Frame: Up to 21 days ]

Locations (1)

FacilityCityStateZIPSite coordinators
OHSU Knight Cancer InstitutePortlandOregon97239-

Find similar trials in Portland, OR

By research site
OHSU Knight Cancer Institute· Portland, OR

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