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Debio 1347-101 Phase I Trial in Advanced Solid Tumours With Fibroblast Growth Factor Receptor (FGFR) Alterations

This study is currently recruiting participants. (see Contacts and Locations)
Verified November 2014 by Debiopharm International SA
Sponsor:
Information provided by (Responsible Party):
Debiopharm International SA
ClinicalTrials.gov Identifier:
NCT01948297
First received: August 26, 2013
Last updated: November 13, 2014
Last verified: November 2014

August 26, 2013
November 13, 2014
August 2013
September 2015   (final data collection date for primary outcome measure)
Incidence rate of dose limiting toxicities (DLTs) of Debio 1347 [ Time Frame: Approximately 18 months ] [ Designated as safety issue: Yes ]
The dose escalation part of the study will be guided by a well-established statistical method/model to estimate the maximum tolerated dose(s) and/or the recommended dose for expansion (RDE). Safety(incidence and nature of DLTs), pharmacokinetic and pharmacodynamic data will guide dose escalation decisions.
Incidence rate of dose limiting toxicities (DLTs) of Debio 1347 [ Time Frame: Approximately 18 months ] [ Designated as safety issue: Yes ]
The dose escalation part of the study will be guided by a well-established statistical method/model to estimate the maximum tolerated dose(s) and/or the recommended dose for expansion (RDE). Safety(incidence and nature of DLTs), pharmacokinetic and pharmacodynamic data will guide dose escalation decisioins.
Complete list of historical versions of study NCT01948297 on ClinicalTrials.gov Archive Site
  • Safety and tolerability of Debio 1347 combination at the recommended dose (RDE) for expansion [ Time Frame: Every 28 days from baseline visit to 28 days after study drug discontinuation ] [ Designated as safety issue: Yes ]
    This will be assessed by looking at the number of Adverse Events (AEs), serious AEs (SAEs) changes in hematology and chemistry values, vital signs, electrocardiograms (ECGs), dose interruptions and reductions
  • Markers of FGFR inhibition in plasma and tumor [ Time Frame: Baseline and day 8 ] [ Designated as safety issue: No ]
  • Time vs. concentration profile of Debio 1347 [ Time Frame: Every 28 days for up to the end of the study ] [ Designated as safety issue: Yes ]
    Plasma concentration versus time profiles. Plasma PK parameters will be used to characterize the PK profiles of Debio 1347
  • Safety and tolerability of Debio 1347 combination at the recommended dose (RDE) for expansion [ Time Frame: Every 28 days from baseline visit to 28 days after study drug discontinuation ] [ Designated as safety issue: Yes ]
    This will be assessed by looking at the number of Adverse Events (AEs), serious AEs (SAEs) changes in hematology and chemistry values, vital signs, electrocardiograms (ECGs), dose interruptions and reductions
  • Markers of FGFR inhibition (FGF-23 and FGF-2) in plasma and tumor [ Time Frame: Baseline and day 8 ] [ Designated as safety issue: No ]
  • Time vs. concentration profile of Debio 1347 [ Time Frame: Every 28 days for up to the end of the study ] [ Designated as safety issue: Yes ]
    Plasma concentration versus time profiles. Plasma PK parameters will be used to characterize the PK profiles of Debio 1347
Overall response rate [ Time Frame: Every 8 weeks from the date of baseline visit ] [ Designated as safety issue: No ]
Assessment of preliminary antitumor activity of Debio 1347; Overall response rate = complete response + partial response
Same as current
 
Debio 1347-101 Phase I Trial in Advanced Solid Tumours With Fibroblast Growth Factor Receptor (FGFR) Alterations
A Phase I, Gene Alteration-based, Open Label, Multicenter Study of Oral Debio 1347 (CH5183284) in Patients With Advanced Solid Malignancies, Whose Tumours Have an Alteration of the Fibroblast Growth Factor Receptor (FGFR) 1, 2 or 3 Genes

This study is primarily designed to assess the safety and the tolerability of Debio 1347(CH5183284) at increasing doses in patients with advanced solid malignancies, whose tumours have an alteration of the Fibroblast Growth Factor Receptor (FGFR) 1, 2 or 3 genes.

Not Provided
Interventional
Phase 1
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Solid Tumours
Drug: Debio 1347 (CH5183284)
Debio 1347 (CH5183284) will be administered orally once daily on a continuous basis 28 day cycles until progression of disease or unacceptable toxicity.
Experimental: Debio 1347 (CH5183284)
Eligible patients will receive Debio 1347(CH5183284)
Intervention: Drug: Debio 1347 (CH5183284)
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
106
November 2016
September 2015   (final data collection date for primary outcome measure)

Inclusion Criteria

  1. Signed written informed consent approved before undertaking any study-specific procedures.
  2. Patients with advanced solid malignancies, whose tumours have an alteration of the FGFR 1, 2 or 3 genes, confirmed by local site genetic tests on a biopsy.
  3. Age ≥ 18 years.
  4. Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) ≤ 2.
  5. Histologically or cytologically confirmed advanced solid tumour that has recurred or progressed following standard therapy, has not responded to standard therapy or for which no standard therapy exists.
  6. Patients have measurable or non-measurable disease.
  7. Adequate organ function in bone marrow, cardiovascular, hepatic and renal systems.

Exclusion Criteria:

  1. History of hypersensitivity to any of the excipients in the Debio 1347 (CH5183284) formulation.
  2. History of another malignancy, unless patient has been disease-free for 5 years.
  3. Patients with brain tumours and/or brain metastases unless brain metastases are asymptomatic and they are not currently receiving corticosteroids and/or anticonvulsants.
  4. History and/or current evidence of endocrine alteration of calcium-phosphate homeostasis.
  5. History and or current evidence of ectopic mineralisation/calcification including but not limited to the soft tissue, kidneys, intestine, myocardium and lung with the exception of calcified lymph nodes and asymptomatic coronary calcification.
  6. Concomitant use of a systemic steroid or any other drug that affect calcium and phosphorus metabolism.
  7. Corneal disease, such as bullous or band keratopathy, corneal desquamation, keratitis, corneal ulcer, or keratoconjunctivitis.

Other protocol-defined inclusion/exclusion criteria may apply.

Both
18 Years to 90 Years
No
Contact: Claudio Zanna, MD +41213210111
Contact: Christian Aeschlimann, MS +41213210111
United States,   Spain
 
NCT01948297
Debio 1347-101
No
Debiopharm International SA
Debiopharm International SA
Not Provided
Study Chair: José Baselga, MD, PhD Memorial Sloan-Kettering Hospital
Debiopharm International SA
November 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP