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NCT01897116
A Phase I Trial of Vemurafenib and Hydroxychloroquine in Patients With Advanced BRAF Mutant Melanoma
Phase 1 trial testing Hydroxychloroquine (HCQ) in Melanoma in 8 participants. Completed in 5 October 2016.
12 July 2016
Quick facts
| Lead sponsor | Abramson Cancer Center at Penn Medicine |
|---|---|
| Phase | Phase 1 |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | na |
| Design | single group |
| Masking | single |
| Primary purpose | treatment |
| Enrollment | 8 |
| Start date | 1 June 2013 |
| Primary completion | 12 July 2016 |
| Estimated completion | 5 October 2016 |
| Sites | 1 location across United States |
Drugs / interventions tested
- Hydroxychloroquine (HCQ) — full drug profile →
- Vemurafenib (VEM) — full drug profile →
Conditions studied
- Melanoma — all drugs for Melanoma →
Sponsor
Abramson Cancer Center at Penn Medicine — full company profile →
Who can join
18 and older, any sex, with Melanoma. Patients with the condition only — healthy volunteers not accepted.
What's being measured
Primary outcomes are the specific endpoints the trial is designed to prove or disprove.
-
Number of Adverse Events
Time frame: 8 weeks
Sponsor's own description
This is a Phase I study combining vemurafenib and hydroxychloroquine in the treatment of BRAF V600E+ metastatic melanoma.
Publications & conference data
8 peer-reviewed publications reference this trial (live from Europe PMC):
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Targeting autophagy in cancer.
Levy JMM, Towers CG, Thorburn A. · · 2017 · cited 2029× · PMID 28751651 · DOI 10.1038/nrc.2017.53 -
Targeting ER stress-induced autophagy overcomes BRAF inhibitor resistance in melanoma.
Ma XH, Piao SF, Dey S, McAfee Q, et al · · 2014 · cited 377× · PMID 24569374 · DOI 10.1172/jci70454 -
Emerging strategies to effectively target autophagy in cancer.
Rebecca VW, Amaravadi RK. · · 2016 · cited 209× · PMID 25893285 · DOI 10.1038/onc.2015.99 -
Repurposing Drugs in Oncology (ReDO)-chloroquine and hydroxychloroquine as anti-cancer agents.
Verbaanderd C, Maes H, Schaaf MB, Sukhatme VP, et al · · 2017 · cited 198× · PMID 29225688 · DOI 10.3332/ecancer.2017.781 -
Pathways and therapeutic targets in melanoma.
Shtivelman E, Davies MQ, Hwu P, Yang J, et al · · 2014 · cited 163× · PMID 24743024 · DOI 10.18632/oncotarget.1892 -
Chloroquine and hydroxychloroquine for cancer therapy.
Manic G, Obrist F, Kroemer G, Vitale I, et al · · 2014 · cited 150× · PMID 27308318 · DOI 10.4161/mco.29911 -
Tumor suppression and promotion by autophagy.
Ávalos Y, Canales J, Bravo-Sagua R, Criollo A, et al · · 2014 · cited 141× · PMID 25328887 · DOI 10.1155/2014/603980 -
Overcoming resistance to BRAF inhibition in BRAF-mutated metastatic melanoma.
Spagnolo F, Ghiorzo P, Queirolo P. · · 2014 · cited 92× · PMID 25344914 · DOI 10.18632/oncotarget.2602
Verify or expand the search:
- PubMed search for NCT01897116
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
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Trials testing the same drug.
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- NCT04358068 — Evaluating the Efficacy of Hydroxychloroquine and Azithromycin to Prevent Hospitalization or Death in Persons With COVID · Phase 2 · terminated
- NCT04349228 — Assessment of the Efficacy and Safety of (HCQ) as a Prophylaxis for COVID19 for Health Professionals · Phase 3 · withdrawn
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Other recruiting trials for Melanoma
Currently open trials in the same condition.
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Other Abramson Cancer Center at Penn Medicine trials
Trials by the same sponsor.
- NCT07478848 — Radiation, Oral Vancomycin, and CAR-T for B-Cell Lymphomas · Phase 1 · not yet recruiting
- NCT07059611 — Neoadjuvant Intra-tumoral RP2 and FLOT in Gastroesophageal Adenocarcinoma · Phase 2 · not yet recruiting
- NCT07454499 — Engaging M-health for Symptom Monitoring and Health Promotion for Women on Endocrine Therapy for Breast Cancer (EmSHAPE) · NA · not yet recruiting
- NCT07222241 — Comparing Numbing Techniques in Mohs Micrographic Surgery · NA · recruiting
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Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT01897116 (US National Library of Medicine, public domain)
- Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Abramson Cancer Center at Penn Medicine
- Last refreshed: 28 May 2020
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT01897116.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing