Phase I Study of Oral PQR309 in Patients With Relapsed or Refractory Lymphomas
Conditions
Relapsed or Refractory Lymphomas
Conditions: official terms
Lymphoma
Study Type
Interventional
Study Phase
Phase 1
Study Design
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Intervention
Name: PQR309
Type: Drug
Overall Status
Recruiting
Summary
The main goal of this study is to determine the Maximum Tolerated Dose (MTD) and the Recommended Phase II Dose (RP2D) as well as preliminary antitumor activity of PQR309 administered orally, as once daily capsules for a period of 21 days per cycle, in patients with relapsed or refractory lymphomas.
Criteria for eligibility
Healthy Volunteers: No
Maximum Age: N/A
Minimum Age: 18 Years
Gender: Both
Criteria: Inclusion Criteria:

- Histologically confirmed diagnosis of relapsed or refractory lymphoma and received at least one prior line of therapy.

- Age ≥ 18 years

- Use of adequate contraceptive measures for male patients.

- Eastern Cooperative Oncology Group (ECOG) Performance Score of 0-1.

- Signed informed consent.

Exclusion Criteria:

- Previous allogeneic hematopoietic stem cell transplant (HSCT transplant).

- Autologous stem cell transplant within the last 6 months.

- Concomitant anticancer therapy (e.g., chemotherapy, radiotherapy, hormonal, immunotherapy, biological response modifier, signal transduction inhibitors).

- Patients with a history of myocardial infarction or coronary artery bypass within the last 3 years.

- Patients with severe/unstable angina, coronary/peripheral arterial bypass, symptomatic congestive heart failure NYHA Class 3 or 4, hypertension BP>150/100mmHg.

- Pre-diagnosed diabetes mellitus.

- Fasting glucose > 7.0 mmol/L or HbA1c > 6.4%.
Location
Oncology Institute of Southern Switzerland
Bellinzona, Switzerland
Status: Recruiting
Contact: Natasa Cmiljanovic, Dr. - Natasa.Cmiljanovic@piqur.com
Start Date
May 2015
Completion Date
December 2016
Sponsors
PIQUR Therapeutics AG
Source
PIQUR Therapeutics AG
Record processing date
ClinicalTrials.gov processed this data on July 28, 2015
ClinicalTrials.gov page