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Solid Tumors and Non-Hodgkin's LymphomaPhase 1INPAKTNCT02018874

A Phase Ib Study of the Safety, Tolerability and Efficacy of LY2780301 in Combination With Gemcitabine

A Phase 1 study testing LY2780301 and Gemcitabine in people with Solid Tumors and Non-Hodgkin's Lymphoma, run by Gustave Roussy, Cancer Campus, Grand Paris at 1 site in France.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

In the First-in-Human, JWAA trial, the LY2780301 displayed a favourable safety profile, a high pharmacokinetic exposure and the ability to decrease pS6. LY2780301 has shown synergistic activity in combination with targeted agents or chemotherapy including gemcitabine. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Solid Tumors and Non-Hodgkin's Lymphoma
What is being tested?
LY2780301 and Gemcitabine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
52 participants
Where
1 siteFrance
Study dates
Sep 2013to Apr 2016
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

  • 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
Show all 12Show fewer
  • 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 ;

Who cannot join

  • [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 ;

Trial locations and contacts

1 site in 1 country.

France1 site

  • Gustave Roussy

    Villejuif, Val de Marne, 94805

Other trials in France

About this study

Official title: 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

In the First-in-Human, JWAA trial, the LY2780301 displayed a favourable safety profile, a high pharmacokinetic exposure and the ability to decrease pS6. LY2780301 has shown synergistic activity in combination with targeted agents or chemotherapy including gemcitabine. We propose herein to combine LY2780301 with gemcitabine and to treat different tumor types with molecular alterations. This may validate the anti-tumor activity of the LY2780301 and it will increase our knowledge regarding molecular predictors of its efficacy.

Being tested
LY2780301, Gemcitabine
Medical subject headings
Lymphoma, Non-Hodgkin

What participants receive

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

  • LY2780301Drug

    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 :

    • Dose level -1: 300 mg Q.D.
    • Dose level -0.5: 400 mg Q.D.
    • Dose level 1: 400 mg Q.D.
    • Dose level 1.5: 500 mg Q.D.
    • Dose level 2 : 500 mg Q.D.

  • GemcitabineDrug

    The dose level of Gemcitabine will be fixed (1000 mg/m2). Gemcitabine will be administered over a 30 minutes infusion.

Study groups in NCT02018874
Study groupRoleWhat they receive
LY2780301ExperimentalNot described
Receives: Drug: LY2780301; Drug: Gemcitabine

What is being measured

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

  1. Safety

    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.

    Measured: Up to 4 weeks

  2. Efficacy

    • Solid Tumors: Response Evaluation Criteria in Solid Tumors (RECIST) 1.1
    • Non-Measurable Ovarian Cancer: Response Criteria for Patients with Ovarian Cancer Who Have Evaluable but Non-Measurable Disease
    • Non-Hodgkin Lymphoma: the Revised Response Criteria for Malignant Lymphoma

    Measured: Assessed every 8 weeks from inclusion until progression up to 5 months

Timeline

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

  1. First posted23 Dec 2013 (estimated)
  2. Study startSep 2013
  3. Primary completionApr 2016
  4. Study completionApr 2016

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
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
52 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02018874
Sponsor's protocol ID
2013-000671-33
Other IDs
2013/1975
Acronym
INPAKT
Status last verified
Jul 2016
First submitted
3 Dec 2013
Last updated
12 Jul 2016
Results posted
No
Data monitoring committee
No

Publications

  • Angevin E, Cassier PA, Italiano A, Goncalves A, Gazzah A, Terret C, Toulmonde M, Gravis G, Varga A, Parlavecchio C, Paci A, Poinsignon V, Soria JC, Drubay D, Hollebecque A. Safety, tolerability and antitumour activity of LY2780301 (p70S6K/AKT inhibitor) in combination with gemcitabine in molecularly selected patients with advanced or metastatic cancer: a phase IB dose escalation study. Eur J Cancer. 2017 Sep;83:194-202. doi: 10.1016/j.ejca.2017.06.036. Epub 2017 Jul 24.

    PubMed 28750271

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing LY2780301 and Gemcitabine in people with Solid Tumors and Non-Hodgkin's Lymphoma, run by Gustave Roussy, Cancer Campus, Grand Paris at 1 site in France.

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 12 inclusion and 1 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: finished, as of the sponsor's last update on 12 Jul 2016. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in France. 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

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?

Safety (time frame: Up to 4 weeks). 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 NCT02018874, which also lists 1 linked publication.

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 12 Jul 2016.

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