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Solid TumorPhase 1NCT01929941

An Open-Label Study of a Novel JAK-inhibitor, INCB047986, Given in Patients With Advanced Malignancies

A Phase 1 study testing INCB047986, Gemcitabine and nab-paclitaxel in people with Solid Tumor and Hodgkin's Lymphoma, run by Incyte Corporation at 3 sites in United States.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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Trial summary

This is an open-label study of INCB047986 given to two distinct groups of patients (Group 1 and Group 2) with advanced malignancies. The purpose of the study is to evaluate the safety, tolerability and pharmacokinetics of INCB047986 and to determine the maximum tolerated dose of INCB047986 in combination with… Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
INCB047986, Gemcitabine and nab-paclitaxel
Could I receive a placebo?
No, everyone receives an active treatment
How many people
5 participants
Where
3 sitesUnited States
Study dates
Sep 2013to Aug 2014
Phase
Phase 1
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Group 1
  • Aged 18 years or older, with histologically or cytologically confirmed solid tumor, Hodgkin's lymphoma, aggressive or indolent non-Hodgkin's lymphoma. (NOTE: Patients with acute and chronic leukemia, Burkitt's lymphoma, precursor B lymphoblastic leukemia/lymphoma, and myeloma are excluded)
  • Life expectancy of 12 weeks or longer.
  • Subject must have received ≥ 1 prior treatment regimen.
  • The subject must not be a candidate for potentially curative therapy, including transplant.
  • Group 2
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  • Aged 18 years or older
  • Part 1 - Histologically or cytologically confirmed pancreatic adenocarcinoma (first or second line), triple-negative breast cancer (second line), or urothelial cancer (second line)
  • Part 2 - Histologically or cytologically confirmed pancreatic adenocarcinoma
  • No more than 1 prior chemotherapy regimen for advanced or metastatic disease (not including neoadjuvant and/or adjuvant therapy).
  • There is no restriction on the number of prior non-myelosuppressive targeted therapies or hormonal agents (e.g., epidermal growth factor receptor-targeted therapy for lung cancer and hormonal therapy for breast cancer or ovarian cancer); NOTE: Targeted and/or hormonal therapy alone will not be considered chemotherapy for the purposes of this study.

Who cannot join

  • Group 1 and 2
  • Received an investigational study drug within 28 days or 5 half-lives (whichever is longer) prior to receiving their first dose of study drug.
  • Received any approved anticancer medications within 21 days or 5 half-lives (whichever is longer) prior to receiving the first dose of study drug (42 days for nitrosoureas) EXCEPT steroids at ≤ 10 mg prednisone daily (or equivalent).
  • Has any unresolved toxicity ≥ Grade 2 from previous anticancer therapy without medical monitor approval.
  • o Subjects with ongoing chronic toxicities such as fatigue or neuropathy may be allowed after approval from the sponsor's medical monitor
  • Evidence of uncontrolled brain metastases or history of spinal cord compression, or primary central nervous system (CNS) tumors.
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  • Has an Eastern Cooperative Oncology Group (ECOG) performance status of ≥ 2.
  • Received allogeneic hematopoietic stem cell transplant within the last 6 months, or has active graft versus host disease (GVHD) following allogeneic transplant, or is currently receiving immunosuppressive therapy following allogeneic transplant.
  • Received autologous hematopoietic stem cell transplant within the last 3 months.
  • Radiation treatment within the previous 4 weeks.
  • History of active hepatitis or positive serology for hepatitis B (unless due to vaccination) or C

Trial locations and contacts

3 sites in 1 country.

United States3 sites

  • Study site

    Atlanta, Georgia

  • Study site

    Dallas, Texas

  • Study site

    Nashville, Tennessee

Other trials in United States

About this study

Official title: A Phase 1, Open-Label, Dose-Escalation, Safety and Tolerability Study of INCB047986 in Subjects With Advanced Malignancies

This is an open-label study of INCB047986 given to two distinct groups of patients (Group 1 and Group 2) with advanced malignancies. The purpose of the study is to evaluate the safety, tolerability and pharmacokinetics of INCB047986 and to determine the maximum tolerated dose of INCB047986 in combination with gemcitabine and nab paclitaxel in a select group of patients with solid tumors. Each patient group will participate in a phase of the study which is divided into two parts. The patient groups will be enrolled in a sequential manner starting with Patient Group 1.

Patient Group 1

Read more

Group 1 will be comprised of patients with advanced malignancies who will receive INCB047986 as monotherapy.

Part 1: Dose Escalation Phase - This phase will evaluate the safety, tolerability and pharmacokinetics (PK) of INCB047986 when given as described to patients with advanced malignancies. A goal of Part 1 will be to identify the maximally tolerated dose (MTD) of INCB047986 and/or other dose(s) that are tolerated doses and produce a substantial pharmacologic effect. These doses will be used in Part 2 of the study.

