Advanced Solid Tumours
Conditions
Interventions
Product Code: CP-751,871
Pharmaceutical Form: Solution for injection
Current Sponsor code: CP-751,871
Concentration unit: mg/ml milligram(s)/millilitre
Sponsors
Pfizer Inc. - Research & Development
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Men and women at least 18 years old. Ewing’s sarcoma family histology extension Cohort (only): Patients 9 years old and older. Histologically or cytologically confirmed (no new biopsy required) advanced solid tumors relapsed or refractory to standard therapy or for whom no effective therapy exists Eastern Cooperative Oncology Group (ECOG) Performance Status of 0-1 (Appendix D) Adequate bone marrow function documented within 2 weeks prior to treatment, as defined in the study protocol A4021010 Adequate renal and hepatic function documented within 2 weeks prior to study treatment, as defined in the study protocol A4021010 Trivial or lesser degree of mitral valve regurgitation as determined by Doppler Echocardiogram Fully recovered (=65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: Subjects presenting with any of the following will not be included in the trial: 1. Concurrent treatment with any anti tumor agents (concurrent treatment with LHRH analogs in prostate cancer patients with rising PSA is allowed); 2. Treatment with any other investigational therapy within 4 weeks prior to study treatment; 3. Major surgery within 4 weeks prior to study treatment; 4. Patients with symptomatic brain metastases. Patients with previously diagnosed brain metastases are eligible if they have completed their CNS treatment and have recovered from the acute effects of radiation therapy or surgery prior to the start of study medication, have discontinued corticosteroid treatment for these metastases for at least 4 weeks, and are neurologically stable; 5. Males having reproductive potential who are not using an effective method of birth control and females who are pregnant or breastfeeding or have a positive (urine or serum) pregnancy test during baseline; 6. Significant active cardiac disease including: uncontrolled high blood pressure (ie, systolic blood pressure >160 mm Hg, diastolic blood pressure >95 mm Hg), unstable angina, congestive heart failure, myocardial infarction within the previous 6 months, or serious cardiac arrhythmias; 7. Subjects who are receiving chronic high dose immunosuppressive steroid therapy. Use of high dose corticosteroids within 2 weeks prior to enrollment (>=100 mg prednisone per day or >40 mg dexamethasone per day). Previous high dose steroid treatment is allowed but must be stopped at enrollment (see also Concomitant Medications section); 8. Ongoing or active infection; 9. Other uncontrolled concurrent illness that would preclude study participation; or 10. Psychiatric illness or social situation that would preclude study participation.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To define the safety, tolerability, maximum tolerated dose (MTD) and recommended Phase 2 dose (RP2D) of CP-751,871 in patients with advanced solid tumors.;Primary end point(s): To define the safety, tolerability, maximum tolerated dose (MTD) and recommended Phase 2 dose (RP2D) of CP-751,871 in patients with advanced solid tumors.; Secondary Objective: To characterize the PK of CP-751,871 To explore the effect of CP-751, 871 on the number of CTC and IGF-1R expressing CTC and to explore the downregulation of IGF-1R on granulocytes To evaluate any HAHA response to CP-751,871 | — |
Countries
Italy, United Kingdom
Outcome results
None listed