None listed
Conditions
Interventions
Group 1 Type of group
AP23573 will be administered once a day as oral tablets for 5 consecutive days followed by a 2-day break each week (QDx5 / week) at a dose of 40 mg daily.
Group name:Group 2 Type of group
Patients randomized to the placebo arm will receive equal tablets consisting of excipients without active ingredient.
Sponsors
Merck Sharp & Dohme Corp,
Eligibility
Sex/Gender
All
Age
8 Years to 90 Years
Inclusion criteria
Inclusion criteria: • Documented histological diagnosis of soft tissue or bone sarcoma that has metastasized, except for certain histopathological subtypes of sarcomas for which experts recognize that they do not benefit from conventional chemotherapies or with characteristically different natural histories. See Appendix G for a list of excluded sarcoma subtypes. • Complete response, partial response or continuous stable disease defined by RECIST guidelines for a minimum of 4 cycles (and a maximum of 12 months) of any prior cytotoxic chemotherapy of 1, 2 or 3 line for metastatic disease. • Disease status (EE or better response) confirmed by a central review of the 2 most recent radiological evaluations (eg, CT or MRI) obtained with a minimum of 6 and a maximum of 10 weeks between studies. • Patients with partial response or stable disease upon admission to the study must have at least one measurable or evaluable lesion defined according to the RECIST guidelines. • Patients with metastatic bone sarcoma should have at least one measurable visceral lesion or have achieved a complete response of visceral metastasis. • ECOO performance status of 0 or 1 • Male or female patients> 13 years of age (patients 13-17 years of age must weigh at least 100 lbs. (45.4 kg)). In regions where applicable local laws prohibit the recruitment of patients 18 years of age will be eligible. • Patients must have normal organ and marrow function as defined below: leukocytes> 3,000 uL, absolute neutrophil count> 1,500 / uL, platelets> 100,000 / uL, total bilirubin below the upper normal institutional limit ( unless the patient has Gilbert´s disease, in which case 50 mL / min / 1.73 m2) • Serum cholesterol 3 weeks before randomization • Randomization and treatment should start <8 weeks after previous treatment
Exclusion criteria
Exclusion criteria: • Pregnant or lactating women • Presence of brain metastases or in known or active CNS • Previous treatment with rapamycin or rapamycin analogs, including AP23573 • Continuous toxicity associated with previous anticancer treatment> Grade 2 (excluding alopecia) according to the NCI standard terminology criteria • Another primary malignancy in the last three years (except for non-melanoma skin cancer and cervical carcinoma in situ) • Known hypersensitivity Grade 3 or 4 to macrolide antibiotics (eg, clarithromycin, erythromycin, azithromycin) • Concomitant treatment with drugs that induce or inhibit CYP3A. Patients must have stopped taking these medications> 2 weeks before the first dose of AP23573 • Uncontrolled significant cardiovascular disease • Active infection that requires systemic treatment • Known HIV infection • Concurrent treatment with immunosuppressive agents apart from corticosteroids prescribed at stable doses for> 2 weeks before the first planned dose of study medication • Inadequate recovery from any previous surgical procedure or having undergone any major surgical procedure within 2 weeks prior to the first dose of the study medication (except minor procedures, eg central venous catheter placement) • Presence of any life-threatening disease or organ or system dysfunction that, in the opinion of the investigator, could affect patient safety or interfere with the safety evaluation of the study medication
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Outcome name:Defined as the time from the date of randomization to the date of documented progressive illness, recurrence or death (whichever comes first) Measure:Progression free survival Timepoints:Until the date of documented progressive illness, recurrence or death (whichever comes first) | — |
Secondary
| Measure | Time frame |
|---|---|
| Outcome name:Defined as the time from the randomization date to the date of death Measure:General survival Timepoints:Until the date of death ; Outcome name:Defined as the best change in synthesis of white lesions from baseline to progression of the disease Measure:Better response of white lesion Timepoints:During the study ; Outcome name:Clinical examination of signs and symptoms during the study Measure:Changes in selected symptoms related to cancer Timepoints:During the study ; Outcome name:It will be evaluated through physical examination, intermediate clinical history and laboratory evaluations. Adverse events will be classified according to the NCI Common Terminology Criteria for Adverse Events Measure:Safety and tolerability Timepoints:During the study | — |
Countries
Australia, Brazil, Canada, Chile, Czech Republic, France, Germany, Greece, India, Israel, Italy, Korea North, Mexico, Netherlands, New Zealand, Poland, Slovakia, South Africa, Spain, Sweden, United Kindgdom, United States
Contacts
Public ContactLuis Mas
SYNEOS HEALTH PERU S.R.L.
Outcome results
None listed