Part 2: Expansion Phase - This phase will further explore the safety, tolerability, PK, and preliminary clinical activity of INCB047986 using the doses identified in Part 1.

Group 2

Group 2 will be in subjects with advanced or metastatic pancreatic cancer, breast cancer or urothelial cancer.

Part 1: Dose Optimization Phase - This phase will identify the MTD of INCB047986 in combination with gemcitabine and nab-paclitaxel in patients with advanced or metastatic solid tumors. Specifically, these will be patients with pancreatic adenocarcinoma (first or second line), triple-negative breast cancer (second line) or urothelial cancer (second line).

Part 2: Expansion Phase - This phase will explore the safety, tolerability, PK, biomarkers, and preliminary clinical activity of the dose regimen(s) identified in Part 1. Patients enrolled in this phase will be limited to those with advanced or metastatic pancreatic cancer.

Being tested
INCB047986, Gemcitabine, nab-paclitaxel
Medical subject headings
Hodgkin Disease, Lymphoma, Non-Hodgkin, Pancreatic Neoplasms, Breast Neoplasms, Neoplasm Metastasis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • INCB047986Drug

    Initial cohort dose of INCB047986 monotherapy at the protocol-specified starting dose, with subsequent cohort escalations based on protocol-specific criteria

  • INCB047986Drug

    INCB047986 tablets administered orally at the protocol specified dose and frequency

  • GemcitabineDrug

    Also called Gemzar®

    Gemcitabine administered intravenously over 30 minutes at the protocol-specified dose and frequency

  • nab-paclitaxelDrug

    Also called Abraxane®

    nab-paclitaxel administered intravenously over 30 minutes at the protocol-specified dose and frequency

Study groups in NCT01929941
Study groupRoleWhat they receive
Group 1 INCB047986ExperimentalNot described
Receives: Drug: INCB047986
Group 2 Experimental: INCB047986, gemcitabine, nab-paclitaxelExperimentalNot described
Receives: Drug: INCB047986; Drug: Gemcitabine; Drug: nab-paclitaxel

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Adverse events that are defined as dose limiting toxicities occurring in the first 21 days of treatment in Group 1 and the first 28 days of treatment in Group 2.

    Measured: Approximately 21 days (Group 1); Approximately 28 days (Group 2)

  2. Safety and tolerability of INCB047986 monotherapy and in combination with gemcitabine and nab-paclitaxel as assessed by summary of clinical laboratory assessments, Electrocardiogram (ECG), and Adverse Events (AEs).

    Group 1: Baseline and weekly for Cycle 1 and then Day 1 for all subsequent cycles until the End of Treatment visit. Group 2: Baseline and weekly for Cycle 1 and then Day 1, Week 8 and Week 15 for all subsequent cycles until the End of Treatment visit.

    Measured: Group 1 and Group 2: up to 6 months

Secondary outcomes (6)

  1. Tumor response rates will be derived from investigator assessment of response in subjects with measurable disease

    Measured: Approximately 6 months

  2. Plasma concentrations will be used to estimate peak plasma concentration (cmax) and area under the plasma concentration curve (AUC)

    Measured: Day 15 of treatment at a given dose

  3. Duration of Response (DOR) and Progression Free Survival (PFS) in subjects with measureable disease

    Measured: Approximately 6 months

  4. Plasma concentration of biomarkers and cytokines before and during treatment

    Measured: Approximately 6 months

  5. Change in body weight

    Measured: Approximately 6 months

  6. Change in Eastern Cooperative Oncology Group (ECOG) status from baseline to each visit where the variable is measured

    Measured: Approximately 6 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted28 Aug 2013 (estimated)
  2. Study startSep 2013
  3. Primary completionAug 2014
  4. Study completionAug 2014

Why it stopped: Business decision.

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1
Primary purpose
Treatment
Allocation
Non-randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
5 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01929941
Sponsor's protocol ID
INCB 47986-103
Status last verified
Jan 2018
First submitted
22 Aug 2013
Last updated
17 Jan 2018
Results posted
No
Data monitoring committee
No

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing INCB047986, Gemcitabine and nab-paclitaxel in people with Solid Tumor and Hodgkin's Lymphoma, run by Incyte Corporation at 3 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 11 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 17 Jan 2018. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 3 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study was stopped early (reason given: Business decision.). Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Adverse events that are defined as dose limiting toxicities occurring in the first 21 days of treatment in Group 1 and the first 28 days of treatment in Group 2. (time frame: Approximately 21 days (Group 1); Approximately 28 days (Group 2)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01929941.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Jan 2018.

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