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Dose Escalation and Dose Expansion Study of IPN60090 in Patients With Advanced Solid Tumours

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ClinicalTrials.gov Identifier: NCT03894540
Recruitment Status : Recruiting
First Posted : March 28, 2019
Last Update Posted : January 10, 2020
Sponsor:
Information provided by (Responsible Party):
Ipsen

Study Description
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Brief Summary:
The purpose of the protocol is to determine safety, tolerability, recommended dose (RD), pharmacokinetics (PK), pharmacodynamics (PD) and preliminary anti-tumour activity of IPN60090 as a single agent (Part A) and in combination with pembrolizumab (Part B) or paclitaxel (Part C) in patients with advanced solid tumours and to evaluate food effect (Part D).

Condition or disease Intervention/treatment Phase
Solid Tumor Drug: IPN60090 Drug: pembrolizumab Drug: paclitaxel Drug: IPN60090 single administration Phase 1

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 236 participants
Allocation: Non-Randomized
Intervention Model: Sequential Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase I, Open Label, Dose Escalation and Dose Expansion Study to Investigate the Safety, Pharmacokinetics, Pharmacodynamics and Anti-tumour Activity of IPN60090 as Single Agent and in Combination in Patients With Advanced Solid Tumours
Actual Study Start Date : March 22, 2019
Estimated Primary Completion Date : October 10, 2021
Estimated Study Completion Date : October 10, 2021
Arms and Interventions
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Arm Intervention/treatment
Experimental: 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

 Drug: IPN60090
Oral capsules given daily
Experimental: 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

 Drug: IPN60090
Oral capsules given daily

Drug: pembrolizumab
An intravenous solution in single-use vial to be diluted for infusion.
Experimental: 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

 Drug: IPN60090
Oral capsules given daily

Drug: paclitaxel
An intravenous solution in single-use vial to be diluted for infusion.
Experimental: 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.

 Drug: IPN60090 single administration
Oral capsules given once


Outcome Measures
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Primary Outcome Measures :
  1. Rate of Dose Limiting Toxicities (DLTs) [ Time Frame: Cycle 1 day 21 at each dose level ]
    Safety and tolerability of oral IPN60090 as a single agent (Part A) and in combination therapy with pembrolizumab (Part B) or paclitaxel (Part C), as determined by the rate of Dose Limiting Toxicities (DLTs)

  2. Maximum Tolerated Dose (MTD) [ Time Frame: up to 8 months ]
  3. Recommended Dose (RD) [ Time Frame: up to 8 months ]

Secondary Outcome Measures :
  1. Clinical Benefit Rate (CBR) [ Time Frame: up to 6 months ]
    Proportion of patients with Best Overall Response (BOR) of Complete response (CR), Partial Response (PR) and Stable Disease (SD) lasting ≥12 weeks


Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Male or female patients ≥18 years of age
  • 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:

  • Prior malignancy within the previous 2 years except for locally curable cancers that have been cured, such as basal or squamous cell skin cancer, or carcinoma in situ of the cervix, breast or bladder
  • 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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03894540


Contacts
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Contact: Ipsen Recruitment Enquiries clinical.trials@ipsen.com

Locations
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United States, Texas
MD Anderson Cancer Center Recruiting
Houston, Texas, United States, 77030
Sponsors and Collaborators
Ipsen
Investigators
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Study Director: Ipsen Medical Director Ipsen
More Information
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Responsible Party: Ipsen
ClinicalTrials.gov Identifier: NCT03894540    
Other Study ID Numbers: D-US-60090-001
2018-003681-13 ( EudraCT Number )
First Posted: March 28, 2019    Key Record Dates
Last Update Posted: January 10, 2020
Last Verified: January 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: Where patient data can be anonymized, Ipsen will share all individual participant data that underlie the results reported in the published journal article with qualified researchers who provide a valid research question. Study documents, such as the study protocol and clinical study report, are not always available.
Time Frame: Data are available beginning 6 months and ending 5 years after the publication of the findings in a journal; after this time, only raw data may be available.
Access Criteria: Proposals should be submitted to DataSharing@ipsen.com and will be assessed by a scientific review board.

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Neoplasms
Paclitaxel
Albumin-Bound Paclitaxel
Pembrolizumab
Antineoplastic Agents, Phytogenic
Antineoplastic Agents
 Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents, Immunological