- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02018874
A Phase Ib Study of the Safety, Tolerability and Efficacy of LY2780301 in Combination With Gemcitabine (INPAKT)
A Phase Ib, Open-label, Dose Escalation Study of the Safety, Tolerability and Efficacy of LY2780301 (a p70/AKT Inhibitor) in Combination With Gemcitabine in Patients With Advanced or Metastatic Cancer
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Actual)
Phase
- Phase 1
Contacts and Locations
Study Locations
-
-
Val de Marne
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Villejuif, Val de Marne, France, 94805
- Gustave Roussy
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Dose Escalation portion (Part 1): have histological or cytological evidence of a diagnosis of cancer that is advanced and/or metastatic disease (including Non-Hodgkin's Lymphoma) with selected molecular alterations and for which no proven effective therapy exists. ;
Dose Confirmation portion (Part 2): have histological or cytological evidence of cancer (solid tumor or Non-Hodgkin's Lymphoma) that is advanced and/or metastatic disease:
- Cohort A: Up to 20 patients of any histological type (solid tumor or Non-Hodgkin's Lymphoma) with selected molecular alterations
- Cohort B: Up to 12 patients with ovarian cancer and with selected molecular alterations 1.1 (Appendix 4) for solid tumors or by the Revised Response Criteria for Malignant Lymphoma
Dose Confirmation portion:
- Measurable disease as defined by RECIST 1.1 for solid tumors (Appendix 4) except ovarian cancer or
- Response Criteria for Patients with Ovarian Cancer Who Have Evaluable but Non-Measurable Disease (Appendix 5) or
Revised Response Criteria for Non-Hodgkins Lymphoma (Appendix 6) [4] Are >/=18 years of age ; [5] Written informed consent ; [6] Have adequate organ function including:
Hematologic: absolute neutrophil count (ANC) >/=1.5 x 109/L, platelets
>/=100 x 109/L, and hemoglobin >/=9 g/dL.
- Hepatic: bilirubin </=1.5 times upper limits of normal (ULN); alanine transaminase (ALT) and AST </=2.5 x ULN. (</=5 x ULN if the liver has tumor involvement).
- Renal: Serum creatinine </=1.5 x ULN or calculated creatinine clearance >45 ml/min (MDRD) [7] ECOG performance status </= 1 ; [8] Have discontinued all previous therapies for cancer, including chemotherapy, radiotherapy, cancer-related hormonal therapy, or other investigational therapy for at least 2 weeks (3 weeks for myelosuppressive agents) prior to study enrolment and all prior treatment related toxicities must be CTCAE (Version 4.0) </= Grade 1 (except alopecia) at the time of enrolment. Patients with prostate cancers progressing under LHRH agonist therapy, may have that treatment continued while receiving study drug ; [9] Males and females with reproductive potential must agree to use medically approved contraceptive precautions during the trial and for 6 months following the last dose of study drug ; [10] Females with childbearing potential must have had a negative serum pregnancy test </= 14 days prior to the first dose of study drug ; [11] Have an estimated life expectancy >/=12 weeks ; [12] Able to swallow and retain orally administered medication and does not have any clinically significant gastrointestinal abnormalities that may alter absorption such as malabsorption syndrome or major resection of the stomach or bowels ;
Exclusion Criteria:
[13] Any serious and/or unstable pre-existing medical conditions, psychiatric disorder, or other conditions that could, in the opinion of the investigator, interfere with subject's safety, obtaining informed consent or compliance to the study procedures ; [14] Have symptomatic CNS malignancy or symptomatic brain metastasis. Patients with treated CNS metastases are eligible provided their disease is radiographically stable and asymptomatic and they are not currently receiving corticosteroids. Screening of asymptomatic patients without history of CNS metastasis is not required ; [15] Have pre-existing not controlled cardiovascular disease (including acute coronary syndromes, unstable angina, coronary angioplasty, or stenting within the past 6 months) or any QTc prolongation (defined as a QTc interval > 480 ms according to Friedericia's correction) or other significant ECG abnormalities including 2nd degree AV block type II, 3rd degree AV block, or bradycardia (HR < 50 bpm), or any history of 2nd or 3rd degree block ; [16] Concomitant treatment prohibited in section 7.8 ; [17] Pregnancy and Breast Feeding ;
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: LY2780301
|
LY2780301 will be given orally Q.D. at different dose levels. Because of a favourable safety profile, the different dose levels will be as follow :
The dose level of Gemcitabine will be fixed (1000 mg/m2).
Gemcitabine will be administered over a 30 minutes infusion.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Safety
Time Frame: Up to 4 weeks
|
Patients fulfilling the inclusion criteria will be enrolled in successive cohorts of 3 to 6 patients.
If no DLT is observed during the first 4 weeks of study treatment in 3 patients, the dose of LY2780301 will be escalated to the dose level (DL) immediately above.
If One DLT is observed among 3 patients, the cohort will be expanded to 6 evaluable patients.
If two patients out of 3 or 2 /6 patients experience a DLT, the dose will be considered intolerable and the DL immediately below will be further explored.
The recommended phase II dose (RP2D) will be the highest DL in which no more than 1/6 patients experiences a DLT.
If no DLT is observed at the highest planned DL, this DL will be deemed the RP2D.
Intermediate DLs could be added, if clinically relevant.
|
Up to 4 weeks
|
Efficacy
Time Frame: Assessed every 8 weeks from inclusion until progression up to 5 months
|
|
Assessed every 8 weeks from inclusion until progression up to 5 months
|
Collaborators and Investigators
Investigators
- Principal Investigator: Jean Charles Soria, MD, PhD, Gustave Roussy, Cancer Campus, Grand Paris
Publications and helpful links
Helpful Links
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Immune System Diseases
- Neoplasms by Histologic Type
- Neoplasms
- Lymphoproliferative Disorders
- Lymphatic Diseases
- Immunoproliferative Disorders
- Lymphoma
- Lymphoma, Non-Hodgkin
- Physiological Effects of Drugs
- Molecular Mechanisms of Pharmacological Action
- Anti-Infective Agents
- Antiviral Agents
- Enzyme Inhibitors
- Antimetabolites, Antineoplastic
- Antimetabolites
- Antineoplastic Agents
- Immunosuppressive Agents
- Immunologic Factors
- Gemcitabine
Other Study ID Numbers
- 2013-000671-33
- 2013/1975 (Other Identifier: CSET number)
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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