Advanced Refractory Solid TumorsPhase 1NCT01762410
Clinical Study of Oral PI3K/mTOR Inhibitor in Patients With Advanced Refractory Solid Tumors
A Phase 1 study testing P7170 in people with Advanced Refractory Solid Tumors, run by Piramal Enterprises Limited at 4 sites in 2 countries.
Trial summary
Clinical study of oral PI3K/mTOR inhibitor P7170 in patients with advanced refractory solid tumors. The primary objective is to determine the maximum tolerated dose and dose limiting toxicity of oral PI3K/mTOR inhibitor P7170 in patients with advanced refractory solid tumors Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Advanced Refractory Solid Tumors
- What is being tested?
- P7170
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 4 sitesin 2 countries
- Study dates
- Sep 2012to Mar 2016
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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 age.
- 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:
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- 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 metastases
- 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 document.
Who cannot join
- 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.
- 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.
- 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.)
- Patients with a history of myocardial infarction or uncontrolled cardiac dysfunction during the previous 6 months.
- 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.
- Clinically significant medical condition of malabsorption, inflammatory bowel disease, or chronic diarrheal condition that might affect the absorption of the investigational agent.
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- Patients on chronic anticoagulation treatment. Prophylactic anticoagulation with low-molecular heparin is allowed.
- 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.
- Patients with a known history of allergic reaction to any other medication considered to be clinically significant by the investigator.
- Women who are pregnant or nursing.
- Patients with immune deficiency and at increased risk of lethal infections, for example, known h/o HIV, HBV or HCV.
Trial locations and contacts
4 sites in 2 countries.
4 sites in 2 countries
India3 sites
Medanta Duke Research Institute (MDRI)
Gurgaon, Haryana, 122001
Meenakshi Mission Hospital & Research Centre
Madurai, Tamil Nadu, 625107
Central India Cancer Research Institute
Nagpur, Maharashtra
United States1 site
USC Norris Comprehensive Cancer Center
Los Angeles, California, 90033
About this study
Official title: An Open Label Multicentric Phase 1 Study of Oral PI3K/mTOR Inhibitor P7170 in Patients With Advanced Refractory Solid Tumors.
Clinical study of oral PI3K/mTOR inhibitor P7170 in patients with advanced refractory solid tumors. The primary objective is to determine the maximum tolerated dose and dose limiting toxicity of oral PI3K/mTOR inhibitor P7170 in patients with advanced refractory solid tumors
Read the detailed description
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.
- Conditions
- Advanced Refractory Solid Tumors
- Being tested
- P7170
- Keywords
- Advanced refractory solid tumors
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
P7170Drug
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. This 21 day administration will define a treatment cycle. Patients may receive consecutive treatment cycles until evidence of disease progression, intolerance of therapy, death or withdrawal from the protocol as specified.
| Study group | Role | What they receive |
|---|---|---|
| P7170 | Experimental | Patients will receive study drug on a daily basis until disease progression or unacceptable toxicity in sequential cohorts following accelerated titration design. Receives: Drug: P7170 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Maximum tolerated dose
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.
Measured: End of Cycle 1 (i.e. 21 Days)
Secondary outcomes (4)
Number of subject with adverse events
The toxic effects of the drug would be assessed from adverse events, vital signs and by clinically significant changes in the laboratory evaluations.
Measured: Until disease progression or unacceptable toxicity (expected to be 4-6 months)
Pharmacokinetic profile(Cmax,Tmax and AUC)
The effect of dose for AUC0-t, AUC0-inf and Cmax. Tmax and T1/2 will be given as patient-wise narratives at each dose level.
Measured: Until disease progression or unacceptable toxicity (expected to be 4-6 months)
Activity of P7170 based on selected biomarkers
Plasma samples will be used for analysis of exploratory biomarkers that are found in plasma and levels of which are likely to change in response to P7170 administration
Measured: Until disease progression or unacceptable toxicity (expected to be 4-6 months)
Objective response
Evaluation of Response: Clinical responses will be presented patient wise for different dose levels.
Measured: Until disease progression or unacceptable toxicity (expected to be 4-6 months)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jan 2013 (estimated)
- Study startSep 2012
- Primary completionNov 2015 (estimated)
- Study completionMar 2016 (estimated)
Why it stopped: Sponsor decision not related to patient safety
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Advanced Refractory Solid TumorsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Piramal Enterprises Limited
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Anthony El-Khoueiry, MD, Principal investigator, University of Southern California
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01762410
- Sponsor's protocol ID
- P7170/70/11
- Status last verified
- Sep 2014
- First submitted
- 20 Dec 2012
- Last updated
- 29 Sep 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Sep 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open Label Multicentric Phase 1 Study of Oral PI3K/mTOR Inhibitor P7170 in Patients With Advanced Refractory Solid Tumors.
- ClinicalTrials.gov ID
- NCT01762410
- Acronym / sponsor ID
- P7170/70/11
- Conditions
- Advanced Refractory Solid Tumors
- Keywords
- Advanced refractory solid tumors
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- SuspendedReason stopped: Sponsor decision not related to patient safety
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Piramal Enterprises LimitedIndustry (pharma, biotech, devices)
- Study start
- Sep 2012
- Primary completion
- Nov 2015 (estimated)
- Study completion
- Mar 2016 (estimated)
- First posted
- 7 Jan 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Clinical study of oral PI3K/mTOR inhibitor P7170 in patients with advanced refractory solid tumors. The primary objective is to determine the maximum tolerated dose and dose limiting toxicity of oral PI3K/mTOR inhibitor P7170 in patients with advanced refractory solid tumors
Detailed description
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| P7170 | Experimental | Drug: P7170Patients will receive study drug on a daily basis until disease progression or unacceptable toxicity in sequential cohorts following accelerated titration design. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (13 listed)
- 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 age.
- 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.
Key exclusion criteria (11 listed)
- 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.
- 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.
- 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.)
- Patients with a history of myocardial infarction or uncontrolled cardiac dysfunction during the previous 6 months.
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| P7170Patients 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. This 21 day administration will define a treatment cycle. Patients may receive consecutive treatment cycles until evidence of disease progression, intolerance of therapy, death or withdrawal from the protocol as specified. | Drug | P7170 |
Primary outcome
Maximum tolerated dose
Time frame: End of Cycle 1 (i.e. 21 Days)
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.
4 secondary outcomes
Number of subject with adverse events
Time frame: Until disease progression or unacceptable toxicity (expected to be 4-6 months)
Pharmacokinetic profile(Cmax,Tmax and AUC)
Time frame: Until disease progression or unacceptable toxicity (expected to be 4-6 months)
Activity of P7170 based on selected biomarkers
Time frame: Until disease progression or unacceptable toxicity (expected to be 4-6 months)
Objective response
Time frame: Until disease progression or unacceptable toxicity (expected to be 4-6 months)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Sep 2014.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Anthony El-Khoueiry, MD principal investigator
University of Southern California
4 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing P7170 in people with Advanced Refractory Solid Tumors, run by Piramal Enterprises Limited at 4 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 13 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: paused, as of the sponsor's last update on 29 Sep 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in India, United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Maximum tolerated dose (time frame: End of Cycle 1 (i.e. 21 Days)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Sep 2014.