A Study to Evaluate the Effects of Rifampin on Pharmacokinetics (PK) of Pevonedistat in Participants With Advanced Solid Tumors



Status:Recruiting
Healthy:No
Age Range:18 - Any
Updated:10/10/2018
Start Date:August 13, 2018
End Date:May 13, 2019
Contact:Takeda Study Registration Call Center
Email:globaloncologymedinfo@takeda.com
Phone:+1-866-835-2233

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A Phase 1 Study to Evaluate the Effects of Rifampin on Pharmacokinetics of Pevonedistat in Patients With Advanced Solid Tumors

The purpose of this study is to assess the effect of multiple-dose administration of rifampin
on the single dose PK of pevonedistat in adult participants with advanced solid tumors.

The study will enroll approximately 20 participants. The study will be conducted in two
Parts: Part A and optional Part B. Part A will have a drug-drug interaction (DDI) assessment.
In Part A, participants will be assigned to:

• Pevonedistat 50 mg/m^2 + Rifampin

Eligible participants from Part A will continue treatment in optional Part B with
pevonedistat in combination with SoC chemotherapy, docetaxel or carboplatin plus paclitaxel.
The investigator will decide which SoC combination partner a participant will receive.

- Pevonedistat 25 mg/m^2 + Docetaxel

- Pevonedistat 20 mg/m^2 + Carboplatin + Paclitaxel

This multi-center trial will be conducted in the United States. The overall time to
participate in this study is 18 months. Participants will make a final visit to the clinic 30
days after receiving their last dose of study drug or before the start of subsequent therapy.

Inclusion Criteria:

1. Adult participants who have a histologically or cytologically confirmed metastatic or
locally advanced solid tumor that is appropriate for treatment with either docetaxel
or carboplatin + paclitaxel in Part B of this study, or have progressed despite
standard therapy, or for whom conventional therapy is not considered effective.

2. Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1.

3. Expected survival of at least 3 months from the date of enrollment in the study.

4. Recovered (that is, less than or equal to (<=) Grade 1 toxicity) from the effects of
prior antineoplastic therapy.

5. Adequate organ functions (kidney, liver, cardiac, bone marrow).

6. Suitable venous access for the study-required blood sampling (including PK sampling).

Exclusion Criteria:

1. Prior treatment with radiation therapy involving greater than or equal to (>=) 25% of
the hematopoietically active bone marrow.

2. Life-threatening illness or serious (acute or chronic) medical or psychiatric illness
unrelated to cancer.

3. Active, uncontrolled infection or severe infectious disease.

4. Known human immunodeficiency virus (HIV) seropositive or known hepatitis B or
hepatitis C infection.

5. With significant heart or pulmonary disease.

6. Requiring chronic treatment with breast cancer resistance protein (BCRP) inhibitors.

Criteria for Continuation into Optional Part B:

To be eligible for Part B, participants must have completed Part A and be reassessed to
determine if they meet the continuation criteria for Part B.
We found this trial at
4
sites
675 N Saint Clair St # 21-100
Chicago, Illinois 60611
(312) 695-1156
Robert H. Lurie Comprehensive Cancer Center at Northwestern University The cancer center was first established...
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Chicago, IL
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201 Dowman Dr
Atlanta, Georgia 30303
(404) 727-6123
Emory University Emory University, recognized internationally for its outstanding liberal artscolleges, graduate and professional schools,...
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Atlanta, GA
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4100 John R
Detroit, Michigan 48201
800-527-6266
Barbara Ann Karmanos Cancer Institute Karmanos is based in southeast Michigan, in midtown Detroit, and...
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Detroit, MI
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Greenville, SC
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