A Food Effect and QTc Study of Perifosine in Patients With Advanced Malignancies
| Status: | Completed |
|---|---|
| Conditions: | Cancer, Cancer |
| Therapuetic Areas: | Oncology |
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 4/17/2018 |
| Start Date: | January 24, 2012 |
| End Date: | November 4, 2013 |
This is a Phase I study which will analyze any food-drug effects as well as QTc effects of
perifosine. Safety and efficacy will also be evaluated.
Patients who complete the first 24 days on single agent perifosine may have the opportunity
to 1) continue on single agent perifosine; 2) switch to the combination of capecitabine +
perifosine; or 3) switch to the combination of sorafenib + perifosine.
perifosine. Safety and efficacy will also be evaluated.
Patients who complete the first 24 days on single agent perifosine may have the opportunity
to 1) continue on single agent perifosine; 2) switch to the combination of capecitabine +
perifosine; or 3) switch to the combination of sorafenib + perifosine.
Exclusion Criteria:
1. Patients with prior exposure to perifosine.
2. Patients receiving any other chemotherapy, targeted agents, investigational agents or
devices within four weeks (28 days) or 5 half‐lives of the agent(s), whichever is
longer, prior to Day1 of study treatment.
3. Patients must have finished radiotherapy 28 days prior to start of treatment.
Radiotherapy is not permitted in the Treatment Phase. Palliative radiotherapy to single
sites for symptom control is allowed only during the Continuation Phase. The clinical
coordinator should be contacted prior to initiating radiotherapy in this setting.
4. Patients who have had a major surgical procedure, open biopsy, or significant traumatic
injury ≤4 weeks prior to Day 1 of study treatment.
5. Patients with a serious non‐healing wound, active ulcer, or untreated bone fracture.
6. Patients with known central nervous system (CNS) metastases. Patients with CNS
metastases that have been treated and are stable and who do not require corticosteroid
treatment for the metastases (off steroids > 4 weeks) will be allowed.
7. Serious active infection requiring parenteral antibiotics or antifungal therapy.
8. History of allergic reactions attributed to compounds of similar chemical or biologic
composition to perifosine (miltefosine or edelfosine).
9. Patients with known dipyrimidine dehydrogenase (DPD) deficiency or prior severe reaction
to 5‐FU (for patients electing to receive capecitabine therapy in the Continuation
Phase).
10. Patients with known HIV or acute or chronic active Hepatitis B or Hepatitis C.
11. Uncontrolled inter‐current illness including, but not limited to, ongoing or active
infection and psychiatric illness/social situations that would Limit compliance with
study requirements.
12. Patients with a history of unstable or newly diagnosed angina pectoris, recent
myocardial infarction (within 6 months of enrollment), or New York Heart Association
class II‐IV congestive heart failure (Appendix B).
13. Female patients who are pregnant or lactating. All females of childbearing potential
must have a negative serum pregnancy test within 72 hours of treatment. Women of
childbearing potential and men with partners of child‐bearing potential, must agree to
employ adequate contraception to prevent pregnancy while on therapy and for 4 weeks
after the completion of treatment (see Appendix C).
14. A history of additional risk factors for Torsades de Pointes (e.g. familial long QT
syndrome, hypokalemia, heart failure (Appendix B), left ventricular hypertrophy, slow
heart rate (<45 bpm)).
15. Required use of concomitant medications known to prolong the QT/QTc interval
1. Patients with prior exposure to perifosine.
2. Patients receiving any other chemotherapy, targeted agents, investigational agents or
devices within four weeks (28 days) or 5 half‐lives of the agent(s), whichever is
longer, prior to Day1 of study treatment.
3. Patients must have finished radiotherapy 28 days prior to start of treatment.
Radiotherapy is not permitted in the Treatment Phase. Palliative radiotherapy to single
sites for symptom control is allowed only during the Continuation Phase. The clinical
coordinator should be contacted prior to initiating radiotherapy in this setting.
4. Patients who have had a major surgical procedure, open biopsy, or significant traumatic
injury ≤4 weeks prior to Day 1 of study treatment.
5. Patients with a serious non‐healing wound, active ulcer, or untreated bone fracture.
6. Patients with known central nervous system (CNS) metastases. Patients with CNS
metastases that have been treated and are stable and who do not require corticosteroid
treatment for the metastases (off steroids > 4 weeks) will be allowed.
7. Serious active infection requiring parenteral antibiotics or antifungal therapy.
8. History of allergic reactions attributed to compounds of similar chemical or biologic
composition to perifosine (miltefosine or edelfosine).
9. Patients with known dipyrimidine dehydrogenase (DPD) deficiency or prior severe reaction
to 5‐FU (for patients electing to receive capecitabine therapy in the Continuation
Phase).
10. Patients with known HIV or acute or chronic active Hepatitis B or Hepatitis C.
11. Uncontrolled inter‐current illness including, but not limited to, ongoing or active
infection and psychiatric illness/social situations that would Limit compliance with
study requirements.
12. Patients with a history of unstable or newly diagnosed angina pectoris, recent
myocardial infarction (within 6 months of enrollment), or New York Heart Association
class II‐IV congestive heart failure (Appendix B).
13. Female patients who are pregnant or lactating. All females of childbearing potential
must have a negative serum pregnancy test within 72 hours of treatment. Women of
childbearing potential and men with partners of child‐bearing potential, must agree to
employ adequate contraception to prevent pregnancy while on therapy and for 4 weeks
after the completion of treatment (see Appendix C).
14. A history of additional risk factors for Torsades de Pointes (e.g. familial long QT
syndrome, hypokalemia, heart failure (Appendix B), left ventricular hypertrophy, slow
heart rate (<45 bpm)).
15. Required use of concomitant medications known to prolong the QT/QTc interval
Inclusion Criteria:
- Patients with advanced malignancies
- Patients with adequate organ and marrow function
Exclusion Criteria:
- Patients previously treated with perifosine
- Patients receiving any other chemotherapy, targeted agents, investigational agents or
devices within four weeks (28 days) prior to Day 1 of study treatment
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