Dose Escalation and Dose Expansion Study of IPN60090 in Patients With Advanced Solid Tumours
NCT ID: NCT03894540
Last Updated: 2022-09-13
Study Results
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View full resultsBasic Information
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TERMINATED
PHASE1
22 participants
INTERVENTIONAL
2019-03-22
2020-12-21
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
SEQUENTIAL
TREATMENT
NONE
Study Groups
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IPN60090
Part 1: Dose escalation of IPN60090, Part 2: Dose expansion
IPN60090 given as a Bis in Die (BID) oral dose administered up to Maximum Tolerated Dose (MTD) over a 21-day cycle
IPN60090
Oral capsules given daily
IPN60090 in combination with pembrolizumab
Part 1: Dose escalation of IPN60090 in combination with pembrolizumab, Part 2: Dose expansion
IPN60090 given as a Bis in Die (BID) oral dose, starting with pharmacologically active dose identified in 1dose escalation of IPN60090 as a single agent, over a 21-day cycle in combination with 200 mg pembrolizumab given every 21 days (Day 1 of every cycle) as IV infusion
IPN60090
Oral capsules given daily
pembrolizumab
An intravenous solution in single-use vial to be diluted for infusion.
IPN60090 in combination with paclitaxel
Part 1: Dose escalation of IPN60090 in combination with paclitaxel, Part 2: Dose expansion
IPN60090 given as a BID oral dose, starting with pharmacologically active dose identified in dose escalation of IPN60090 as a single agent over a 21-day cycle in combination with 175 mg/m2 or 135 mg/m2 paclitaxel given every 21 days (Day 1 of every cycle) as IV infusion
IPN60090
Oral capsules given daily
paclitaxel
An intravenous solution in single-use vial to be diluted for infusion.
IPN60090 food effect
Part 1: Food Effect of IPN60090
IPN60090 given as a single oral dose as a single agent at the recommended dose (RD) under fasting and fed conditions followed by IPN60090 given as a BID oral dose administered at the RD over a 21-day cycle.
IPN60090 single administration
Oral capsules given once
Interventions
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IPN60090
Oral capsules given daily
pembrolizumab
An intravenous solution in single-use vial to be diluted for infusion.
paclitaxel
An intravenous solution in single-use vial to be diluted for infusion.
IPN60090 single administration
Oral capsules given once
Eligibility Criteria
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Inclusion Criteria
* Patients with solid tumours who have received at least one line of therapy for advanced disease
* Measurable or non-measurable evaluable disease per RECIST 1.1
* Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) ≤1
* Standard of care and/or any investigational therapies must have been completed at least 3 weeks prior to treatment
Exclusion Criteria
* Known primary central malignancy or symptomatic central nervous system metastasis
* Major surgical intervention within 28 days before study drug administration
* Significant acute or chronic infections
18 Years
ALL
No
Sponsors
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Ipsen
INDUSTRY
Responsible Party
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Principal Investigators
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Ipsen Medical Director
Role: STUDY_DIRECTOR
Ipsen
Locations
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MD Anderson Cancer Center
Houston, Texas, United States
Countries
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Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Other Identifiers
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2018-003681-13
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
D-US-60090-001
Identifier Type: -
Identifier Source: org_study_id
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