Sitravatinib in Metastatic Breast Cancer

NCT04123704 | Terminated Phase 2 Results DMC FDA Drug

• 1 other identifier: H-43432
• Study Type: interventional
• Target: 3
• Locations: 1 country
• Sites: 1

Brief Summary

This study evaluates the efficacy of sitravatinib in patients with metastatic breast cancer. All study participants will receive sitravatinib, 100 mg daily, until their cancer worsens, or until they develop intolerable side effects.

Conditions

Breast Cancer Stage IV; Triple Negative Breast Cancer; Breast Neoplasms; Breast Cancer Metastatic

Keywords

triple negative; metastatic breast cancer; sitravatinib

Outcome Measures

Primary Outcomes (1)

• Efficacy: Progression-Free Survival at 24 Weeks (PFS24)

  Progression-free survival 24 weeks after starting study treatment. Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1) for target lesions and assessed by MRI: Progressive Disease, \>=20% increase in the sum of the smallest diameter of target lesions, or appearance of one or more new lesions.

  24 weeks

Secondary Outcomes (4)

• Time to Progression (TTP)

  Up to 16 months

• Objective Response Rate (ORR)

  Up to 16 months

• Clinical Benefit Rate (CBR)

  Up to 16 months

• Number of Participants With Grade 3 or Higher AEs

  Up to 16 months

Study Arms (1)

Sitravatinib

EXPERIMENTAL

Sitravatinib 100 mg daily

Drug: Sitravatinib

Interventions

Sitravatinib DRUG

sitravatinib capsule

Also known as: MGCD516

Sitravatinib

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Women or men age 18 and older
• Metastatic or locally advanced inoperable breast cancer (beyond curative management) that is measurable according to RECIST 1.1 criteria. Note: Patients with bone-only disease are eligible if there is at least 1 lytic lesion that can be followed for response.
• Tumor is estrogen receptor (ER) negative and progesterone receptor (PR) negative per the American Society of Clinical Oncology/College of American Pathologists (ASCO/CAP) Guidelines of 2010.
• Tumor is HER2neu negative per ASCO/CAP Guidelines of 2018
• Patient has archival tissue from metastatic or locally advanced breast cancer for the analysis of PTPN12 status
• At least one prior line of chemotherapy with or without a PD-L1 or PD-1 antibody in the metastatic setting
• Eastern Cooperative Oncology Group (ECOG) performance status ≤ 2 (Karnofsky ≥ 60%)
• Normal organ and marrow function as defined below:
• Absolute neutrophil count \> 1000/mcL
• Hemoglobin \> 11 g/dL
• Platelets \> 100,000/mcL
• Total bilirubin \< 1.5 X normal institutional limits
• Aspartate aminotransferase (AST) / alanine aminotransferase (ALT) \< 2.5 X institutional ULN or ≤ 5.0 × ULN for patients with documented liver metastases.
• Creatinine within normal institutional limits
• Creatinine clearance ≥ 30 mL/min

You may not qualify if:

• Uncontrolled hypertension defined as systolic blood pressure \> 150 and/or diastolic blood pressure \> 100, on two or more occasions within 30 days prior to enrollment.
• Imaging suggestive of Lymphangitic carcinomatosis in the lung, or use of home oxygen
• Untreated brain metastases.
• Women who are pregnant or nursing
• Concurrent metastatic disease of another tumor type
• Impairment of gastrointestinal (GI) function or GI disease that may significantly alter the absorption of sitravatinib
• History of stroke, pulmonary embolus (PE), or myocardial infarction (MI)
• Known proteinuria of ≥ 2 g urinary protein/24 h
• HIV-positive participants
• History of Hepatitis C or Hepatitis B infection
• History of congestive heart failure (CHF), and/or LVEF less than 50%
• Concurrent use of medications that prolong QTc (listed in Section 9, Table 11). These medications need to be discontinued at least 2 weeks prior to starting study treatment.
• Concurrent medical condition that, in the sole judgment of the principal investigator, would make the patient inappropriate for trial participation.

Sponsors & Collaborators

• Xiang Zhang: lead
• Mirati Therapeutics Inc.: collaborator

Study Sites (1)

Baylor College of Medicine

Houston, Texas, 77030, United States

Location

MeSH Terms

Conditions

Breast Neoplasms; Triple Negative Breast Neoplasms

Interventions

sitravatinib

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Results Point of Contact

• Title: Dr. C. Kent Osborne
• Organization: Baylor College of Medicine, Dan L Duncan Comprehensive Cancer Center

kosborne@bcm.edu

713-798-1640

Study Officials

• C. Kent Osborne, MD

  Baylor College of Medicine

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: October 9, 2019
• First Posted: October 11, 2019
• Study Start: September 22, 2021
• Primary Completion: January 22, 2023
• Study Completion: January 22, 2023
• Last Updated: August 26, 2024
• Results First Posted: August 26, 2024

Record last verified: 2024-06

Locations

US (1)