A Clinical Trial of Anti-Angiogenic Drug Combination Tl-118 for Pancreatic Cancer Patients Who Are Starting Gemcitabine Treatment

Tiltan Pharma

Status and phase: Unknown; Phase 2

Conditions: Metastatic Pancreatic Cancer

Treatments: Drug: Gemcitabine; Drug: TL-118

Study type: Interventional

Funder types: Industry; Other

Identifiers

NCT01509911

TLH-206

Details and patient eligibility

About

TL-118 is an anti-angiogenic drug combination designed for the treatment of cancer. The investigational product Tl-118 comprises of four well-known active components. The therapy is administrated at a unique dosing regimen that was found to be effective and advantageous in terms of safety. The product is formulated as an oral suspension, conveniently administrated by the patients at home and not requiring medical staff assistance. This Phase II clinical trial aims to evaluate the efficacy, safety and tolerability of TL-118 in Gemcitabine treated Pancreatic Cancer patients

Enrollment: 99 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Age at least 18 years at enrollment.
2. Metastatic Pancreatic Cancer
3. The patient has histologically or cytologically confirmed pancreatic adenocarcinoma.
4. Patient has measurable disease by (RECIST).
5. Patient is starting standard of care Gemcitabine treatment
6. ECOG performance status ≤ 1
7. Adequate renal function
8. Adequate hepatic function
9. Adequate bone marrow reserve
10. Resolution of prior therapy acute adverse events.
11. Patient is capable of swallowing.
12. Patient's Informed Consent. -

Exclusion criteria

1. Hypersensitivity to one or more of the TL-118 active components
2. Known Glucose-6-phosphate-dehydrogenase deficiency (G6PD).
3. CNS or Brain metastases
4. Prior systemic therapy for pancreas cancer
5. Subjects who received any investigational medication, prior local therapy for pancreas cancer , or any significant change in treatment within 1 month prior to screening
6. Concurrent use of any other investigational product
7. Subjects with a clinically significant or unstable medical condition that would preclude safe and complete study participation
8. Use of supplements or complementary medicines/botanicals, except for conventional multivitamin supplements, calcium, selenium and soy supplements.
9. Patient has known historical or active infection with HIV, hepatitis B, or hepatitis C
10. Circumstances likely to interfere with absorption of orally administrated drugs.
11. History of noncompliance to medical regimens or coexisting -

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

99 participants in 2 patient groups

TL-118 with standard of care Gemcitabine

Experimental group

Treatment:

Drug: TL-118

Gemcitabine with out TL-118

Active Comparator group

Treatment:

Drug: Gemcitabine