Multicenter, open-label, exploratory, phase II clinical trial to evaluate the efficacy and safety of PM01183 in previously treated patients with advanced solid tumors
Patients with relapsed small cell lung cancer (SCLC), head and neck carcinoma (H\&N), neuroendocrine tumors (NETs), biliary tract carcinoma, endometrial carcinoma, BRCA 1/2-associated metastatic breast carcinoma, carcinoma of unknown primary site, germ cell tumors (GCTs), and Ewing's family of tumors (EFTs) will be enrolled in nine different cohorts. Up to 25 evaluable patients are planned to be enrolled in each cohort (50 in the endometrial carcinoma and 100 in the SCLC cohort).
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
345
Overall Response Rate (ORR)
Overall Response Rate was defined as the percentage of patients with a confirmed response, either CR or PR, according to the RECIST v.1.1. Complete Response (CR): Disappearance of all target lesions; Partial Response (PR): ≥30% decrease in the sum of the longest diameters of target lesions compared with baseline; Progressive disease: ≥20% increase in the sum of the longest diameter of target lesions compared with the smallest-sum longest; diameter recorded or the appearance of one or more new lesions; Stable Disease: Neither PR or PD
Time frame: From the start of treatment to the date of progression or the start of a subsequent therapy or end of patient's follow-up, until Cycle 6 (21-day cycle)
Response by Investigator Assessment
When response is the primary endpoint, and thus all patients must have measurable disease to enter the trial, all patients included in the study must be accounted for in the report of the results, even if there are major protocol treatment deviations or if they are not evaluable. Each patient will be assigned one of the following: Complete Response: Disappearance of all target lesions; Partial Response: ≥30% decrease in the sum of the longest diameters of target lesions; Progressive disease: ≥20% increase in the sum of the longest diameter of target lesions; diameter recorded or the appearance of one or more new lesions; Stable Disease: Neither PR or PD; Inevaluable for response: specify reasons (for example: early death, malignant disease, toxicity; tumour assessments not repeated/incomplete; other). Normally, all eligible patients should be included in the denominator for the calculation of the response rate for phase II trials.
Time frame: From the start of treatment to the date of progression or the start of a subsequent therapy or end of patient's follow-up, until Cycle 6 (21-day cycle)
Duration of Response
Duration of Response by Investigator's Assessment, defined as the time between the date when the response criteria (PR or CR, whichever one is first reached) are fulfilled to the first date when disease progression (PD), recurrence or death is documented.
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Sarcoma Oncology Research Center, LLC
Santa Monica, California, United States
University of Colorado Cancer Center
Aurora, Colorado, United States
Massachussets General Hospital
Boston, Massachusetts, United States
Beth Israel Deaconess Medical Centre
Boston, Massachusetts, United States
Dana Farber Cancer Institute
Boston, Massachusetts, United States
The University of Texas MD Anderson Cancer Center
Houston, Texas, United States
Institute for Drug Development, Cancer Therapy & Research Center at University of Texas Health Science Center
San Antonio, Texas, United States
Institut Jules Bordet
Brussels, Belgium
Hôpital Cochin
Paris, France
Institut Claudius Regaud
Toulouse, France
...and 30 more locations
Time frame: From the start of treatment to the date of progression or the start of a subsequent therapy or end of patient's follow-up, until Cycle 6 (21-day cycle)
Clinical Benefit
Clinical Benefit Rate was defined as Overall Response Rate or Stable Disease lasting over four months (SD ≥ 4 months)
Time frame: From the start of treatment to the date of progression or the start of a subsequent therapy or end of patient's follow-up, until Cycle 6 (21-day cycle)
Disease Control Rate
Disease Control Rate was defined as Overall Response Rate or Stable Disease
Time frame: From the start of treatment to the date of progression or the start of a subsequent therapy or end of patient's follow-up, until Cycle 6
Progression Free Survival (PFS)
Progression-free Survival (PFS), defined as the period of time from the date of first infusion to the date of PD, death (of any cause), or last tumor evaluation. Progressive disease: ≥20% increase in the sum of the longest diameter of target lesions compared with the smallest-sum longest
Time frame: From the date of first infusion to the date of progression disease, death (of any cause), or last tumor evaluation, up to an average of 5 years
Progression-free Survival at 4 Months
Progression-free Survival at 4, defined as the probability of being free from progression and death after the first infusion at 4 months. Progressive disease: ≥20% increase in the sum of the longest diameter of target lesions compared with the smallest-sum longest
Time frame: At 4 months
Progression-free Survival at 6 Months
Progression-free Survival at 6, defined as the probability of being free from progression and death after the first infusion at 6 months. Progressive disease: ≥20% increase in the sum of the longest diameter of target lesions compared with the smallest-sum longest
Time frame: At 6 months
Overall Survival (OS)
Overall survival defined as the period of time from the date of first infusion to the date of death or last contact in case of patients lost to follow-up or alive at the clinical cutoff established for the cohort.
Time frame: From the date of first infusion to the date of death or last contact, up to an average of 5 years
Overall Survival at 6 Months
Overall Survival at 6 months defined as the probability of being alive after the first infusion at 6 months
Time frame: At 6 months
Overall Survival at 12 Months
Overall Survival at 12 months defined as the probability of being alive after the first infusion at 12 months
Time frame: At 12 months