An Open-Label Study of a Novel JAK-inhibitor, INCB047986, Given in Patients With Advanced Malignancies
| Status: | Terminated |
|---|---|
| Conditions: | Breast Cancer, Cancer, Lymphoma, Lymphoma, Psychiatric, Pancreatic Cancer |
| Therapuetic Areas: | Oncology, Psychiatry / Psychology |
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 1/19/2018 |
| Start Date: | September 2013 |
| End Date: | August 2014 |
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
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.
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
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.
Inclusion Criteria:
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
- 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.
Exclusion Criteria:
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.
- 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
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