An Open-Label, Multicenter, Rollover Study to Provide Continued Treatment for Participants With Advanced Malignancies Previously Enrolled in Studies of Pemigatinib

Overview

Sponsor-declared trial summary

Key facts

Sponsor

Incyte Corp.

Participant type

Patients

Age range

18-64 years, 65+ years

Gender

Male and Female

Therapeutic area

Diseases [C] - Neoplasms [C04]

Trial duration

13 Dec 2021 → 11 Apr 2024

Decision date (initial)

2023-06-09

Transition trial

Yes

Low-intervention

No

Rare-disease indication

No

Vulnerable population

Yes

External identifiers

EU CT number

2023-503406-36-00

EudraCT number

2021-002207-36

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Safety

To evaluate the long-term safety and tolerability of pemigatinib.

Conditions and MedDRA coding

Male and female participants at least 18 years of age who are actively receiving treatment with pemigatinib under a parent protocol and receiving clinical benefit and who do not have access to pemigatinib outside of a clinical trial

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 7

1. Currently enrolled and receiving treatment in an Incyte-sponsored clinical study (parent protocol) of pemigatinib as monotherapy or combination therapy.
2. Currently benefiting from and tolerating treatment with pemigatinib, as determined by the investigator.
3. Demonstrated compliance, as assessed by the investigator, with the parent protocol requirements.
4. Willingness and ability to comply with scheduled visits, treatment plans, and any other study procedures.
5. Currently have no evidence of progressive disease, as determined by the investigator, following treatment with pemigatinib as monotherapy or combination therapy.
6. Willingness to avoid pregnancy or fathering children based on the criteria below. a. Male participants must agree to take appropriate precautions to avoid fathering children (with at least 99% certainty) from signing of the ICF through 90 days after the last dose of pemigatinib and 6 months after the last dose of gemcitabine and/or cisplatin and must refrain from donating sperm during this period. Permitted methods that are at least 99% effective in preventing pregnancy should be communicated to the participants and their understanding confirmed. NOTE: Men being treated with gemcitabine must be advised to seek further advice regarding cryoconservation of sperm before treatment because of the possibility of infertility due to therapy with gemcitabine. b. Women of nonchildbearing potential (ie, surgically sterile with a hysterectomy and/or bilateral oophorectomy OR ≥ 12 months of amenorrhea) are eligible. c. Women of childbearing potential must have a negative serum pregnancy test at signing of the ICF and before the first dose on Day 1 and must agree to take appropriate precautions to avoid pregnancy (with at least 99% certainty) from signing of the ICF through safety follow-up (30-35 days after the last dose of pemigatinib) and through 6 months after the last dose of gemcitabine and/or cisplatin. Permitted methods that are at least 99% effective in preventing pregnancy should be communicated to the participants and their understanding confirmed.
7. Written informed consent obtained prior to enrolling in the rollover study. If consent cannot be expressed in writing, it must be formally documented and witnessed, ideally via an independent trusted witness.

Exclusion criteria 4

1. Able to access pemigatinib commercially or outside of a clinical trial.
2. Permanently discontinued from the parent protocol for any reason.
3. No longer meet the inclusion/exclusion criteria from the parent protocol if still receiving treatment.
4. Women who are pregnant or breastfeeding or participants expecting to conceive or father children within the projected duration of the study, starting with Day 1 of the rollover study visit through completion of safety follow-up or through 90 days from the date of last dose of study treatment.

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 1

1. Frequency and nature of AEs and SAEs as assessed by CTCAE v5.0.

Investigational products

Investigational medicinal products (IMPs), comparators, placebo, auxiliary

Test 4

Sponsors and contacts

Sponsor organisations, regulatory contacts, third parties

Incyte Corp.

Sponsor organisation

Incyte Corp.

Address

1801 Augustine Cut Off

City

Wilmington

Postcode

19803-4404

Country

United States

Scientific contact point

Organisation

Incyte Corp.

Contact name

Aaron Packman

Public contact point

Organisation

Incyte Corp.

Contact name

Aaron Packman

Third parties 3

Locations

1 EU/EEA country · 2 investigational sites

By country

Investigational sites

Country notifications

Trial-start, recruitment-start, end and early-termination notifications submitted per Member State

Results and documents

Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial

Summary of results Art. 37(4) CTR

Layperson summary Annex V

Documents 4 files

Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.

Application history

1 submissions — initial application plus substantial / non-substantial modifications