Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Hydroxychloroquine · 1 trial · 2 indications
Anti-tumor activity will be measured via disease control rate (DCR), which will be defined as the proportion of patients with complete response (CR), partial response (PR) or stable disease (SD) that persists for ≥ 4 months. Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1) for target lesions and assessed by MRI or CT: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), \>=30% decrease in the sum of the diameters of target lesions; Stable Disease (SD), Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum diameters while on study.
| Arm | Type | Description |
|---|---|---|
| Safety Lead-In Cohort | EXPERIMENTAL | The research study procedures include screening for eligibility and study treatment. Study treatment will include evaluations, biopsies, and follow up visits. A treatment cycle will be defined as 28 consecutive days. Treatment will be administered on an outpatient basis. Test the safety of study drugs in combination and define dose levels. * LY3214996 * HCQ |
| LY3214996 and HCQ Combination | EXPERIMENTAL | The research study procedures include screening for eligibility and study treatment. Study treatment will include evaluations, biopsies, and follow up visits. A treatment cycle will be defined as 28 consecutive days. Treatment will be administered on an outpatient basis. Combined dosage per determined Lead-In Cohort * LY3214996 * HCQ |
| LY3214996-Monotherapy | EXPERIMENTAL | The research study procedures include screening for eligibility and study treatment. Study treatment will include evaluations, biopsies, and follow up visits. A treatment cycle will be defined as 28 consecutive days.Treatment will be administered on an outpatient basis. -LY3214996 |
| Cross Over Arm | EXPERIMENTAL | Participants who are enrolled to Arm 2 who experience radiologic disease progression on monotherapy will have the option to cross-over to receive treatment with the combination. Crossover will occur at the treating investigator's discretion following consultation and approval from the overall principal investigator. Combined dosage per determined Lead-In Cohort * LY3214996 * HCQ |
| Name | Type | Description |
|---|---|---|
| Hydroxychloroquine Sulfate | DRUG | HCQ will be administered by mouth twice daily continuously throughout each treatment per 28 day cycle |
| LY3214996 | DRUG | LY3214996-daily oral dosage per protocol per 28 day cycle |
Inclusion Criteria: * Participants must have histologically or cytologically confirmed adenocarcinoma or poorly differentiated carcinoma of the pancreas. * Age ≥ 18 years. * ECOG performance status ≤ 1 * Participants must have measurable disease, defined as at least one lesion that can be accuratel...
Top 20 of 68 competitors
Hydroxychloroquine is being studied for the treatment of pancreatic cancer and advanced cancer. It is an investigational small molecule in Phase 2 clinical development. In the completed clinical trial NCT04386057, it was evaluated in combination with another investigational drug in patients with these conditions.
Hydroxychloroquine is being developed by Eli Lilly and Company, a pharmaceutical company traded on the New York Stock Exchange under the ticker symbol LLY. The company is conducting clinical research to evaluate the drug's potential in oncology, specifically for pancreatic cancer.
Hydroxychloroquine is in Phase 2 clinical development for pancreatic cancer. It is an investigational drug, meaning it has not been approved by regulatory authorities for this use. The drug is being studied in a clinical trial setting to assess its safety and efficacy.
Hydroxychloroquine has been studied in one completed clinical trial, NCT04386057, titled "LY3214996 +/- HCQ in Pancreatic Cancer." This Phase 2 trial enrolled 52 participants with pancreatic cancer or advanced cancer in the United States. The trial was controlled and randomized, and it required a biomarker for patient selection.
No, Hydroxychloroquine is not the same as LY3214996. In the clinical trial NCT04386057, Hydroxychloroquine was studied in combination with LY3214996, which is a separate investigational drug. The trial compared the combination of LY3214996 plus Hydroxychloroquine against LY3214996 alone in patients with pancreatic cancer.