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An Open Label Multicentric Phase 1 Study of Oral PI3K/mTOR Inhibitor P7170 in Patients With Advanced Refractory Solid Tumors.

Phase 1
18 Years
90 Years
Open (Enrolling)
Advanced Refractory Solid Tumors

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Trial Information

An Open Label Multicentric Phase 1 Study of Oral PI3K/mTOR Inhibitor P7170 in Patients With Advanced Refractory Solid Tumors.

An open label multicentric Phase 1 study of oral PI3K/mTOR inhibitor P7170 in patients with
advanced refractory solid tumors.The study will follow an Accelerated Titration Design (ATD)
with 100% dose increments until significant toxicity as described below; followed by
standard dose titration with 40% dose increments. Dose and schedule (alternate dosing
regimen eg. OD, BID, intermittent) will be determined by the dose escalation outlined in the
protocol and considering pharmacokinetics of the study drug determined from earlier cohorts.

Inclusion Criteria:

- Patients having histologically and/or cytologically confirmed non-haematological
malignancy that is metastatic or unresectable and for which standard
curative/palliative treatment does not exist or is no longer effective or is not
tolerated by patient.

- Patients of either sex, of all races and ethnic groups, and more than 18 years of

- ECOG (Eastern Cooperative Oncology Group) performance status less than 2.

- Patients with life expectancy of at least 4 months.

- Patients with measurable or evaluable disease per Response Evaluation Criteria In
Solid Tumors (RECIST) version 1.1.

- Patients must have adequate organ and marrow function as defined below:

- Absolute neutrophil count more than equal to 1500/cmm

- Platelets more than equal 100,000/cmm

- Total bilirubin within normal limits of the institution.

- AST/ALT less than equal 2.5 X institutional upper limit of normal (ULN) or less than
equal 5 X institutional upper limit of normal (ULN) in the presence of liver

- Creatinine less than equal 1.5 X institutional upper limit of normal (ULN)

- Women of childbearing potential and men willing to agree to use adequate
contraception (hormonal or barrier method of birth control; abstinence) prior to
study entry, during the duration of study participation and for at least 4 weeks
after withdrawal from the study, unless they are surgically sterilised.

- Ability to understand and the willingness to provide a written informed consent

Exclusion Criteria:

1. Patients who have received any prior chemotherapy, radiotherapy, biologic/targeted
anti-cancer therapy or surgery within 4 weeks (3 months for monoclonal antibodies,
radioactive monoclonal antibodies or any radio- or toxin- immunoconjugates) before
study drug administration and have not recovered (to < Grade 1) from the toxic
effects from any prior therapy.

2. Patients having received any other investigational agents within 4 weeks prior to the
date of enrolment and have not recovered completely (to < Grade 1) from the side
effects of the earlier investigational agent.

3. Patients with known brain metastases (except for patients who have previously-treated
CNS metastases, are asymptomatic, and have had no requirement for steroids or
anti-seizure medication for two months prior to first dose of study drug.)

4. Patients with a history of myocardial infarction or uncontrolled cardiac dysfunction
during the previous 6 months.

5. Patients with diabetes mellitus requiring insulin therapy at screening or patients
with clinically significant diabetic complications, such as neuropathy, retinopathy,
peripheral vascular disease or nephropathy.

6. Clinically significant medical condition of malabsorption, inflammatory bowel
disease, or chronic diarrheal condition that might affect the absorption of the
investigational agent.

7. Patients on chronic anticoagulation treatment. Prophylactic anticoagulation with
low-molecular heparin is allowed.

8. Patients with inter-current illness including, but not limited to ongoing or
clinically significant active infection, symptomatic congestive heart failure,
unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social
situations that would limit compliance with study requirements.

9. Patients with a known history of allergic reaction to any other medication considered
to be clinically significant by the investigator.

10. Women who are pregnant or nursing.

11. Patients with immune deficiency and at increased risk of lethal infections, for
example, known h/o HIV, HBV or HCV.

Type of Study:


Study Design:

Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Maximum tolerated dose

Outcome Description:

Patients will receive study drug on a daily basis for twenty-one days according to the dose and schedule specified for a particular cohort of therapy. Toxicities observed in Cycle 1 will be considered for dose limiting toxicity (DLT) and Maximum tolerated dose (MTD)determination.

Outcome Time Frame:

End of Cycle 1 (i.e. 21 Days)

Safety Issue:


Principal Investigator

Anthony El-Khoueiry, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

USC/Norris Comprehensive Cancer Center


United States: Food and Drug Administration

Study ID:




Start Date:

September 2012

Completion Date:

March 2014

Related Keywords:

  • Advanced Refractory Solid Tumors
  • Advanced refractory solid tumors
  • Neoplasms



USC Norris Comprehensive Cancer CenterLos Angeles, California  90089