E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
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MedDRA Classification |
E.1.3 | Condition being studied is a rare disease | Yes |
E.2 Objective of the trial |
E.2.1 | Main objective of the trial |
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. |
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E.2.2 | Secondary objectives of the trial |
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
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E.2.3 | Trial contains a sub-study | Information not present in EudraCT |
E.3 | Principal 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 (< Grade 1 or deemed irreversible) from the acute effects of prior cancer therapy before initiation of study treatment, as defined in the study protocol A4021010 Females must be either of non-childbearing potential (surgically sterilized or at least 2 years postmenopausal). OR if of childbearing potential, using an adequate method of contraception. Written consent form signed and dated.
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E.4 | Principal 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.
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E.5 End points |
E.5.1 | 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. |
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E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | No |
E.6.2 | Prophylaxis | No |
E.6.3 | Therapy | No |
E.6.4 | Safety | Yes |
E.6.5 | Efficacy | Yes |
E.6.6 | Pharmacokinetic | Yes |
E.6.7 | Pharmacodynamic | Yes |
E.6.8 | Bioequivalence | No |
E.6.9 | Dose response | Yes |
E.6.10 | Pharmacogenetic | Information not present in EudraCT |
E.6.11 | Pharmacogenomic | Yes |
E.6.12 | Pharmacoeconomic | No |
E.6.13 | Others | No |
E.7 | Trial type and phase |
E.7.1 | Human pharmacology (Phase I) | Yes |
E.7.1.1 | First administration to humans | No |
E.7.1.2 | Bioequivalence study | No |
E.7.1.3 | Other | No |
E.7.1.3.1 | Other trial type description | |
E.7.2 | Therapeutic exploratory (Phase II) | No |
E.7.3 | Therapeutic confirmatory (Phase III) | No |
E.7.4 | Therapeutic use (Phase IV) | No |
E.8 Design of the trial |
E.8.1 | Controlled | No |
E.8.1.1 | Randomised | No |
E.8.1.2 | Open | No |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | No |
E.8.1.5 | Parallel group | No |
E.8.1.6 | Cross over | No |
E.8.1.7 | Other | No |
E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | No |
E.8.2.2 | Placebo | No |
E.8.2.3 | Other | No |
E.8.3 |
The trial involves single site in the Member State concerned
| No |
E.8.4 | The trial involves multiple sites in the Member State concerned | Yes |
E.8.5 | The trial involves multiple Member States | No |
E.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | Yes |
E.8.6.2 | Trial being conducted completely outside of the EEA | Information not present in EudraCT |
E.8.6.3 | If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned |
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E.8.7 | Trial has a data monitoring committee | Information not present in EudraCT |
E.8.8 |
Definition of the end of the trial and justification where it is not the last
visit of the last subject undergoing the trial
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End of Study visit will occur approximately 28 days following the last dose of study drug. The required End of Study safety assessments and samples are summarized in the Visit Schedule. Further details are reported in the Study protocol. |
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E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | 1 |
E.8.9.1 | In the Member State concerned months | 3 |
E.8.9.1 | In the Member State concerned days | |