This is an open-label Phase 1b/2 multicenter study of rebastinib (DCC-2036) in combination with paclitaxel designed to evaluate the safety, tolerability, and pharmacokinetics (PK) in patients with advanced or metastatic solid tumors.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
177
Administered orally
Paclitaxel administered by IV infusion at 80 mg/m\^2
University of Alabama Comprehensive Cancer Center
Birmingham, Alabama, United States
University of Colorado Denver- Anschutz Medical Center
Aurora, Colorado, United States
Number of Participants With Adverse Events
Number of participants (pts) who experienced serious adverse events (SAE) and adverse events (AE).
Time frame: Baseline up to 2.89 years
Objective Response Rate (ORR) (Part 2 Expansion)
Percentage of participants who achieved an objective response of Complete Response (CR) or Partial Response (PR) per Response Evaluation Criteria in Solid Tumor (RECIST) v1.1. CR is defined as disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) had to have reduction in short axis to \<10 mm. PR is defined as at least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters. Progressive Disease (PD) is defined as at least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study including baseline, or the appearance of one or more new lesions.
Time frame: Baseline to PD or Death due to Any Cause (Up to 1.54 years)
Objective Response Rate (ORR) (Part 1 Escalation)
Percentage of pts who achieved an objective response of Complete Response (CR) or Partial Response (PR). Per RECIST v1.1, CR defined as disappearance of all target lesions. Any pathological lymph nodes (target or non-target) had to have reduction in short axis to \<10 mm. PR defined as at least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters. PD defined as at least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study, or the appearance of one or more new lesions. Modified RECIST (mRECIST) used for pleural mesothelioma defines CR as the disappearance of any intratumoural arterial enhancement in all target lesions; PR as at least a 30% decrease in the sum of diameters of viable target lesions, taking as reference the baseline sum of the diameters of target lesions; PD as an increase of at least 20% in the sum of the diameters of viable target les
Time frame: Baseline to PD or Death due to Any Cause (Up to 0.92 years)
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Northwestern University Feinberg School of Medicine
Chicago, Illinois, United States
The University of Kansas Clinical Research Center
Kansas City, Kansas, United States
Dana-Farber
Boston, Massachusetts, United States
Northwell Health/Monter Cancer Center
Lake Success, New York, United States
Montefiore Medical Center
The Bronx, New York, United States
Ohio State University Wexner Medical Center
Columbus, Ohio, United States
University of Oklahoma Health Sciences Center
Oklahoma City, Oklahoma, United States
Fox Chase Cancer Center
Philadelphia, Pennsylvania, United States
...and 4 more locations
Duration of Response (DOR)
Time from CR or PR to the earliest documented evidence of PD or death due to any cause. Per RECIST v1.1, CR defined as disappearance of all target lesions. Any pathological lymph nodes (target or non-target) had to have reduction in short axis to \<10 mm. PR defined as at least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters. PD defined as at least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study, or the appearance of one or more new lesions. mRECIST used for pleural mesothelioma defines CR as the disappearance of any intratumoural arterial enhancement in all target lesions; PR as at least a 30% decrease in the sum of diameters of viable target lesions, taking as reference the baseline sum of the diameters of target lesions; PD as an increase of at least 20% in the sum of the diameters of viable target lesions.
Time frame: Time from CR or PR to PD or Death due to Any Cause (Up to 1.54 years)
Time to Progression (TTP)
Time from first dose of study drug to the earliest documented evidence of PD. Per RECIST v1.1, PD defined as at least a 20% increase in the sum of the disease measurements for measurable lesions, taking as reference the smallest disease measurement recorded since the start of treatment, or the appearance of one or more new lesions. mRECIST used for pleural mesothelioma defines PD as an increase of at least 20% in the sum of the diameters of viable target lesions.
Time frame: First Dose of Study Drug to PD (Up to 2.61 years)
Progression-free-survival (PFS)
Time from first dose of study drug to the earliest documented evidence of PD or death due to any cause. Participants who undergo surgical resection of target or non-target lesions, who have received other anticancer treatments, including surgical resection or radiation (other than palliative radiation to pre-existing bone metastases'), or who do not have a documented date of progression or death due to any cause will be censored at the date of the last assessment. PD per RECIST v1.1 is defined as at least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study including baseline; or the appearance of one or more new lesions. mRECIST used for pleural mesothelioma defines PD as an increase of at least 20% in the sum of the diameters of viable target lesions.
Time frame: First Dose of Study Drug to PD or Death due to Any Cause (Up to 2.61 years)
Overall Survival (OS)
Time from first dose of study drug to date of death due to any cause. Participants who were still alive or who were lost to follow-up will be censored at the date of last contact.
Time frame: First Dose of Study Drug to Death due to Any Cause (Up to 2.82 years)
Pharmacokinetics (PK): Maximum Observed Concentration (Cmax) of Rebastinib (Part 1)
Measure the Cmax
Time frame: Part 1: Cycle 1 Day 1 (C1 D1), C1 D15 (Cycle = 28 days)
PK: Area Under the Concentration-time Curve (AUC) 0-6 Hours of Rebastinib (Part 1)
Measure the AUC 0-6 hours
Time frame: Part 1: Cycle 1 Day 1 (C1 D1), C1 D15 (Cycle = 28 days)