OKN-007 (IV) Combined with Temozolomide in Patients with Recurrent Glioblastoma
This is a phase II open-label study investigating the efficacy, safety and pharmacokinetic (PK) properties of OKN-007 combined with temozolomide (TMZ) in patients with recurrent glioblastoma (GBM). All patients will have previously received the standard-of-care treatment which includes surgical resection, radiation, and chemotherapy, and in some cases treatment for recurrent disease. Patients with unequivocal recurrence (first or second) established by MRI and meeting the inclusion and exclusion criteria, will be eligible for this protocol.
Investigator Initiated Trial (IIT) for patients with naïve GBM
This is investigator initiated single arm pilot trial to assess the safety and efficacy of IV administration of OKN-007 combined with Temozolomide and adjuvant chemo-radiotherapy for adults with newly diagnosed WHO grade III or grade IV Glioblastoma Multiforme. All enrolled patients will have surgical resection of the primary lesion within 49 days before enrollment.
OKN-007 (IV) Phase 1b for patients with recurrent GBM
This is a multi-center, open label Phase 1b clinical study in recurrent malignant glioma patients to examine the safety and tolerability of OKN-007. Patients with recurrence, adequate performance status and organ function, receiving clinically appropriate doses of steroids, with a life expectancy greater than 8 weeks were eligible. OKN-007 was administered by intravenous infusion.
OKN-007 (Oral) Phase 1b/2 for patients with recurrent GBM
The objective of this study is to investigate tolerability, safety, pharmacokinetics (PK), and efficacy of oral OKN-007 in participants with recurrent high-grade glioma.
Not yet recruiting
Expanded Access Program (EAP)
What is Expanded Access Program (EAP)?
For patients with serious or life-threatening disease who have exhausted all available treatments and are not eligible for a clinical trial, Expanded Access may be an option. Also known as Compassionate Use or Single Patient Request, this request process is a potential pathway for access to investigational medicines.
For more information, please visit “https://navigator.reaganudall.org/resources/single-patient-expanded-access-infographic”.
What Does Oblato Do?
Oblato Inc. (Oblato) is a pharmaceutical company focused on the development and commercialization of novel cancer therapeutics to address their unmet medical needs and to improve the quality of a patient’s life. Oblato has developed an Expanded Access Program to investigational drug policy in the United States. This is an important policy area for our company, as we know that many of the patients seeking access to our investigational medicines are facing serious or life-threatening illness and often have no further treatment options or a clinical trial available to them.
OKN-007 as a novel therapeutic in Oblato has been granted Fast Track status by the FDA for Diffuse Intrinsic Pontine Glioma (DIPG) indication and Oblato provides OKN-007 as an investigation drug for expanded access use in the United States for patients with DIPG, who cannot be treated by currently available drugs or clinical trials.
1) How to Request Single Patient Expanded Access (“Compassionate Use”)
When treatment option with OKN-007 is discussed with your physician, the physician may submit a request to Oblato. Oblato has provided details below so your physician can contact us directly.
If you are a U.S-based physicians and would like to request access to our investigational treatment for your patient, contact at 609-734-4329 or firstname.lastname@example.org for further details. For a request, the physician will need to include the following:
- Name and address of the physician
- Name of their Institution/clinic
- Details of how the patient meets all the criteria outlined below
- When the physician would expect to submit to their IRB, the name and contact information for their IRB
Note that incomplete requests may delay, or exclude a request for Expanded Access.
2) Oblato reviews request
Your safety and wellbeing are our first priority. Therefore, we need time to carefully consider your physician’s request. We will let your physician know that we have received the request within 5 working days. We may require additional information from a treating physician in order to fully evaluate the request. We can only agree to provide an investigational drug to your physician if we agree with their medical evaluation that the possible benefits of the drug outweigh the potential risks. Once we have all the information we need, we will do our best to complete our assessment and get back to your physician as soon as possible. We consider all requests for access carefully, but we cannot guarantee that it will be granted.
3) General Criteria for Replies and Evaluation
The primary option for patients to get access to investigational drugs is to participate in a clinical trial. Patients and physicians can learn more by reviewing information on current or planned clinical trials that is maintained by the U.S. National Institutes of Health.
We recognize that there are extraordinary circumstances where access to these investigational drugs outside of a clinical trial is appropriate. Under our Access to Investigational Drugs Policy, a patient’s physician can request consideration for access if the five basic criteria below are met:
- Patient has a serious disease or condition, or whose life is immediately threatened by their disease or condition.
- There is no comparable or satisfactory alternative therapy to diagnose, monitor, or treat the disease or condition.
- Patient enrollment in a clinical trial is not possible.
- Potential patient benefit justifies the potential risks of treatment.
- The investigational medical product will not interfere with investigational trials that could support a medical product’s development or marketing approval for the treatment indication.
4) Links to Clinical Trial Status
In general, patients can access an investigational drug by joining a clinical trial. Clinical trials are research studies that are designed to determine if a medicine is safe and effective for patients. However, clinical trials with OKN-007 for DIPG patients are not planned yet. We will provide clinical trial status on http://clinicaltrials.gov when it is available.