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perifosine+ temsirolimus

Phase 1

Pediatric Solid Tumors | Small molecule | Oncology |COSCIENS Biopharma Inc.|Last Updated: Mar 10, 2017

Success Probability

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Market & Valuation

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Trial Design

UNCONTROLLEDBiomarker
Total Trials1
Total Enrollment23

FDA Designations

No designations recorded

Clinical trial landscape

perifosine+ temsirolimus · 1 trial · 1 indication

Phase 1 1
NCT01049841Perifosine With Temsirolimus for Recurrent Pediatric Solid TumorsPediatric Solid Tumors
COMPLETED23 Analytics
PHASE1COMPLETED
Perifosine With Temsirolimus for Recurrent Pediatric Solid Tumors
Pediatric Solid TumorsUnlock trial analytics

Study Endpoints

Primary Endpoints

Maximum Tolerated Dose (MTD) of perifosine + temsirolimus combination in children with cancer.
2 years

Secondary Endpoints

To determine whether pharmacokinetic serum levels of both perifosine and temsirolimus correlate with toxicity.
2 years
To record preliminary data on the efficacy of the perifosine + temsirolimus combination.
2 years
If previously resected tissue is available, determine whether molecular features predict response including, Elevated PI3K/AKT/mTOR signaling, Elevated RAS/MAPK signaling, Cell cycle markers
2 years
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Study Design & Arms

AllocationNA
MaskingNONE
ModelSINGLE_GROUP
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
perifosine + temsirolimusEXPERIMENTALThis is a single arm, phase I study. Eligible patients will receive a loading dose of oral perifosine on the first day, followed by a maintenance dose starting on the second day until progression. Each patient is assigned to a group according to their body surface area (BSA). Temsirolimus will be combined with perifosine at four dose levels to determine the MTD for the combination therapy. Temsirolimus dosing will start on the same day as the perifosine load.

Interventions

NameTypeDescription
perifosine + temsirolimusDRUGThe patient will take oral tablets of perifosine at a dose and frequency to be determined their height, weight and time when they enter the study as those entering early will be treated with lower dose levels (dosing frequency will vary from once a week to daily). The patient will receive an intravenous injection of temsirolimus once a week at a dose to be determined by their height, weight and time when they enter the study as those entering early will be treated with lower doses. In addition they will be asked to keep a medicine diary.
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Eligibility Criteria

Age RangeN/A to 21 Years
SexALL
Healthy VolunteersNo
Study Sites1

Inclusion Criteria: * Any solid tumor that has failed standard therapy * Patient must have evidence of tumor by CT, MRI, MIBG scan, serum markers, or tissue sampling. * Age ≤ 21 years (age ≤ 35 years for biopsy proven medulloblastoma or neuroblastoma) * Karnofsky/Lansky performance status ≥ 50% (Ka...

Countries:United States
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Frequently asked questions about perifosine+ temsirolimus

What is Perifosine?

Perifosine is an investigational small molecule being developed by COSCIENS Biopharma Inc. (CSCI) for the treatment of various cancers, including gastrointestinal stromal tumors, colorectal cancer, renal cell carcinoma, chondrosarcomas, and other neoplasms. It is currently in Phase 1 clinical development.

What does Perifosine target?

Perifosine is an investigational oncology drug. Its specific molecular target has not been disclosed in available information. It is being studied for its potential effects in multiple cancer types, including kidney cancer and solid tumors.

Who makes Perifosine?

Perifosine is being developed by COSCIENS Biopharma Inc., a biopharmaceutical company listed on the stock exchange under the ticker symbol CSCI. The company is conducting clinical trials to evaluate the drug's safety and efficacy in oncology indications.

What phase is Perifosine in?

Perifosine is in Phase 1 clinical development. It has completed several clinical trials, including Phase 1 and Phase 2 studies, but is not yet approved by regulatory authorities. The drug remains investigational and is being evaluated for safety and dosing.

What clinical trials is Perifosine in?

Perifosine has been studied in several completed clinical trials. These include NCT00415064, a Phase 1 study combining perifosine with lenalidomide and dexamethasone for multiple myeloma; NCT00498966, a Phase 2 study for kidney cancer; NCT00776867, a Phase 1 study for pediatric solid tumors; and NCT01224730, a food effect and QTc study in advanced malignancies.

Is Perifosine the same as other drugs?

Perifosine is a distinct investigational drug with no known alternative names. It is being studied as a single agent and in combination with other therapies, such as lenalidomide and dexamethasone, but it is not the same as those drugs.