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

NCT01948297 | Terminated Phase 1

• 2 other identifiers: Debio 1347-1012013-000316-19
• Study Type: interventional
• Target: 77
• Locations: 5 countries
• Sites: 8

Brief Summary

This study is primarily designed to assess the safety and the tolerability of Debio1347 (CH5183284) in patients with advanced solid malignancies, whose tumours have an alteration of the Fibroblast Growth Factor Receptor (FGFR) 1, 2 or 3 genes, for whom standard treatment does not exist or is not indicated. The main objective of Part A is to identify the dose-limiting toxicities (DLTs) and estimate the maximum tolerated dose (MTD) based on the safety and tolerability of Debio1347 orally administered daily to these patients, in order to determine the recommended dose. The main objective of Part B is to evaluate the safety profile at the recommended dose, in a larger cohort of these patients.

Conditions

Solid Tumours

Outcome Measures

Primary Outcomes (5)

• Part A: Percentage of Participants With Dose-Limiting Toxicities (DLTs) From Debio 1347

  within approximately 18 months

• Part B: Percentage of Participants With Treatment-Emergent Serious Adverse Events (SAEs)

  within 2 years of starting treatment

• Part B: Number of Participants With Abnormal Laboratory Values and/or Adverse Events That Are Related to Treatment

  within 2 years of starting treatment

• Part B: Severity of Treatment-Emergent AEs

  Categories: NCI-Common Terminology Criteria for Adverse Events (CTCAE) version 4 severity criteria

  within 2 years of starting treatment

• Part B: Severity of Laboratory Abnormalities

  Categories: NCI-Common Terminology Criteria for Adverse Events (CTCAE) version 4 severity criteria

  within 2 years of starting treatment

Secondary Outcomes (37)

• Part A: Percentage of Participants With Treatment-Emergent Serious Adverse Events (SAEs)

  within 2 years of starting treatment

• Part A: Number of Participants With Abnormal Laboratory Values and/or Adverse Events That Are Related to Treatment

  within 2 years of starting treatment

• Part A: Severity of Treatment-Emergent AEs

  within 2 years of starting treatment

• Part A: Severity of Laboratory Abnormalities

  within 2 years of starting treatment

• Part A and Part B: Percentage of Participants With Treatment Discontinuations or Modifications due to AEs and Laboratory Abnormalities

  within 2 years of starting treatment

Study Arms (2)

Part A

EXPERIMENTAL

Adaptive doses of Debio1347 (CH5183284) - (10 mg to 210 mg/day) until the recommended dose (RD) is determined.

Drug: Debio1347 (CH5183284)

Part B

EXPERIMENTAL

Participants with various tumours receive Debio1347 (CH5183284) orally at the recommended dose established during Part A.

Drug: Debio1347 (CH5183284)

Interventions

Debio1347 (CH5183284) DRUG

Debio1347 (CH5183284) tablets for oral administration

Also known as: CH5183284

Part A; Part B

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Meets protocol-specified criteria for qualification and contraception
• Is willing and able to remain confined in the study unit for the entire duration of each treatment period and comply with restrictions related to food, drink and medications
• Voluntarily consents to participate and provides written informed consent prior to any protocol-specific procedures

You may not qualify if:

• Has history or current use of over-the-counter medications, dietary supplements, or drugs (including nicotine and alcohol) outside protocol-specified parameters
• Has signs, symptoms or history of any condition that, per protocol or in the opinion of the investigator, might compromise:
• the safety or well-being of the participant or study staff
• the safety or well-being of the participant's offspring (such as through pregnancy or breast-feeding)
• the analysis of results

Sponsors & Collaborators

• Debiopharm International SA: lead

Study Sites (8)

Dana-Farber Cancer Institute

Boston, Massachusetts, 02114, United States

Location

Massachusetts General Hospital

Boston, Massachusetts, 02215, United States

Location

Memorial Sloan-Kettering Hospital

New York, New York, 10065, United States

Location

The University of Texas; MD Anderson Cancer Center

Houston, Texas, 77030-4009, United States

Location

National Cancer Center Singapore

Singapore, 169610, Singapore

Location

Seoul National University Hospital

Seoul, 03080, South Korea

Location

Vall d'Hebron University Hospital

Barcelona, Spain

Location

Taipei Medical University Hospital

Taipei, 11031, Taiwan

Location

Related Links

• Related Info

MeSH Terms

Interventions

CH5183284

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 26, 2013
• First Posted: September 23, 2013
• Study Start: August 1, 2013
• Primary Completion: June 26, 2020
• Study Completion: June 26, 2020
• Last Updated: September 9, 2020

Record last verified: 2020-09

Locations

US (4); KR (1); SG (1); ES (1); TW (1)